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: OnconovaCancerStage - Detailed Descriptions

Active as of 2026-03-18

Definitions for the onconova-cancer-stage 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.

Shortassessment observationMeasurements 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-stg-req-1: The subject element is required and must be provided. (subject.exists())
o-stg-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
o-stg-req-3: The valueCodeableConcept element is required and must be provided. (valueCodeableConcept.exists() and valueCodeableConcept.coding.exists())
o-stg-breslow: For Breslow stages, the exact Breslow depth must be provided. (code.coding.code = '106243009' implies value.extension('https://onconova.github.io/fhir/StructureDefinition/onconova-ext-cancer-stage-breslow-depth').valueQuantity.value.hasValue())
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.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())
6. 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()))
8. Observation.category
Definition

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

Short(USCDI) Classification of type of observationClassification of type of observation
Comments

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

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

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

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

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

    Short(USCDI) Classification of type of observationClassification 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 SHALL be taken from The codes SHOULD be taken from US Core Simple Observation Categoryhttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
    (required to http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category)

    Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


    Codes for high level observation categories.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

    Used for filtering what observations are retrieved and displayed.

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

    The kind of stage reported, e.g., a pathologic TNM stage, a Lugano lymphoma stage, or a Rai stage for leukemia. This element identifies the type of value that is reported in Observation.value and is necessary for the correct interpretation of that value. The distinction between Observation.code and Observation.method is important. Observation.code identifies the kind of stage being reported while Observation.method represents the staging system used to determine the code. Observation.code may imply the staging system. For example, the SNOMED CT 103420007 says the reported value is a modified Dukes stage, implying the Modified Dukes staging system (SNOMED CT 385359000) was used to determine the stage. When the staging system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a staging system (for example, if the code is SNOMED CT 385388004 Lymphoma stage), then the staging system must be specified in Observation.method. The value (Observation.valueCodeableConcept) may also imply certain things about the kind of stage being reported. For example, the value cN0 implies the value is a clinical stage. However, even if the value is partly or wholly self-identifying, it is not a reliable indicator of the type of stage being reported or the method of staging. Therefore, Observation.code must in all cases be reported.


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

    ShortThe type of stage information reported.Type 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
    BindingThe codes SHOULD be taken from For example codes, see Cancer Stage Type Value Sethttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
    (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-stage-type-vs)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

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

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

    The patient associated with staging assessment.


    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.

    Short(USCDI) Who and/or what the observation is aboutWho 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()))
      16. Observation.focus
      Definition

      Staging is associated with a particular primary cancer condition. Observation.focus is used to point back to that condition.


      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.

      ShortThe cancer condition associated with staging assessment.What 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, Resource)
      Is Modifierfalse
      Must Supporttrue
      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()))
        18. 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()))
        20. 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".


        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.

        Short(USCDI) Clinically relevant time/time-period for observationClinically relevant time/time-period for observation
        Comments

        At least a date should be present unless this observation is a historical report.


        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
        Must Support TypesdateTime
        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()))
          22. Observation.issued
          Definition

          Not used in this profile


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

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

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

          Control0..1
          Typeinstant
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          24. 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, US Core Organization Profile, US Core Patient Profile, PractitionerRole, US Core CareTeam Profile, US Core RelatedPerson Profile, Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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()))
          26. Observation.value[x]
          Definition

          The stage, stage group, category, or classification resulting from the staging evaluation.


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

          ShortThe value of the stageActual 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 SHOULD be taken from For codes, see Cancer Stage Value Set
          (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-stage-value-vs)
          TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesCodeableConceptQuantity
          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()))
            28. Observation.value[x].extension:breslowDepth
            Slice NamebreslowDepth
            Definition

            The actual measured Breslow depth as a quantity

            ShortCancer Stage Breslow Depth
            Control0..1
            TypeExtension(Cancer Stage Breslow Depth) (Extension Type: Quantity)
            Is Modifierfalse
            Must Supporttrue
            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()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              30. Observation.interpretation
              Definition

              Not used in this profile


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

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

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

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

              Codes identifying interpretations of observations.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

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

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

              Not used in this profile


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

              ShortNot used in this profileObserved body part
              Comments

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

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

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

              Codes describing anatomical locations. May include laterality.

