Onconova Implementation Guide
0.2.0 - ci-build

Onconova Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: OnconovaGenomicVariant - Detailed Descriptions

Active as of 2026-03-18

Definitions for the onconova-genomic-variant resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Observation
Definition

Measurements and simple assertions made about a patient, device or other subject.

ShortVariantMeasurements and simple assertions
Comments

Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
o-var-req-1: The subject element is required and must be provided. (subject.exists())
o-var-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
o-var-req-3: The genes extension is required and must be provided. (component.where(code.coding.code = '48018-6').exists())
o-var-req-4: At least one HGVS representation (coding, protein, or genomic) must be provided. (component.where(code.coding.code = '48004-6').exists() or component.where(code.coding.code = '81290-9').exists() or component.where(code.coding.code = '48005-3').exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.extension:secondary-finding
Slice Namesecondary-finding
Definition

Secondary findings are genetic test results that provide information about variants in a gene unrelated to the primary purpose for the testing, most often discovered when Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS) is performed. This extension should be used to denote when a genetic finding is being shared as a secondary finding, and ideally refer to a corresponding guideline or policy statement.

For more detail, please see: https://ghr.nlm.nih.gov/primer/testing/secondaryfindings.

ShortSecondary findings are genetic test results that provide information about variants in a gene unrelated to the primary purpose for the testing, most often discovered when [Whole Exome Sequencing (WES)](https://en.wikipedia.org/wiki/Exome_sequencing) or [Whole Genome Sequencing (WGS)](https://en.wikipedia.org/wiki/Whole_genome_sequencing) is performed. This extension should be used to denote when a genetic finding is being shared as a secondary finding, and ideally refer to a corresponding guideline or policy statement. For more detail, please see: https://ghr.nlm.nih.gov/primer/testing/secondaryfindings
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(Observation Secondary Finding) (Extension Type: CodeableConcept)
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Observation.extension:body-structure
Slice Namebody-structure
Definition

Record details about the anatomical location of a specimen or body part. This resource may be used when a coded concept does not provide the necessary detail needed for the use case.

ShortTarget anatomic location or structure
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(BodyStructure Reference) (Extension Type: Reference(BodyStructure))
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Observation.extension:genomic-variant-assessment-date
Slice Namegenomic-variant-assessment-date
Definition

Date at which the genomic variant was assessed and/or reported.

ShortGenomic Variant Assessment Date
Control0..1
TypeExtension(Genomic Variant Assessment Date) (Extension Type: dateTime)
Is Modifierfalse
Must Supporttrue
Obligations
    ObligationsActor
    SHALL:populateCreator (Onconova)
    SHOULD:persistConsumer (Onconova)
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    10. Observation.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Summaryfalse
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    12. Observation.status
    Definition

    Not used in this profile


    The status of the result value.

    ShortNot used in this profileregistered | preliminary | final | amended +
    Comments

    This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

    Control1..1
    BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
    (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

    Codes providing the status of an observation.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Need to track the status of individual results. Some results are finalized before the whole report is finalized.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Observation.category
    Definition

    A code that classifies the general type of observation being made.

    ShortClassification of type of observation
    Comments

    In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

    Control10..*
    BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
    (preferred to http://hl7.org/fhir/ValueSet/observation-category)

    Codes for high level observation categories.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

    Used for filtering what observations are retrieved and displayed.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ coding
    • 16. Observation.category:labCategory
      Slice NamelabCategory
      Definition

      A code that classifies the general type of observation being made.

      ShortClassification of type of observation
      Comments

      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

      Control10..1*
      BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
      (preferred to http://hl7.org/fhir/ValueSet/observation-category)

      Codes for high level observation categories.

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Requirements

      Used for filtering what observations are retrieved and displayed.

      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
          "code" : "laboratory"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. Observation.category:labCategory.coding
      Definition

      A reference to a code defined by a terminology system.

      ShortCode defined by a terminology system
      Comments

      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control10..1*
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

      Pattern Value{
        "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
        "code" : "laboratory"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Observation.code
      Definition

      Describes what was observed. Sometimes this is called the observation "name".

      Short69548-6Type of observation (code / type)
      Comments

      All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

      Control1..1
      BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
      (example to http://hl7.org/fhir/ValueSet/observation-codes)

      Codes identifying names of simple observations.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Knowing what kind of observation is being made is essential to understanding the observation.

      Alternate NamesName
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "69548-6"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Observation.subject
      Definition

      The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

      ShortWho and/or what the observation is about
      Comments

      One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

      Control10..1
      TypeReference(Cancer Patient Profile, Patient, Group, Device, Location)
      Is Modifierfalse
      Must Supporttrue
      Obligations
        ObligationsActor
        SHALL:populateCreator (Onconova)
        SHOULD:persistConsumer (Onconova)
        Summarytrue
        Requirements

        Observations have no value if you don't know who or what they're about.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. Observation.focus
        Definition

        Not used in this profile


        The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

        ShortNot used in this profileWhat the observation is about, when it is not about the subject of record
        Comments

        Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

        Control0..*
        TypeReference(Resource, Resource)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. Observation.encounter
        Definition

        Not used in this profile


        The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

        ShortNot used in this profileHealthcare event during which this observation is made
        Comments

        This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

        Control0..1
        TypeReference(Encounter, Encounter)
        Is Modifierfalse
        Summarytrue
        Requirements

        For some observations it may be important to know the link between an observation and a particular encounter.

        Alternate NamesContext
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. Observation.effective[x]
        Definition

        The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

        ShortClinically-relevant date of the genomic variant (e.g. the specimen collection date)Clinically relevant time/time-period for observation
        Comments

        At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

        Control10..1
        TypedateTime, Period, Timing, instant
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Knowing when an observation was deemed true is important to its relevance as well as determining trends.

        Alternate NamesOccurrence
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • type @ $this
        • 30. Observation.effective[x]:effectiveDateTime
          Slice NameeffectiveDateTime
          Definition

          The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

          ShortClinically relevant time/time-period for observation
          Comments

          At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

          Control0..1
          TypedateTime, Period, Timing, instant
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Obligations
            ObligationsActor
            SHALL:populateCreator (Onconova)
            SHOULD:persistConsumer (Onconova)
            Summarytrue
            Requirements

            Knowing when an observation was deemed true is important to its relevance as well as determining trends.

            Alternate NamesOccurrence
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. Observation.issued
            Definition

            Not used in this profile


            The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

            ShortNot used in this profileDate/Time this version was made available
            Comments

            For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

            Control0..1
            Typeinstant
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            34. Observation.performer
            Definition

            Not used in this profile


            Who was responsible for asserting the observed value as "true".

            ShortNot used in this profileWho is responsible for the observation
            Control0..*
            TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson, Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
            Is Modifierfalse
            Summarytrue
            Requirements

            May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            36. Observation.value[x]
            Definition

            The information determined as a result of making the observation, if the information has a simple value.

            ShortActual result
            Comments

            An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

            Control0..1
            This element is affected by the following invariants: obs-7
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • type @ $this
            • 38. Observation.value[x]:valueCodeableConcept
              Slice NamevalueCodeableConcept
              Definition

              The presence or absence of the variant described in the components. If not searching for specific variations and merely reporting what's found, the profile's value should be set to 'Present'.


              The information determined as a result of making the observation, if the information has a simple value.

              ShortIndeterminate | No call | Present | Absent.Actual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              BindingThe codes SHALL be taken from For codes, see LOINC Answer List LL1971-2
              (required to http://loinc.org/vs/LL1971-2)
              TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              40. Observation.dataAbsentReason
              Definition

              Provides a reason why the expected value in the element Observation.value[x] is missing.

              ShortWhy the result is missing
              Comments

              Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

              Control0..1
              This element is affected by the following invariants: obs-6
              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

              Codes specifying why the result (Observation.value[x]) is missing.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Requirements

              For many results it is necessary to handle exceptional values in measurements.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. Observation.interpretation
              Definition

              Not used in this profile


              A categorical assessment of an observation value. For example, high, low, normal.

              ShortNot used in this profileHigh, low, normal, etc.
              Comments

              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

              Control0..*
              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

              Codes identifying interpretations of observations.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

              Alternate NamesAbnormal Flag
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              44. Observation.bodySite
              Definition

              Not used in this profile


              Indicates the site on the subject's body where the observation was made (i.e. the target site).

              ShortNot used in this profileObserved body part
              Comments

              Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

              If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

              Control0..1
              BindingFor example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site|4.0.1
              (example to http://hl7.org/fhir/ValueSet/body-site)

              Codes describing anatomical locations. May include laterality.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              46. Observation.method
              Definition

              Indicates the mechanism used to perform the observation.

              ShortSequencing | SNP array | PCR | Computational analysis | ...How it was done
              Comments

              Only used if not implicit in code for Observation.code.

              Control0..1
              BindingUnless not suitable, these codes SHALL be taken from For example codes, see LOINC Answer List LL4048-6http://hl7.org/fhir/ValueSet/observation-methods|4.0.1
              (extensible to http://loinc.org/vs/LL4048-6)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Requirements

              In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              48. Observation.specimen
              Definition

              Not used in this profile


              The specimen that was used when this observation was made.

              ShortNot used in this profileSpecimen used for this observation
              Comments

              Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

              Control0..1
              TypeReference(Human Specimen Profile, Specimen)
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              50. Observation.device
              Definition

              Not used in this profile


              The device used to generate the observation data.

              ShortNot used in this profile(Measurement) Device
              Comments

              Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

              Control0..1
              TypeReference(Device, DeviceMetric, Device, DeviceMetric)
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              52. Observation.component
              Definition

              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

              ShortComponent results
              Comments

              For a discussion on the ways Observations can be assembled in groups together see Notes below.

              Control30..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Requirements

              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • pattern @ code
              • 54. Observation.component.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                56. Observation.component.code
                Definition

                Describes what was observed. Sometimes this is called the observation "code".

                ShortType of component observation (code / type)
                Comments

                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                Control1..1
                BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                Codes identifying names of simple observations.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Requirements

                Knowing what kind of observation is being made is essential to understanding the observation.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                58. Observation.component:conclusion-string
                Slice Nameconclusion-string
                Definition

                Not used in this profile


                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                ShortNot used in this profileComponent results
                Comments

                An example would be the interpretative information, typically canned, about a variant identified in the patient.


                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                Control0..1*
                TypeBackboneElement
                Is Modifierfalse
                Summarytrue
                Requirements

                Need to be able to provide a conclusion that is not lost among the basic result data.


                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                60. Observation.component:conclusion-string.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                62. Observation.component:conclusion-string.code
                Definition

                Describes what was observed. Sometimes this is called the observation "code".

                Shortconclusion-stringType of component observation (code / type)
                Comments

                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                Control1..1
                BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                Codes identifying names of simple observations.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Requirements

                Knowing what kind of observation is being made is essential to understanding the observation.

                Pattern Value{
                  "coding" : [{
                    "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                    "code" : "conclusion-string"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                64. Observation.component:gene-studied
                Slice Namegene-studied
                Definition

                The gene(s) on which the variant is located.


                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                ShortGene StudiedComponent results
                Comments

                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                66. Observation.component:gene-studied.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                68. Observation.component:gene-studied.code
                Definition

                Describes what was observed. Sometimes this is called the observation "code".

                Short48018-6Type of component observation (code / type)
                Comments

                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                Control1..1
                BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                Codes identifying names of simple observations.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                Knowing what kind of observation is being made is essential to understanding the observation.

                Pattern Value{
                  "coding" : [{
                    "system" : "http://loinc.org",
                    "code" : "48018-6"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. Observation.component:gene-studied.value[x]
                Definition

                The information determined as a result of making the observation, if the information has a simple value.

                ShortThe HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.Actual component result
                Comments

                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                Control10..1
                BindingUnless not suitable, these codes SHALL be taken from For codes, see HUGO Gene Nomenclature Committee Gene Names (HGNC)
                (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc-vs)
                TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                72. Observation.component:cytogenetic-location
                Slice Namecytogenetic-location
                Definition

                The relevant chromosomal region. The combination of numbers and letters provide a genetic 'address'.


                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                ShortCytogenetic (Chromosome) LocationComponent results
                Comments

                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Obligations
                  ObligationsActor
                  MAY:ignoreCreator (Onconova)
                  MAY:persistConsumer (Onconova)
                  Summarytrue
                  Requirements

                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  74. Observation.component:cytogenetic-location.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  76. Observation.component:cytogenetic-location.code
                  Definition

                  Describes what was observed. Sometimes this is called the observation "code".

                  Short48001-2Type of component observation (code / type)
                  Comments

                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                  Control1..1
                  BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                  Codes identifying names of simple observations.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Knowing what kind of observation is being made is essential to understanding the observation.

                  Pattern Value{
                    "coding" : [{
                      "system" : "http://loinc.org",
                      "code" : "48001-2"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  78. Observation.component:cytogenetic-location.value[x]
                  Definition

                  The information determined as a result of making the observation, if the information has a simple value.

                  ShortExample: 1q21.1Actual component result
                  Comments

                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                  Control10..1
                  TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  80. Observation.component:reference-sequence-assembly
                  Slice Namereference-sequence-assembly
                  Definition

                  The reference genome/assembly used in this analysis.


                  Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                  ShortHuman Reference Sequence AssemblyComponent results
                  Comments

                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Obligations
                    ObligationsActor
                    SHOULD:populate-if-knownCreator (Onconova)
                    MAY:persistConsumer (Onconova)
                    Summarytrue
                    Requirements

                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    82. Observation.component:reference-sequence-assembly.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                    ShortExtensions that cannot be ignored even if unrecognized
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    Summarytrue
                    Requirements

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    84. Observation.component:reference-sequence-assembly.code
                    Definition

                    Describes what was observed. Sometimes this is called the observation "code".

                    Short62374-4Type of component observation (code / type)
                    Comments

                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                    Control1..1
                    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                    Codes identifying names of simple observations.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    Knowing what kind of observation is being made is essential to understanding the observation.

                    Pattern Value{
                      "coding" : [{
                        "system" : "http://loinc.org",
                        "code" : "62374-4"
                      }]
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    86. Observation.component:reference-sequence-assembly.value[x]
                    Definition

                    The information determined as a result of making the observation, if the information has a simple value.

                    ShortGRCh37 | GRCh38 | ...Actual component result
                    Comments

                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                    Control10..1
                    BindingUnless not suitable, these codes SHALL be taken from For codes, see LOINC Answer List LL1040-6
                    (extensible to http://loinc.org/vs/LL1040-6)
                    TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    88. Observation.component:coding-hgvs
                    Slice Namecoding-hgvs
                    Definition

                    Description of the coding (cDNA) sequence change using a valid HGVS-formatted string.


                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                    ShortCoding (cDNA) Change - cHGVSComponent results
                    Comments

                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                    Control0..1*
                    TypeBackboneElement
                    Is Modifierfalse
                    Obligations
                      ObligationsActor
                      SHALL:populate-if-knownCreator (Onconova)
                      SHOULD:persistConsumer (Onconova)
                      Summarytrue
                      Requirements

                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      90. Observation.component:coding-hgvs.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      92. Observation.component:coding-hgvs.code
                      Definition

                      Describes what was observed. Sometimes this is called the observation "code".

                      Short48004-6Type of component observation (code / type)
                      Comments

                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                      Control1..1
                      BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                      Codes identifying names of simple observations.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      Knowing what kind of observation is being made is essential to understanding the observation.

                      Pattern Value{
                        "coding" : [{
                          "system" : "http://loinc.org",
                          "code" : "48004-6"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      94. Observation.component:coding-hgvs.value[x]
                      Definition

                      The information determined as a result of making the observation, if the information has a simple value.

                      ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'c.' string, e.g. NM_005228.5:c.2369C>TActual component result
                      Comments

                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                      Control10..1
                      BindingThe codes SHALL be taken from For codes, see Human Genome Variation Society (HGVS) Nomenclature
                      (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs)
                      TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      96. Observation.component:genomic-hgvs
                      Slice Namegenomic-hgvs
                      Definition

                      Description of the genomic (gDNA) sequence change using a valid HGVS-formatted string.


                      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                      ShortGenomic (gDNA) Change - gHGVSComponent results
                      Comments

                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                      Control0..1*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supporttrue
                      Obligations
                        ObligationsActor
                        SHALL:populate-if-knownCreator (Onconova)
                        SHOULD:persistConsumer (Onconova)
                        Summarytrue
                        Requirements

                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        98. Observation.component:genomic-hgvs.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        100. Observation.component:genomic-hgvs.code
                        Definition

                        Describes what was observed. Sometimes this is called the observation "code".

                        Short81290-9Type of component observation (code / type)
                        Comments

                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                        Control1..1
                        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                        Codes identifying names of simple observations.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        Knowing what kind of observation is being made is essential to understanding the observation.

                        Pattern Value{
                          "coding" : [{
                            "system" : "http://loinc.org",
                            "code" : "81290-9"
                          }]
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        102. Observation.component:genomic-hgvs.value[x]
                        Definition

                        The information determined as a result of making the observation, if the information has a simple value.

                        ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'g.' string, e.g. NC_000016.9:g.2124200_2138612dupActual component result
                        Comments

                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                        Control10..1
                        BindingThe codes SHALL be taken from For codes, see Human Genome Variation Society (HGVS) Nomenclature
                        (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs)
                        TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        104. Observation.component:cytogenomic-nomenclature
                        Slice Namecytogenomic-nomenclature
                        Definition

                        Fully describes a variant with a single code. Typically a large variant such as a mosaic, abnormal chromosome numbers, etc.


                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                        ShortCytogenomic Nomenclature (ISCN)Component results
                        Comments

                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                        Control0..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        106. Observation.component:cytogenomic-nomenclature.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        108. Observation.component:cytogenomic-nomenclature.code
                        Definition

                        Describes what was observed. Sometimes this is called the observation "code".

                        Short81291-7Type of component observation (code / type)
                        Comments

                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                        Control1..1
                        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                        Codes identifying names of simple observations.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        Knowing what kind of observation is being made is essential to understanding the observation.

                        Pattern Value{
                          "coding" : [{
                            "system" : "http://loinc.org",
                            "code" : "81291-7"
                          }]
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        110. Observation.component:cytogenomic-nomenclature.value[x]
                        Definition

                        The information determined as a result of making the observation, if the information has a simple value.

                        ShortActual component result
                        Comments

                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                        Control10..1
                        Binding

                        Binding not yet defined

                        TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        112. Observation.component:genomic-ref-seq
                        Slice Namegenomic-ref-seq
                        Definition

                        ID of the genomic reference sequence, which includes transcribed and non transcribed stretches


                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                        ShortGenomic Reference SequenceComponent results
                        Comments

                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                        Control0..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Obligations
                          ObligationsActor
                          MAY:ignoreCreator (Onconova)
                          MAY:persistConsumer (Onconova)
                          Summarytrue
                          Requirements

                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          114. Observation.component:genomic-ref-seq.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          116. Observation.component:genomic-ref-seq.code
                          Definition

                          Describes what was observed. Sometimes this is called the observation "code".

                          Short48013-7Type of component observation (code / type)
                          Comments

                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                          Control1..1
                          BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                          Codes identifying names of simple observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          Knowing what kind of observation is being made is essential to understanding the observation.

                          Pattern Value{
                            "coding" : [{
                              "system" : "http://loinc.org",
                              "code" : "48013-7"
                            }]
                          }
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          118. Observation.component:genomic-ref-seq.value[x]
                          Definition

                          The information determined as a result of making the observation, if the information has a simple value.

                          ShortVersioned genomic reference sequence identifierActual component result
                          Comments

                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                          Control10..1
                          Binding

                          Multiple bindings acceptable (NCBI or LRG)

                          TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          120. Observation.component:transcript-ref-seq
                          Slice Nametranscript-ref-seq
                          Definition

                          NCBI's RefSeq ('NM_...'), Ensembl ('ENST...'), and LRG ('LRG...' plus 't1' to indicate transcript)


                          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                          ShortReference TranscriptComponent results
                          Comments

                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                          Control0..1*
                          TypeBackboneElement
                          Is Modifierfalse
                          Obligations
                            ObligationsActor
                            MAY:ignoreCreator (Onconova)
                            MAY:persistConsumer (Onconova)
                            Summarytrue
                            Requirements

                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            122. Observation.component:transcript-ref-seq.modifierExtension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                            Summarytrue
                            Requirements

                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                            Alternate Namesextensions, user content, modifiers
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            124. Observation.component:transcript-ref-seq.code
                            Definition

                            Describes what was observed. Sometimes this is called the observation "code".

                            Short51958-7Type of component observation (code / type)
                            Comments

                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                            Control1..1
                            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                            Codes identifying names of simple observations.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Summarytrue
                            Requirements

                            Knowing what kind of observation is being made is essential to understanding the observation.

                            Pattern Value{
                              "coding" : [{
                                "system" : "http://loinc.org",
                                "code" : "51958-7"
                              }]
                            }
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            126. Observation.component:transcript-ref-seq.value[x]
                            Definition

                            The information determined as a result of making the observation, if the information has a simple value.

                            ShortVersioned transcript reference sequence identifierActual component result
                            Comments

                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                            Control10..1
                            Binding

                            Multiple bindings acceptable (NCBI or LRG)

                            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Is Modifierfalse
                            Summarytrue
                            Requirements

                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            128. Observation.component:exact-start-end
                            Slice Nameexact-start-end
                            Definition

                            The exact integer-based genomic coordinates of the start and end of the variant region.


                            Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                            ShortExact Start-EndComponent results
                            Comments

                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                            Control0..1*
                            TypeBackboneElement
                            Is Modifierfalse
                            Obligations
                              ObligationsActor
                              MAY:ignoreCreator (Onconova)
                              MAY:persistConsumer (Onconova)
                              Summarytrue
                              Requirements

                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              130. Observation.component:exact-start-end.modifierExtension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                              Summarytrue
                              Requirements

                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              132. Observation.component:exact-start-end.code
                              Definition

                              Describes what was observed. Sometimes this is called the observation "code".

                              Short81254-5Type of component observation (code / type)
                              Comments

                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                              Control1..1
                              BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                              Codes identifying names of simple observations.

                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Requirements

                              Knowing what kind of observation is being made is essential to understanding the observation.

                              Pattern Value{
                                "coding" : [{
                                  "system" : "http://loinc.org",
                                  "code" : "81254-5"
                                }]
                              }
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              134. Observation.component:inner-start-end
                              Slice Nameinner-start-end
                              Definition

                              The genomic coordinates of the narrowest genomic range in which the variant might reside. Used when the exact boundaries of the variant are not clear.


                              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                              ShortInner Start-EndComponent results
                              Comments

                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                              Control0..1*
                              TypeBackboneElement
                              Is Modifierfalse
                              Obligations
                                ObligationsActor
                                MAY:ignoreCreator (Onconova)
                                MAY:persistConsumer (Onconova)
                                Summarytrue
                                Requirements

                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                136. Observation.component:inner-start-end.modifierExtension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                Summarytrue
                                Requirements

                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                Alternate Namesextensions, user content, modifiers
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                138. Observation.component:inner-start-end.code
                                Definition

                                Describes what was observed. Sometimes this is called the observation "code".

                                Short81302-2Type of component observation (code / type)
                                Comments

                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                Control1..1
                                BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                Codes identifying names of simple observations.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Summarytrue
                                Requirements

                                Knowing what kind of observation is being made is essential to understanding the observation.

                                Pattern Value{
                                  "coding" : [{
                                    "system" : "http://loinc.org",
                                    "code" : "81302-2"
                                  }]
                                }
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                140. Observation.component:outer-start-end
                                Slice Nameouter-start-end
                                Definition

                                The genomic coordinates of the widest genomic range in which the variant might reside. Used when the exact boundaries of the variant are not clear.


                                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                ShortOuter Start-EndComponent results
                                Comments

                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                Control0..1*
                                TypeBackboneElement
                                Is Modifierfalse
                                Obligations
                                  ObligationsActor
                                  MAY:ignoreCreator (Onconova)
                                  MAY:persistConsumer (Onconova)
                                  Summarytrue
                                  Requirements

                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  142. Observation.component:outer-start-end.modifierExtension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                  ShortExtensions that cannot be ignored even if unrecognized
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                  Summarytrue
                                  Requirements

                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                  Alternate Namesextensions, user content, modifiers
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  144. Observation.component:outer-start-end.code
                                  Definition

                                  Describes what was observed. Sometimes this is called the observation "code".

                                  Short81301-4Type of component observation (code / type)
                                  Comments

                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                  Control1..1
                                  BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                  Codes identifying names of simple observations.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                  Pattern Value{
                                    "coding" : [{
                                      "system" : "http://loinc.org",
                                      "code" : "81301-4"
                                    }]
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  146. Observation.component:coordinate-system
                                  Slice Namecoordinate-system
                                  Definition

                                  These are different ways of identifying nucleotides or amino acids within a sequence. In the 1-based system, the first unit of the polymer (e.g. the first nucleotide) is counted as number 1. In the 0-based system, the number 0 designates the location before the first nucleotide. Different databases and file types may use different systems.


                                  Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                  ShortCoordinate SystemComponent results
                                  Comments

                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                  Control0..1*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Obligations
                                    ObligationsActor
                                    SHOULD:populate-if-knownCreator (Onconova)
                                    MAY:persistConsumer (Onconova)
                                    Summarytrue
                                    Requirements

                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    148. Observation.component:coordinate-system.modifierExtension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                    ShortExtensions that cannot be ignored even if unrecognized
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                    Summarytrue
                                    Requirements

                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                    Alternate Namesextensions, user content, modifiers
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    150. Observation.component:coordinate-system.code
                                    Definition

                                    Describes what was observed. Sometimes this is called the observation "code".

                                    Short92822-6Type of component observation (code / type)
                                    Comments

                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                    Control1..1
                                    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                    Codes identifying names of simple observations.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                    Pattern Value{
                                      "coding" : [{
                                        "system" : "http://loinc.org",
                                        "code" : "92822-6"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    152. Observation.component:coordinate-system.value[x]
                                    Definition

                                    The information determined as a result of making the observation, if the information has a simple value.

                                    Short0-based interval counting | 0-based character counting | 1-based character countingActual component result
                                    Comments

                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                    Control10..1
                                    BindingUnless not suitable, these codes SHALL be taken from For codes, see LOINC Answer List LL5323-2
                                    (extensible to http://loinc.org/vs/LL5323-2)
                                    TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    154. Observation.component:ref-allele
                                    Slice Nameref-allele
                                    Definition

                                    Not used in this profile


                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                    ShortNot used in this profileComponent results
                                    Comments

                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                    Control0..1*
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    156. Observation.component:ref-allele.modifierExtension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                    ShortExtensions that cannot be ignored even if unrecognized
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                    Summarytrue
                                    Requirements

                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                    Alternate Namesextensions, user content, modifiers
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    158. Observation.component:ref-allele.code
                                    Definition

                                    Describes what was observed. Sometimes this is called the observation "code".

                                    Short69547-8Type of component observation (code / type)
                                    Comments

                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                    Control1..1
                                    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                    Codes identifying names of simple observations.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                    Pattern Value{
                                      "coding" : [{
                                        "system" : "http://loinc.org",
                                        "code" : "69547-8"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    160. Observation.component:alt-allele
                                    Slice Namealt-allele
                                    Definition

                                    Not used in this profile


                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                    ShortNot used in this profileComponent results
                                    Comments

                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                    Control0..1*
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    162. Observation.component:alt-allele.modifierExtension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                    ShortExtensions that cannot be ignored even if unrecognized
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                    Summarytrue
                                    Requirements

                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                    Alternate Namesextensions, user content, modifiers
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    164. Observation.component:alt-allele.code
                                    Definition

                                    Describes what was observed. Sometimes this is called the observation "code".

