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: OnconovaImagingDiseaseStatus - Detailed Descriptions

Active as of 2026-03-18

Definitions for the onconova-imaging-disease-status 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.

ShortMeasurements 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-res-req-1: The subject element is required and must be provided. (subject.exists())
o-res-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
o-res-req-3: The valueCodeableConcept element is required and must be provided. (valueCodeableConcept.exists() and valueCodeableConcept.coding.exists())
o-res-req-4: The method element is required and must be provided. (method.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:evidenceType
Slice NameevidenceType
Definition

Categorization of the kind of evidence contributing to a clinical judgment on cancer disease progression.

ShortCancer Disease Status Evidence Type Extension
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(Cancer Disease Status Evidence Type Extension) (Extension Type: CodeableConcept)
Is Modifierfalse
Must Supporttrue
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:evidenceType.extension
Definition

An Extension


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.

ShortExtensionAdditional 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..0*
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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. Observation.extension:evidenceType.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    Fixed Valuehttp://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
    10. Observation.extension:evidenceType.value[x]
    Definition

    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortValue of extension
    Control10..1
    BindingThe codes SHALL be taken from For codes, see Cancer Disease Status Evidence Type Value Set
    (required to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-disease-status-evidence-type-vs)
    TypeCodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Summaryfalse
    Pattern Value{
      "coding" : [{
        "system" : "http://snomed.info/sct",
        "code" : "363679005",
        "display" : "Imaging (procedure)"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. 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())
    14. Observation.basedOn
    Definition

    Not used in this profile


    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.

    ShortNot used in this profileFulfills plan, proposal or order
    Control0..*
    TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest, 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()))
    16. Observation.partOf
    Definition

    Not used in this profile


    A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

    ShortNot used in this profilePart 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, 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()))
    18. 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()))
    20. 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.

    Control0..*
    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" : "imaging",
        "display" : "Imaging"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Observation.code
    Definition

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

    ShortType 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" : "97509-4"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. Observation.subject
    Definition

    Patient whose disease status is recorded.


    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()))
      26. Observation.focus
      Definition

      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.

      ShortWhat 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.

      Control10..*
      TypeReference(Primary Cancer Condition Profile, Secondary Cancer Condition Profile, Resource)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Obligations
        ObligationsActor
        SHALL:populateCreator (Onconova)
        SHOULD:persistConsumer (Onconova)
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. 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()))
        30. 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 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
        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.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(US Core Practitioner Profile, 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()))
          34. 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.

          Control10..1
          This element is affected by the following invariants: obs-7
          BindingThe codes SHALL be taken from For codes, see https://loinc.org/LL4721-8/
          (required to https://loinc.org/LL4721-8/)
          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
          Obligations
            ObligationsActor
            SHALL:populateCreator (Onconova)
            SHOULD:persistConsumer (Onconova)
            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()))
            36. Observation.value[x].extension:interpreted
            Slice Nameinterpreted
            Definition

            Indicates that whether the RECIST was interpreted from a radiology report rather than extracted.

            ShortTreatment Response RECIST Is Interpreted
            Control0..1
            TypeExtension(Treatment Response RECIST Is Interpreted) (Extension Type: boolean)
            Is Modifierfalse
            Must Supporttrue
            Obligations
              ObligationsActor
              SHOULD:populate-if-knownCreator (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())
              38. Observation.bodySite
              Definition

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

              ShortObserved 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
              BindingThe codes SHALL be taken from For example codes, see Observation Body Sites Value Sethttp://hl7.org/fhir/ValueSet/body-site|4.0.1
              (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-observation-bodysites)
              TypeCodeableConcept
              Is Modifierfalse
              Obligations
                ObligationsActor
                SHALL:populate-if-knownCreator (Onconova)
                SHOULD:persistConsumer (Onconova)
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                40. Observation.method
                Definition

                Indicates the mechanism used to perform the observation.

                ShortHow it was done
                Comments

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

                Control0..1
                BindingThe codes SHALL be taken from For example codes, see Cancer Imaging Methods Value Sethttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
                (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-cancer-imaging-methods)
                TypeCodeableConcept
                Is Modifierfalse
                Obligations
                  ObligationsActor
                  SHALL:populateCreator (Onconova)
                  SHOULD:persistConsumer (Onconova)
                  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()))
                  42. Observation.derivedFrom
                  Definition

                  Not used in this profile


                  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.