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

              The staging system or protocol used to determine the stage, stage group, or category of the cancer based on its extent. When the staging system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a staging system (for example, if the code is SNOMED CT 385388004 Lymphoma stage), then the staging system must be specified in Observation.method.


              Indicates the mechanism used to perform the observation.

              ShortThe staging system used.How it was done
              Comments

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

              Control0..1
              BindingThe codes SHOULD be taken from For example codes, see Cancer Staging Method Value Sethttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
              (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-method-vs)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Obligations
                ObligationsActor
                SHALL:populate-if-knownCreator (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()))
                36. Observation.specimen
                Definition

                Not used in this profile


                The specimen that was used when this observation was made.

                ShortNot used in this profileSpecimen used for this observation
                Comments

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

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

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

                ShortComponent results
                Comments

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

                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()))
                SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ code
                • 40. 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())
                  42. Observation.component.code
                  Definition

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

                  ShortType of prognostic factorType 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
                  BindingThe codes SHOULD be taken from For example codes, see Cancer Staging Prognostic Factors Typeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                  (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-prognostic-factor-type-vs)
                  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()))
                  44. Observation.component:ulceration
                  Slice Nameulceration
                  Definition

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

                  ShortPresence of ulcerationComponent results
                  Comments

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

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

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

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

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

                    ShortType of prognostic factorType 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
                    BindingThe codes SHOULD be taken from For example codes, see Cancer Staging Prognostic Factors Typeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                    (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-prognostic-factor-type-vs)
                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Requirements

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

                    Pattern Value{
                      "coding" : [{
                        "system" : "http://loinc.org",
                        "code" : "105600-1",
                        "display" : "Ulceration status [Presence] in Tissue"
                      }]
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    50. Observation.component:ulceration.value[x]
                    Definition

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

                    ShortPrognostic factor valueActual component result
                    Comments

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

                    Control0..1
                    BindingThe codes SHALL be taken from For codes, see https://loinc.org/LL4443-9
                    (required to https://loinc.org/LL4443-9)
                    TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Requirements

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

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

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

                    0. Observation
                    Invariantso-stg-req-1: The subject element is required and must be provided. (subject.exists())
                    o-stg-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
                    o-stg-req-3: The valueCodeableConcept element is required and must be provided. (valueCodeableConcept.exists() and valueCodeableConcept.coding.exists())
                    o-stg-breslow: For Breslow stages, the exact Breslow depth must be provided. (code.coding.code = '106243009' implies value.extension('https://onconova.github.io/fhir/StructureDefinition/onconova-ext-cancer-stage-breslow-depth').valueQuantity.value.hasValue())
                    2. Observation.status
                    Definition

                    Not used in this profile

                    ShortNot used in this profile
                    4. Observation.subject
                    TypeReference(Cancer Patient Profile)
                    Obligations
                      ObligationsActor
                      SHALL:populateCreator (Onconova)
                      SHOULD:persistConsumer (Onconova)
                      6. Observation.focus
                      Control1..?
                      TypeReference(Primary Cancer Condition Profile)
                      Obligations
                        ObligationsActor
                        SHALL:populateCreator (Onconova)
                        SHOULD:persistConsumer (Onconova)
                        8. Observation.encounter
                        Definition

                        Not used in this profile

                        ShortNot used in this profile
                        10. Observation.effective[x]
                        Control1..?
                        TypedateTime, Period, Timing, instant
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Obligations
                          ObligationsActor
                          SHALL:populateCreator (Onconova)
                          SHOULD:persistConsumer (Onconova)
                          12. Observation.issued
                          Definition