                                    Short69551-0Type of component observation (code / type)
                                    Comments

                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                    Control1..1
                                    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                    Codes identifying names of simple observations.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                    Pattern Value{
                                      "coding" : [{
                                        "system" : "http://loinc.org",
                                        "code" : "69551-0"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    166. Observation.component:coding-change-type
                                    Slice Namecoding-change-type
                                    Definition

                                    Type of DNA change observed. Convenience property for variants with exact breakpoints, required otherwise.


                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                    ShortCoding DNA Change TypeComponent results
                                    Comments

                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                    Control0..1*
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Obligations
                                      ObligationsActor
                                      MAY:ignoreCreator (Onconova)
                                      MAY:persistConsumer (Onconova)
                                      Summarytrue
                                      Requirements

                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      168. Observation.component:coding-change-type.modifierExtension
                                      Definition

                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                      ShortExtensions that cannot be ignored even if unrecognized
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                      Summarytrue
                                      Requirements

                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                      Alternate Namesextensions, user content, modifiers
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      170. Observation.component:coding-change-type.code
                                      Definition

                                      Describes what was observed. Sometimes this is called the observation "code".

                                      Short48019-4Type of component observation (code / type)
                                      Comments

                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                      Control1..1
                                      BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                      Codes identifying names of simple observations.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                      Pattern Value{
                                        "coding" : [{
                                          "system" : "http://loinc.org",
                                          "code" : "48019-4"
                                        }]
                                      }
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      172. Observation.component:coding-change-type.value[x]
                                      Definition

                                      The information determined as a result of making the observation, if the information has a simple value.

                                      Shortdeletion | insertion | delins | SNV | copy_number_gain | copy_number_loss | ... (many)Actual component result
                                      Comments

                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                      Control10..1
                                      BindingThe codes SHALL be taken from For codes, see Coding DNA Change Types Value Set
                                      (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-dna-change-types)
                                      TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      174. Observation.component:genomic-source-class
                                      Slice Namegenomic-source-class
                                      Definition

                                      The genomic class of the specimen being analyzed: Germline for inherited genome, somatic for cancer genome, and prenatal for fetal genome.


                                      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                      ShortGenomic Source ClassComponent results
                                      Comments

                                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                      Control0..1*
                                      TypeBackboneElement
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Obligations
                                        ObligationsActor
                                        SHOULD:populate-if-knownCreator (Onconova)
                                        MAY:persistConsumer (Onconova)
                                        Summarytrue
                                        Requirements

                                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        176. Observation.component:genomic-source-class.modifierExtension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                        ShortExtensions that cannot be ignored even if unrecognized
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                        Summarytrue
                                        Requirements

                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                        Alternate Namesextensions, user content, modifiers
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        178. Observation.component:genomic-source-class.code
                                        Definition

                                        Describes what was observed. Sometimes this is called the observation "code".

                                        Short48002-0Type of component observation (code / type)
                                        Comments

                                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                        Control1..1
                                        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                        Codes identifying names of simple observations.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        Knowing what kind of observation is being made is essential to understanding the observation.

                                        Pattern Value{
                                          "coding" : [{
                                            "system" : "http://loinc.org",
                                            "code" : "48002-0"
                                          }]
                                        }
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        180. Observation.component:genomic-source-class.value[x]
                                        Definition

                                        The information determined as a result of making the observation, if the information has a simple value.

                                        ShortGermline | Somatic | Fetal | Likely germline | Likely somatic | Likely fetal | Unknown genomic origin | De novoActual component result
                                        Comments

                                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                        Control10..1
                                        BindingUnless not suitable, these codes SHALL be taken from For codes, see LOINC Answer List LL378-1
                                        (extensible to http://loinc.org/vs/LL378-1)
                                        TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        182. Observation.component:sample-allelic-frequency
                                        Slice Namesample-allelic-frequency
                                        Definition

                                        The relative frequency of the allele at a given locus in the sample.


                                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                        ShortSample Allelic FrequencyComponent results
                                        Comments

                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                        Control0..1*
                                        TypeBackboneElement
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Obligations
                                          ObligationsActor
                                          SHOULD:populate-if-knownCreator (Onconova)
                                          MAY:persistConsumer (Onconova)
                                          Summarytrue
                                          Requirements

                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          184. Observation.component:sample-allelic-frequency.modifierExtension
                                          Definition

                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                          Summarytrue
                                          Requirements

                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                          Alternate Namesextensions, user content, modifiers
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          186. Observation.component:sample-allelic-frequency.code
                                          Definition

                                          Describes what was observed. Sometimes this is called the observation "code".

                                          Short81258-6Type of component observation (code / type)
                                          Comments

                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                          Control1..1
                                          BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                          Codes identifying names of simple observations.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          Knowing what kind of observation is being made is essential to understanding the observation.

                                          Pattern Value{
                                            "coding" : [{
                                              "system" : "http://loinc.org",
                                              "code" : "81258-6"
                                            }]
                                          }
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          188. Observation.component:sample-allelic-frequency.value[x]
                                          Definition

                                          The information determined as a result of making the observation, if the information has a simple value.

                                          ShortRelative frequency in the sampleActual component result
                                          Comments

                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                          Control0..1
                                          TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          190. Observation.component:sample-allelic-frequency.value[x].comparator
                                          Definition

                                          How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                          Short< | <= | >= | > - how to understand the value
                                          Control0..1
                                          BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
                                          (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                          How the Quantity should be understood and represented.

                                          Typecode
                                          Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                          Meaning if MissingIf there is no comparator, then there is no modification of the value
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          192. Observation.component:sample-allelic-frequency.value[x].system
                                          Definition

                                          The identification of the system that provides the coded form of the unit.

                                          ShortSystem that defines coded unit form
                                          Control0..1
                                          This element is affected by the following invariants: qty-3
                                          Typeuri
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need to know the system that defines the coded form of the unit.

                                          Pattern Valuehttp://unitsofmeasure.org
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          194. Observation.component:allelic-read-depth
                                          Slice Nameallelic-read-depth
                                          Definition

                                          Specifies the number of reads that identified the allele in question whether it consists of one or a small sequence of contiguous nucleotides. Different methods and purposes require different numbers of reads to be acceptable. Often >400, sometimes as few as 2-4.


                                          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                          ShortAllelic Read DepthComponent results
                                          Comments

                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                          Control0..1*
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Obligations
                                            ObligationsActor
                                            SHOULD:populate-if-knownCreator (Onconova)
                                            MAY:persistConsumer (Onconova)
                                            Summarytrue
                                            Requirements

                                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            196. Observation.component:allelic-read-depth.modifierExtension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                            ShortExtensions that cannot be ignored even if unrecognized
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                            Summarytrue
                                            Requirements

                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                            Alternate Namesextensions, user content, modifiers
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            198. Observation.component:allelic-read-depth.code
                                            Definition

                                            Describes what was observed. Sometimes this is called the observation "code".

                                            Short82121-5Type of component observation (code / type)
                                            Comments

                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                            Control1..1
                                            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                            Codes identifying names of simple observations.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Summarytrue
                                            Requirements

                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                            Pattern Value{
                                              "coding" : [{
                                                "system" : "http://loinc.org",
                                                "code" : "82121-5"
                                              }]
                                            }
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            200. Observation.component:allelic-state
                                            Slice Nameallelic-state
                                            Definition

                                            The observed level of occurrence of the variant in the set of chromosomes.


                                            Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                            ShortAllelic StateComponent results
                                            Comments

                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                            Control0..1*
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Obligations
                                              ObligationsActor
                                              SHOULD:populate-if-knownCreator (Onconova)
                                              MAY:persistConsumer (Onconova)
                                              Summarytrue
                                              Requirements

                                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              202. Observation.component:allelic-state.modifierExtension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                              ShortExtensions that cannot be ignored even if unrecognized
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                              Summarytrue
                                              Requirements

                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                              Alternate Namesextensions, user content, modifiers
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              204. Observation.component:allelic-state.code
                                              Definition

                                              Describes what was observed. Sometimes this is called the observation "code".

                                              Short53034-5Type of component observation (code / type)
                                              Comments

                                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                              Control1..1
                                              BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                              Codes identifying names of simple observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summarytrue
                                              Requirements

                                              Knowing what kind of observation is being made is essential to understanding the observation.

                                              Pattern Value{
                                                "coding" : [{
                                                  "system" : "http://loinc.org",
                                                  "code" : "53034-5"
                                                }]
                                              }
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              206. Observation.component:allelic-state.value[x]
                                              Definition

                                              The information determined as a result of making the observation, if the information has a simple value.

                                              ShortHeteroplasmic | Homoplasmic | Homozygous | Heterozygous | HemizygousActual component result
                                              Comments

                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                              Control10..1
                                              BindingUnless not suitable, these codes SHALL be taken from For codes, see LOINC Answer List LL381-5
                                              (extensible to http://loinc.org/vs/LL381-5)
                                              TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summarytrue
                                              Requirements

                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              208. Observation.component:variant-inheritance
                                              Slice Namevariant-inheritance
                                              Definition

                                              By which parent the variant was inherited in the patient, if known.


                                              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                              ShortVariant InheritanceComponent results
                                              Comments

                                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                              Control0..1*
                                              TypeBackboneElement
                                              Is Modifierfalse
                                              Obligations
                                                ObligationsActor
                                                SHOULD:populate-if-knownCreator (Onconova)
                                                MAY:persistConsumer (Onconova)
                                                Summarytrue
                                                Requirements

                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                210. Observation.component:variant-inheritance.modifierExtension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                ShortExtensions that cannot be ignored even if unrecognized
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                Summarytrue
                                                Requirements

                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                Alternate Namesextensions, user content, modifiers
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                212. Observation.component:variant-inheritance.code
                                                Definition

                                                Describes what was observed. Sometimes this is called the observation "code".

                                                Shortvariant-inheritanceType of component observation (code / type)
                                                Comments

                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                Control1..1
                                                BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                Codes identifying names of simple observations.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Summarytrue
                                                Requirements

                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                Pattern Value{
                                                  "coding" : [{
                                                    "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                    "code" : "variant-inheritance"
                                                  }]
                                                }
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                214. Observation.component:variant-inheritance.value[x]
                                                Definition

                                                The information determined as a result of making the observation, if the information has a simple value.

                                                ShortMaternal | Paternal | UnknownActual component result
                                                Comments

                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                Control10..1
                                                BindingUnless not suitable, these codes SHALL be taken from For codes, see Variant Inheritances
                                                (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/variant-inheritance-vs)
                                                TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                Is Modifierfalse
                                                Summarytrue
                                                Requirements

                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                216. Observation.component:variation-code
                                                Slice Namevariation-code
                                                Definition

                                                Accession number in a variant database such as ClinVar, given for cross-reference.


                                                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                ShortVariation CodeComponent results
                                                Comments

                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                Control0..*
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Obligations
                                                  ObligationsActor
                                                  SHOULD:populate-if-knownCreator (Onconova)
                                                  MAY:persistConsumer (Onconova)
                                                  Summarytrue
                                                  Requirements

                                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  218. Observation.component:variation-code.modifierExtension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  Requirements

                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  220. Observation.component:variation-code.code
                                                  Definition

                                                  Describes what was observed. Sometimes this is called the observation "code".

                                                  Short81252-9Type of component observation (code / type)
                                                  Comments

                                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                  Control1..1
                                                  BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                  Codes identifying names of simple observations.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Requirements

                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                  Pattern Value{
                                                    "coding" : [{
                                                      "system" : "http://loinc.org",
                                                      "code" : "81252-9"
                                                    }]
                                                  }
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  222. Observation.component:variation-code.value[x]
                                                  Definition

                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                  ShortClinVar ID or similarActual component result
                                                  Comments

                                                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                  Control10..1
                                                  Binding

                                                  Multiple bindings acceptable

                                                  TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Requirements

                                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  224. Observation.component:chromosome-identifier
                                                  Slice Namechromosome-identifier
                                                  Definition

                                                  An indicator, enumerated in humans by numbers 1-22, X, and Y, representing the chromosome on which the variant is located.


                                                  Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                  ShortChromosome IdentifierComponent results
                                                  Comments

                                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                  Control0..*
                                                  TypeBackboneElement
                                                  Is Modifierfalse
                                                  Obligations
                                                    ObligationsActor
                                                    MAY:ignoreCreator (Onconova)
                                                    MAY:persistConsumer (Onconova)
                                                    Summarytrue
                                                    Requirements

                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    226. Observation.component:chromosome-identifier.modifierExtension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                    Summarytrue
                                                    Requirements

                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                    Alternate Namesextensions, user content, modifiers
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    228. Observation.component:chromosome-identifier.code
                                                    Definition

                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                    Short48000-4Type of component observation (code / type)
                                                    Comments

                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                    Control1..1
                                                    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                    Codes identifying names of simple observations.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Summarytrue
                                                    Requirements

                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                    Pattern Value{
                                                      "coding" : [{
                                                        "system" : "http://loinc.org",
                                                        "code" : "48000-4"
                                                      }]
                                                    }
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    230. Observation.component:chromosome-identifier.value[x]
                                                    Definition

                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                    ShortChromosome 1 | Chromosome 2 | ... | Chromosome 22 | Chromosome X | Chromosome YActual component result
                                                    Comments

                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                    Control10..1
                                                    BindingThe codes SHALL be taken from For codes, see LOINC Answer List LL2938-0
                                                    (required to http://loinc.org/vs/LL2938-0)
                                                    TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                    Is Modifierfalse
                                                    Summarytrue
                                                    Requirements

                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    232. Observation.component:protein-hgvs
                                                    Slice Nameprotein-hgvs
                                                    Definition

                                                    Description of the protein (amino acid) sequence change using a valid HGVS-formatted string. The description of the variant is surrounded in parentheses if it is calculated rather than directly observed.


                                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                    ShortProtein (Amino Acid) Change - pHGVSComponent results
                                                    Comments

                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                    Control0..1*
                                                    TypeBackboneElement
                                                    Is Modifierfalse
                                                    Must Supporttrue
                                                    Obligations
                                                      ObligationsActor
                                                      SHALL:populate-if-knownCreator (Onconova)
                                                      SHOULD:persistConsumer (Onconova)
                                                      Summarytrue
                                                      Requirements

                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      234. Observation.component:protein-hgvs.modifierExtension
                                                      Definition

                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                      Comments

                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                      Summarytrue
                                                      Requirements

                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                      Alternate Namesextensions, user content, modifiers
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      236. Observation.component:protein-hgvs.code
                                                      Definition

                                                      Describes what was observed. Sometimes this is called the observation "code".

                                                      Short48005-3Type of component observation (code / type)
                                                      Comments

                                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                      Control1..1
                                                      BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                      Codes identifying names of simple observations.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Summarytrue
                                                      Requirements

                                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                                      Pattern Value{
                                                        "coding" : [{
                                                          "system" : "http://loinc.org",
                                                          "code" : "48005-3"
                                                        }]
                                                      }
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      238. Observation.component:protein-hgvs.value[x]
                                                      Definition

                                                      The information determined as a result of making the observation, if the information has a simple value.

                                                      ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'p.' string, e.g. NP_000050.2:p.(Asn1836Lys)Actual component result
                                                      Comments

                                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                      Control10..1
                                                      BindingThe codes SHALL be taken from For codes, see Human Genome Variation Society (HGVS) Nomenclature
                                                      (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs)
                                                      TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Summarytrue
                                                      Requirements

                                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      240. Observation.component:amino-acid-change-type
                                                      Slice Nameamino-acid-change-type
                                                      Definition

                                                      Codified type for associated Amino Acid Marker, for convenience.


                                                      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                      ShortAmino Acid Change TypeComponent results
                                                      Comments

                                                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                      Control0..1*
                                                      TypeBackboneElement
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Obligations
                                                        ObligationsActor
                                                        MAY:ignoreCreator (Onconova)
                                                        MAY:persistConsumer (Onconova)
                                                        Summarytrue
                                                        Requirements

                                                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        242. Observation.component:amino-acid-change-type.modifierExtension
                                                        Definition

                                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                        Comments

                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                        Control0..*
                                                        TypeExtension
                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                        Summarytrue
                                                        Requirements

                                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                        Alternate Namesextensions, user content, modifiers
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                        244. Observation.component:amino-acid-change-type.code
                                                        Definition

                                                        Describes what was observed. Sometimes this is called the observation "code".

                                                        Short48006-1Type of component observation (code / type)
                                                        Comments

                                                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                        Control1..1
                                                        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                        Codes identifying names of simple observations.

                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summarytrue
                                                        Requirements

                                                        Knowing what kind of observation is being made is essential to understanding the observation.

                                                        Pattern Value{
                                                          "coding" : [{
                                                            "system" : "http://loinc.org",
                                                            "code" : "48006-1"
                                                          }]
                                                        }
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        246. Observation.component:amino-acid-change-type.value[x]
                                                        Definition

                                                        The information determined as a result of making the observation, if the information has a simple value.

                                                        ShortWild type | Deletion | Duplication | Frameshift | Initiating Methionine | Insertion | Insertion and Deletion | Missense | Nonsense | SilentActual component result
                                                        Comments

                                                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                        Control10..1
                                                        BindingThe codes SHALL be taken from For codes, see Amino Acid Change Type Value Set
                                                        (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-amino-acid-change-types)
                                                        TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summarytrue
                                                        Requirements

                                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        248. Observation.component:molecular-consequence
                                                        Slice Namemolecular-consequence
                                                        Definition

                                                        The calculated or observed effect of a variant on its downstream transcript and, if applicable, ensuing protein sequence.


                                                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                        ShortMolecular ConsequenceComponent results
                                                        Comments

                                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                        Control0..1*
                                                        TypeBackboneElement
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Obligations
                                                          ObligationsActor
                                                          MAY:ignoreCreator (Onconova)
                                                          MAY:persistConsumer (Onconova)
                                                          Summarytrue
                                                          Requirements

                                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          250. Observation.component:molecular-consequence.modifierExtension
                                                          Definition

                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                          Comments

                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                          Control0..*
                                                          TypeExtension
                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                          Summarytrue
                                                          Requirements

                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                          Alternate Namesextensions, user content, modifiers
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          252. Observation.component:molecular-consequence.code
                                                          Definition

                                                          Describes what was observed. Sometimes this is called the observation "code".

                                                          Shortmolecular-consequenceType of component observation (code / type)
                                                          Comments

                                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                          Control1..1
                                                          BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                          Codes identifying names of simple observations.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supporttrue
                                                          Summarytrue
                                                          Requirements

                                                          Knowing what kind of observation is being made is essential to understanding the observation.

                                                          Pattern Value{
                                                            "coding" : [{
                                                              "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                              "code" : "molecular-consequence"
                                                            }]
                                                          }
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          254. Observation.component:molecular-consequence.value[x]
                                                          Definition

                                                          The information determined as a result of making the observation, if the information has a simple value.

                                                          Shortstop_lost | stop_gained | inframe_insertion | frameshift_variant | ... (many)Actual component result
                                                          Comments

                                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                          Control10..1
                                                          BindingUnless not suitable, these codes SHALL be taken from For codes, see Molecular Consequence
                                                          (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/molecular-consequence-vs)

                                                          Concepts in sequence ontology under SO:0001537.

                                                          TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                          Is Modifierfalse
                                                          Must Supporttrue
                                                          Summarytrue
                                                          Requirements

                                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          256. Observation.component:copy-number
                                                          Slice Namecopy-number
                                                          Definition

                                                          The copy number of the large variant. In HGVS, this is the numeric value following the “X”. It is a unit-less value. Note that a copy number of 1 can imply a deletion.


                                                          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                          ShortGenomic Structural Variant Copy NumberComponent results
                                                          Comments

                                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                          Control0..1*
                                                          TypeBackboneElement
                                                          Is Modifierfalse
                                                          Must Supporttrue
                                                          Obligations
                                                            ObligationsActor
                                                            SHALL:populate-if-knownCreator (Onconova)
                                                            MAY:persistConsumer (Onconova)
                                                            Summarytrue
                                                            Requirements

                                                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            258. Observation.component:copy-number.modifierExtension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                            Summarytrue
                                                            Requirements

                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                            Alternate Namesextensions, user content, modifiers
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            260. Observation.component:copy-number.code
                                                            Definition

                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                            Short82155-3Type of component observation (code / type)
                                                            Comments

                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                            Control1..1
                                                            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                            Codes identifying names of simple observations.

                                                            TypeCodeableConcept
                                                            Is Modifierfalse
                                                            Must Supporttrue
                                                            Summarytrue
                                                            Requirements

                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                            Pattern Value{
                                                              "coding" : [{
                                                                "system" : "http://loinc.org",
                                                                "code" : "82155-3"
                                                              }]
                                                            }
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            262. Observation.component:copy-number.value[x]
                                                            Definition

                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                            ShortActual component result
                                                            Comments

                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                            Control0..1
                                                            TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                            Is Modifierfalse
                                                            Must Supporttrue
                                                            Summarytrue
                                                            Requirements

                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            cnt-3: There SHALL be a code with a value of '1' if there is a value. If system is present, it SHALL be UCUM. If present, the value SHALL be a whole number. ((code.exists() or value.empty()) and (system.empty() or system = %ucum) and (code.empty() or code = '1') and (value.empty() or value.hasValue().not() or value.toString().contains('.').not()))
                                                            264. Observation.component:variant-confidence-status
                                                            Slice Namevariant-confidence-status
                                                            Definition

                                                            A code that represents the confidence of a true positive variant call.


                                                            Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                            ShortVariant Confidence StatusComponent results
                                                            Comments

                                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                            Control0..1*
                                                            TypeBackboneElement
                                                            Is Modifierfalse
                                                            Obligations
                                                              ObligationsActor
                                                              SHOULD:populate-if-knownCreator (Onconova)
                                                              MAY:persistConsumer (Onconova)
                                                              Summarytrue
                                                              Requirements

                                                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              266. Observation.component:variant-confidence-status.modifierExtension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                              Summarytrue
                                                              Requirements

                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                              Alternate Namesextensions, user content, modifiers
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              268. Observation.component:variant-confidence-status.code
                                                              Definition

                                                              Describes what was observed. Sometimes this is called the observation "code".

                                                              Shortvariant-confidence-statusType of component observation (code / type)
                                                              Comments

                                                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                              Control1..1
                                                              BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                              Codes identifying names of simple observations.

                                                              TypeCodeableConcept
                                                              Is Modifierfalse
                                                              Summarytrue
                                                              Requirements

                                                              Knowing what kind of observation is being made is essential to understanding the observation.

                                                              Pattern Value{
                                                                "coding" : [{
                                                                  "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                                  "code" : "variant-confidence-status"
                                                                }]
                                                              }
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              270. Observation.component:variant-confidence-status.value[x]
                                                              Definition

                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                              ShortHigh | Intermediate | LowActual component result
                                                              Comments

                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                              Control10..1
                                                              BindingThe codes SHALL be taken from For codes, see Variant Confidence Status
                                                              (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/variant-confidence-status-vs)
                                                              TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                              Is Modifierfalse
                                                              Summarytrue
                                                              Requirements

                                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              272. Observation.component:clinical-relevance
                                                              Slice Nameclinical-relevance
                                                              Definition

                                                              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                              ShortClinical relevance of the genomic variantComponent results
                                                              Comments

                                                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                              Control10..1*
                                                              TypeBackboneElement
                                                              Is Modifierfalse
                                                              Must Supporttrue
                                                              Obligations
                                                                ObligationsActor
                                                                SHALL:populateCreator (Onconova)
                                                                SHOULD:persistConsumer (Onconova)
                                                                Summarytrue
                                                                Requirements

                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                274. Observation.component:clinical-relevance.modifierExtension
                                                                Definition

                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                Comments

                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                Control0..*
                                                                TypeExtension
                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                Summarytrue
                                                                Requirements

                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                Alternate Namesextensions, user content, modifiers
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                276. Observation.component:clinical-relevance.code
                                                                Definition

                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                ShortType of component observation (code / type)
                                                                Comments

                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                Control1..1
                                                                BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                Codes identifying names of simple observations.

                                                                TypeCodeableConcept
                                                                Is Modifierfalse
                                                                Must Supporttrue
                                                                Summarytrue
                                                                Requirements

                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                Pattern Value{
                                                                  "coding" : [{
                                                                    "system" : "http://loinc.org",
                                                                    "code" : "LL4034-6",
                                                                    "display" : "ACMG_Clinical significance of genetic variation"
                                                                  }]
                                                                }
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                278. Observation.component:clinical-relevance.value[x]
                                                                Definition

                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                ShortActual component result
                                                                Comments

                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                Control0..1
                                                                BindingThe codes SHALL be taken from For codes, see Clinical Relevance Value Set
                                                                (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-clinical-relevances)
                                                                TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                Is Modifierfalse
                                                                Must Supporttrue
                                                                Summarytrue
                                                                Requirements

                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                280. Observation.component:nucleotides-count
                                                                Slice Namenucleotides-count
                                                                Definition

                                                                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                ShortLength of of the variant in nNucleotidesComponent results
                                                                Comments

                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                Control10..1*
                                                                TypeBackboneElement
                                                                Is Modifierfalse
                                                                Must Supporttrue
                                                                Obligations
                                                                  ObligationsActor
                                                                  MAY:ignoreCreator (Onconova)
                                                                  MAY:persistConsumer (Onconova)
                                                                  Summarytrue
                                                                  Requirements

                                                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  282. Observation.component:nucleotides-count.modifierExtension
                                                                  Definition

                                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                                  Comments

                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                  Control0..*
                                                                  TypeExtension
                                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                  Summarytrue
                                                                  Requirements

                                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                  Alternate Namesextensions, user content, modifiers
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  284. Observation.component:nucleotides-count.code
                                                                  Definition

                                                                  Describes what was observed. Sometimes this is called the observation "code".

                                                                  ShortType of component observation (code / type)
                                                                  Comments

                                                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                  Control1..1
                                                                  BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                  Codes identifying names of simple observations.

                                                                  TypeCodeableConcept
                                                                  Is Modifierfalse
                                                                  Must Supporttrue
                                                                  Summarytrue
                                                                  Requirements

                                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                                  Pattern Value{
                                                                    "coding" : [{
                                                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                      "code" : "C709",
                                                                      "display" : "Nucleotides"
                                                                    }]
                                                                  }
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  286. Observation.component:nucleotides-count.value[x]
                                                                  Definition

                                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                                  ShortActual component result
                                                                  Comments

                                                                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                  Control0..1
                                                                  Typeinteger, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, time, Range, CodeableConcept
                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Must Supporttrue
                                                                  Summarytrue
                                                                  Requirements

                                                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  288. Observation.component:gene-region
                                                                  Slice Namegene-region
                                                                  Definition

                                                                  Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                  ShortRegion (exon, intron, etc.) of the gene affected by the variantComponent results
                                                                  Comments

                                                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                  Control0..*
                                                                  TypeBackboneElement
                                                                  Is Modifierfalse
                                                                  Must Supporttrue
                                                                  Obligations
                                                                    ObligationsActor
                                                                    SHALL:populateCreator (Onconova)
                                                                    SHOULD:persistConsumer (Onconova)
                                                                    MAY:ignoreCreator (Onconova)
                                                                    MAY:persistConsumer (Onconova)
                                                                    Summarytrue
                                                                    Requirements

                                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    290. Observation.component:gene-region.modifierExtension
                                                                    Definition

                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                    Comments

                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                    Control0..*
                                                                    TypeExtension
                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                    Summarytrue
                                                                    Requirements

                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                    Alternate Namesextensions, user content, modifiers
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    292. Observation.component:gene-region.code
                                                                    Definition

                                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                                    ShortType of component observation (code / type)
                                                                    Comments

                                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                    Control1..1
                                                                    BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                    Codes identifying names of simple observations.