                  ShortNot used in this profileRelated 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, 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()))

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

                  0. Observation
                  Invariantso-res-req-1: The subject element is required and must be provided. (subject.exists())
                  o-res-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
                  o-res-req-3: The valueCodeableConcept element is required and must be provided. (valueCodeableConcept.exists() and valueCodeableConcept.coding.exists())
                  o-res-req-4: The method element is required and must be provided. (method.exists())
                  2. Observation.extension:evidenceType
                  Slice NameevidenceType
                  4. Observation.extension:evidenceType.value[x]
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://snomed.info/sct",
                      "code" : "363679005",
                      "display" : "Imaging (procedure)"
                    }]
                  }
                  6. Observation.basedOn
                  Definition

                  Not used in this profile

                  ShortNot used in this profile
                  8. Observation.partOf
                  Definition

                  Not used in this profile

                  ShortNot used in this profile
                  10. Observation.status
                  Definition

                  Not used in this profile

                  ShortNot used in this profile
                  12. Observation.category
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                      "code" : "imaging",
                      "display" : "Imaging"
                    }]
                  }
                  14. Observation.subject
                  TypeReference(Cancer Patient Profile)
                  Obligations
                    ObligationsActor
                    SHALL:populateCreator (Onconova)
                    SHOULD:persistConsumer (Onconova)
                    16. Observation.focus
                    Control1..?
                    TypeReference(Primary Cancer Condition Profile, Secondary Cancer Condition Profile)
                    Obligations
                      ObligationsActor
                      SHALL:populateCreator (Onconova)
                      SHOULD:persistConsumer (Onconova)
                      18. Observation.encounter
                      Definition

                      Not used in this profile

                      ShortNot used in this profile
                      20. Observation.effective[x]
                      Control1..?
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Obligations
                        ObligationsActor
                        SHALL:populateCreator (Onconova)
                        SHOULD:persistConsumer (Onconova)
                        22. Observation.performer
                        Definition

                        Not used in this profile

                        ShortNot used in this profile
                        24. Observation.value[x]
                        Control1..?
                        BindingThe codes SHALL be taken from https://loinc.org/LL4721-8/
                        (required to https://loinc.org/LL4721-8/)
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Obligations
                          ObligationsActor
                          SHALL:populateCreator (Onconova)
                          SHOULD:persistConsumer (Onconova)
                          26. Observation.value[x].extension:interpreted
                          Slice Nameinterpreted
                          Control0..1
                          TypeExtension(Treatment Response RECIST Is Interpreted) (Extension Type: boolean)
                          Must Supporttrue
                          Obligations
                            ObligationsActor
                            SHOULD:populate-if-knownCreator (Onconova)
                            SHOULD:persistConsumer (Onconova)
                            28. Observation.bodySite
                            BindingThe codes SHALL be taken from Observation Body Sites Value Set
                            (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-observation-bodysites)
                            Obligations
                              ObligationsActor
                              SHALL:populate-if-knownCreator (Onconova)
                              SHOULD:persistConsumer (Onconova)
                              30. Observation.method
                              BindingThe codes SHALL be taken from Cancer Imaging Methods Value Set
                              (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-cancer-imaging-methods)
                              Obligations
                                ObligationsActor
                                SHALL:populateCreator (Onconova)
                                SHOULD:persistConsumer (Onconova)
                                32. Observation.derivedFrom
                                Definition

                                Not used in this profile

                                ShortNot used in this 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.

                                ShortMeasurements 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-res-req-1: The subject element is required and must be provided. (subject.exists())
                                o-res-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
                                o-res-req-3: The valueCodeableConcept element is required and must be provided. (valueCodeableConcept.exists() and valueCodeableConcept.coding.exists())
                                o-res-req-4: The method element is required and must be provided. (method.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:evidenceType
                                  Slice NameevidenceType
                                  Definition

                                  Categorization of the kind of evidence contributing to a clinical judgment on cancer disease progression.

                                  ShortCancer Disease Status Evidence Type Extension
                                  Control0..*
                                  This element is affected by the following invariants: ele-1
                                  TypeExtension(Cancer Disease Status Evidence Type Extension) (Extension Type: CodeableConcept)
                                  Is Modifierfalse
                                  Must Supporttrue
                                  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:evidenceType.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
                                  20. Observation.extension:evidenceType.extension
                                  Definition

                                  An Extension

                                  ShortExtension
                                  Control0..0
                                  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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 22. Observation.extension:evidenceType.url
                                    Definition

                                    Source of the definition for the extension code - a logical name or a URL.