                          Not used in this profile

                          ShortNot used in this profile
                          14. Observation.performer
                          Definition

                          Not used in this profile

                          ShortNot used in this profile
                          16. Observation.value[x]
                          Control1..?
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Obligations
                            ObligationsActor
                            SHALL:populateCreator (Onconova)
                            SHOULD:persistConsumer (Onconova)
                            18. Observation.value[x].extension:breslowDepth
                            Slice NamebreslowDepth
                            Control0..1
                            TypeExtension(Cancer Stage Breslow Depth) (Extension Type: Quantity)
                            Must Supporttrue
                            Obligations
                              ObligationsActor
                              SHALL:populate-if-knownCreator (Onconova)
                              SHOULD:persistConsumer (Onconova)
                              20. Observation.interpretation
                              Definition

                              Not used in this profile

                              ShortNot used in this profile
                              22. Observation.bodySite
                              Definition

                              Not used in this profile

                              ShortNot used in this profile
                              24. Observation.method
                              Obligations
                                ObligationsActor
                                SHALL:populate-if-knownCreator (Onconova)
                                SHOULD:persistConsumer (Onconova)
                                26. Observation.specimen
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                28. Observation.component
                                SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ code
                                • 30. Observation.component:ulceration
                                  Slice Nameulceration
                                  ShortPresence of ulceration
                                  Control0..1
                                  Must Supporttrue
                                  Obligations
                                    ObligationsActor
                                    SHOULD:populate-if-knownCreator (Onconova)
                                    SHOULD:persistConsumer (Onconova)
                                    32. Observation.component:ulceration.code
                                    Must Supporttrue
                                    Pattern Value{
                                      "coding" : [{
                                        "system" : "http://loinc.org",
                                        "code" : "105600-1",
                                        "display" : "Ulceration status [Presence] in Tissue"
                                      }]
                                    }
                                    34. Observation.component:ulceration.value[x]
                                    BindingThe codes SHALL be taken from https://loinc.org/LL4443-9
                                    (required to https://loinc.org/LL4443-9)
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    Must Supporttrue

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

                                    0. Observation
                                    Definition

                                    -

                                    Shortassessment observation
                                    Comments

                                    -

                                    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-stg-req-1: The subject element is required and must be provided. (subject.exists())
                                    o-stg-req-2: The effectiveDateTime element is required and must be provided. (effectiveDateTime.exists() and effectiveDateTime.hasValue())
                                    o-stg-req-3: The valueCodeableConcept element is required and must be provided. (valueCodeableConcept.exists() and valueCodeableConcept.coding.exists())
                                    o-stg-breslow: For Breslow stages, the exact Breslow depth must be provided. (code.coding.code = '106243009' implies value.extension('https://onconova.github.io/fhir/StructureDefinition/onconova-ext-cancer-stage-breslow-depth').valueQuantity.value.hasValue())
                                    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

                                    May be used to represent additional information that is not part of the basic definition of the resource. 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())
                                    16. 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())
                                    18. 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()))
                                    20. Observation.basedOn
                                    Definition

                                    A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

                                    ShortFulfills plan, proposal or order
                                    Control0..*
                                    TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

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

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

                                    ShortPart of referenced event
                                    Comments

                                    To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

                                    Control0..*
                                    TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                                    Is Modifierfalse
                                    Summarytrue
                                    Alternate NamesContainer
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    24. 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()))
                                    26. Observation.category
                                    Definition

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

                                    Short(USCDI) Classification of type of observation
                                    Comments

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

                                    Control1..*
                                    BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                    (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                    Codes for high level observation categories.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summaryfalse
                                    Requirements

                                    Used for filtering what observations are retrieved and displayed.

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

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

                                      Short(USCDI) Classification 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 SHALL be taken from US Core Simple Observation Category
                                      (required to http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category)

                                      Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summaryfalse
                                      Requirements

                                      Used for filtering what observations are retrieved and displayed.