                                                                    TypeCodeableConcept
                                                                    Is Modifierfalse
                                                                    Must Supporttrue
                                                                    Summarytrue
                                                                    Requirements

                                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                                    Pattern Value{
                                                                      "coding" : [{
                                                                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                        "code" : "C13445",
                                                                        "display" : "Gene Feature"
                                                                      }]
                                                                    }
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    294. Observation.component:gene-region.value[x]
                                                                    Definition

                                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                                    ShortActual component result
                                                                    Comments

                                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                    Control0..1
                                                                    Typestring, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                    Is Modifierfalse
                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                    Must Supporttrue
                                                                    Summarytrue
                                                                    Requirements

                                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    296. Observation.component:gene-panel-sequencing
                                                                    Slice Namegene-panel-sequencing
                                                                    Definition

                                                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                    ShortComponent results
                                                                    Comments

                                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                    Control0..1*
                                                                    TypeBackboneElement
                                                                    Is Modifierfalse
                                                                    Must Supporttrue
                                                                    Obligations
                                                                      ObligationsActor
                                                                      SHOULD:populate-if-knownCreator (Onconova)
                                                                      SHOULD:persistConsumer (Onconova)
                                                                      Summarytrue
                                                                      Requirements

                                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      298. Observation.component:gene-panel-sequencing.modifierExtension
                                                                      Definition

                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                      Comments

                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                      Control0..*
                                                                      TypeExtension
                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                      Summarytrue
                                                                      Requirements

                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                      Alternate Namesextensions, user content, modifiers
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                      300. Observation.component:gene-panel-sequencing.code
                                                                      Definition

                                                                      Describes what was observed. Sometimes this is called the observation "code".

                                                                      ShortType of component observation (code / type)
                                                                      Comments

                                                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                      Control1..1
                                                                      BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                      Codes identifying names of simple observations.

                                                                      TypeCodeableConcept
                                                                      Is Modifierfalse
                                                                      Must Supporttrue
                                                                      Summarytrue
                                                                      Requirements

                                                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                                                      Pattern Value{
                                                                        "coding" : [{
                                                                          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                          "code" : "C165600",
                                                                          "display" : "Tumor Panel Sequencing"
                                                                        }]
                                                                      }
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      302. Observation.component:gene-panel-sequencing.value[x]
                                                                      Definition

                                                                      The information determined as a result of making the observation, if the information has a simple value.

                                                                      ShortSequencing Gene PanelActual component result
                                                                      Comments

                                                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                      Control0..1
                                                                      Typestring, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                      Is Modifierfalse
                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                      Must Supporttrue
                                                                      Summarytrue
                                                                      Requirements

                                                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      304. Observation.component:hgvs-version
                                                                      Slice Namehgvs-version
                                                                      Definition

                                                                      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                      ShortHGVS VersionComponent results
                                                                      Comments

                                                                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                      Control10..1*
                                                                      TypeBackboneElement
                                                                      Is Modifierfalse
                                                                      Must Supporttrue
                                                                      Obligations
                                                                        ObligationsActor
                                                                        SHALL:populateCreator (Onconova)
                                                                        SHOULD:persistConsumer (Onconova)
                                                                        Summarytrue
                                                                        Requirements

                                                                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        306. Observation.component:hgvs-version.modifierExtension
                                                                        Definition

                                                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                                        Comments

                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                        Control0..*
                                                                        TypeExtension
                                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                        Summarytrue
                                                                        Requirements

                                                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                        Alternate Namesextensions, user content, modifiers
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                        308. Observation.component:hgvs-version.code
                                                                        Definition

                                                                        Describes what was observed. Sometimes this is called the observation "code".

                                                                        ShortType of component observation (code / type)
                                                                        Comments

                                                                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                        Control1..1
                                                                        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                        Codes identifying names of simple observations.

                                                                        TypeCodeableConcept
                                                                        Is Modifierfalse
                                                                        Must Supporttrue
                                                                        Summarytrue
                                                                        Requirements

                                                                        Knowing what kind of observation is being made is essential to understanding the observation.

                                                                        Pattern Value{
                                                                          "coding" : [{
                                                                            "system" : "http://loinc.org",
                                                                            "code" : "81303-0",
                                                                            "display" : "HGVS version [ID]"
                                                                          }]
                                                                        }
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        310. Observation.component:hgvs-version.value[x]
                                                                        Definition

                                                                        The information determined as a result of making the observation, if the information has a simple value.

                                                                        ShortActual component result
                                                                        Comments

                                                                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                        Control0..1
                                                                        Typestring, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                        Is Modifierfalse
                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                        Must Supporttrue
                                                                        Summarytrue
                                                                        Requirements

                                                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        312. Observation.component:rna-hgvs
                                                                        Slice Namerna-hgvs
                                                                        Definition

                                                                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                        ShortComponent results
                                                                        Comments

                                                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                        Control0..1*
                                                                        TypeBackboneElement
                                                                        Is Modifierfalse
                                                                        Must Supporttrue
                                                                        Obligations
                                                                          ObligationsActor
                                                                          SHOULD:populate-if-knownCreator (Onconova)
                                                                          SHOULD:persistConsumer (Onconova)
                                                                          Summarytrue
                                                                          Requirements

                                                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          314. Observation.component:rna-hgvs.modifierExtension
                                                                          Definition

                                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                                          Comments

                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                          Control0..*
                                                                          TypeExtension
                                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                          Summarytrue
                                                                          Requirements

                                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                          Alternate Namesextensions, user content, modifiers
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                          316. Observation.component:rna-hgvs.code
                                                                          Definition

                                                                          Describes what was observed. Sometimes this is called the observation "code".

                                                                          ShortType of component observation (code / type)
                                                                          Comments

                                                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                          Control1..1
                                                                          BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                                                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                          Codes identifying names of simple observations.

                                                                          TypeCodeableConcept
                                                                          Is Modifierfalse
                                                                          Must Supporttrue
                                                                          Summarytrue
                                                                          Requirements

                                                                          Knowing what kind of observation is being made is essential to understanding the observation.

                                                                          Pattern Value{
                                                                            "coding" : [{
                                                                              "system" : "http://onconova.github.io/fhir/CodeSystem/onconova-cs-tbd",
                                                                              "code" : "rna-hgvs",
                                                                              "display" : "Transcript RNA change (rHGVS)"
                                                                            }]
                                                                          }
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          318. Observation.component:rna-hgvs.value[x]
                                                                          Definition

                                                                          The information determined as a result of making the observation, if the information has a simple value.

                                                                          ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'r.' string, e.g. NM_005228.5:r.2369c>tActual component result
                                                                          Comments

                                                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                          Control0..1
                                                                          TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                          Is Modifierfalse
                                                                          Must Supporttrue
                                                                          Summarytrue
                                                                          Requirements

                                                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                                                                          Guidance on how to interpret the contents of this table can be foundhere

                                                                          0. Observation
                                                                          Invariantso-var-req-1: The subject element is required and must be provided. (subject.exists())
                                                                          o-var-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
                                                                          o-var-req-3: The genes extension is required and must be provided. (component.where(code.coding.code = '48018-6').exists())
                                                                          o-var-req-4: At least one HGVS representation (coding, protein, or genomic) must be provided. (component.where(code.coding.code = '48004-6').exists() or component.where(code.coding.code = '81290-9').exists() or component.where(code.coding.code = '48005-3').exists())
                                                                          2. Observation.extension:genomic-variant-assessment-date
                                                                          Slice Namegenomic-variant-assessment-date
                                                                          Control0..1
                                                                          TypeExtension(Genomic Variant Assessment Date) (Extension Type: dateTime)
                                                                          Must Supporttrue
                                                                          Obligations
                                                                            ObligationsActor
                                                                            SHALL:populateCreator (Onconova)
                                                                            SHOULD:persistConsumer (Onconova)
                                                                            4. Observation.status
                                                                            Definition

                                                                            Not used in this profile

                                                                            ShortNot used in this profile
                                                                            6. Observation.subject
                                                                            Control1..?
                                                                            TypeReference(Cancer Patient Profile)
                                                                            Obligations
                                                                              ObligationsActor
                                                                              SHALL:populateCreator (Onconova)
                                                                              SHOULD:persistConsumer (Onconova)
                                                                              8. Observation.focus
                                                                              Definition

                                                                              Not used in this profile

                                                                              ShortNot used in this profile
                                                                              10. Observation.encounter
                                                                              Definition

                                                                              Not used in this profile

                                                                              ShortNot used in this profile
                                                                              12. Observation.effective[x]
                                                                              ShortClinically-relevant date of the genomic variant (e.g. the specimen collection date)
                                                                              Control1..?
                                                                              TypedateTime, Period, Timing, instant
                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                              14. Observation.effective[x]:effectiveDateTime
                                                                              Slice NameeffectiveDateTime
                                                                              TypedateTime
                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                              Obligations
                                                                                ObligationsActor
                                                                                SHALL:populateCreator (Onconova)
                                                                                SHOULD:persistConsumer (Onconova)
                                                                                16. Observation.issued
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                18. Observation.performer
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                20. Observation.interpretation
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                22. Observation.bodySite
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                24. Observation.specimen
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                26. Observation.device
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                28. Observation.component
                                                                                Control3..?
                                                                                30. Observation.component:conclusion-string
                                                                                Slice Nameconclusion-string
                                                                                Definition

                                                                                Not used in this profile

                                                                                ShortNot used in this profile
                                                                                32. Observation.component:cytogenetic-location
                                                                                Slice Namecytogenetic-location
                                                                                Obligations
                                                                                  ObligationsActor
                                                                                  MAY:ignoreCreator (Onconova)
                                                                                  MAY:persistConsumer (Onconova)
                                                                                  34. Observation.component:reference-sequence-assembly
                                                                                  Slice Namereference-sequence-assembly
                                                                                  Obligations
                                                                                    ObligationsActor
                                                                                    SHOULD:populate-if-knownCreator (Onconova)
                                                                                    MAY:persistConsumer (Onconova)
                                                                                    36. Observation.component:coding-hgvs
                                                                                    Slice Namecoding-hgvs
                                                                                    Obligations
                                                                                      ObligationsActor
                                                                                      SHALL:populate-if-knownCreator (Onconova)
                                                                                      SHOULD:persistConsumer (Onconova)
                                                                                      38. Observation.component:coding-hgvs.value[x]
                                                                                      ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'c.' string, e.g. NM_005228.5:c.2369C>T
                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                      40. Observation.component:genomic-hgvs
                                                                                      Slice Namegenomic-hgvs
                                                                                      Obligations
                                                                                        ObligationsActor
                                                                                        SHALL:populate-if-knownCreator (Onconova)
                                                                                        SHOULD:persistConsumer (Onconova)
                                                                                        42. Observation.component:genomic-hgvs.value[x]
                                                                                        ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'g.' string, e.g. NC_000016.9:g.2124200_2138612dup
                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                        44. Observation.component:genomic-ref-seq
                                                                                        Slice Namegenomic-ref-seq
                                                                                        Obligations
                                                                                          ObligationsActor
                                                                                          MAY:ignoreCreator (Onconova)
                                                                                          MAY:persistConsumer (Onconova)
                                                                                          46. Observation.component:transcript-ref-seq
                                                                                          Slice Nametranscript-ref-seq
                                                                                          Obligations
                                                                                            ObligationsActor
                                                                                            MAY:ignoreCreator (Onconova)
                                                                                            MAY:persistConsumer (Onconova)
                                                                                            48. Observation.component:exact-start-end
                                                                                            Slice Nameexact-start-end
                                                                                            Obligations
                                                                                              ObligationsActor
                                                                                              MAY:ignoreCreator (Onconova)
                                                                                              MAY:persistConsumer (Onconova)
                                                                                              50. Observation.component:inner-start-end
                                                                                              Slice Nameinner-start-end
                                                                                              Obligations
                                                                                                ObligationsActor
                                                                                                MAY:ignoreCreator (Onconova)
                                                                                                MAY:persistConsumer (Onconova)
                                                                                                52. Observation.component:outer-start-end
                                                                                                Slice Nameouter-start-end
                                                                                                Obligations
                                                                                                  ObligationsActor
                                                                                                  MAY:ignoreCreator (Onconova)
                                                                                                  MAY:persistConsumer (Onconova)
                                                                                                  54. Observation.component:coordinate-system
                                                                                                  Slice Namecoordinate-system
                                                                                                  Obligations
                                                                                                    ObligationsActor
                                                                                                    SHOULD:populate-if-knownCreator (Onconova)
                                                                                                    MAY:persistConsumer (Onconova)
                                                                                                    56. Observation.component:ref-allele
                                                                                                    Slice Nameref-allele
                                                                                                    Definition

                                                                                                    Not used in this profile

                                                                                                    ShortNot used in this profile
                                                                                                    58. Observation.component:alt-allele
                                                                                                    Slice Namealt-allele
                                                                                                    Definition

                                                                                                    Not used in this profile

                                                                                                    ShortNot used in this profile
                                                                                                    60. Observation.component:coding-change-type
                                                                                                    Slice Namecoding-change-type
                                                                                                    Obligations
                                                                                                      ObligationsActor
                                                                                                      MAY:ignoreCreator (Onconova)
                                                                                                      MAY:persistConsumer (Onconova)
                                                                                                      62. Observation.component:coding-change-type.value[x]
                                                                                                      BindingThe codes SHALL be taken from Coding DNA Change Types Value Set
                                                                                                      (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-dna-change-types)
                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                      64. Observation.component:genomic-source-class
                                                                                                      Slice Namegenomic-source-class
                                                                                                      Obligations
                                                                                                        ObligationsActor
                                                                                                        SHOULD:populate-if-knownCreator (Onconova)
                                                                                                        MAY:persistConsumer (Onconova)
                                                                                                        66. Observation.component:sample-allelic-frequency
                                                                                                        Slice Namesample-allelic-frequency
                                                                                                        Obligations
                                                                                                          ObligationsActor
                                                                                                          SHOULD:populate-if-knownCreator (Onconova)
                                                                                                          MAY:persistConsumer (Onconova)
                                                                                                          68. Observation.component:allelic-read-depth
                                                                                                          Slice Nameallelic-read-depth
                                                                                                          Obligations
                                                                                                            ObligationsActor
                                                                                                            SHOULD:populate-if-knownCreator (Onconova)
                                                                                                            MAY:persistConsumer (Onconova)
                                                                                                            70. Observation.component:allelic-state
                                                                                                            Slice Nameallelic-state
                                                                                                            Obligations
                                                                                                              ObligationsActor
                                                                                                              SHOULD:populate-if-knownCreator (Onconova)
                                                                                                              MAY:persistConsumer (Onconova)
                                                                                                              72. Observation.component:variant-inheritance
                                                                                                              Slice Namevariant-inheritance
                                                                                                              Obligations
                                                                                                                ObligationsActor
                                                                                                                SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                MAY:persistConsumer (Onconova)
                                                                                                                74. Observation.component:variation-code
                                                                                                                Slice Namevariation-code
                                                                                                                Obligations
                                                                                                                  ObligationsActor
                                                                                                                  SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                  MAY:persistConsumer (Onconova)
                                                                                                                  76. Observation.component:chromosome-identifier
                                                                                                                  Slice Namechromosome-identifier
                                                                                                                  Obligations
                                                                                                                    ObligationsActor
                                                                                                                    MAY:ignoreCreator (Onconova)
                                                                                                                    MAY:persistConsumer (Onconova)
                                                                                                                    78. Observation.component:protein-hgvs
                                                                                                                    Slice Nameprotein-hgvs
                                                                                                                    Obligations
                                                                                                                      ObligationsActor
                                                                                                                      SHALL:populate-if-knownCreator (Onconova)
                                                                                                                      SHOULD:persistConsumer (Onconova)
                                                                                                                      80. Observation.component:protein-hgvs.value[x]
                                                                                                                      ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'p.' string, e.g. NP_000050.2:p.(Asn1836Lys)
                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                      82. Observation.component:amino-acid-change-type
                                                                                                                      Slice Nameamino-acid-change-type
                                                                                                                      Obligations
                                                                                                                        ObligationsActor
                                                                                                                        MAY:ignoreCreator (Onconova)
                                                                                                                        MAY:persistConsumer (Onconova)
                                                                                                                        84. Observation.component:amino-acid-change-type.value[x]
                                                                                                                        BindingThe codes SHALL be taken from Amino Acid Change Type Value Set
                                                                                                                        (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-amino-acid-change-types)
                                                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                        86. Observation.component:molecular-consequence
                                                                                                                        Slice Namemolecular-consequence
                                                                                                                        Obligations
                                                                                                                          ObligationsActor
                                                                                                                          MAY:ignoreCreator (Onconova)
                                                                                                                          MAY:persistConsumer (Onconova)
                                                                                                                          88. Observation.component:copy-number
                                                                                                                          Slice Namecopy-number
                                                                                                                          Obligations
                                                                                                                            ObligationsActor
                                                                                                                            SHALL:populate-if-knownCreator (Onconova)
                                                                                                                            MAY:persistConsumer (Onconova)
                                                                                                                            90. Observation.component:variant-confidence-status
                                                                                                                            Slice Namevariant-confidence-status
                                                                                                                            Obligations
                                                                                                                              ObligationsActor
                                                                                                                              SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                              MAY:persistConsumer (Onconova)
                                                                                                                              92. Observation.component:clinical-relevance
                                                                                                                              Slice Nameclinical-relevance
                                                                                                                              ShortClinical relevance of the genomic variant
                                                                                                                              Control1..1
                                                                                                                              Must Supporttrue
                                                                                                                              Obligations
                                                                                                                                ObligationsActor
                                                                                                                                SHALL:populateCreator (Onconova)
                                                                                                                                SHOULD:persistConsumer (Onconova)
                                                                                                                                94. Observation.component:clinical-relevance.code
                                                                                                                                Must Supporttrue
                                                                                                                                Pattern Value{
                                                                                                                                  "coding" : [{
                                                                                                                                    "system" : "http://loinc.org",
                                                                                                                                    "code" : "LL4034-6",
                                                                                                                                    "display" : "ACMG_Clinical significance of genetic variation"
                                                                                                                                  }]
                                                                                                                                }
                                                                                                                                96. Observation.component:clinical-relevance.value[x]
                                                                                                                                BindingThe codes SHALL be taken from Clinical Relevance Value Set
                                                                                                                                (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-clinical-relevances)
                                                                                                                                TypeCodeableConcept
                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                Must Supporttrue
                                                                                                                                98. Observation.component:nucleotides-count
                                                                                                                                Slice Namenucleotides-count
                                                                                                                                ShortLength of of the variant in nNucleotides
                                                                                                                                Control1..1
                                                                                                                                Must Supporttrue
                                                                                                                                Obligations
                                                                                                                                  ObligationsActor
                                                                                                                                  MAY:ignoreCreator (Onconova)
                                                                                                                                  MAY:persistConsumer (Onconova)
                                                                                                                                  100. Observation.component:nucleotides-count.code
                                                                                                                                  Must Supporttrue
                                                                                                                                  Pattern Value{
                                                                                                                                    "coding" : [{
                                                                                                                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                                                                                      "code" : "C709",
                                                                                                                                      "display" : "Nucleotides"
                                                                                                                                    }]
                                                                                                                                  }
                                                                                                                                  102. Observation.component:nucleotides-count.value[x]
                                                                                                                                  Typeinteger
                                                                                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                  Must Supporttrue
                                                                                                                                  104. Observation.component:gene-region
                                                                                                                                  Slice Namegene-region
                                                                                                                                  ShortRegion (exon, intron, etc.) of the gene affected by the variant
                                                                                                                                  Control0..*
                                                                                                                                  Must Supporttrue
                                                                                                                                  Obligations
                                                                                                                                    ObligationsActor
                                                                                                                                    SHALL:populateCreator (Onconova)
                                                                                                                                    SHOULD:persistConsumer (Onconova)
                                                                                                                                    MAY:ignoreCreator (Onconova)
                                                                                                                                    MAY:persistConsumer (Onconova)
                                                                                                                                    106. Observation.component:gene-region.code
                                                                                                                                    Must Supporttrue
                                                                                                                                    Pattern Value{
                                                                                                                                      "coding" : [{
                                                                                                                                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                                                                                        "code" : "C13445",
                                                                                                                                        "display" : "Gene Feature"
                                                                                                                                      }]
                                                                                                                                    }
                                                                                                                                    108. Observation.component:gene-region.value[x]
                                                                                                                                    Typestring
                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                    Must Supporttrue
                                                                                                                                    110. Observation.component:gene-panel-sequencing
                                                                                                                                    Slice Namegene-panel-sequencing
                                                                                                                                    Control0..1
                                                                                                                                    Must Supporttrue
                                                                                                                                    Obligations
                                                                                                                                      ObligationsActor
                                                                                                                                      SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                      SHOULD:persistConsumer (Onconova)
                                                                                                                                      112. Observation.component:gene-panel-sequencing.code
                                                                                                                                      Must Supporttrue
                                                                                                                                      Pattern Value{
                                                                                                                                        "coding" : [{
                                                                                                                                          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                                                                                          "code" : "C165600",
                                                                                                                                          "display" : "Tumor Panel Sequencing"
                                                                                                                                        }]
                                                                                                                                      }
                                                                                                                                      114. Observation.component:gene-panel-sequencing.value[x]
                                                                                                                                      ShortSequencing Gene Panel
                                                                                                                                      Typestring
                                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                      Must Supporttrue
                                                                                                                                      116. Observation.component:hgvs-version
                                                                                                                                      Slice Namehgvs-version
                                                                                                                                      ShortHGVS Version
                                                                                                                                      Control1..1
                                                                                                                                      Must Supporttrue
                                                                                                                                      Obligations
                                                                                                                                        ObligationsActor
                                                                                                                                        SHALL:populateCreator (Onconova)
                                                                                                                                        SHOULD:persistConsumer (Onconova)
                                                                                                                                        118. Observation.component:hgvs-version.code
                                                                                                                                        Must Supporttrue
                                                                                                                                        Pattern Value{
                                                                                                                                          "coding" : [{
                                                                                                                                            "system" : "http://loinc.org",
                                                                                                                                            "code" : "81303-0",
                                                                                                                                            "display" : "HGVS version [ID]"
                                                                                                                                          }]
                                                                                                                                        }
                                                                                                                                        120. Observation.component:hgvs-version.value[x]
                                                                                                                                        Typestring
                                                                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                        Must Supporttrue
                                                                                                                                        122. Observation.component:rna-hgvs
                                                                                                                                        Slice Namerna-hgvs
                                                                                                                                        Control0..1
                                                                                                                                        Must Supporttrue
                                                                                                                                        Obligations
                                                                                                                                          ObligationsActor
                                                                                                                                          SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                          SHOULD:persistConsumer (Onconova)
                                                                                                                                          124. Observation.component:rna-hgvs.code
                                                                                                                                          Must Supporttrue
                                                                                                                                          Pattern Value{
                                                                                                                                            "coding" : [{
                                                                                                                                              "system" : "http://onconova.github.io/fhir/CodeSystem/onconova-cs-tbd",
                                                                                                                                              "code" : "rna-hgvs",
                                                                                                                                              "display" : "Transcript RNA change (rHGVS)"
                                                                                                                                            }]
                                                                                                                                          }
                                                                                                                                          126. Observation.component:rna-hgvs.value[x]
                                                                                                                                          ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'r.' string, e.g. NM_005228.5:r.2369c>t
                                                                                                                                          TypeCodeableConcept
                                                                                                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                          Must Supporttrue

                                                                                                                                          Guidance on how to interpret the contents of this table can be foundhere

                                                                                                                                          0. Observation
                                                                                                                                          Definition

                                                                                                                                          Measurements and simple assertions made about a patient, device or other subject.

                                                                                                                                          ShortVariant
                                                                                                                                          Comments

                                                                                                                                          Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

                                                                                                                                          Control0..*
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Summaryfalse
                                                                                                                                          Alternate NamesVital Signs, Measurement, Results, Tests
                                                                                                                                          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                                                                                                                                          dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                                                                                                                                          dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                                                                                                                                          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                                                                                                                                          dom-6: A resource should have narrative for robust management (text.`div`.exists())
                                                                                                                                          obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
                                                                                                                                          obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
                                                                                                                                          o-var-req-1: The subject element is required and must be provided. (subject.exists())
                                                                                                                                          o-var-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
                                                                                                                                          o-var-req-3: The genes extension is required and must be provided. (component.where(code.coding.code = '48018-6').exists())
                                                                                                                                          o-var-req-4: At least one HGVS representation (coding, protein, or genomic) must be provided. (component.where(code.coding.code = '48004-6').exists() or component.where(code.coding.code = '81290-9').exists() or component.where(code.coding.code = '48005-3').exists())
                                                                                                                                          2. Observation.id
                                                                                                                                          Definition

                                                                                                                                          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                                                                                                                                          ShortLogical id of this artifact
                                                                                                                                          Comments

                                                                                                                                          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                                                                                                                                          Control0..1
                                                                                                                                          Typeid
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Summarytrue
                                                                                                                                          4. Observation.meta
                                                                                                                                          Definition

                                                                                                                                          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                                                                                                                                          ShortMetadata about the resource
                                                                                                                                          Control0..1
                                                                                                                                          TypeMeta
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Summarytrue
                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                          6. Observation.implicitRules
                                                                                                                                          Definition

                                                                                                                                          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                                                                                                                                          ShortA set of rules under which this content was created
                                                                                                                                          Comments

                                                                                                                                          Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

                                                                                                                                          Control0..1
                                                                                                                                          Typeuri
                                                                                                                                          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                                                                                                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                          Summarytrue
                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                          8. Observation.language
                                                                                                                                          Definition

                                                                                                                                          The base language in which the resource is written.

                                                                                                                                          ShortLanguage of the resource content
                                                                                                                                          Comments

                                                                                                                                          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                                                                                                                                          Control0..1
                                                                                                                                          BindingThe codes SHOULD be taken from CommonLanguages
                                                                                                                                          (preferred to http://hl7.org/fhir/ValueSet/languages)

                                                                                                                                          A human language.

                                                                                                                                          Additional BindingsPurpose
                                                                                                                                          AllLanguagesMax Binding
                                                                                                                                          Typecode
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                          Summaryfalse
                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                          10. Observation.text
                                                                                                                                          Definition

                                                                                                                                          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                                                                                                                                          ShortText summary of the resource, for human interpretation
                                                                                                                                          Comments

                                                                                                                                          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                                                                                                                                          Control0..1
                                                                                                                                          TypeNarrative
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Summaryfalse
                                                                                                                                          Alternate Namesnarrative, html, xhtml, display
                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                          12. Observation.contained
                                                                                                                                          Definition

                                                                                                                                          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

                                                                                                                                          ShortContained, inline Resources
                                                                                                                                          Comments

                                                                                                                                          This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

                                                                                                                                          Control0..*
                                                                                                                                          TypeResource
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Summaryfalse
                                                                                                                                          Alternate Namesinline resources, anonymous resources, contained resources
                                                                                                                                          14. Observation.extension
                                                                                                                                          Definition

                                                                                                                                          An Extension

                                                                                                                                          ShortExtension
                                                                                                                                          Control0..*
                                                                                                                                          TypeExtension
                                                                                                                                          Is Modifierfalse
                                                                                                                                          Summaryfalse
                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                          SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                                                                                          • value @ url
                                                                                                                                          • 16. Observation.extension:secondary-finding
                                                                                                                                            Slice Namesecondary-finding
                                                                                                                                            Definition

                                                                                                                                            Secondary findings are genetic test results that provide information about variants in a gene unrelated to the primary purpose for the testing, most often discovered when Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS) is performed. This extension should be used to denote when a genetic finding is being shared as a secondary finding, and ideally refer to a corresponding guideline or policy statement.