                                    Shortidentifies the meaning of the extension
                                    Comments

                                    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                    Control1..1
                                    Typeuri
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    Fixed Valuehttp://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
                                    24. Observation.extension:evidenceType.value[x]
                                    Definition

                                    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                    ShortValue of extension
                                    Control1..1
                                    BindingThe codes SHALL be taken from Cancer Disease Status Evidence Type Value Set
                                    (required to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-disease-status-evidence-type-vs)
                                    TypeCodeableConcept
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    Is Modifierfalse
                                    Summaryfalse
                                    Pattern Value{
                                      "coding" : [{
                                        "system" : "http://snomed.info/sct",
                                        "code" : "363679005",
                                        "display" : "Imaging (procedure)"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    26. 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())
                                    28. 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()))
                                    30. Observation.basedOn
                                    Definition

                                    Not used in this profile

                                    ShortNot used in this profile
                                    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()))
                                    32. Observation.partOf
                                    Definition

                                    Not used in this profile

                                    ShortNot used in this profile
                                    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()))
                                    34. 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()))
                                    36. 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.

                                    Control0..*
                                    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" : "imaging",
                                        "display" : "Imaging"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    38. Observation.code
                                    Definition

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

                                    ShortType 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 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" : "97509-4"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    40. Observation.subject
                                    Definition

                                    Patient whose disease status is recorded.

                                    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()))
                                      42. Observation.focus
                                      Definition

                                      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.

                                      ShortWhat 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.

                                      Control1..*
                                      TypeReference(Primary Cancer Condition Profile, Secondary Cancer Condition Profile)
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Must Support TypesNo must-support rules about the choice of types/profiles
                                      Obligations
                                        ObligationsActor
                                        SHALL:populateCreator (Onconova)
                                        SHOULD:persistConsumer (Onconova)
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        44. 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()))
                                        46. 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 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.

                                        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
                                        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()))
                                          48. Observation.issued
                                          Definition

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

                                          ShortDate/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()))
                                          50. Observation.performer
                                          Definition

                                          Not used in this profile

                                          ShortNot used in this profile
                                          Control0..*
                                          TypeReference(US Core Practitioner Profile)
                                          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()))
                                          52. 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.

                                          Control1..1
                                          This element is affected by the following invariants: obs-7
                                          BindingThe codes SHALL be taken from https://loinc.org/LL4721-8/
                                          (required to https://loinc.org/LL4721-8/)
                                          TypeCodeableConcept
                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Obligations
                                            ObligationsActor
                                            SHALL:populateCreator (Onconova)
                                            SHOULD:persistConsumer (Onconova)
                                            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()))
                                            54. Observation.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
                                            56. Observation.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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 58. Observation.value[x].extension:interpreted
                                              Slice Nameinterpreted
                                              Definition

                                              Indicates that whether the RECIST was interpreted from a radiology report rather than extracted.

                                              ShortTreatment Response RECIST Is Interpreted
                                              Control0..1
                                              TypeExtension(Treatment Response RECIST Is Interpreted) (Extension Type: boolean)
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Obligations
                                                ObligationsActor
                                                SHOULD:populate-if-knownCreator (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())
                                                60. Observation.value[x].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.

                                                Control0..*
                                                TypeCoding
                                                Is Modifierfalse
                                                Summarytrue
                                                Requirements

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

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

                                                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()))
                                                68. Observation.note
                                                Definition

                                                Comments about the observation or the results.

                                                ShortComments about the observation
                                                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.

                                                Control0..*
                                                TypeAnnotation
                                                Is Modifierfalse
                                                Summaryfalse
                                                Requirements

                                                Need to be able to provide free text additional information.

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

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

                                                ShortObserved 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
                                                BindingThe codes SHALL be taken from Observation Body Sites Value Set
                                                (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-observation-bodysites)
                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Obligations
                                                  ObligationsActor
                                                  SHALL:populate-if-knownCreator (Onconova)
                                                  SHOULD:persistConsumer (Onconova)
                                                  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.

                                                  ShortHow it was done
                                                  Comments

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

                                                  Control0..1
                                                  BindingThe codes SHALL be taken from Cancer Imaging Methods Value Set
                                                  (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-cancer-imaging-methods)
                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Obligations
                                                    ObligationsActor
                                                    SHALL:populateCreator (Onconova)
                                                    SHOULD:persistConsumer (Onconova)
                                                    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(Specimen)
                                                    Is Modifierfalse
                                                    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

                                                    Not used in this profile

                                                    ShortNot used in this profile
                                                    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

                                                    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..*
                                                    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()))
                                                    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()))