                                                                                                                                            For more detail, please see: https://ghr.nlm.nih.gov/primer/testing/secondaryfindings.

                                                                                                                                            ShortSecondary findings are genetic test results that provide information about variants in a gene unrelated to the primary purpose for the testing, most often discovered when [Whole Exome Sequencing (WES)](https://en.wikipedia.org/wiki/Exome_sequencing) or [Whole Genome Sequencing (WGS)](https://en.wikipedia.org/wiki/Whole_genome_sequencing) is performed. This extension should be used to denote when a genetic finding is being shared as a secondary finding, and ideally refer to a corresponding guideline or policy statement. For more detail, please see: https://ghr.nlm.nih.gov/primer/testing/secondaryfindings
                                                                                                                                            Control0..1
                                                                                                                                            This element is affected by the following invariants: ele-1
                                                                                                                                            TypeExtension(Observation Secondary Finding) (Extension Type: CodeableConcept)
                                                                                                                                            Is Modifierfalse
                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                            18. Observation.extension:body-structure
                                                                                                                                            Slice Namebody-structure
                                                                                                                                            Definition

                                                                                                                                            Record details about the anatomical location of a specimen or body part. This resource may be used when a coded concept does not provide the necessary detail needed for the use case.

                                                                                                                                            ShortTarget anatomic location or structure
                                                                                                                                            Control0..1
                                                                                                                                            This element is affected by the following invariants: ele-1
                                                                                                                                            TypeExtension(BodyStructure Reference) (Extension Type: Reference(BodyStructure))
                                                                                                                                            Is Modifierfalse
                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                            20. Observation.extension:genomic-variant-assessment-date
                                                                                                                                            Slice Namegenomic-variant-assessment-date
                                                                                                                                            Definition

                                                                                                                                            Date at which the genomic variant was assessed and/or reported.

                                                                                                                                            ShortGenomic Variant Assessment Date
                                                                                                                                            Control0..1
                                                                                                                                            TypeExtension(Genomic Variant Assessment Date) (Extension Type: dateTime)
                                                                                                                                            Is Modifierfalse
                                                                                                                                            Must Supporttrue
                                                                                                                                            Obligations
                                                                                                                                              ObligationsActor
                                                                                                                                              SHALL:populateCreator (Onconova)
                                                                                                                                              SHOULD:persistConsumer (Onconova)
                                                                                                                                              Summaryfalse
                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                              22. Observation.modifierExtension
                                                                                                                                              Definition

                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                              ShortExtensions that cannot be ignored
                                                                                                                                              Comments

                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                              Control0..*
                                                                                                                                              TypeExtension
                                                                                                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                                                                                                                                              Summaryfalse
                                                                                                                                              Requirements

                                                                                                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                              Alternate Namesextensions, user content
                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                              24. Observation.identifier
                                                                                                                                              Definition

                                                                                                                                              A unique identifier assigned to this observation.

                                                                                                                                              ShortBusiness Identifier for observation
                                                                                                                                              NoteThis is a business identifier, not a resource identifier (see discussion)
                                                                                                                                              Control0..*
                                                                                                                                              TypeIdentifier
                                                                                                                                              Is Modifierfalse
                                                                                                                                              Summarytrue
                                                                                                                                              Requirements

                                                                                                                                              Allows observations to be distinguished and referenced.

                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              26. Observation.basedOn
                                                                                                                                              Definition

                                                                                                                                              A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

                                                                                                                                              ShortFulfills plan, proposal or order
                                                                                                                                              Control0..*
                                                                                                                                              TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                                                                                                                                              Is Modifierfalse
                                                                                                                                              Summarytrue
                                                                                                                                              Requirements

                                                                                                                                              Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

                                                                                                                                              Alternate NamesFulfills
                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              28. Observation.partOf
                                                                                                                                              Definition

                                                                                                                                              A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

                                                                                                                                              ShortPart of referenced event
                                                                                                                                              Comments

                                                                                                                                              To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

                                                                                                                                              Control0..*
                                                                                                                                              TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                                                                                                                                              Is Modifierfalse
                                                                                                                                              Summarytrue
                                                                                                                                              Alternate NamesContainer
                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              30. Observation.status
                                                                                                                                              Definition

                                                                                                                                              Not used in this profile

                                                                                                                                              ShortNot used in this profile
                                                                                                                                              Comments

                                                                                                                                              This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

                                                                                                                                              Control1..1
                                                                                                                                              BindingThe codes SHALL be taken from ObservationStatus
                                                                                                                                              (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

                                                                                                                                              Codes providing the status of an observation.

                                                                                                                                              Typecode
                                                                                                                                              Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                                                                                                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                              Must Supporttrue
                                                                                                                                              Summarytrue
                                                                                                                                              Requirements

                                                                                                                                              Need to track the status of individual results. Some results are finalized before the whole report is finalized.

                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              32. Observation.category
                                                                                                                                              Definition

                                                                                                                                              A code that classifies the general type of observation being made.

                                                                                                                                              ShortClassification of type of observation
                                                                                                                                              Comments

                                                                                                                                              In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                                                                                                                              Control1..*
                                                                                                                                              BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                                                                                                                              (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                                                                                                                              Codes for high level observation categories.

                                                                                                                                              TypeCodeableConcept
                                                                                                                                              Is Modifierfalse
                                                                                                                                              Must Supporttrue
                                                                                                                                              Summaryfalse
                                                                                                                                              Requirements

                                                                                                                                              Used for filtering what observations are retrieved and displayed.

                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                              SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                                                                                              • value @ coding
                                                                                                                                              • 34. Observation.category:labCategory
                                                                                                                                                Slice NamelabCategory
                                                                                                                                                Definition

                                                                                                                                                A code that classifies the general type of observation being made.

                                                                                                                                                ShortClassification of type of observation
                                                                                                                                                Comments

                                                                                                                                                In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                                                                                                                                Control1..1
                                                                                                                                                BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                                                                                                                                (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                                                                                                                                Codes for high level observation categories.

                                                                                                                                                TypeCodeableConcept
                                                                                                                                                Is Modifierfalse
                                                                                                                                                Summaryfalse
                                                                                                                                                Requirements

                                                                                                                                                Used for filtering what observations are retrieved and displayed.

                                                                                                                                                Pattern Value{
                                                                                                                                                  "coding" : [{
                                                                                                                                                    "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                                                                                                                                    "code" : "laboratory"
                                                                                                                                                  }]
                                                                                                                                                }
                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                36. Observation.category:labCategory.id
                                                                                                                                                Definition

                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                Control0..1
                                                                                                                                                Typestring
                                                                                                                                                Is Modifierfalse
                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                Summaryfalse
                                                                                                                                                38. Observation.category:labCategory.extension
                                                                                                                                                Definition

                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                Comments

                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                Control0..*
                                                                                                                                                TypeExtension
                                                                                                                                                Is Modifierfalse
                                                                                                                                                Summaryfalse
                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                SlicingThis element introduces a set of slices on Observation.category.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                                                                                                • value @ url
                                                                                                                                                • 40. Observation.category:labCategory.coding
                                                                                                                                                  Definition

                                                                                                                                                  A reference to a code defined by a terminology system.

                                                                                                                                                  ShortCode defined by a terminology system
                                                                                                                                                  Comments

                                                                                                                                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                                                                                                                  Control1..1
                                                                                                                                                  TypeCoding
                                                                                                                                                  Is Modifierfalse
                                                                                                                                                  Summarytrue
                                                                                                                                                  Requirements

                                                                                                                                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                                                                                                                                  Pattern Value{
                                                                                                                                                    "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                                                                                                                                    "code" : "laboratory"
                                                                                                                                                  }
                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                  42. Observation.category:labCategory.text
                                                                                                                                                  Definition

                                                                                                                                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                                                                                                                  ShortPlain text representation of the concept
                                                                                                                                                  Comments

                                                                                                                                                  Very often the text is the same as a displayName of one of the codings.

                                                                                                                                                  Control0..1
                                                                                                                                                  Typestring
                                                                                                                                                  Is Modifierfalse
                                                                                                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                  Summarytrue
                                                                                                                                                  Requirements

                                                                                                                                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                  44. Observation.code
                                                                                                                                                  Definition

                                                                                                                                                  Describes what was observed. Sometimes this is called the observation "name".

                                                                                                                                                  Short69548-6
                                                                                                                                                  Comments

                                                                                                                                                  All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                  Control1..1
                                                                                                                                                  BindingFor example codes, see LOINCCodes
                                                                                                                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                  Codes identifying names of simple observations.

                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                  Is Modifierfalse
                                                                                                                                                  Must Supporttrue
                                                                                                                                                  Summarytrue
                                                                                                                                                  Requirements

                                                                                                                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                  Alternate NamesName
                                                                                                                                                  Pattern Value{
                                                                                                                                                    "coding" : [{
                                                                                                                                                      "system" : "http://loinc.org",
                                                                                                                                                      "code" : "69548-6"
                                                                                                                                                    }]
                                                                                                                                                  }
                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                  46. Observation.subject
                                                                                                                                                  Definition

                                                                                                                                                  The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

                                                                                                                                                  ShortWho and/or what the observation is about
                                                                                                                                                  Comments

                                                                                                                                                  One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

                                                                                                                                                  Control1..1
                                                                                                                                                  TypeReference(Cancer Patient Profile)
                                                                                                                                                  Is Modifierfalse
                                                                                                                                                  Must Supporttrue
                                                                                                                                                  Obligations
                                                                                                                                                    ObligationsActor
                                                                                                                                                    SHALL:populateCreator (Onconova)
                                                                                                                                                    SHOULD:persistConsumer (Onconova)
                                                                                                                                                    Summarytrue
                                                                                                                                                    Requirements

                                                                                                                                                    Observations have no value if you don't know who or what they're about.

                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                    48. Observation.focus
                                                                                                                                                    Definition

                                                                                                                                                    Not used in this profile

                                                                                                                                                    ShortNot used in this profile
                                                                                                                                                    Comments

                                                                                                                                                    Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

                                                                                                                                                    Control0..*
                                                                                                                                                    TypeReference(Resource)
                                                                                                                                                    Is Modifierfalse
                                                                                                                                                    Summarytrue
                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                    50. Observation.encounter
                                                                                                                                                    Definition

                                                                                                                                                    Not used in this profile

                                                                                                                                                    ShortNot used in this profile
                                                                                                                                                    Comments

                                                                                                                                                    This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

                                                                                                                                                    Control0..1
                                                                                                                                                    TypeReference(Encounter)
                                                                                                                                                    Is Modifierfalse
                                                                                                                                                    Summarytrue
                                                                                                                                                    Requirements

                                                                                                                                                    For some observations it may be important to know the link between an observation and a particular encounter.

                                                                                                                                                    Alternate NamesContext
                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                    52. Observation.effective[x]
                                                                                                                                                    Definition

                                                                                                                                                    The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                                                                                                                                                    ShortClinically-relevant date of the genomic variant (e.g. the specimen collection date)
                                                                                                                                                    Comments

                                                                                                                                                    At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

                                                                                                                                                    Control1..1
                                                                                                                                                    TypedateTime
                                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                    Is Modifierfalse
                                                                                                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                    Must Supporttrue
                                                                                                                                                    Summarytrue
                                                                                                                                                    Requirements

                                                                                                                                                    Knowing when an observation was deemed true is important to its relevance as well as determining trends.

                                                                                                                                                    Alternate NamesOccurrence
                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                    SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                                                                                                                    • type @ $this
                                                                                                                                                    • 54. Observation.effective[x]:effectiveDateTime
                                                                                                                                                      Slice NameeffectiveDateTime
                                                                                                                                                      Definition

                                                                                                                                                      The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                                                                                                                                                      ShortClinically relevant time/time-period for observation
                                                                                                                                                      Comments

                                                                                                                                                      At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

                                                                                                                                                      Control0..1
                                                                                                                                                      TypedateTime
                                                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                      Is Modifierfalse
                                                                                                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                      Must Supporttrue
                                                                                                                                                      Obligations
                                                                                                                                                        ObligationsActor
                                                                                                                                                        SHALL:populateCreator (Onconova)
                                                                                                                                                        SHOULD:persistConsumer (Onconova)
                                                                                                                                                        Summarytrue
                                                                                                                                                        Requirements

                                                                                                                                                        Knowing when an observation was deemed true is important to its relevance as well as determining trends.

                                                                                                                                                        Alternate NamesOccurrence
                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                        56. Observation.issued
                                                                                                                                                        Definition

                                                                                                                                                        Not used in this profile

                                                                                                                                                        ShortNot used in this profile
                                                                                                                                                        Comments

                                                                                                                                                        For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

                                                                                                                                                        Control0..1
                                                                                                                                                        Typeinstant
                                                                                                                                                        Is Modifierfalse
                                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                        Summarytrue
                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                        58. Observation.performer
                                                                                                                                                        Definition

                                                                                                                                                        Not used in this profile

                                                                                                                                                        ShortNot used in this profile
                                                                                                                                                        Control0..*
                                                                                                                                                        TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                                                                                                                                                        Is Modifierfalse
                                                                                                                                                        Summarytrue
                                                                                                                                                        Requirements

                                                                                                                                                        May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                        60. Observation.value[x]
                                                                                                                                                        Definition

                                                                                                                                                        The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                        ShortActual result
                                                                                                                                                        Comments

                                                                                                                                                        An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                        Control0..1
                                                                                                                                                        This element is affected by the following invariants: obs-7
                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                        Is Modifierfalse
                                                                                                                                                        Must Supporttrue
                                                                                                                                                        Summarytrue
                                                                                                                                                        Requirements

                                                                                                                                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                        SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                                                                                                                        • type @ $this
                                                                                                                                                        • 62. Observation.value[x]:valueCodeableConcept
                                                                                                                                                          Slice NamevalueCodeableConcept
                                                                                                                                                          Definition

                                                                                                                                                          The presence or absence of the variant described in the components. If not searching for specific variations and merely reporting what's found, the profile's value should be set to 'Present'.

                                                                                                                                                          ShortIndeterminate | No call | Present | Absent.
                                                                                                                                                          Comments

                                                                                                                                                          An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                          Control0..1
                                                                                                                                                          This element is affected by the following invariants: obs-7
                                                                                                                                                          BindingThe codes SHALL be taken from LOINC Answer List LL1971-2
                                                                                                                                                          (required to http://loinc.org/vs/LL1971-2)
                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summarytrue
                                                                                                                                                          Requirements

                                                                                                                                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          64. Observation.dataAbsentReason
                                                                                                                                                          Definition

                                                                                                                                                          Provides a reason why the expected value in the element Observation.value[x] is missing.

                                                                                                                                                          ShortWhy the result is missing
                                                                                                                                                          Comments

                                                                                                                                                          Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

                                                                                                                                                          The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

                                                                                                                                                          Control0..1
                                                                                                                                                          This element is affected by the following invariants: obs-6
                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                          Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Must Supporttrue
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          66. Observation.interpretation
                                                                                                                                                          Definition

                                                                                                                                                          Not used in this profile

                                                                                                                                                          ShortNot used in this profile
                                                                                                                                                          Comments

                                                                                                                                                          Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                          Control0..*
                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                          Codes identifying interpretations of observations.

                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                          Alternate NamesAbnormal Flag
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          68. Observation.note
                                                                                                                                                          Definition

                                                                                                                                                          A text note which also contains information about who made the statement and when.

                                                                                                                                                          ShortComments about the Observation that also contain a coded type
                                                                                                                                                          Comments

                                                                                                                                                          May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. The CodedAnnotation data type, while not allowing for or intending to make the content computable, does allow the author to indicate the type of note. This does not replace the use of interpretation, value, or component values. One important note is that Annotation is a FHIR data type, this is NOT about annotations in the genomic context.

                                                                                                                                                          Control0..*
                                                                                                                                                          This element is affected by the following invariants: ele-1
                                                                                                                                                          TypeAnnotation(Coded Annotation)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Requirements

                                                                                                                                                          Need to be able to provide free text additional information. Notes SHALL NOT contain information which can be captured in a structured way.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          70. Observation.bodySite
                                                                                                                                                          Definition

                                                                                                                                                          Not used in this profile

                                                                                                                                                          ShortNot used in this profile
                                                                                                                                                          Comments

                                                                                                                                                          Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

                                                                                                                                                          If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

                                                                                                                                                          Control0..1
                                                                                                                                                          BindingFor example codes, see SNOMEDCTBodyStructures
                                                                                                                                                          (example to http://hl7.org/fhir/ValueSet/body-site)

                                                                                                                                                          Codes describing anatomical locations. May include laterality.

                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          72. Observation.method
                                                                                                                                                          Definition

                                                                                                                                                          Indicates the mechanism used to perform the observation.

                                                                                                                                                          ShortSequencing | SNP array | PCR | Computational analysis | ...
                                                                                                                                                          Comments

                                                                                                                                                          Only used if not implicit in code for Observation.code.

                                                                                                                                                          Control0..1
                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from LOINC Answer List LL4048-6
                                                                                                                                                          (extensible to http://loinc.org/vs/LL4048-6)
                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Must Supporttrue
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          74. Observation.specimen
                                                                                                                                                          Definition

                                                                                                                                                          Not used in this profile

                                                                                                                                                          ShortNot used in this profile
                                                                                                                                                          Comments

                                                                                                                                                          Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

                                                                                                                                                          Control0..1
                                                                                                                                                          TypeReference(Human Specimen Profile)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Must Supporttrue
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          76. Observation.device
                                                                                                                                                          Definition

                                                                                                                                                          Not used in this profile

                                                                                                                                                          ShortNot used in this profile
                                                                                                                                                          Comments

                                                                                                                                                          Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

                                                                                                                                                          Control0..1
                                                                                                                                                          TypeReference(Device, DeviceMetric)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          78. Observation.referenceRange
                                                                                                                                                          Definition

                                                                                                                                                          Not used in this profile

                                                                                                                                                          ShortNot used in this profile
                                                                                                                                                          Comments

                                                                                                                                                          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                          Control0..*
                                                                                                                                                          TypeBackboneElement
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                                                                                                                                                          80. Observation.referenceRange.id
                                                                                                                                                          Definition

                                                                                                                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                          ShortUnique id for inter-element referencing
                                                                                                                                                          Control0..1
                                                                                                                                                          Typestring
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                          Summaryfalse
                                                                                                                                                          82. Observation.referenceRange.extension
                                                                                                                                                          Definition

                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                          ShortAdditional content defined by implementations
                                                                                                                                                          Comments

                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                          Control0..*
                                                                                                                                                          TypeExtension
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Alternate Namesextensions, user content
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                          84. Observation.referenceRange.modifierExtension
                                                                                                                                                          Definition

                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                          Comments

                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                          Control0..*
                                                                                                                                                          TypeExtension
                                                                                                                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                          Summarytrue
                                                                                                                                                          Requirements

                                                                                                                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                          Alternate Namesextensions, user content, modifiers
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                          86. Observation.referenceRange.low
                                                                                                                                                          Definition

                                                                                                                                                          The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

                                                                                                                                                          ShortLow Range, if relevant
                                                                                                                                                          Control0..1
                                                                                                                                                          This element is affected by the following invariants: obs-3
                                                                                                                                                          TypeQuantity(SimpleQuantity)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          88. Observation.referenceRange.high
                                                                                                                                                          Definition

                                                                                                                                                          The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

                                                                                                                                                          ShortHigh Range, if relevant
                                                                                                                                                          Control0..1
                                                                                                                                                          This element is affected by the following invariants: obs-3
                                                                                                                                                          TypeQuantity(SimpleQuantity)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          90. Observation.referenceRange.type
                                                                                                                                                          Definition

                                                                                                                                                          Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                                                                                                                                                          ShortReference range qualifier
                                                                                                                                                          Comments

                                                                                                                                                          This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                                                                                                                                                          Control0..1
                                                                                                                                                          BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                                                                                                                                                          (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

                                                                                                                                                          Code for the meaning of a reference range.

                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          92. Observation.referenceRange.appliesTo
                                                                                                                                                          Definition

                                                                                                                                                          Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                                                                                                                                                          ShortReference range population
                                                                                                                                                          Comments

                                                                                                                                                          This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                                                                                                                                                          Control0..*
                                                                                                                                                          BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                                                                                                                                                          (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                                                                                                                                                          Codes identifying the population the reference range applies to.

                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          Need to be able to identify the target population for proper interpretation.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          94. Observation.referenceRange.age
                                                                                                                                                          Definition

                                                                                                                                                          The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

                                                                                                                                                          ShortApplicable age range, if relevant
                                                                                                                                                          Control0..1
                                                                                                                                                          TypeRange
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Requirements

                                                                                                                                                          Some analytes vary greatly over age.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          96. Observation.referenceRange.text
                                                                                                                                                          Definition

                                                                                                                                                          Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

                                                                                                                                                          ShortText based reference range in an observation
                                                                                                                                                          Control0..1
                                                                                                                                                          Typestring
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                          Summaryfalse
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          98. Observation.hasMember
                                                                                                                                                          Definition

                                                                                                                                                          Not used in this profile

                                                                                                                                                          ShortNot used in this profile
                                                                                                                                                          Comments

                                                                                                                                                          When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

                                                                                                                                                          Control0..*
                                                                                                                                                          TypeReference(Observation, QuestionnaireResponse, MolecularSequence)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summarytrue
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          100. Observation.derivedFrom
                                                                                                                                                          Definition

                                                                                                                                                          The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                                                                                                                                                          ShortRelated measurements the observation is made from
                                                                                                                                                          Comments

                                                                                                                                                          All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

                                                                                                                                                          Control0..*
                                                                                                                                                          TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Summarytrue
                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          102. Observation.component
                                                                                                                                                          Definition

                                                                                                                                                          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                          ShortComponent results
                                                                                                                                                          Comments

                                                                                                                                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                          Control3..*
                                                                                                                                                          TypeBackboneElement
                                                                                                                                                          Is Modifierfalse
                                                                                                                                                          Must Supporttrue
                                                                                                                                                          Summarytrue
                                                                                                                                                          Requirements

                                                                                                                                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                          SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                                                                                                          • pattern @ code
                                                                                                                                                          • 104. Observation.component.id
                                                                                                                                                            Definition

                                                                                                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                            ShortUnique id for inter-element referencing
                                                                                                                                                            Control0..1
                                                                                                                                                            Typestring
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                            Summaryfalse
                                                                                                                                                            106. Observation.component.extension
                                                                                                                                                            Definition

                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                            ShortAdditional content defined by implementations
                                                                                                                                                            Comments

                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeExtension
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Alternate Namesextensions, user content
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                            108. Observation.component.modifierExtension
                                                                                                                                                            Definition

                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                            Comments

                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeExtension
                                                                                                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                            Alternate Namesextensions, user content, modifiers
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                            110. Observation.component.code
                                                                                                                                                            Definition

                                                                                                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                            ShortType of component observation (code / type)
                                                                                                                                                            Comments

                                                                                                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                            Control1..1
                                                                                                                                                            BindingFor example codes, see LOINCCodes
                                                                                                                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                            Codes identifying names of simple observations.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            112. Observation.component.value[x]
                                                                                                                                                            Definition

                                                                                                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                            ShortActual component result
                                                                                                                                                            Comments

                                                                                                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                            Control0..1
                                                                                                                                                            TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                                                                                                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            114. Observation.component.dataAbsentReason
                                                                                                                                                            Definition

                                                                                                                                                            Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                            ShortWhy the component result is missing
                                                                                                                                                            Comments

                                                                                                                                                            "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                            Control0..1
                                                                                                                                                            This element is affected by the following invariants: obs-6
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                            Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            116. Observation.component.interpretation
                                                                                                                                                            Definition

                                                                                                                                                            A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                            ShortHigh, low, normal, etc.
                                                                                                                                                            Comments

                                                                                                                                                            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                            Control0..*
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                            Codes identifying interpretations of observations.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                            Alternate NamesAbnormal Flag
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            118. Observation.component.referenceRange
                                                                                                                                                            Definition

                                                                                                                                                            Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                            ShortProvides guide for interpretation of component result
                                                                                                                                                            Comments

                                                                                                                                                            Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            120. Observation.component:conclusion-string
                                                                                                                                                            Slice Nameconclusion-string
                                                                                                                                                            Definition

                                                                                                                                                            Not used in this profile

                                                                                                                                                            ShortNot used in this profile
                                                                                                                                                            Comments

                                                                                                                                                            An example would be the interpretative information, typically canned, about a variant identified in the patient.

                                                                                                                                                            Control0..1
                                                                                                                                                            TypeBackboneElement
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Need to be able to provide a conclusion that is not lost among the basic result data.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            122. Observation.component:conclusion-string.id
                                                                                                                                                            Definition

                                                                                                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                            ShortUnique id for inter-element referencing
                                                                                                                                                            Control0..1
                                                                                                                                                            Typestring
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                            Summaryfalse
                                                                                                                                                            124. Observation.component:conclusion-string.extension
                                                                                                                                                            Definition

                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                            ShortAdditional content defined by implementations
                                                                                                                                                            Comments

                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeExtension
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Alternate Namesextensions, user content
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                            126. Observation.component:conclusion-string.modifierExtension
                                                                                                                                                            Definition

                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                            Comments

                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeExtension
                                                                                                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                            Alternate Namesextensions, user content, modifiers
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                            128. Observation.component:conclusion-string.code
                                                                                                                                                            Definition

                                                                                                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                            Shortconclusion-string
                                                                                                                                                            Comments

                                                                                                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                            Control1..1
                                                                                                                                                            BindingFor example codes, see LOINCCodes
                                                                                                                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                            Codes identifying names of simple observations.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                            Pattern Value{
                                                                                                                                                              "coding" : [{
                                                                                                                                                                "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                                                                                                                                "code" : "conclusion-string"
                                                                                                                                                              }]
                                                                                                                                                            }
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            130. Observation.component:conclusion-string.value[x]
                                                                                                                                                            Definition

                                                                                                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                            ShortSummary conclusion (interpretation/impression)
                                                                                                                                                            Comments

                                                                                                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                            Control0..1
                                                                                                                                                            Typestring
                                                                                                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            132. Observation.component:conclusion-string.dataAbsentReason
                                                                                                                                                            Definition

                                                                                                                                                            Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                            ShortWhy the component result is missing
                                                                                                                                                            Comments

                                                                                                                                                            "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                            Control0..1
                                                                                                                                                            This element is affected by the following invariants: obs-6
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                            Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            134. Observation.component:conclusion-string.interpretation
                                                                                                                                                            Definition

                                                                                                                                                            A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                            ShortHigh, low, normal, etc.
                                                                                                                                                            Comments

                                                                                                                                                            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                            Control0..*
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                            Codes identifying interpretations of observations.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                            Alternate NamesAbnormal Flag
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            136. Observation.component:conclusion-string.referenceRange
                                                                                                                                                            Definition

                                                                                                                                                            Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                            ShortProvides guide for interpretation of component result
                                                                                                                                                            Comments

                                                                                                                                                            Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            138. Observation.component:gene-studied
                                                                                                                                                            Slice Namegene-studied
                                                                                                                                                            Definition

                                                                                                                                                            The gene(s) on which the variant is located.

                                                                                                                                                            ShortGene Studied
                                                                                                                                                            Comments

                                                                                                                                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeBackboneElement
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Must Supporttrue
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            140. Observation.component:gene-studied.id
                                                                                                                                                            Definition

                                                                                                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                            ShortUnique id for inter-element referencing
                                                                                                                                                            Control0..1
                                                                                                                                                            Typestring
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                            Summaryfalse
                                                                                                                                                            142. Observation.component:gene-studied.extension
                                                                                                                                                            Definition

                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                            ShortAdditional content defined by implementations
                                                                                                                                                            Comments

                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeExtension
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Alternate Namesextensions, user content
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                            144. Observation.component:gene-studied.modifierExtension
                                                                                                                                                            Definition

                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                            Comments

                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeExtension
                                                                                                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                            Alternate Namesextensions, user content, modifiers
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                            146. Observation.component:gene-studied.code
                                                                                                                                                            Definition

                                                                                                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                            Short48018-6
                                                                                                                                                            Comments

                                                                                                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                            Control1..1
                                                                                                                                                            BindingFor example codes, see LOINCCodes
                                                                                                                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                            Codes identifying names of simple observations.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Must Supporttrue
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                            Pattern Value{
                                                                                                                                                              "coding" : [{
                                                                                                                                                                "system" : "http://loinc.org",
                                                                                                                                                                "code" : "48018-6"
                                                                                                                                                              }]
                                                                                                                                                            }
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            148. Observation.component:gene-studied.value[x]
                                                                                                                                                            Definition

                                                                                                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                            ShortThe HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
                                                                                                                                                            Comments

                                                                                                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                            Control1..1
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from HUGO Gene Nomenclature Committee Gene Names (HGNC)
                                                                                                                                                            (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc-vs)
                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Must Supporttrue
                                                                                                                                                            Summarytrue
                                                                                                                                                            Requirements

                                                                                                                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            150. Observation.component:gene-studied.dataAbsentReason
                                                                                                                                                            Definition

                                                                                                                                                            Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                            ShortWhy the component result is missing
                                                                                                                                                            Comments

                                                                                                                                                            "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                            Control0..1
                                                                                                                                                            This element is affected by the following invariants: obs-6
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                            Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            152. Observation.component:gene-studied.interpretation
                                                                                                                                                            Definition

                                                                                                                                                            A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                            ShortHigh, low, normal, etc.
                                                                                                                                                            Comments

                                                                                                                                                            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                            Control0..*
                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                            Codes identifying interpretations of observations.

                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                            Alternate NamesAbnormal Flag
                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            154. Observation.component:gene-studied.referenceRange
                                                                                                                                                            Definition

                                                                                                                                                            Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                            ShortProvides guide for interpretation of component result
                                                                                                                                                            Comments

                                                                                                                                                            Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Summaryfalse
                                                                                                                                                            Requirements

                                                                                                                                                            Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                            156. Observation.component:cytogenetic-location
                                                                                                                                                            Slice Namecytogenetic-location
                                                                                                                                                            Definition

                                                                                                                                                            The relevant chromosomal region. The combination of numbers and letters provide a genetic 'address'.

                                                                                                                                                            ShortCytogenetic (Chromosome) Location
                                                                                                                                                            Comments

                                                                                                                                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                            Control0..*
                                                                                                                                                            TypeBackboneElement
                                                                                                                                                            Is Modifierfalse
                                                                                                                                                            Must Supporttrue
                                                                                                                                                            Obligations
                                                                                                                                                              ObligationsActor
                                                                                                                                                              MAY:ignoreCreator (Onconova)
                                                                                                                                                              MAY:persistConsumer (Onconova)
                                                                                                                                                              Summarytrue
                                                                                                                                                              Requirements

                                                                                                                                                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              158. Observation.component:cytogenetic-location.id
                                                                                                                                                              Definition

                                                                                                                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                              ShortUnique id for inter-element referencing
                                                                                                                                                              Control0..1
                                                                                                                                                              Typestring
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                              Summaryfalse
                                                                                                                                                              160. Observation.component:cytogenetic-location.extension
                                                                                                                                                              Definition

                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                              ShortAdditional content defined by implementations
                                                                                                                                                              Comments

                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                              Control0..*
                                                                                                                                                              TypeExtension
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Summaryfalse
                                                                                                                                                              Alternate Namesextensions, user content
                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                              162. Observation.component:cytogenetic-location.modifierExtension
                                                                                                                                                              Definition

                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                              Comments

                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                              Control0..*
                                                                                                                                                              TypeExtension
                                                                                                                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                              Summarytrue
                                                                                                                                                              Requirements

                                                                                                                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                              Alternate Namesextensions, user content, modifiers
                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                              164. Observation.component:cytogenetic-location.code
                                                                                                                                                              Definition

                                                                                                                                                              Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                              Short48001-2
                                                                                                                                                              Comments

                                                                                                                                                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                              Control1..1
                                                                                                                                                              BindingFor example codes, see LOINCCodes
                                                                                                                                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                              Codes identifying names of simple observations.

                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Must Supporttrue
                                                                                                                                                              Summarytrue
                                                                                                                                                              Requirements

                                                                                                                                                              Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                              Pattern Value{
                                                                                                                                                                "coding" : [{
                                                                                                                                                                  "system" : "http://loinc.org",
                                                                                                                                                                  "code" : "48001-2"
                                                                                                                                                                }]
                                                                                                                                                              }
                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              166. Observation.component:cytogenetic-location.value[x]
                                                                                                                                                              Definition

                                                                                                                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                              ShortExample: 1q21.1
                                                                                                                                                              Comments

                                                                                                                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                              Control1..1
                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Must Supporttrue
                                                                                                                                                              Summarytrue
                                                                                                                                                              Requirements

                                                                                                                                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              168. Observation.component:cytogenetic-location.dataAbsentReason
                                                                                                                                                              Definition

                                                                                                                                                              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                              ShortWhy the component result is missing
                                                                                                                                                              Comments

                                                                                                                                                              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                              Control0..1
                                                                                                                                                              This element is affected by the following invariants: obs-6
                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                              Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Summaryfalse
                                                                                                                                                              Requirements

                                                                                                                                                              For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              170. Observation.component:cytogenetic-location.interpretation
                                                                                                                                                              Definition

                                                                                                                                                              A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                              ShortHigh, low, normal, etc.
                                                                                                                                                              Comments

                                                                                                                                                              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                              Control0..*
                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                              Codes identifying interpretations of observations.

                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Summaryfalse
                                                                                                                                                              Requirements

                                                                                                                                                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                              Alternate NamesAbnormal Flag
                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              172. Observation.component:cytogenetic-location.referenceRange
                                                                                                                                                              Definition

                                                                                                                                                              Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                              ShortProvides guide for interpretation of component result
                                                                                                                                                              Comments

                                                                                                                                                              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                              Control0..*
                                                                                                                                                              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Summaryfalse
                                                                                                                                                              Requirements

                                                                                                                                                              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                              174. Observation.component:reference-sequence-assembly
                                                                                                                                                              Slice Namereference-sequence-assembly
                                                                                                                                                              Definition

                                                                                                                                                              The reference genome/assembly used in this analysis.

                                                                                                                                                              ShortHuman Reference Sequence Assembly
                                                                                                                                                              Comments

                                                                                                                                                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                              Control0..*
                                                                                                                                                              TypeBackboneElement
                                                                                                                                                              Is Modifierfalse
                                                                                                                                                              Obligations
                                                                                                                                                                ObligationsActor
                                                                                                                                                                SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                MAY:persistConsumer (Onconova)
                                                                                                                                                                Summarytrue
                                                                                                                                                                Requirements

                                                                                                                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                176. Observation.component:reference-sequence-assembly.id
                                                                                                                                                                Definition

                                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                                Control0..1
                                                                                                                                                                Typestring
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                Summaryfalse
                                                                                                                                                                178. Observation.component:reference-sequence-assembly.extension
                                                                                                                                                                Definition

                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                                Comments

                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                Control0..*
                                                                                                                                                                TypeExtension
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Summaryfalse
                                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                180. Observation.component:reference-sequence-assembly.modifierExtension
                                                                                                                                                                Definition

                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                Comments

                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                Control0..*
                                                                                                                                                                TypeExtension
                                                                                                                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                Summarytrue
                                                                                                                                                                Requirements

                                                                                                                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                Alternate Namesextensions, user content, modifiers
                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                182. Observation.component:reference-sequence-assembly.code
                                                                                                                                                                Definition

                                                                                                                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                Short62374-4
                                                                                                                                                                Comments

                                                                                                                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                Control1..1
                                                                                                                                                                BindingFor example codes, see LOINCCodes
                                                                                                                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                Codes identifying names of simple observations.

                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Summarytrue
                                                                                                                                                                Requirements

                                                                                                                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                Pattern Value{
                                                                                                                                                                  "coding" : [{
                                                                                                                                                                    "system" : "http://loinc.org",
                                                                                                                                                                    "code" : "62374-4"
                                                                                                                                                                  }]
                                                                                                                                                                }
                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                184. Observation.component:reference-sequence-assembly.value[x]
                                                                                                                                                                Definition

                                                                                                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                ShortGRCh37 | GRCh38 | ...
                                                                                                                                                                Comments

                                                                                                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                Control1..1
                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from LOINC Answer List LL1040-6
                                                                                                                                                                (extensible to http://loinc.org/vs/LL1040-6)
                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Summarytrue
                                                                                                                                                                Requirements

                                                                                                                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                186. Observation.component:reference-sequence-assembly.dataAbsentReason
                                                                                                                                                                Definition

                                                                                                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                ShortWhy the component result is missing
                                                                                                                                                                Comments

                                                                                                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                Control0..1
                                                                                                                                                                This element is affected by the following invariants: obs-6
                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Summaryfalse
                                                                                                                                                                Requirements

                                                                                                                                                                For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                188. Observation.component:reference-sequence-assembly.interpretation
                                                                                                                                                                Definition

                                                                                                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                ShortHigh, low, normal, etc.
                                                                                                                                                                Comments

                                                                                                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                Control0..*
                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                Codes identifying interpretations of observations.

                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Summaryfalse
                                                                                                                                                                Requirements

                                                                                                                                                                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                Alternate NamesAbnormal Flag
                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                190. Observation.component:reference-sequence-assembly.referenceRange
                                                                                                                                                                Definition

                                                                                                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                ShortProvides guide for interpretation of component result
                                                                                                                                                                Comments

                                                                                                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                Control0..*
                                                                                                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Summaryfalse
                                                                                                                                                                Requirements

                                                                                                                                                                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                192. Observation.component:coding-hgvs
                                                                                                                                                                Slice Namecoding-hgvs
                                                                                                                                                                Definition

                                                                                                                                                                Description of the coding (cDNA) sequence change using a valid HGVS-formatted string.

                                                                                                                                                                ShortCoding (cDNA) Change - cHGVS
                                                                                                                                                                Comments

                                                                                                                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                Control0..1
                                                                                                                                                                TypeBackboneElement
                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                Obligations
                                                                                                                                                                  ObligationsActor
                                                                                                                                                                  SHALL:populate-if-knownCreator (Onconova)
                                                                                                                                                                  SHOULD:persistConsumer (Onconova)
                                                                                                                                                                  Summarytrue
                                                                                                                                                                  Requirements

                                                                                                                                                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  194. Observation.component:coding-hgvs.id
                                                                                                                                                                  Definition

                                                                                                                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                  ShortUnique id for inter-element referencing
                                                                                                                                                                  Control0..1
                                                                                                                                                                  Typestring
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                  Summaryfalse
                                                                                                                                                                  196. Observation.component:coding-hgvs.extension
                                                                                                                                                                  Definition

                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                  ShortAdditional content defined by implementations
                                                                                                                                                                  Comments

                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                  Control0..*
                                                                                                                                                                  TypeExtension
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Summaryfalse
                                                                                                                                                                  Alternate Namesextensions, user content
                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                  198. Observation.component:coding-hgvs.modifierExtension
                                                                                                                                                                  Definition

                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                  Comments

                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                  Control0..*
                                                                                                                                                                  TypeExtension
                                                                                                                                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                  Summarytrue
                                                                                                                                                                  Requirements

                                                                                                                                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                  Alternate Namesextensions, user content, modifiers
                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                  200. Observation.component:coding-hgvs.code
                                                                                                                                                                  Definition

                                                                                                                                                                  Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                  Short48004-6
                                                                                                                                                                  Comments

                                                                                                                                                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                  Control1..1
                                                                                                                                                                  BindingFor example codes, see LOINCCodes
                                                                                                                                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                  Codes identifying names of simple observations.

                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Summarytrue
                                                                                                                                                                  Requirements

                                                                                                                                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                  Pattern Value{
                                                                                                                                                                    "coding" : [{
                                                                                                                                                                      "system" : "http://loinc.org",
                                                                                                                                                                      "code" : "48004-6"
                                                                                                                                                                    }]
                                                                                                                                                                  }
                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  202. Observation.component:coding-hgvs.value[x]
                                                                                                                                                                  Definition

                                                                                                                                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                  ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'c.' string, e.g. NM_005228.5:c.2369C>T
                                                                                                                                                                  Comments

                                                                                                                                                                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                  Control1..1
                                                                                                                                                                  BindingThe codes SHALL be taken from Human Genome Variation Society (HGVS) Nomenclature
                                                                                                                                                                  (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs)
                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Summarytrue
                                                                                                                                                                  Requirements

                                                                                                                                                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  204. Observation.component:coding-hgvs.dataAbsentReason
                                                                                                                                                                  Definition

                                                                                                                                                                  Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                  ShortWhy the component result is missing
                                                                                                                                                                  Comments

                                                                                                                                                                  "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                  The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                  Control0..1
                                                                                                                                                                  This element is affected by the following invariants: obs-6
                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                  Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Summaryfalse
                                                                                                                                                                  Requirements

                                                                                                                                                                  For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  206. Observation.component:coding-hgvs.interpretation
                                                                                                                                                                  Definition

                                                                                                                                                                  A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                  ShortHigh, low, normal, etc.
                                                                                                                                                                  Comments

                                                                                                                                                                  Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                  Control0..*
                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                  Codes identifying interpretations of observations.

                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Summaryfalse
                                                                                                                                                                  Requirements

                                                                                                                                                                  For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                  Alternate NamesAbnormal Flag
                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  208. Observation.component:coding-hgvs.referenceRange
                                                                                                                                                                  Definition

                                                                                                                                                                  Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                  ShortProvides guide for interpretation of component result
                                                                                                                                                                  Comments

                                                                                                                                                                  Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                  Control0..*
                                                                                                                                                                  TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Summaryfalse
                                                                                                                                                                  Requirements

                                                                                                                                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                  210. Observation.component:genomic-hgvs
                                                                                                                                                                  Slice Namegenomic-hgvs
                                                                                                                                                                  Definition

                                                                                                                                                                  Description of the genomic (gDNA) sequence change using a valid HGVS-formatted string.

                                                                                                                                                                  ShortGenomic (gDNA) Change - gHGVS
                                                                                                                                                                  Comments

                                                                                                                                                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                  Control0..1
                                                                                                                                                                  TypeBackboneElement
                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                  Obligations
                                                                                                                                                                    ObligationsActor
                                                                                                                                                                    SHALL:populate-if-knownCreator (Onconova)
                                                                                                                                                                    SHOULD:persistConsumer (Onconova)
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    212. Observation.component:genomic-hgvs.id
                                                                                                                                                                    Definition

                                                                                                                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                    ShortUnique id for inter-element referencing
                                                                                                                                                                    Control0..1
                                                                                                                                                                    Typestring
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    214. Observation.component:genomic-hgvs.extension
                                                                                                                                                                    Definition

                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                    ShortAdditional content defined by implementations
                                                                                                                                                                    Comments

                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    TypeExtension
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Alternate Namesextensions, user content
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                    216. Observation.component:genomic-hgvs.modifierExtension
                                                                                                                                                                    Definition

                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                    Comments

                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    TypeExtension
                                                                                                                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                    Alternate Namesextensions, user content, modifiers
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                    218. Observation.component:genomic-hgvs.code
                                                                                                                                                                    Definition

                                                                                                                                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                    Short81290-9
                                                                                                                                                                    Comments

                                                                                                                                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                    Control1..1
                                                                                                                                                                    BindingFor example codes, see LOINCCodes
                                                                                                                                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                    Codes identifying names of simple observations.

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                    Pattern Value{
                                                                                                                                                                      "coding" : [{
                                                                                                                                                                        "system" : "http://loinc.org",
                                                                                                                                                                        "code" : "81290-9"
                                                                                                                                                                      }]
                                                                                                                                                                    }
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    220. Observation.component:genomic-hgvs.value[x]
                                                                                                                                                                    Definition

                                                                                                                                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                    ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'g.' string, e.g. NC_000016.9:g.2124200_2138612dup
                                                                                                                                                                    Comments

                                                                                                                                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                    Control1..1
                                                                                                                                                                    BindingThe codes SHALL be taken from Human Genome Variation Society (HGVS) Nomenclature
                                                                                                                                                                    (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs)
                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    222. Observation.component:genomic-hgvs.dataAbsentReason
                                                                                                                                                                    Definition

                                                                                                                                                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                    ShortWhy the component result is missing
                                                                                                                                                                    Comments

                                                                                                                                                                    "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                    Control0..1
                                                                                                                                                                    This element is affected by the following invariants: obs-6
                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                    Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Requirements

                                                                                                                                                                    For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    224. Observation.component:genomic-hgvs.interpretation
                                                                                                                                                                    Definition

                                                                                                                                                                    A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                    ShortHigh, low, normal, etc.
                                                                                                                                                                    Comments

                                                                                                                                                                    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                    Codes identifying interpretations of observations.

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Requirements

                                                                                                                                                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                    Alternate NamesAbnormal Flag
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    226. Observation.component:genomic-hgvs.referenceRange
                                                                                                                                                                    Definition

                                                                                                                                                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                    ShortProvides guide for interpretation of component result
                                                                                                                                                                    Comments

                                                                                                                                                                    Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Requirements

                                                                                                                                                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    228. Observation.component:cytogenomic-nomenclature
                                                                                                                                                                    Slice Namecytogenomic-nomenclature
                                                                                                                                                                    Definition

                                                                                                                                                                    Fully describes a variant with a single code. Typically a large variant such as a mosaic, abnormal chromosome numbers, etc.

                                                                                                                                                                    ShortCytogenomic Nomenclature (ISCN)
                                                                                                                                                                    Comments

                                                                                                                                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                    Control0..1
                                                                                                                                                                    TypeBackboneElement
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    230. Observation.component:cytogenomic-nomenclature.id
                                                                                                                                                                    Definition

                                                                                                                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                    ShortUnique id for inter-element referencing
                                                                                                                                                                    Control0..1
                                                                                                                                                                    Typestring
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    232. Observation.component:cytogenomic-nomenclature.extension
                                                                                                                                                                    Definition

                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                    ShortAdditional content defined by implementations
                                                                                                                                                                    Comments

                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    TypeExtension
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Alternate Namesextensions, user content
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                    234. Observation.component:cytogenomic-nomenclature.modifierExtension
                                                                                                                                                                    Definition

                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                    Comments

                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    TypeExtension
                                                                                                                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                    Alternate Namesextensions, user content, modifiers
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                    236. Observation.component:cytogenomic-nomenclature.code
                                                                                                                                                                    Definition

                                                                                                                                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                    Short81291-7
                                                                                                                                                                    Comments

                                                                                                                                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                    Control1..1
                                                                                                                                                                    BindingFor example codes, see LOINCCodes
                                                                                                                                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                    Codes identifying names of simple observations.

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                    Pattern Value{
                                                                                                                                                                      "coding" : [{
                                                                                                                                                                        "system" : "http://loinc.org",
                                                                                                                                                                        "code" : "81291-7"
                                                                                                                                                                      }]
                                                                                                                                                                    }
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    238. Observation.component:cytogenomic-nomenclature.value[x]
                                                                                                                                                                    Definition

                                                                                                                                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                    ShortActual component result
                                                                                                                                                                    Comments

                                                                                                                                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                    Control1..1
                                                                                                                                                                    Binding

                                                                                                                                                                    Binding not yet defined

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                    Summarytrue
                                                                                                                                                                    Requirements

                                                                                                                                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    240. Observation.component:cytogenomic-nomenclature.dataAbsentReason
                                                                                                                                                                    Definition

                                                                                                                                                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                    ShortWhy the component result is missing
                                                                                                                                                                    Comments

                                                                                                                                                                    "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                    Control0..1
                                                                                                                                                                    This element is affected by the following invariants: obs-6
                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                    Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Requirements

                                                                                                                                                                    For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    242. Observation.component:cytogenomic-nomenclature.interpretation
                                                                                                                                                                    Definition

                                                                                                                                                                    A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                    ShortHigh, low, normal, etc.
                                                                                                                                                                    Comments

                                                                                                                                                                    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                    Codes identifying interpretations of observations.

                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Requirements

                                                                                                                                                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                    Alternate NamesAbnormal Flag
                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    244. Observation.component:cytogenomic-nomenclature.referenceRange
                                                                                                                                                                    Definition

                                                                                                                                                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                    ShortProvides guide for interpretation of component result
                                                                                                                                                                    Comments

                                                                                                                                                                    Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                    Control0..*
                                                                                                                                                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Summaryfalse
                                                                                                                                                                    Requirements

                                                                                                                                                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                    246. Observation.component:genomic-ref-seq
                                                                                                                                                                    Slice Namegenomic-ref-seq
                                                                                                                                                                    Definition

                                                                                                                                                                    ID of the genomic reference sequence, which includes transcribed and non transcribed stretches

                                                                                                                                                                    ShortGenomic Reference Sequence
                                                                                                                                                                    Comments

                                                                                                                                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                    Control0..1
                                                                                                                                                                    TypeBackboneElement
                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                    Obligations
                                                                                                                                                                      ObligationsActor
                                                                                                                                                                      MAY:ignoreCreator (Onconova)
                                                                                                                                                                      MAY:persistConsumer (Onconova)
                                                                                                                                                                      Summarytrue
                                                                                                                                                                      Requirements

                                                                                                                                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      248. Observation.component:genomic-ref-seq.id
                                                                                                                                                                      Definition

                                                                                                                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                      ShortUnique id for inter-element referencing
                                                                                                                                                                      Control0..1
                                                                                                                                                                      Typestring
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                      Summaryfalse
                                                                                                                                                                      250. Observation.component:genomic-ref-seq.extension
                                                                                                                                                                      Definition

                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                      ShortAdditional content defined by implementations
                                                                                                                                                                      Comments

                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                      Control0..*
                                                                                                                                                                      TypeExtension
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Summaryfalse
                                                                                                                                                                      Alternate Namesextensions, user content
                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                      252. Observation.component:genomic-ref-seq.modifierExtension
                                                                                                                                                                      Definition

                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                      Comments

                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                      Control0..*
                                                                                                                                                                      TypeExtension
                                                                                                                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                      Summarytrue
                                                                                                                                                                      Requirements

                                                                                                                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                      Alternate Namesextensions, user content, modifiers
                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                      254. Observation.component:genomic-ref-seq.code
                                                                                                                                                                      Definition

                                                                                                                                                                      Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                      Short48013-7
                                                                                                                                                                      Comments

                                                                                                                                                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                      Control1..1
                                                                                                                                                                      BindingFor example codes, see LOINCCodes
                                                                                                                                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                      Codes identifying names of simple observations.

                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Summarytrue
                                                                                                                                                                      Requirements

                                                                                                                                                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                      Pattern Value{
                                                                                                                                                                        "coding" : [{
                                                                                                                                                                          "system" : "http://loinc.org",
                                                                                                                                                                          "code" : "48013-7"
                                                                                                                                                                        }]
                                                                                                                                                                      }
                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      256. Observation.component:genomic-ref-seq.value[x]
                                                                                                                                                                      Definition

                                                                                                                                                                      The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                      ShortVersioned genomic reference sequence identifier
                                                                                                                                                                      Comments

                                                                                                                                                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                      Control1..1
                                                                                                                                                                      Binding

                                                                                                                                                                      Multiple bindings acceptable (NCBI or LRG)

                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Summarytrue
                                                                                                                                                                      Requirements

                                                                                                                                                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      258. Observation.component:genomic-ref-seq.dataAbsentReason
                                                                                                                                                                      Definition

                                                                                                                                                                      Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                      ShortWhy the component result is missing
                                                                                                                                                                      Comments

                                                                                                                                                                      "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                      The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                      Control0..1
                                                                                                                                                                      This element is affected by the following invariants: obs-6
                                                                                                                                                                      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                      Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Summaryfalse
                                                                                                                                                                      Requirements

                                                                                                                                                                      For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      260. Observation.component:genomic-ref-seq.interpretation
                                                                                                                                                                      Definition

                                                                                                                                                                      A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                      ShortHigh, low, normal, etc.
                                                                                                                                                                      Comments

                                                                                                                                                                      Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                      Control0..*
                                                                                                                                                                      BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                      (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                      Codes identifying interpretations of observations.

                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Summaryfalse
                                                                                                                                                                      Requirements

                                                                                                                                                                      For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                      Alternate NamesAbnormal Flag
                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      262. Observation.component:genomic-ref-seq.referenceRange
                                                                                                                                                                      Definition

                                                                                                                                                                      Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                      ShortProvides guide for interpretation of component result
                                                                                                                                                                      Comments

                                                                                                                                                                      Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                      Control0..*
                                                                                                                                                                      TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Summaryfalse
                                                                                                                                                                      Requirements

                                                                                                                                                                      Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                      264. Observation.component:transcript-ref-seq
                                                                                                                                                                      Slice Nametranscript-ref-seq
                                                                                                                                                                      Definition

                                                                                                                                                                      NCBI's RefSeq ('NM_...'), Ensembl ('ENST...'), and LRG ('LRG...' plus 't1' to indicate transcript)

                                                                                                                                                                      ShortReference Transcript
                                                                                                                                                                      Comments

                                                                                                                                                                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                      Control0..1
                                                                                                                                                                      TypeBackboneElement
                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                      Obligations
                                                                                                                                                                        ObligationsActor
                                                                                                                                                                        MAY:ignoreCreator (Onconova)
                                                                                                                                                                        MAY:persistConsumer (Onconova)
                                                                                                                                                                        Summarytrue
                                                                                                                                                                        Requirements

                                                                                                                                                                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        266. Observation.component:transcript-ref-seq.id
                                                                                                                                                                        Definition

                                                                                                                                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                        ShortUnique id for inter-element referencing
                                                                                                                                                                        Control0..1
                                                                                                                                                                        Typestring
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                        Summaryfalse
                                                                                                                                                                        268. Observation.component:transcript-ref-seq.extension
                                                                                                                                                                        Definition

                                                                                                                                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                        ShortAdditional content defined by implementations
                                                                                                                                                                        Comments

                                                                                                                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                        Control0..*
                                                                                                                                                                        TypeExtension
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Summaryfalse
                                                                                                                                                                        Alternate Namesextensions, user content
                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                        270. Observation.component:transcript-ref-seq.modifierExtension
                                                                                                                                                                        Definition

                                                                                                                                                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                        Comments

                                                                                                                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                        Control0..*
                                                                                                                                                                        TypeExtension
                                                                                                                                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                        Summarytrue
                                                                                                                                                                        Requirements

                                                                                                                                                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                        Alternate Namesextensions, user content, modifiers
                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                        272. Observation.component:transcript-ref-seq.code
                                                                                                                                                                        Definition

                                                                                                                                                                        Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                        Short51958-7
                                                                                                                                                                        Comments

                                                                                                                                                                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                        Control1..1
                                                                                                                                                                        BindingFor example codes, see LOINCCodes
                                                                                                                                                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                        Codes identifying names of simple observations.

                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Summarytrue
                                                                                                                                                                        Requirements

                                                                                                                                                                        Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                        Pattern Value{
                                                                                                                                                                          "coding" : [{
                                                                                                                                                                            "system" : "http://loinc.org",
                                                                                                                                                                            "code" : "51958-7"
                                                                                                                                                                          }]
                                                                                                                                                                        }
                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        274. Observation.component:transcript-ref-seq.value[x]
                                                                                                                                                                        Definition

                                                                                                                                                                        The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                        ShortVersioned transcript reference sequence identifier
                                                                                                                                                                        Comments

                                                                                                                                                                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                        Control1..1
                                                                                                                                                                        Binding

                                                                                                                                                                        Multiple bindings acceptable (NCBI or LRG)

                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Summarytrue
                                                                                                                                                                        Requirements

                                                                                                                                                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        276. Observation.component:transcript-ref-seq.dataAbsentReason
                                                                                                                                                                        Definition

                                                                                                                                                                        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                        ShortWhy the component result is missing
                                                                                                                                                                        Comments

                                                                                                                                                                        "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                        The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                        Control0..1
                                                                                                                                                                        This element is affected by the following invariants: obs-6
                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                        Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Summaryfalse
                                                                                                                                                                        Requirements

                                                                                                                                                                        For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        278. Observation.component:transcript-ref-seq.interpretation
                                                                                                                                                                        Definition

                                                                                                                                                                        A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                        ShortHigh, low, normal, etc.
                                                                                                                                                                        Comments

                                                                                                                                                                        Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                        Control0..*
                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                        Codes identifying interpretations of observations.

                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Summaryfalse
                                                                                                                                                                        Requirements

                                                                                                                                                                        For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                        Alternate NamesAbnormal Flag
                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        280. Observation.component:transcript-ref-seq.referenceRange
                                                                                                                                                                        Definition

                                                                                                                                                                        Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                        ShortProvides guide for interpretation of component result
                                                                                                                                                                        Comments

                                                                                                                                                                        Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                        Control0..*
                                                                                                                                                                        TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Summaryfalse
                                                                                                                                                                        Requirements

                                                                                                                                                                        Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                        282. Observation.component:exact-start-end
                                                                                                                                                                        Slice Nameexact-start-end
                                                                                                                                                                        Definition

                                                                                                                                                                        The exact integer-based genomic coordinates of the start and end of the variant region.

                                                                                                                                                                        ShortExact Start-End
                                                                                                                                                                        Comments

                                                                                                                                                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                        Control0..1
                                                                                                                                                                        TypeBackboneElement
                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                        Obligations
                                                                                                                                                                          ObligationsActor
                                                                                                                                                                          MAY:ignoreCreator (Onconova)
                                                                                                                                                                          MAY:persistConsumer (Onconova)
                                                                                                                                                                          Summarytrue
                                                                                                                                                                          Requirements

                                                                                                                                                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          284. Observation.component:exact-start-end.id
                                                                                                                                                                          Definition

                                                                                                                                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                          ShortUnique id for inter-element referencing
                                                                                                                                                                          Control0..1
                                                                                                                                                                          Typestring
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                          Summaryfalse
                                                                                                                                                                          286. Observation.component:exact-start-end.extension
                                                                                                                                                                          Definition

                                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                          ShortAdditional content defined by implementations
                                                                                                                                                                          Comments

                                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                          Control0..*
                                                                                                                                                                          TypeExtension
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Summaryfalse
                                                                                                                                                                          Alternate Namesextensions, user content
                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                          288. Observation.component:exact-start-end.modifierExtension
                                                                                                                                                                          Definition

                                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                          Comments

                                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                          Control0..*
                                                                                                                                                                          TypeExtension
                                                                                                                                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                          Summarytrue
                                                                                                                                                                          Requirements

                                                                                                                                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                          Alternate Namesextensions, user content, modifiers
                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                          290. Observation.component:exact-start-end.code
                                                                                                                                                                          Definition

                                                                                                                                                                          Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                          Short81254-5
                                                                                                                                                                          Comments

                                                                                                                                                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                          Control1..1
                                                                                                                                                                          BindingFor example codes, see LOINCCodes
                                                                                                                                                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                          Codes identifying names of simple observations.

                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Summarytrue
                                                                                                                                                                          Requirements

                                                                                                                                                                          Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                          Pattern Value{
                                                                                                                                                                            "coding" : [{
                                                                                                                                                                              "system" : "http://loinc.org",
                                                                                                                                                                              "code" : "81254-5"
                                                                                                                                                                            }]
                                                                                                                                                                          }
                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          292. Observation.component:exact-start-end.value[x]
                                                                                                                                                                          Definition

                                                                                                                                                                          The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                          ShortRange in question. 'High' can be omitted for single nucleotide variants.
                                                                                                                                                                          Comments

                                                                                                                                                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                          Control0..1
                                                                                                                                                                          TypeRange
                                                                                                                                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Summarytrue
                                                                                                                                                                          Requirements

                                                                                                                                                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          294. Observation.component:exact-start-end.dataAbsentReason
                                                                                                                                                                          Definition

                                                                                                                                                                          Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                          ShortWhy the component result is missing
                                                                                                                                                                          Comments

                                                                                                                                                                          "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                          The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                          Control0..1
                                                                                                                                                                          This element is affected by the following invariants: obs-6
                                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                          Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Summaryfalse
                                                                                                                                                                          Requirements

                                                                                                                                                                          For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          296. Observation.component:exact-start-end.interpretation
                                                                                                                                                                          Definition

                                                                                                                                                                          A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                          ShortHigh, low, normal, etc.
                                                                                                                                                                          Comments

                                                                                                                                                                          Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                          Control0..*
                                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                          Codes identifying interpretations of observations.

                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Summaryfalse
                                                                                                                                                                          Requirements

                                                                                                                                                                          For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                          Alternate NamesAbnormal Flag
                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          298. Observation.component:exact-start-end.referenceRange
                                                                                                                                                                          Definition

                                                                                                                                                                          Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                          ShortProvides guide for interpretation of component result
                                                                                                                                                                          Comments

                                                                                                                                                                          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                          Control0..*
                                                                                                                                                                          TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Summaryfalse
                                                                                                                                                                          Requirements

                                                                                                                                                                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                          300. Observation.component:inner-start-end
                                                                                                                                                                          Slice Nameinner-start-end
                                                                                                                                                                          Definition

                                                                                                                                                                          The genomic coordinates of the narrowest genomic range in which the variant might reside. Used when the exact boundaries of the variant are not clear.

                                                                                                                                                                          ShortInner Start-End
                                                                                                                                                                          Comments

                                                                                                                                                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                          Control0..1
                                                                                                                                                                          TypeBackboneElement
                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                          Obligations
                                                                                                                                                                            ObligationsActor
                                                                                                                                                                            MAY:ignoreCreator (Onconova)
                                                                                                                                                                            MAY:persistConsumer (Onconova)
                                                                                                                                                                            Summarytrue
                                                                                                                                                                            Requirements

                                                                                                                                                                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            302. Observation.component:inner-start-end.id
                                                                                                                                                                            Definition

                                                                                                                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                            ShortUnique id for inter-element referencing
                                                                                                                                                                            Control0..1
                                                                                                                                                                            Typestring
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                            Summaryfalse
                                                                                                                                                                            304. Observation.component:inner-start-end.extension
                                                                                                                                                                            Definition

                                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                            ShortAdditional content defined by implementations
                                                                                                                                                                            Comments

                                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                            Control0..*
                                                                                                                                                                            TypeExtension
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Summaryfalse
                                                                                                                                                                            Alternate Namesextensions, user content
                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                            306. Observation.component:inner-start-end.modifierExtension
                                                                                                                                                                            Definition

                                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                            Comments

                                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                            Control0..*
                                                                                                                                                                            TypeExtension
                                                                                                                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                            Summarytrue
                                                                                                                                                                            Requirements

                                                                                                                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                            Alternate Namesextensions, user content, modifiers
                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                            308. Observation.component:inner-start-end.code
                                                                                                                                                                            Definition

                                                                                                                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                            Short81302-2
                                                                                                                                                                            Comments

                                                                                                                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                            Control1..1
                                                                                                                                                                            BindingFor example codes, see LOINCCodes
                                                                                                                                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                            Codes identifying names of simple observations.

                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Summarytrue
                                                                                                                                                                            Requirements

                                                                                                                                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                            Pattern Value{
                                                                                                                                                                              "coding" : [{
                                                                                                                                                                                "system" : "http://loinc.org",
                                                                                                                                                                                "code" : "81302-2"
                                                                                                                                                                              }]
                                                                                                                                                                            }
                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            310. Observation.component:inner-start-end.value[x]
                                                                                                                                                                            Definition

                                                                                                                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                            ShortImprecise variant inner-bounding range
                                                                                                                                                                            Comments

                                                                                                                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                            Control0..1
                                                                                                                                                                            TypeRange
                                                                                                                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Summarytrue
                                                                                                                                                                            Requirements

                                                                                                                                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            312. Observation.component:inner-start-end.dataAbsentReason
                                                                                                                                                                            Definition

                                                                                                                                                                            Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                            ShortWhy the component result is missing
                                                                                                                                                                            Comments

                                                                                                                                                                            "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                            Control0..1
                                                                                                                                                                            This element is affected by the following invariants: obs-6
                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                            Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Summaryfalse
                                                                                                                                                                            Requirements

                                                                                                                                                                            For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            314. Observation.component:inner-start-end.interpretation
                                                                                                                                                                            Definition

                                                                                                                                                                            A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                            ShortHigh, low, normal, etc.
                                                                                                                                                                            Comments

                                                                                                                                                                            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                            Control0..*
                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                            Codes identifying interpretations of observations.

                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Summaryfalse
                                                                                                                                                                            Requirements

                                                                                                                                                                            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                            Alternate NamesAbnormal Flag
                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            316. Observation.component:inner-start-end.referenceRange
                                                                                                                                                                            Definition

                                                                                                                                                                            Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                            ShortProvides guide for interpretation of component result
                                                                                                                                                                            Comments

                                                                                                                                                                            Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                            Control0..*
                                                                                                                                                                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Summaryfalse
                                                                                                                                                                            Requirements

                                                                                                                                                                            Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                            318. Observation.component:outer-start-end
                                                                                                                                                                            Slice Nameouter-start-end
                                                                                                                                                                            Definition

                                                                                                                                                                            The genomic coordinates of the widest genomic range in which the variant might reside. Used when the exact boundaries of the variant are not clear.

                                                                                                                                                                            ShortOuter Start-End
                                                                                                                                                                            Comments

                                                                                                                                                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                            Control0..1
                                                                                                                                                                            TypeBackboneElement
                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                            Obligations
                                                                                                                                                                              ObligationsActor
                                                                                                                                                                              MAY:ignoreCreator (Onconova)
                                                                                                                                                                              MAY:persistConsumer (Onconova)
                                                                                                                                                                              Summarytrue
                                                                                                                                                                              Requirements

                                                                                                                                                                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              320. Observation.component:outer-start-end.id
                                                                                                                                                                              Definition

                                                                                                                                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                              ShortUnique id for inter-element referencing
                                                                                                                                                                              Control0..1
                                                                                                                                                                              Typestring
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                              Summaryfalse
                                                                                                                                                                              322. Observation.component:outer-start-end.extension
                                                                                                                                                                              Definition

                                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                              ShortAdditional content defined by implementations
                                                                                                                                                                              Comments

                                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                              Control0..*
                                                                                                                                                                              TypeExtension
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Summaryfalse
                                                                                                                                                                              Alternate Namesextensions, user content
                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                              324. Observation.component:outer-start-end.modifierExtension
                                                                                                                                                                              Definition

                                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                              Comments

                                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                              Control0..*
                                                                                                                                                                              TypeExtension
                                                                                                                                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                              Summarytrue
                                                                                                                                                                              Requirements

                                                                                                                                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                              Alternate Namesextensions, user content, modifiers
                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                              326. Observation.component:outer-start-end.code
                                                                                                                                                                              Definition

                                                                                                                                                                              Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                              Short81301-4
                                                                                                                                                                              Comments

                                                                                                                                                                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                              Control1..1
                                                                                                                                                                              BindingFor example codes, see LOINCCodes
                                                                                                                                                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                              Codes identifying names of simple observations.

                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Summarytrue
                                                                                                                                                                              Requirements

                                                                                                                                                                              Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                              Pattern Value{
                                                                                                                                                                                "coding" : [{
                                                                                                                                                                                  "system" : "http://loinc.org",
                                                                                                                                                                                  "code" : "81301-4"
                                                                                                                                                                                }]
                                                                                                                                                                              }
                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              328. Observation.component:outer-start-end.value[x]
                                                                                                                                                                              Definition

                                                                                                                                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                              ShortImprecise variant outer-bounding range
                                                                                                                                                                              Comments

                                                                                                                                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                              Control0..1
                                                                                                                                                                              TypeRange
                                                                                                                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Summarytrue
                                                                                                                                                                              Requirements

                                                                                                                                                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              330. Observation.component:outer-start-end.dataAbsentReason
                                                                                                                                                                              Definition

                                                                                                                                                                              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                              ShortWhy the component result is missing
                                                                                                                                                                              Comments

                                                                                                                                                                              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                              Control0..1
                                                                                                                                                                              This element is affected by the following invariants: obs-6
                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                              Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Summaryfalse
                                                                                                                                                                              Requirements

                                                                                                                                                                              For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              332. Observation.component:outer-start-end.interpretation
                                                                                                                                                                              Definition

                                                                                                                                                                              A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                              ShortHigh, low, normal, etc.
                                                                                                                                                                              Comments

                                                                                                                                                                              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                              Control0..*
                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                              Codes identifying interpretations of observations.

                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Summaryfalse
                                                                                                                                                                              Requirements

                                                                                                                                                                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                              Alternate NamesAbnormal Flag
                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              334. Observation.component:outer-start-end.referenceRange
                                                                                                                                                                              Definition

                                                                                                                                                                              Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                              ShortProvides guide for interpretation of component result
                                                                                                                                                                              Comments

                                                                                                                                                                              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                              Control0..*
                                                                                                                                                                              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Summaryfalse
                                                                                                                                                                              Requirements

                                                                                                                                                                              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                              336. Observation.component:coordinate-system
                                                                                                                                                                              Slice Namecoordinate-system
                                                                                                                                                                              Definition

                                                                                                                                                                              These are different ways of identifying nucleotides or amino acids within a sequence. In the 1-based system, the first unit of the polymer (e.g. the first nucleotide) is counted as number 1. In the 0-based system, the number 0 designates the location before the first nucleotide. Different databases and file types may use different systems.

                                                                                                                                                                              ShortCoordinate System
                                                                                                                                                                              Comments

                                                                                                                                                                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                              Control0..1
                                                                                                                                                                              TypeBackboneElement
                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                              Obligations
                                                                                                                                                                                ObligationsActor
                                                                                                                                                                                SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                MAY:persistConsumer (Onconova)
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                338. Observation.component:coordinate-system.id
                                                                                                                                                                                Definition

                                                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                                                Control0..1
                                                                                                                                                                                Typestring
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                340. Observation.component:coordinate-system.extension
                                                                                                                                                                                Definition

                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                                                Comments

                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeExtension
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                342. Observation.component:coordinate-system.modifierExtension
                                                                                                                                                                                Definition

                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                Comments

                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeExtension
                                                                                                                                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                344. Observation.component:coordinate-system.code
                                                                                                                                                                                Definition

                                                                                                                                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                Short92822-6
                                                                                                                                                                                Comments

                                                                                                                                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                Control1..1
                                                                                                                                                                                BindingFor example codes, see LOINCCodes
                                                                                                                                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                Codes identifying names of simple observations.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                Pattern Value{
                                                                                                                                                                                  "coding" : [{
                                                                                                                                                                                    "system" : "http://loinc.org",
                                                                                                                                                                                    "code" : "92822-6"
                                                                                                                                                                                  }]
                                                                                                                                                                                }
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                346. Observation.component:coordinate-system.value[x]
                                                                                                                                                                                Definition

                                                                                                                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                Short0-based interval counting | 0-based character counting | 1-based character counting
                                                                                                                                                                                Comments

                                                                                                                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                Control1..1
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from LOINC Answer List LL5323-2
                                                                                                                                                                                (extensible to http://loinc.org/vs/LL5323-2)
                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                348. Observation.component:coordinate-system.dataAbsentReason
                                                                                                                                                                                Definition

                                                                                                                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                ShortWhy the component result is missing
                                                                                                                                                                                Comments

                                                                                                                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                This element is affected by the following invariants: obs-6
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                350. Observation.component:coordinate-system.interpretation
                                                                                                                                                                                Definition

                                                                                                                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                ShortHigh, low, normal, etc.
                                                                                                                                                                                Comments

                                                                                                                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                Codes identifying interpretations of observations.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                Alternate NamesAbnormal Flag
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                352. Observation.component:coordinate-system.referenceRange
                                                                                                                                                                                Definition

                                                                                                                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                ShortProvides guide for interpretation of component result
                                                                                                                                                                                Comments

                                                                                                                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                354. Observation.component:ref-allele
                                                                                                                                                                                Slice Nameref-allele
                                                                                                                                                                                Definition

                                                                                                                                                                                Not used in this profile

                                                                                                                                                                                ShortNot used in this profile
                                                                                                                                                                                Comments

                                                                                                                                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                TypeBackboneElement
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                356. Observation.component:ref-allele.id
                                                                                                                                                                                Definition

                                                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                                                Control0..1
                                                                                                                                                                                Typestring
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                358. Observation.component:ref-allele.extension
                                                                                                                                                                                Definition

                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                                                Comments

                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeExtension
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                360. Observation.component:ref-allele.modifierExtension
                                                                                                                                                                                Definition

                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                Comments

                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeExtension
                                                                                                                                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                362. Observation.component:ref-allele.code
                                                                                                                                                                                Definition

                                                                                                                                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                Short69547-8
                                                                                                                                                                                Comments

                                                                                                                                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                Control1..1
                                                                                                                                                                                BindingFor example codes, see LOINCCodes
                                                                                                                                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                Codes identifying names of simple observations.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                Pattern Value{
                                                                                                                                                                                  "coding" : [{
                                                                                                                                                                                    "system" : "http://loinc.org",
                                                                                                                                                                                    "code" : "69547-8"
                                                                                                                                                                                  }]
                                                                                                                                                                                }
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                364. Observation.component:ref-allele.value[x]
                                                                                                                                                                                Definition

                                                                                                                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                ShortNormalized string per the VCF format.
                                                                                                                                                                                Comments

                                                                                                                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                Typestring
                                                                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                366. Observation.component:ref-allele.dataAbsentReason
                                                                                                                                                                                Definition

                                                                                                                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                ShortWhy the component result is missing
                                                                                                                                                                                Comments

                                                                                                                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                This element is affected by the following invariants: obs-6
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                368. Observation.component:ref-allele.interpretation
                                                                                                                                                                                Definition

                                                                                                                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                ShortHigh, low, normal, etc.
                                                                                                                                                                                Comments

                                                                                                                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                Codes identifying interpretations of observations.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                Alternate NamesAbnormal Flag
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                370. Observation.component:ref-allele.referenceRange
                                                                                                                                                                                Definition

                                                                                                                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                ShortProvides guide for interpretation of component result
                                                                                                                                                                                Comments

                                                                                                                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                372. Observation.component:alt-allele
                                                                                                                                                                                Slice Namealt-allele
                                                                                                                                                                                Definition

                                                                                                                                                                                Not used in this profile

                                                                                                                                                                                ShortNot used in this profile
                                                                                                                                                                                Comments

                                                                                                                                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                TypeBackboneElement
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                374. Observation.component:alt-allele.id
                                                                                                                                                                                Definition

                                                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                                                Control0..1
                                                                                                                                                                                Typestring
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                376. Observation.component:alt-allele.extension
                                                                                                                                                                                Definition

                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                                                Comments

                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeExtension
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                378. Observation.component:alt-allele.modifierExtension
                                                                                                                                                                                Definition

                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                Comments

                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeExtension
                                                                                                                                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                380. Observation.component:alt-allele.code
                                                                                                                                                                                Definition

                                                                                                                                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                Short69551-0
                                                                                                                                                                                Comments

                                                                                                                                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                Control1..1
                                                                                                                                                                                BindingFor example codes, see LOINCCodes
                                                                                                                                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                Codes identifying names of simple observations.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                Pattern Value{
                                                                                                                                                                                  "coding" : [{
                                                                                                                                                                                    "system" : "http://loinc.org",
                                                                                                                                                                                    "code" : "69551-0"
                                                                                                                                                                                  }]
                                                                                                                                                                                }
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                382. Observation.component:alt-allele.value[x]
                                                                                                                                                                                Definition

                                                                                                                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                ShortNormalized string per the VCF format.
                                                                                                                                                                                Comments

                                                                                                                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                Typestring
                                                                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                Summarytrue
                                                                                                                                                                                Requirements

                                                                                                                                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                384. Observation.component:alt-allele.dataAbsentReason
                                                                                                                                                                                Definition

                                                                                                                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                ShortWhy the component result is missing
                                                                                                                                                                                Comments

                                                                                                                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                This element is affected by the following invariants: obs-6
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                386. Observation.component:alt-allele.interpretation
                                                                                                                                                                                Definition

                                                                                                                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                ShortHigh, low, normal, etc.
                                                                                                                                                                                Comments

                                                                                                                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                Codes identifying interpretations of observations.

                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                Alternate NamesAbnormal Flag
                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                388. Observation.component:alt-allele.referenceRange
                                                                                                                                                                                Definition

                                                                                                                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                ShortProvides guide for interpretation of component result
                                                                                                                                                                                Comments

                                                                                                                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                Control0..*
                                                                                                                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                Requirements

                                                                                                                                                                                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                390. Observation.component:coding-change-type
                                                                                                                                                                                Slice Namecoding-change-type
                                                                                                                                                                                Definition

                                                                                                                                                                                Type of DNA change observed. Convenience property for variants with exact breakpoints, required otherwise.

                                                                                                                                                                                ShortCoding DNA Change Type
                                                                                                                                                                                Comments

                                                                                                                                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                Control0..1
                                                                                                                                                                                TypeBackboneElement
                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                Must Supporttrue
                                                                                                                                                                                Obligations
                                                                                                                                                                                  ObligationsActor
                                                                                                                                                                                  MAY:ignoreCreator (Onconova)
                                                                                                                                                                                  MAY:persistConsumer (Onconova)
                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  392. Observation.component:coding-change-type.id
                                                                                                                                                                                  Definition

                                                                                                                                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                  ShortUnique id for inter-element referencing
                                                                                                                                                                                  Control0..1
                                                                                                                                                                                  Typestring
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                  394. Observation.component:coding-change-type.extension
                                                                                                                                                                                  Definition

                                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                  ShortAdditional content defined by implementations
                                                                                                                                                                                  Comments

                                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                  Control0..*
                                                                                                                                                                                  TypeExtension
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                  Alternate Namesextensions, user content
                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                  396. Observation.component:coding-change-type.modifierExtension
                                                                                                                                                                                  Definition

                                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                  Comments

                                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                  Control0..*
                                                                                                                                                                                  TypeExtension
                                                                                                                                                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                  Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                  398. Observation.component:coding-change-type.code
                                                                                                                                                                                  Definition

                                                                                                                                                                                  Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                  Short48019-4
                                                                                                                                                                                  Comments

                                                                                                                                                                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                  Control1..1
                                                                                                                                                                                  BindingFor example codes, see LOINCCodes
                                                                                                                                                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                  Codes identifying names of simple observations.

                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                  Pattern Value{
                                                                                                                                                                                    "coding" : [{
                                                                                                                                                                                      "system" : "http://loinc.org",
                                                                                                                                                                                      "code" : "48019-4"
                                                                                                                                                                                    }]
                                                                                                                                                                                  }
                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  400. Observation.component:coding-change-type.value[x]
                                                                                                                                                                                  Definition

                                                                                                                                                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                  Shortdeletion | insertion | delins | SNV | copy_number_gain | copy_number_loss | ... (many)
                                                                                                                                                                                  Comments

                                                                                                                                                                                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                  Control1..1
                                                                                                                                                                                  BindingThe codes SHALL be taken from Coding DNA Change Types Value Set
                                                                                                                                                                                  (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-dna-change-types)
                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  402. Observation.component:coding-change-type.dataAbsentReason
                                                                                                                                                                                  Definition

                                                                                                                                                                                  Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                  ShortWhy the component result is missing
                                                                                                                                                                                  Comments

                                                                                                                                                                                  "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                  The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                  Control0..1
                                                                                                                                                                                  This element is affected by the following invariants: obs-6
                                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                  Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  404. Observation.component:coding-change-type.interpretation
                                                                                                                                                                                  Definition

                                                                                                                                                                                  A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                  ShortHigh, low, normal, etc.
                                                                                                                                                                                  Comments

                                                                                                                                                                                  Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                  Control0..*
                                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                  Codes identifying interpretations of observations.

                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                  Alternate NamesAbnormal Flag
                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  406. Observation.component:coding-change-type.referenceRange
                                                                                                                                                                                  Definition

                                                                                                                                                                                  Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                  ShortProvides guide for interpretation of component result
                                                                                                                                                                                  Comments

                                                                                                                                                                                  Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                  Control0..*
                                                                                                                                                                                  TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                  Requirements

                                                                                                                                                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                  408. Observation.component:genomic-source-class
                                                                                                                                                                                  Slice Namegenomic-source-class
                                                                                                                                                                                  Definition

                                                                                                                                                                                  The genomic class of the specimen being analyzed: Germline for inherited genome, somatic for cancer genome, and prenatal for fetal genome.

                                                                                                                                                                                  ShortGenomic Source Class
                                                                                                                                                                                  Comments

                                                                                                                                                                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                  Control0..1
                                                                                                                                                                                  TypeBackboneElement
                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                  Obligations
                                                                                                                                                                                    ObligationsActor
                                                                                                                                                                                    SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                    MAY:persistConsumer (Onconova)
                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    410. Observation.component:genomic-source-class.id
                                                                                                                                                                                    Definition

                                                                                                                                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                    ShortUnique id for inter-element referencing
                                                                                                                                                                                    Control0..1
                                                                                                                                                                                    Typestring
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                    412. Observation.component:genomic-source-class.extension
                                                                                                                                                                                    Definition

                                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                    ShortAdditional content defined by implementations
                                                                                                                                                                                    Comments

                                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                    Control0..*
                                                                                                                                                                                    TypeExtension
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                    Alternate Namesextensions, user content
                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                    414. Observation.component:genomic-source-class.modifierExtension
                                                                                                                                                                                    Definition

                                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                    Comments

                                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                    Control0..*
                                                                                                                                                                                    TypeExtension
                                                                                                                                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                    Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                    416. Observation.component:genomic-source-class.code
                                                                                                                                                                                    Definition

                                                                                                                                                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                    Short48002-0
                                                                                                                                                                                    Comments

                                                                                                                                                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                    Control1..1
                                                                                                                                                                                    BindingFor example codes, see LOINCCodes
                                                                                                                                                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                    Codes identifying names of simple observations.

                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                    Pattern Value{
                                                                                                                                                                                      "coding" : [{
                                                                                                                                                                                        "system" : "http://loinc.org",
                                                                                                                                                                                        "code" : "48002-0"
                                                                                                                                                                                      }]
                                                                                                                                                                                    }
                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    418. Observation.component:genomic-source-class.value[x]
                                                                                                                                                                                    Definition

                                                                                                                                                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                    ShortGermline | Somatic | Fetal | Likely germline | Likely somatic | Likely fetal | Unknown genomic origin | De novo
                                                                                                                                                                                    Comments

                                                                                                                                                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                    Control1..1
                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from LOINC Answer List LL378-1
                                                                                                                                                                                    (extensible to http://loinc.org/vs/LL378-1)
                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    420. Observation.component:genomic-source-class.dataAbsentReason
                                                                                                                                                                                    Definition

                                                                                                                                                                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                    ShortWhy the component result is missing
                                                                                                                                                                                    Comments

                                                                                                                                                                                    "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                    Control0..1
                                                                                                                                                                                    This element is affected by the following invariants: obs-6
                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                    Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    422. Observation.component:genomic-source-class.interpretation
                                                                                                                                                                                    Definition

                                                                                                                                                                                    A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                    ShortHigh, low, normal, etc.
                                                                                                                                                                                    Comments

                                                                                                                                                                                    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                    Control0..*
                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                    Codes identifying interpretations of observations.

                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                    Alternate NamesAbnormal Flag
                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    424. Observation.component:genomic-source-class.referenceRange
                                                                                                                                                                                    Definition

                                                                                                                                                                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                    ShortProvides guide for interpretation of component result
                                                                                                                                                                                    Comments

                                                                                                                                                                                    Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                    Control0..*
                                                                                                                                                                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                    Requirements

                                                                                                                                                                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                    426. Observation.component:sample-allelic-frequency
                                                                                                                                                                                    Slice Namesample-allelic-frequency
                                                                                                                                                                                    Definition

                                                                                                                                                                                    The relative frequency of the allele at a given locus in the sample.

                                                                                                                                                                                    ShortSample Allelic Frequency
                                                                                                                                                                                    Comments

                                                                                                                                                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                    Control0..1
                                                                                                                                                                                    TypeBackboneElement
                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                    Obligations
                                                                                                                                                                                      ObligationsActor
                                                                                                                                                                                      SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                      MAY:persistConsumer (Onconova)
                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                      Requirements

                                                                                                                                                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                      428. Observation.component:sample-allelic-frequency.id
                                                                                                                                                                                      Definition

                                                                                                                                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                      ShortUnique id for inter-element referencing
                                                                                                                                                                                      Control0..1
                                                                                                                                                                                      Typestring
                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                      430. Observation.component:sample-allelic-frequency.extension
                                                                                                                                                                                      Definition

                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                      ShortAdditional content defined by implementations
                                                                                                                                                                                      Comments

                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                      Control0..*
                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                      Alternate Namesextensions, user content
                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                      432. Observation.component:sample-allelic-frequency.modifierExtension
                                                                                                                                                                                      Definition

                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                      Comments

                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                      Control0..*
                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                      Requirements

                                                                                                                                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                      Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                      434. Observation.component:sample-allelic-frequency.code
                                                                                                                                                                                      Definition

                                                                                                                                                                                      Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                      Short81258-6
                                                                                                                                                                                      Comments

                                                                                                                                                                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                      Control1..1
                                                                                                                                                                                      BindingFor example codes, see LOINCCodes
                                                                                                                                                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                      Codes identifying names of simple observations.

                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                      Requirements

                                                                                                                                                                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                      Pattern Value{
                                                                                                                                                                                        "coding" : [{
                                                                                                                                                                                          "system" : "http://loinc.org",
                                                                                                                                                                                          "code" : "81258-6"
                                                                                                                                                                                        }]
                                                                                                                                                                                      }
                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                      436. Observation.component:sample-allelic-frequency.value[x]
                                                                                                                                                                                      Definition

                                                                                                                                                                                      The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                      ShortRelative frequency in the sample
                                                                                                                                                                                      Comments

                                                                                                                                                                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                      Control0..1
                                                                                                                                                                                      TypeQuantity
                                                                                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                      Requirements

                                                                                                                                                                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                      438. Observation.component:sample-allelic-frequency.value[x].id
                                                                                                                                                                                      Definition

                                                                                                                                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                      ShortUnique id for inter-element referencing
                                                                                                                                                                                      Control0..1
                                                                                                                                                                                      Typestring
                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                      440. Observation.component:sample-allelic-frequency.value[x].extension
                                                                                                                                                                                      Definition

                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                      ShortAdditional content defined by implementations
                                                                                                                                                                                      Comments

                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                      Control0..*
                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                      Alternate Namesextensions, user content
                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                      SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                                                                                                                                      • value @ url
                                                                                                                                                                                      • 442. Observation.component:sample-allelic-frequency.value[x].value
                                                                                                                                                                                        Definition

                                                                                                                                                                                        The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                                                                                                                                                                        ShortNumerical value (with implicit precision)
                                                                                                                                                                                        Comments

                                                                                                                                                                                        The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        Typedecimal
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        Precision is handled implicitly in almost all cases of measurement.

                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        444. Observation.component:sample-allelic-frequency.value[x].comparator
                                                                                                                                                                                        Definition

                                                                                                                                                                                        How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                                                                                                                                                                        Short< | <= | >= | > - how to understand the value
                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        BindingThe codes SHALL be taken from QuantityComparator
                                                                                                                                                                                        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                                                                                                                                                                        How the Quantity should be understood and represented.

                                                                                                                                                                                        Typecode
                                                                                                                                                                                        Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                                                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                                                                                                                                                                        Meaning if MissingIf there is no comparator, then there is no modification of the value
                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        446. Observation.component:sample-allelic-frequency.value[x].unit
                                                                                                                                                                                        Definition

                                                                                                                                                                                        A human-readable form of the unit.

                                                                                                                                                                                        ShortUnit representation
                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        Typestring
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        448. Observation.component:sample-allelic-frequency.value[x].system
                                                                                                                                                                                        Definition

                                                                                                                                                                                        The identification of the system that provides the coded form of the unit.

                                                                                                                                                                                        ShortSystem that defines coded unit form
                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        This element is affected by the following invariants: qty-3
                                                                                                                                                                                        Typeuri
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        Need to know the system that defines the coded form of the unit.

                                                                                                                                                                                        Pattern Valuehttp://unitsofmeasure.org
                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        450. Observation.component:sample-allelic-frequency.value[x].code
                                                                                                                                                                                        Definition

                                                                                                                                                                                        A computer processable form of the unit in some unit representation system.

                                                                                                                                                                                        ShortCoded form of the unit
                                                                                                                                                                                        Comments

                                                                                                                                                                                        The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        Typecode
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        452. Observation.component:sample-allelic-frequency.dataAbsentReason
                                                                                                                                                                                        Definition

                                                                                                                                                                                        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                        ShortWhy the component result is missing
                                                                                                                                                                                        Comments

                                                                                                                                                                                        "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                        The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        This element is affected by the following invariants: obs-6
                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                        Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        454. Observation.component:sample-allelic-frequency.interpretation
                                                                                                                                                                                        Definition

                                                                                                                                                                                        A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                        ShortHigh, low, normal, etc.
                                                                                                                                                                                        Comments

                                                                                                                                                                                        Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                        Control0..*
                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                        Codes identifying interpretations of observations.

                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                        Alternate NamesAbnormal Flag
                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        456. Observation.component:sample-allelic-frequency.referenceRange
                                                                                                                                                                                        Definition

                                                                                                                                                                                        Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                        ShortProvides guide for interpretation of component result
                                                                                                                                                                                        Comments

                                                                                                                                                                                        Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                        Control0..*
                                                                                                                                                                                        TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                        Requirements

                                                                                                                                                                                        Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                        458. Observation.component:allelic-read-depth
                                                                                                                                                                                        Slice Nameallelic-read-depth
                                                                                                                                                                                        Definition

                                                                                                                                                                                        Specifies the number of reads that identified the allele in question whether it consists of one or a small sequence of contiguous nucleotides. Different methods and purposes require different numbers of reads to be acceptable. Often >400, sometimes as few as 2-4.

                                                                                                                                                                                        ShortAllelic Read Depth
                                                                                                                                                                                        Comments

                                                                                                                                                                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                        Control0..1
                                                                                                                                                                                        TypeBackboneElement
                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                        Obligations
                                                                                                                                                                                          ObligationsActor
                                                                                                                                                                                          SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                          MAY:persistConsumer (Onconova)
                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          460. Observation.component:allelic-read-depth.id
                                                                                                                                                                                          Definition

                                                                                                                                                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                          ShortUnique id for inter-element referencing
                                                                                                                                                                                          Control0..1
                                                                                                                                                                                          Typestring
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                          462. Observation.component:allelic-read-depth.extension
                                                                                                                                                                                          Definition

                                                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                          ShortAdditional content defined by implementations
                                                                                                                                                                                          Comments

                                                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                          Control0..*
                                                                                                                                                                                          TypeExtension
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                          Alternate Namesextensions, user content
                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                          464. Observation.component:allelic-read-depth.modifierExtension
                                                                                                                                                                                          Definition

                                                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                          Comments

                                                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                          Control0..*
                                                                                                                                                                                          TypeExtension
                                                                                                                                                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                          Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                          466. Observation.component:allelic-read-depth.code
                                                                                                                                                                                          Definition

                                                                                                                                                                                          Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                          Short82121-5
                                                                                                                                                                                          Comments

                                                                                                                                                                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                          Control1..1
                                                                                                                                                                                          BindingFor example codes, see LOINCCodes
                                                                                                                                                                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                          Codes identifying names of simple observations.

                                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                          Pattern Value{
                                                                                                                                                                                            "coding" : [{
                                                                                                                                                                                              "system" : "http://loinc.org",
                                                                                                                                                                                              "code" : "82121-5"
                                                                                                                                                                                            }]
                                                                                                                                                                                          }
                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          468. Observation.component:allelic-read-depth.value[x]
                                                                                                                                                                                          Definition

                                                                                                                                                                                          The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                          ShortUnfiltered count of supporting reads
                                                                                                                                                                                          Comments

                                                                                                                                                                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                          Control0..1
                                                                                                                                                                                          TypeQuantity
                                                                                                                                                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          470. Observation.component:allelic-read-depth.dataAbsentReason
                                                                                                                                                                                          Definition

                                                                                                                                                                                          Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                          ShortWhy the component result is missing
                                                                                                                                                                                          Comments

                                                                                                                                                                                          "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                          The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                          Control0..1
                                                                                                                                                                                          This element is affected by the following invariants: obs-6
                                                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                          Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          472. Observation.component:allelic-read-depth.interpretation
                                                                                                                                                                                          Definition

                                                                                                                                                                                          A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                          ShortHigh, low, normal, etc.
                                                                                                                                                                                          Comments

                                                                                                                                                                                          Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                          Control0..*
                                                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                          Codes identifying interpretations of observations.

                                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                          Alternate NamesAbnormal Flag
                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          474. Observation.component:allelic-read-depth.referenceRange
                                                                                                                                                                                          Definition

                                                                                                                                                                                          Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                          ShortProvides guide for interpretation of component result
                                                                                                                                                                                          Comments

                                                                                                                                                                                          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                          Control0..*
                                                                                                                                                                                          TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                          Requirements

                                                                                                                                                                                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                          476. Observation.component:allelic-state
                                                                                                                                                                                          Slice Nameallelic-state
                                                                                                                                                                                          Definition

                                                                                                                                                                                          The observed level of occurrence of the variant in the set of chromosomes.

                                                                                                                                                                                          ShortAllelic State
                                                                                                                                                                                          Comments

                                                                                                                                                                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                          Control0..1
                                                                                                                                                                                          TypeBackboneElement
                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                          Must Supporttrue
                                                                                                                                                                                          Obligations
                                                                                                                                                                                            ObligationsActor
                                                                                                                                                                                            SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                            MAY:persistConsumer (Onconova)
                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            478. Observation.component:allelic-state.id
                                                                                                                                                                                            Definition

                                                                                                                                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                            ShortUnique id for inter-element referencing
                                                                                                                                                                                            Control0..1
                                                                                                                                                                                            Typestring
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                            480. Observation.component:allelic-state.extension
                                                                                                                                                                                            Definition

                                                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                            ShortAdditional content defined by implementations
                                                                                                                                                                                            Comments

                                                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                            Control0..*
                                                                                                                                                                                            TypeExtension
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                            Alternate Namesextensions, user content
                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                            482. Observation.component:allelic-state.modifierExtension
                                                                                                                                                                                            Definition

                                                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                            Comments

                                                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                            Control0..*
                                                                                                                                                                                            TypeExtension
                                                                                                                                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                            Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                            484. Observation.component:allelic-state.code
                                                                                                                                                                                            Definition

                                                                                                                                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                            Short53034-5
                                                                                                                                                                                            Comments

                                                                                                                                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                            Control1..1
                                                                                                                                                                                            BindingFor example codes, see LOINCCodes
                                                                                                                                                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                            Codes identifying names of simple observations.

                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Must Supporttrue
                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                            Pattern Value{
                                                                                                                                                                                              "coding" : [{
                                                                                                                                                                                                "system" : "http://loinc.org",
                                                                                                                                                                                                "code" : "53034-5"
                                                                                                                                                                                              }]
                                                                                                                                                                                            }
                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            486. Observation.component:allelic-state.value[x]
                                                                                                                                                                                            Definition

                                                                                                                                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                            ShortHeteroplasmic | Homoplasmic | Homozygous | Heterozygous | Hemizygous
                                                                                                                                                                                            Comments

                                                                                                                                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                            Control1..1
                                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from LOINC Answer List LL381-5
                                                                                                                                                                                            (extensible to http://loinc.org/vs/LL381-5)
                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Must Supporttrue
                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            488. Observation.component:allelic-state.dataAbsentReason
                                                                                                                                                                                            Definition

                                                                                                                                                                                            Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                            ShortWhy the component result is missing
                                                                                                                                                                                            Comments

                                                                                                                                                                                            "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                            Control0..1
                                                                                                                                                                                            This element is affected by the following invariants: obs-6
                                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                            Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            490. Observation.component:allelic-state.interpretation
                                                                                                                                                                                            Definition

                                                                                                                                                                                            A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                            ShortHigh, low, normal, etc.
                                                                                                                                                                                            Comments

                                                                                                                                                                                            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                            Control0..*
                                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                            Codes identifying interpretations of observations.

                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                            Alternate NamesAbnormal Flag
                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            492. Observation.component:allelic-state.referenceRange
                                                                                                                                                                                            Definition

                                                                                                                                                                                            Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                            ShortProvides guide for interpretation of component result
                                                                                                                                                                                            Comments

                                                                                                                                                                                            Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                            Control0..*
                                                                                                                                                                                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                            Requirements

                                                                                                                                                                                            Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                            494. Observation.component:variant-inheritance
                                                                                                                                                                                            Slice Namevariant-inheritance
                                                                                                                                                                                            Definition

                                                                                                                                                                                            By which parent the variant was inherited in the patient, if known.

                                                                                                                                                                                            ShortVariant Inheritance
                                                                                                                                                                                            Comments

                                                                                                                                                                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                            Control0..1
                                                                                                                                                                                            TypeBackboneElement
                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                            Obligations
                                                                                                                                                                                              ObligationsActor
                                                                                                                                                                                              SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                              MAY:persistConsumer (Onconova)
                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              496. Observation.component:variant-inheritance.id
                                                                                                                                                                                              Definition

                                                                                                                                                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                              ShortUnique id for inter-element referencing
                                                                                                                                                                                              Control0..1
                                                                                                                                                                                              Typestring
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                              498. Observation.component:variant-inheritance.extension
                                                                                                                                                                                              Definition

                                                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                              ShortAdditional content defined by implementations
                                                                                                                                                                                              Comments

                                                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                              Control0..*
                                                                                                                                                                                              TypeExtension
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                              Alternate Namesextensions, user content
                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                              500. Observation.component:variant-inheritance.modifierExtension
                                                                                                                                                                                              Definition

                                                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                              Comments

                                                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                              Control0..*
                                                                                                                                                                                              TypeExtension
                                                                                                                                                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                              Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                              502. Observation.component:variant-inheritance.code
                                                                                                                                                                                              Definition

                                                                                                                                                                                              Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                              Shortvariant-inheritance
                                                                                                                                                                                              Comments

                                                                                                                                                                                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                              Control1..1
                                                                                                                                                                                              BindingFor example codes, see LOINCCodes
                                                                                                                                                                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                              Codes identifying names of simple observations.

                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                              Pattern Value{
                                                                                                                                                                                                "coding" : [{
                                                                                                                                                                                                  "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                                                                                                                                                                  "code" : "variant-inheritance"
                                                                                                                                                                                                }]
                                                                                                                                                                                              }
                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              504. Observation.component:variant-inheritance.value[x]
                                                                                                                                                                                              Definition

                                                                                                                                                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                              ShortMaternal | Paternal | Unknown
                                                                                                                                                                                              Comments

                                                                                                                                                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                              Control1..1
                                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from Variant Inheritances
                                                                                                                                                                                              (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/variant-inheritance-vs)
                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              506. Observation.component:variant-inheritance.dataAbsentReason
                                                                                                                                                                                              Definition

                                                                                                                                                                                              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                              ShortWhy the component result is missing
                                                                                                                                                                                              Comments

                                                                                                                                                                                              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                              Control0..1
                                                                                                                                                                                              This element is affected by the following invariants: obs-6
                                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                              Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              508. Observation.component:variant-inheritance.interpretation
                                                                                                                                                                                              Definition

                                                                                                                                                                                              A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                              ShortHigh, low, normal, etc.
                                                                                                                                                                                              Comments

                                                                                                                                                                                              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                              Control0..*
                                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                              Codes identifying interpretations of observations.

                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                              Alternate NamesAbnormal Flag
                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              510. Observation.component:variant-inheritance.referenceRange
                                                                                                                                                                                              Definition

                                                                                                                                                                                              Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                              ShortProvides guide for interpretation of component result
                                                                                                                                                                                              Comments

                                                                                                                                                                                              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                              Control0..*
                                                                                                                                                                                              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                              Requirements

                                                                                                                                                                                              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                              512. Observation.component:variation-code
                                                                                                                                                                                              Slice Namevariation-code
                                                                                                                                                                                              Definition

                                                                                                                                                                                              Accession number in a variant database such as ClinVar, given for cross-reference.

                                                                                                                                                                                              ShortVariation Code
                                                                                                                                                                                              Comments

                                                                                                                                                                                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                              Control0..*
                                                                                                                                                                                              TypeBackboneElement
                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                              Must Supporttrue
                                                                                                                                                                                              Obligations
                                                                                                                                                                                                ObligationsActor
                                                                                                                                                                                                SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                                MAY:persistConsumer (Onconova)
                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                514. Observation.component:variation-code.id
                                                                                                                                                                                                Definition

                                                                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                                                                Control0..1
                                                                                                                                                                                                Typestring
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                516. Observation.component:variation-code.extension
                                                                                                                                                                                                Definition

                                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                                                                Comments

                                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                TypeExtension
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                518. Observation.component:variation-code.modifierExtension
                                                                                                                                                                                                Definition

                                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                Comments

                                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                TypeExtension
                                                                                                                                                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                520. Observation.component:variation-code.code
                                                                                                                                                                                                Definition

                                                                                                                                                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                Short81252-9
                                                                                                                                                                                                Comments

                                                                                                                                                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                Control1..1
                                                                                                                                                                                                BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                Codes identifying names of simple observations.

                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Must Supporttrue
                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                Pattern Value{
                                                                                                                                                                                                  "coding" : [{
                                                                                                                                                                                                    "system" : "http://loinc.org",
                                                                                                                                                                                                    "code" : "81252-9"
                                                                                                                                                                                                  }]
                                                                                                                                                                                                }
                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                522. Observation.component:variation-code.value[x]
                                                                                                                                                                                                Definition

                                                                                                                                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                ShortClinVar ID or similar
                                                                                                                                                                                                Comments

                                                                                                                                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                Control1..1
                                                                                                                                                                                                Binding

                                                                                                                                                                                                Multiple bindings acceptable

                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Must Supporttrue
                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                524. Observation.component:variation-code.dataAbsentReason
                                                                                                                                                                                                Definition

                                                                                                                                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                ShortWhy the component result is missing
                                                                                                                                                                                                Comments

                                                                                                                                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                Control0..1
                                                                                                                                                                                                This element is affected by the following invariants: obs-6
                                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                526. Observation.component:variation-code.interpretation
                                                                                                                                                                                                Definition

                                                                                                                                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                ShortHigh, low, normal, etc.
                                                                                                                                                                                                Comments

                                                                                                                                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                Codes identifying interpretations of observations.

                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                Alternate NamesAbnormal Flag
                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                528. Observation.component:variation-code.referenceRange
                                                                                                                                                                                                Definition

                                                                                                                                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                ShortProvides guide for interpretation of component result
                                                                                                                                                                                                Comments

                                                                                                                                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                Requirements

                                                                                                                                                                                                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                530. Observation.component:chromosome-identifier
                                                                                                                                                                                                Slice Namechromosome-identifier
                                                                                                                                                                                                Definition

                                                                                                                                                                                                An indicator, enumerated in humans by numbers 1-22, X, and Y, representing the chromosome on which the variant is located.

                                                                                                                                                                                                ShortChromosome Identifier
                                                                                                                                                                                                Comments

                                                                                                                                                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                TypeBackboneElement
                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                Obligations
                                                                                                                                                                                                  ObligationsActor
                                                                                                                                                                                                  MAY:ignoreCreator (Onconova)
                                                                                                                                                                                                  MAY:persistConsumer (Onconova)
                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  532. Observation.component:chromosome-identifier.id
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                  ShortUnique id for inter-element referencing
                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                  Typestring
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                  534. Observation.component:chromosome-identifier.extension
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                  ShortAdditional content defined by implementations
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                  TypeExtension
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                  Alternate Namesextensions, user content
                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                  536. Observation.component:chromosome-identifier.modifierExtension
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                  TypeExtension
                                                                                                                                                                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                  Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                  538. Observation.component:chromosome-identifier.code
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                  Short48000-4
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                  Control1..1
                                                                                                                                                                                                  BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                  Codes identifying names of simple observations.

                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                  Pattern Value{
                                                                                                                                                                                                    "coding" : [{
                                                                                                                                                                                                      "system" : "http://loinc.org",
                                                                                                                                                                                                      "code" : "48000-4"
                                                                                                                                                                                                    }]
                                                                                                                                                                                                  }
                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  540. Observation.component:chromosome-identifier.value[x]
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                  ShortChromosome 1 | Chromosome 2 | ... | Chromosome 22 | Chromosome X | Chromosome Y
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                  Control1..1
                                                                                                                                                                                                  BindingThe codes SHALL be taken from LOINC Answer List LL2938-0
                                                                                                                                                                                                  (required to http://loinc.org/vs/LL2938-0)
                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  542. Observation.component:chromosome-identifier.dataAbsentReason
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                  ShortWhy the component result is missing
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                  The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                  This element is affected by the following invariants: obs-6
                                                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                  Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  544. Observation.component:chromosome-identifier.interpretation
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                  ShortHigh, low, normal, etc.
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                  Codes identifying interpretations of observations.

                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                  Alternate NamesAbnormal Flag
                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  546. Observation.component:chromosome-identifier.referenceRange
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                  ShortProvides guide for interpretation of component result
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                  TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                  548. Observation.component:protein-hgvs
                                                                                                                                                                                                  Slice Nameprotein-hgvs
                                                                                                                                                                                                  Definition

                                                                                                                                                                                                  Description of the protein (amino acid) sequence change using a valid HGVS-formatted string. The description of the variant is surrounded in parentheses if it is calculated rather than directly observed.

                                                                                                                                                                                                  ShortProtein (Amino Acid) Change - pHGVS
                                                                                                                                                                                                  Comments

                                                                                                                                                                                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                  TypeBackboneElement
                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                                  Obligations
                                                                                                                                                                                                    ObligationsActor
                                                                                                                                                                                                    SHALL:populate-if-knownCreator (Onconova)
                                                                                                                                                                                                    SHOULD:persistConsumer (Onconova)
                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    550. Observation.component:protein-hgvs.id
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                    ShortUnique id for inter-element referencing
                                                                                                                                                                                                    Control0..1
                                                                                                                                                                                                    Typestring
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                    552. Observation.component:protein-hgvs.extension
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                    ShortAdditional content defined by implementations
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                    TypeExtension
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                    Alternate Namesextensions, user content
                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                    554. Observation.component:protein-hgvs.modifierExtension
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                    TypeExtension
                                                                                                                                                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                    Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                    556. Observation.component:protein-hgvs.code
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                    Short48005-3
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                    Control1..1
                                                                                                                                                                                                    BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                    Codes identifying names of simple observations.

                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                    Pattern Value{
                                                                                                                                                                                                      "coding" : [{
                                                                                                                                                                                                        "system" : "http://loinc.org",
                                                                                                                                                                                                        "code" : "48005-3"
                                                                                                                                                                                                      }]
                                                                                                                                                                                                    }
                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    558. Observation.component:protein-hgvs.value[x]
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                    ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'p.' string, e.g. NP_000050.2:p.(Asn1836Lys)
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                    Control1..1
                                                                                                                                                                                                    BindingThe codes SHALL be taken from Human Genome Variation Society (HGVS) Nomenclature
                                                                                                                                                                                                    (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs)
                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    560. Observation.component:protein-hgvs.dataAbsentReason
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                    ShortWhy the component result is missing
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                    Control0..1
                                                                                                                                                                                                    This element is affected by the following invariants: obs-6
                                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                    Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    562. Observation.component:protein-hgvs.interpretation
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                    ShortHigh, low, normal, etc.
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                    Codes identifying interpretations of observations.

                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                    Alternate NamesAbnormal Flag
                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    564. Observation.component:protein-hgvs.referenceRange
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                    ShortProvides guide for interpretation of component result
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                    566. Observation.component:amino-acid-change-type
                                                                                                                                                                                                    Slice Nameamino-acid-change-type
                                                                                                                                                                                                    Definition

                                                                                                                                                                                                    Codified type for associated Amino Acid Marker, for convenience.

                                                                                                                                                                                                    ShortAmino Acid Change Type
                                                                                                                                                                                                    Comments

                                                                                                                                                                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                    Control0..1
                                                                                                                                                                                                    TypeBackboneElement
                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                                    Obligations
                                                                                                                                                                                                      ObligationsActor
                                                                                                                                                                                                      MAY:ignoreCreator (Onconova)
                                                                                                                                                                                                      MAY:persistConsumer (Onconova)
                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      568. Observation.component:amino-acid-change-type.id
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                      ShortUnique id for inter-element referencing
                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                      Typestring
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                      570. Observation.component:amino-acid-change-type.extension
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                      ShortAdditional content defined by implementations
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                      Alternate Namesextensions, user content
                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                      572. Observation.component:amino-acid-change-type.modifierExtension
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                      Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                      574. Observation.component:amino-acid-change-type.code
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                      Short48006-1
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                      Control1..1
                                                                                                                                                                                                      BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                      Codes identifying names of simple observations.

                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                      Pattern Value{
                                                                                                                                                                                                        "coding" : [{
                                                                                                                                                                                                          "system" : "http://loinc.org",
                                                                                                                                                                                                          "code" : "48006-1"
                                                                                                                                                                                                        }]
                                                                                                                                                                                                      }
                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      576. Observation.component:amino-acid-change-type.value[x]
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                      ShortWild type | Deletion | Duplication | Frameshift | Initiating Methionine | Insertion | Insertion and Deletion | Missense | Nonsense | Silent
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                      Control1..1
                                                                                                                                                                                                      BindingThe codes SHALL be taken from Amino Acid Change Type Value Set
                                                                                                                                                                                                      (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-amino-acid-change-types)
                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      578. Observation.component:amino-acid-change-type.dataAbsentReason
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                      ShortWhy the component result is missing
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                      The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                      This element is affected by the following invariants: obs-6
                                                                                                                                                                                                      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                      Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      580. Observation.component:amino-acid-change-type.interpretation
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                      ShortHigh, low, normal, etc.
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                      BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                      (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                      Codes identifying interpretations of observations.

                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                      Alternate NamesAbnormal Flag
                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      582. Observation.component:amino-acid-change-type.referenceRange
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                      ShortProvides guide for interpretation of component result
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                      TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                      Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                      584. Observation.component:molecular-consequence
                                                                                                                                                                                                      Slice Namemolecular-consequence
                                                                                                                                                                                                      Definition

                                                                                                                                                                                                      The calculated or observed effect of a variant on its downstream transcript and, if applicable, ensuing protein sequence.

                                                                                                                                                                                                      ShortMolecular Consequence
                                                                                                                                                                                                      Comments

                                                                                                                                                                                                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                      TypeBackboneElement
                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                                      Obligations
                                                                                                                                                                                                        ObligationsActor
                                                                                                                                                                                                        MAY:ignoreCreator (Onconova)
                                                                                                                                                                                                        MAY:persistConsumer (Onconova)
                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        586. Observation.component:molecular-consequence.id
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                        ShortUnique id for inter-element referencing
                                                                                                                                                                                                        Control0..1
                                                                                                                                                                                                        Typestring
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                        588. Observation.component:molecular-consequence.extension
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                        ShortAdditional content defined by implementations
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                        TypeExtension
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                        Alternate Namesextensions, user content
                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                        590. Observation.component:molecular-consequence.modifierExtension
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                        TypeExtension
                                                                                                                                                                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                        Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                        592. Observation.component:molecular-consequence.code
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                        Shortmolecular-consequence
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                        Control1..1
                                                                                                                                                                                                        BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                        Codes identifying names of simple observations.

                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Must Supporttrue
                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                        Pattern Value{
                                                                                                                                                                                                          "coding" : [{
                                                                                                                                                                                                            "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                                                                                                                                                                            "code" : "molecular-consequence"
                                                                                                                                                                                                          }]
                                                                                                                                                                                                        }
                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        594. Observation.component:molecular-consequence.value[x]
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                        Shortstop_lost | stop_gained | inframe_insertion | frameshift_variant | ... (many)
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                        Control1..1
                                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from Molecular Consequence
                                                                                                                                                                                                        (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/molecular-consequence-vs)

                                                                                                                                                                                                        Concepts in sequence ontology under SO:0001537.

                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Must Supporttrue
                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        596. Observation.component:molecular-consequence.dataAbsentReason
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                        ShortWhy the component result is missing
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                        The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                        Control0..1
                                                                                                                                                                                                        This element is affected by the following invariants: obs-6
                                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                        Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        598. Observation.component:molecular-consequence.interpretation
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                        ShortHigh, low, normal, etc.
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                        Codes identifying interpretations of observations.

                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                        Alternate NamesAbnormal Flag
                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        600. Observation.component:molecular-consequence.referenceRange
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                        ShortProvides guide for interpretation of component result
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                        TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                        Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                        602. Observation.component:copy-number
                                                                                                                                                                                                        Slice Namecopy-number
                                                                                                                                                                                                        Definition

                                                                                                                                                                                                        The copy number of the large variant. In HGVS, this is the numeric value following the “X”. It is a unit-less value. Note that a copy number of 1 can imply a deletion.

                                                                                                                                                                                                        ShortGenomic Structural Variant Copy Number
                                                                                                                                                                                                        Comments

                                                                                                                                                                                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                        Control0..1
                                                                                                                                                                                                        TypeBackboneElement
                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                        Must Supporttrue
                                                                                                                                                                                                        Obligations
                                                                                                                                                                                                          ObligationsActor
                                                                                                                                                                                                          SHALL:populate-if-knownCreator (Onconova)
                                                                                                                                                                                                          MAY:persistConsumer (Onconova)
                                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          604. Observation.component:copy-number.id
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                          ShortUnique id for inter-element referencing
                                                                                                                                                                                                          Control0..1
                                                                                                                                                                                                          Typestring
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                                          606. Observation.component:copy-number.extension
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                          ShortAdditional content defined by implementations
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                          Control0..*
                                                                                                                                                                                                          TypeExtension
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                                          Alternate Namesextensions, user content
                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                          608. Observation.component:copy-number.modifierExtension
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                          Control0..*
                                                                                                                                                                                                          TypeExtension
                                                                                                                                                                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                          Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                          610. Observation.component:copy-number.code
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                          Short82155-3
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                          Control1..1
                                                                                                                                                                                                          BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                          Codes identifying names of simple observations.

                                                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Must Supporttrue
                                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                          Pattern Value{
                                                                                                                                                                                                            "coding" : [{
                                                                                                                                                                                                              "system" : "http://loinc.org",
                                                                                                                                                                                                              "code" : "82155-3"
                                                                                                                                                                                                            }]
                                                                                                                                                                                                          }
                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          612. Observation.component:copy-number.value[x]
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                          ShortActual component result
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                          Control0..1
                                                                                                                                                                                                          TypeQuantity
                                                                                                                                                                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Must Supporttrue
                                                                                                                                                                                                          Summarytrue
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          cnt-3: There SHALL be a code with a value of '1' if there is a value. If system is present, it SHALL be UCUM. If present, the value SHALL be a whole number. ((code.exists() or value.empty()) and (system.empty() or system = %ucum) and (code.empty() or code = '1') and (value.empty() or value.hasValue().not() or value.toString().contains('.').not()))
                                                                                                                                                                                                          614. Observation.component:copy-number.dataAbsentReason
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                          ShortWhy the component result is missing
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                          The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                          Control0..1
                                                                                                                                                                                                          This element is affected by the following invariants: obs-6
                                                                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                          Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          616. Observation.component:copy-number.interpretation
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                          ShortHigh, low, normal, etc.
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                          Control0..*
                                                                                                                                                                                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                          Codes identifying interpretations of observations.

                                                                                                                                                                                                          TypeCodeableConcept
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                          Alternate NamesAbnormal Flag
                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          618. Observation.component:copy-number.referenceRange
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                          ShortProvides guide for interpretation of component result
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                          Control0..*
                                                                                                                                                                                                          TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Summaryfalse
                                                                                                                                                                                                          Requirements

                                                                                                                                                                                                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                          620. Observation.component:variant-confidence-status
                                                                                                                                                                                                          Slice Namevariant-confidence-status
                                                                                                                                                                                                          Definition

                                                                                                                                                                                                          A code that represents the confidence of a true positive variant call.

                                                                                                                                                                                                          ShortVariant Confidence Status
                                                                                                                                                                                                          Comments

                                                                                                                                                                                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                          Control0..1
                                                                                                                                                                                                          TypeBackboneElement
                                                                                                                                                                                                          Is Modifierfalse
                                                                                                                                                                                                          Obligations
                                                                                                                                                                                                            ObligationsActor
                                                                                                                                                                                                            SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                                            MAY:persistConsumer (Onconova)
                                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            622. Observation.component:variant-confidence-status.id
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                            ShortUnique id for inter-element referencing
                                                                                                                                                                                                            Control0..1
                                                                                                                                                                                                            Typestring
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                                            624. Observation.component:variant-confidence-status.extension
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                            ShortAdditional content defined by implementations
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                            Control0..*
                                                                                                                                                                                                            TypeExtension
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                                            Alternate Namesextensions, user content
                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                            626. Observation.component:variant-confidence-status.modifierExtension
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                            Control0..*
                                                                                                                                                                                                            TypeExtension
                                                                                                                                                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                            Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                            628. Observation.component:variant-confidence-status.code
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                            Shortvariant-confidence-status
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                            Control1..1
                                                                                                                                                                                                            BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                            Codes identifying names of simple observations.

                                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                            Pattern Value{
                                                                                                                                                                                                              "coding" : [{
                                                                                                                                                                                                                "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                                                                                                                                                                                "code" : "variant-confidence-status"
                                                                                                                                                                                                              }]
                                                                                                                                                                                                            }
                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            630. Observation.component:variant-confidence-status.value[x]
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                            ShortHigh | Intermediate | Low
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                            Control1..1
                                                                                                                                                                                                            BindingThe codes SHALL be taken from Variant Confidence Status
                                                                                                                                                                                                            (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/variant-confidence-status-vs)
                                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Summarytrue
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            632. Observation.component:variant-confidence-status.dataAbsentReason
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                            ShortWhy the component result is missing
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                            Control0..1
                                                                                                                                                                                                            This element is affected by the following invariants: obs-6
                                                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                            Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            634. Observation.component:variant-confidence-status.interpretation
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                            ShortHigh, low, normal, etc.
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                            Control0..*
                                                                                                                                                                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                            Codes identifying interpretations of observations.

                                                                                                                                                                                                            TypeCodeableConcept
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                            Alternate NamesAbnormal Flag
                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            636. Observation.component:variant-confidence-status.referenceRange
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                            ShortProvides guide for interpretation of component result
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                            Control0..*
                                                                                                                                                                                                            TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Summaryfalse
                                                                                                                                                                                                            Requirements

                                                                                                                                                                                                            Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                            638. Observation.component:clinical-relevance
                                                                                                                                                                                                            Slice Nameclinical-relevance
                                                                                                                                                                                                            Definition

                                                                                                                                                                                                            Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                                                                            ShortClinical relevance of the genomic variant
                                                                                                                                                                                                            Comments

                                                                                                                                                                                                            For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                            Control1..1
                                                                                                                                                                                                            TypeBackboneElement
                                                                                                                                                                                                            Is Modifierfalse
                                                                                                                                                                                                            Must Supporttrue
                                                                                                                                                                                                            Obligations
                                                                                                                                                                                                              ObligationsActor
                                                                                                                                                                                                              SHALL:populateCreator (Onconova)
                                                                                                                                                                                                              SHOULD:persistConsumer (Onconova)
                                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              640. Observation.component:clinical-relevance.id
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                              ShortUnique id for inter-element referencing
                                                                                                                                                                                                              Control0..1
                                                                                                                                                                                                              Typestring
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                                              642. Observation.component:clinical-relevance.extension
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                              ShortAdditional content defined by implementations
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                              Control0..*
                                                                                                                                                                                                              TypeExtension
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                                              Alternate Namesextensions, user content
                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                              644. Observation.component:clinical-relevance.modifierExtension
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                              Control0..*
                                                                                                                                                                                                              TypeExtension
                                                                                                                                                                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                              Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                              646. Observation.component:clinical-relevance.code
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                              ShortType of component observation (code / type)
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                              Control1..1
                                                                                                                                                                                                              BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                              Codes identifying names of simple observations.

                                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Must Supporttrue
                                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                              Pattern Value{
                                                                                                                                                                                                                "coding" : [{
                                                                                                                                                                                                                  "system" : "http://loinc.org",
                                                                                                                                                                                                                  "code" : "LL4034-6",
                                                                                                                                                                                                                  "display" : "ACMG_Clinical significance of genetic variation"
                                                                                                                                                                                                                }]
                                                                                                                                                                                                              }
                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              648. Observation.component:clinical-relevance.value[x]
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                              ShortActual component result
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                              Control0..1
                                                                                                                                                                                                              BindingThe codes SHALL be taken from Clinical Relevance Value Set
                                                                                                                                                                                                              (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-clinical-relevances)
                                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Must Supporttrue
                                                                                                                                                                                                              Summarytrue
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              650. Observation.component:clinical-relevance.dataAbsentReason
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                              ShortWhy the component result is missing
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                              Control0..1
                                                                                                                                                                                                              This element is affected by the following invariants: obs-6
                                                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                              Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              652. Observation.component:clinical-relevance.interpretation
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                              ShortHigh, low, normal, etc.
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                              Control0..*
                                                                                                                                                                                                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                              Codes identifying interpretations of observations.

                                                                                                                                                                                                              TypeCodeableConcept
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                              Alternate NamesAbnormal Flag
                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              654. Observation.component:clinical-relevance.referenceRange
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                              ShortProvides guide for interpretation of component result
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                              Control0..*
                                                                                                                                                                                                              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Summaryfalse
                                                                                                                                                                                                              Requirements

                                                                                                                                                                                                              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                              656. Observation.component:nucleotides-count
                                                                                                                                                                                                              Slice Namenucleotides-count
                                                                                                                                                                                                              Definition

                                                                                                                                                                                                              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                                                                              ShortLength of of the variant in nNucleotides
                                                                                                                                                                                                              Comments

                                                                                                                                                                                                              For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                              Control1..1
                                                                                                                                                                                                              TypeBackboneElement
                                                                                                                                                                                                              Is Modifierfalse
                                                                                                                                                                                                              Must Supporttrue
                                                                                                                                                                                                              Obligations
                                                                                                                                                                                                                ObligationsActor
                                                                                                                                                                                                                MAY:ignoreCreator (Onconova)
                                                                                                                                                                                                                MAY:persistConsumer (Onconova)
                                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                658. Observation.component:nucleotides-count.id
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                                ShortUnique id for inter-element referencing
                                                                                                                                                                                                                Control0..1
                                                                                                                                                                                                                Typestring
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                                660. Observation.component:nucleotides-count.extension
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                                ShortAdditional content defined by implementations
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                                TypeExtension
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                                Alternate Namesextensions, user content
                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                662. Observation.component:nucleotides-count.modifierExtension
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                                TypeExtension
                                                                                                                                                                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                                Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                664. Observation.component:nucleotides-count.code
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                                ShortType of component observation (code / type)
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                                Control1..1
                                                                                                                                                                                                                BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                                Codes identifying names of simple observations.

                                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Must Supporttrue
                                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                                Pattern Value{
                                                                                                                                                                                                                  "coding" : [{
                                                                                                                                                                                                                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                                                                                                                                                                    "code" : "C709",
                                                                                                                                                                                                                    "display" : "Nucleotides"
                                                                                                                                                                                                                  }]
                                                                                                                                                                                                                }
                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                666. Observation.component:nucleotides-count.value[x]
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                                ShortActual component result
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                                Control0..1
                                                                                                                                                                                                                Typeinteger
                                                                                                                                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                                                Must Supporttrue
                                                                                                                                                                                                                Summarytrue
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                668. Observation.component:nucleotides-count.dataAbsentReason
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                                ShortWhy the component result is missing
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                                Control0..1
                                                                                                                                                                                                                This element is affected by the following invariants: obs-6
                                                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                                Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                670. Observation.component:nucleotides-count.interpretation
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                                ShortHigh, low, normal, etc.
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                                Codes identifying interpretations of observations.

                                                                                                                                                                                                                TypeCodeableConcept
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                                Alternate NamesAbnormal Flag
                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                672. Observation.component:nucleotides-count.referenceRange
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                                ShortProvides guide for interpretation of component result
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Summaryfalse
                                                                                                                                                                                                                Requirements

                                                                                                                                                                                                                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                674. Observation.component:gene-region
                                                                                                                                                                                                                Slice Namegene-region
                                                                                                                                                                                                                Definition

                                                                                                                                                                                                                Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                                                                                ShortRegion (exon, intron, etc.) of the gene affected by the variant
                                                                                                                                                                                                                Comments

                                                                                                                                                                                                                For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                                Control0..*
                                                                                                                                                                                                                TypeBackboneElement
                                                                                                                                                                                                                Is Modifierfalse
                                                                                                                                                                                                                Must Supporttrue
                                                                                                                                                                                                                Obligations
                                                                                                                                                                                                                  ObligationsActor
                                                                                                                                                                                                                  SHALL:populateCreator (Onconova)
                                                                                                                                                                                                                  SHOULD:persistConsumer (Onconova)
                                                                                                                                                                                                                  MAY:ignoreCreator (Onconova)
                                                                                                                                                                                                                  MAY:persistConsumer (Onconova)
                                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  676. Observation.component:gene-region.id
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                                  ShortUnique id for inter-element referencing
                                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                                  Typestring
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                                  678. Observation.component:gene-region.extension
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                                  ShortAdditional content defined by implementations
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                                  TypeExtension
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                                  Alternate Namesextensions, user content
                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                  680. Observation.component:gene-region.modifierExtension
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                                  TypeExtension
                                                                                                                                                                                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                                  Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                  682. Observation.component:gene-region.code
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                                  ShortType of component observation (code / type)
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                                  Control1..1
                                                                                                                                                                                                                  BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                                  Codes identifying names of simple observations.

                                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                                  Pattern Value{
                                                                                                                                                                                                                    "coding" : [{
                                                                                                                                                                                                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                                                                                                                                                                      "code" : "C13445",
                                                                                                                                                                                                                      "display" : "Gene Feature"
                                                                                                                                                                                                                    }]
                                                                                                                                                                                                                  }
                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  684. Observation.component:gene-region.value[x]
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                                  ShortActual component result
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                                  Typestring
                                                                                                                                                                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                                                  Summarytrue
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  686. Observation.component:gene-region.dataAbsentReason
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                                  ShortWhy the component result is missing
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                                  The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                                  This element is affected by the following invariants: obs-6
                                                                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                                  Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  688. Observation.component:gene-region.interpretation
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                                  ShortHigh, low, normal, etc.
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                                  BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                                  (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                                  Codes identifying interpretations of observations.

                                                                                                                                                                                                                  TypeCodeableConcept
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                                  Alternate NamesAbnormal Flag
                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  690. Observation.component:gene-region.referenceRange
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                                  ShortProvides guide for interpretation of component result
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                                  Control0..*
                                                                                                                                                                                                                  TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Summaryfalse
                                                                                                                                                                                                                  Requirements

                                                                                                                                                                                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                  692. Observation.component:gene-panel-sequencing
                                                                                                                                                                                                                  Slice Namegene-panel-sequencing
                                                                                                                                                                                                                  Definition

                                                                                                                                                                                                                  Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                                                                                  ShortComponent results
                                                                                                                                                                                                                  Comments

                                                                                                                                                                                                                  For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                                  Control0..1
                                                                                                                                                                                                                  TypeBackboneElement
                                                                                                                                                                                                                  Is Modifierfalse
                                                                                                                                                                                                                  Must Supporttrue
                                                                                                                                                                                                                  Obligations
                                                                                                                                                                                                                    ObligationsActor
                                                                                                                                                                                                                    SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                                                    SHOULD:persistConsumer (Onconova)
                                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    694. Observation.component:gene-panel-sequencing.id
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                                    ShortUnique id for inter-element referencing
                                                                                                                                                                                                                    Control0..1
                                                                                                                                                                                                                    Typestring
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                                    696. Observation.component:gene-panel-sequencing.extension
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                                    ShortAdditional content defined by implementations
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                                    TypeExtension
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                                    Alternate Namesextensions, user content
                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                    698. Observation.component:gene-panel-sequencing.modifierExtension
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                                    TypeExtension
                                                                                                                                                                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                                    Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                    700. Observation.component:gene-panel-sequencing.code
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                                    ShortType of component observation (code / type)
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                                    Control1..1
                                                                                                                                                                                                                    BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                                    Codes identifying names of simple observations.

                                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                                    Pattern Value{
                                                                                                                                                                                                                      "coding" : [{
                                                                                                                                                                                                                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                                                                                                                                                                                                        "code" : "C165600",
                                                                                                                                                                                                                        "display" : "Tumor Panel Sequencing"
                                                                                                                                                                                                                      }]
                                                                                                                                                                                                                    }
                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    702. Observation.component:gene-panel-sequencing.value[x]
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                                    ShortSequencing Gene Panel
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                                    Control0..1
                                                                                                                                                                                                                    Typestring
                                                                                                                                                                                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                                                    Summarytrue
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    704. Observation.component:gene-panel-sequencing.dataAbsentReason
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                                    ShortWhy the component result is missing
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                                    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                                    Control0..1
                                                                                                                                                                                                                    This element is affected by the following invariants: obs-6
                                                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                                    Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    706. Observation.component:gene-panel-sequencing.interpretation
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                                    ShortHigh, low, normal, etc.
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                                    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                                    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                                    Codes identifying interpretations of observations.

                                                                                                                                                                                                                    TypeCodeableConcept
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                                    Alternate NamesAbnormal Flag
                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    708. Observation.component:gene-panel-sequencing.referenceRange
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                                    ShortProvides guide for interpretation of component result
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                                    Control0..*
                                                                                                                                                                                                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Summaryfalse
                                                                                                                                                                                                                    Requirements

                                                                                                                                                                                                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                    710. Observation.component:hgvs-version
                                                                                                                                                                                                                    Slice Namehgvs-version
                                                                                                                                                                                                                    Definition

                                                                                                                                                                                                                    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                                                                                    ShortHGVS Version
                                                                                                                                                                                                                    Comments

                                                                                                                                                                                                                    For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                                    Control1..1
                                                                                                                                                                                                                    TypeBackboneElement
                                                                                                                                                                                                                    Is Modifierfalse
                                                                                                                                                                                                                    Must Supporttrue
                                                                                                                                                                                                                    Obligations
                                                                                                                                                                                                                      ObligationsActor
                                                                                                                                                                                                                      SHALL:populateCreator (Onconova)
                                                                                                                                                                                                                      SHOULD:persistConsumer (Onconova)
                                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      712. Observation.component:hgvs-version.id
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                                      ShortUnique id for inter-element referencing
                                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                                      Typestring
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                                      714. Observation.component:hgvs-version.extension
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                                      ShortAdditional content defined by implementations
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                                      Alternate Namesextensions, user content
                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                      716. Observation.component:hgvs-version.modifierExtension
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                                      TypeExtension
                                                                                                                                                                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                                      Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                      718. Observation.component:hgvs-version.code
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                                      ShortType of component observation (code / type)
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                                      Control1..1
                                                                                                                                                                                                                      BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                                      Codes identifying names of simple observations.

                                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                                      Pattern Value{
                                                                                                                                                                                                                        "coding" : [{
                                                                                                                                                                                                                          "system" : "http://loinc.org",
                                                                                                                                                                                                                          "code" : "81303-0",
                                                                                                                                                                                                                          "display" : "HGVS version [ID]"
                                                                                                                                                                                                                        }]
                                                                                                                                                                                                                      }
                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      720. Observation.component:hgvs-version.value[x]
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                                      ShortActual component result
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                                      Typestring
                                                                                                                                                                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                                                      Summarytrue
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      722. Observation.component:hgvs-version.dataAbsentReason
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                                      ShortWhy the component result is missing
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                                      The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                                      This element is affected by the following invariants: obs-6
                                                                                                                                                                                                                      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                                      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                                      Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      724. Observation.component:hgvs-version.interpretation
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                                      ShortHigh, low, normal, etc.
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                                      BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                                      (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                                      Codes identifying interpretations of observations.

                                                                                                                                                                                                                      TypeCodeableConcept
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                                      Alternate NamesAbnormal Flag
                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      726. Observation.component:hgvs-version.referenceRange
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                                      ShortProvides guide for interpretation of component result
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                                      Control0..*
                                                                                                                                                                                                                      TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Summaryfalse
                                                                                                                                                                                                                      Requirements

                                                                                                                                                                                                                      Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                      728. Observation.component:rna-hgvs
                                                                                                                                                                                                                      Slice Namerna-hgvs
                                                                                                                                                                                                                      Definition

                                                                                                                                                                                                                      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                                                                                                                                                                      ShortComponent results
                                                                                                                                                                                                                      Comments

                                                                                                                                                                                                                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                                                                                                                                                                      Control0..1
                                                                                                                                                                                                                      TypeBackboneElement
                                                                                                                                                                                                                      Is Modifierfalse
                                                                                                                                                                                                                      Must Supporttrue
                                                                                                                                                                                                                      Obligations
                                                                                                                                                                                                                        ObligationsActor
                                                                                                                                                                                                                        SHOULD:populate-if-knownCreator (Onconova)
                                                                                                                                                                                                                        SHOULD:persistConsumer (Onconova)
                                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        730. Observation.component:rna-hgvs.id
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                                                                                                                                                                        ShortUnique id for inter-element referencing
                                                                                                                                                                                                                        Control0..1
                                                                                                                                                                                                                        Typestring
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                                        732. Observation.component:rna-hgvs.extension
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                                                                                                                                                                        ShortAdditional content defined by implementations
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                                        TypeExtension
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                                        Alternate Namesextensions, user content
                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                        734. Observation.component:rna-hgvs.modifierExtension
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                                                                                                                                                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                                                                                                                                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                                        TypeExtension
                                                                                                                                                                                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                                                                                                                                                                        Alternate Namesextensions, user content, modifiers
                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                                                                                                                                        736. Observation.component:rna-hgvs.code
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        Describes what was observed. Sometimes this is called the observation "code".

                                                                                                                                                                                                                        ShortType of component observation (code / type)
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                                                                                                                                                                        Control1..1
                                                                                                                                                                                                                        BindingFor example codes, see LOINCCodes
                                                                                                                                                                                                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                                                                                                                                                                                        Codes identifying names of simple observations.

                                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        Must Supporttrue
                                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        Knowing what kind of observation is being made is essential to understanding the observation.

                                                                                                                                                                                                                        Pattern Value{
                                                                                                                                                                                                                          "coding" : [{
                                                                                                                                                                                                                            "system" : "http://onconova.github.io/fhir/CodeSystem/onconova-cs-tbd",
                                                                                                                                                                                                                            "code" : "rna-hgvs",
                                                                                                                                                                                                                            "display" : "Transcript RNA change (rHGVS)"
                                                                                                                                                                                                                          }]
                                                                                                                                                                                                                        }
                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        738. Observation.component:rna-hgvs.value[x]
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        The information determined as a result of making the observation, if the information has a simple value.

                                                                                                                                                                                                                        ShortA valid HGVS-formatted (version >= {hgvs-version component}) 'r.' string, e.g. NM_005228.5:r.2369c>t
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                                                                                                                                                        Control0..1
                                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        Must Supporttrue
                                                                                                                                                                                                                        Summarytrue
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        740. Observation.component:rna-hgvs.dataAbsentReason
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                                                                                                                                                        ShortWhy the component result is missing
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                                                                                                                                                        The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                                                                                                                                                        Control0..1
                                                                                                                                                                                                                        This element is affected by the following invariants: obs-6
                                                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

                                                                                                                                                                                                                        Codes specifying why the result (Observation.value[x]) is missing.

                                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        For many results it is necessary to handle exceptional values in measurements.

                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        742. Observation.component:rna-hgvs.interpretation
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        A categorical assessment of an observation value. For example, high, low, normal.

                                                                                                                                                                                                                        ShortHigh, low, normal, etc.
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                                        BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                                                                                                                                                                                        (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                                                                                                                                                                                        Codes identifying interpretations of observations.

                                                                                                                                                                                                                        TypeCodeableConcept
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                                                                                                                                                                                                        Alternate NamesAbnormal Flag
                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                                                                                                                                        744. Observation.component:rna-hgvs.referenceRange
                                                                                                                                                                                                                        Definition

                                                                                                                                                                                                                        Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                                                                                                                                                        ShortProvides guide for interpretation of component result
                                                                                                                                                                                                                        Comments

                                                                                                                                                                                                                        Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                                                                                                                                                        Control0..*
                                                                                                                                                                                                                        TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                                                                                                                                                        Is Modifierfalse
                                                                                                                                                                                                                        Summaryfalse
                                                                                                                                                                                                                        Requirements

                                                                                                                                                                                                                        Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                                                                                                                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))