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

                                      The kind of stage reported, e.g., a pathologic TNM stage, a Lugano lymphoma stage, or a Rai stage for leukemia. This element identifies the type of value that is reported in Observation.value and is necessary for the correct interpretation of that value. The distinction between Observation.code and Observation.method is important. Observation.code identifies the kind of stage being reported while Observation.method represents the staging system used to determine the code. Observation.code may imply the staging system. For example, the SNOMED CT 103420007 says the reported value is a modified Dukes stage, implying the Modified Dukes staging system (SNOMED CT 385359000) was used to determine the stage. When the staging system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a staging system (for example, if the code is SNOMED CT 385388004 Lymphoma stage), then the staging system must be specified in Observation.method. The value (Observation.valueCodeableConcept) may also imply certain things about the kind of stage being reported. For example, the value cN0 implies the value is a clinical stage. However, even if the value is partly or wholly self-identifying, it is not a reliable indicator of the type of stage being reported or the method of staging. Therefore, Observation.code must in all cases be reported.

                                      ShortThe type of stage information reported.
                                      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
                                      BindingThe codes SHOULD be taken from Cancer Stage Type Value Set
                                      (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-stage-type-vs)
                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

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

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

                                      The patient associated with staging assessment.

                                      Short(USCDI) Who 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()))
                                        34. Observation.focus
                                        Definition

                                        Staging is associated with a particular primary cancer condition. Observation.focus is used to point back to that condition.

                                        ShortThe cancer condition associated with staging assessment.
                                        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)
                                        Is Modifierfalse
                                        Must Supporttrue
                                        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()))
                                          36. 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()))
                                          38. 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".

                                          Short(USCDI) Clinically relevant time/time-period for observation
                                          Comments

                                          At least a date should be present unless this observation is a historical report.

                                          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
                                          Must Support TypesdateTime
                                          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()))
                                            40. Observation.issued
                                            Definition

                                            Not used in this profile

                                            ShortNot used in this profile
                                            Comments

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

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

                                            Not used in this profile

                                            ShortNot used in this profile
                                            Control0..*
                                            TypeReference(US Core Practitioner Profile, US Core Organization Profile, US Core Patient Profile, PractitionerRole, US Core CareTeam Profile, US Core RelatedPerson Profile)
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Must Support TypesNo must-support rules about the choice of types/profiles
                                            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()))
                                            44. Observation.value[x]
                                            Definition

                                            The stage, stage group, category, or classification resulting from the staging evaluation.

                                            ShortThe value of the stage
                                            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 SHOULD be taken from Cancer Stage Value Set
                                            (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-stage-value-vs)
                                            TypeCodeableConcept
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Must Support TypesCodeableConcept
                                            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()))
                                              46. 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
                                              48. 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
                                              • 50. Observation.value[x].extension:breslowDepth
                                                Slice NamebreslowDepth
                                                Definition

                                                The actual measured Breslow depth as a quantity

                                                ShortCancer Stage Breslow Depth
                                                Control0..1
                                                TypeExtension(Cancer Stage Breslow Depth) (Extension Type: Quantity)
                                                Is Modifierfalse
                                                Must Supporttrue
                                                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()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  52. 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()))
                                                  54. 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()))
                                                  56. 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()))
                                                  58. Observation.interpretation
                                                  Definition

                                                  Not used in this profile

                                                  ShortNot used in this profile
                                                  Comments

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

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

                                                  Codes identifying interpretations of observations.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

                                                  Alternate NamesAbnormal Flag
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  60. 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()))
                                                  62. Observation.bodySite
                                                  Definition

                                                  Not used in this profile

                                                  ShortNot used in this profile
                                                  Comments

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

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

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

                                                  Codes describing anatomical locations. May include laterality.

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

                                                  The staging system or protocol used to determine the stage, stage group, or category of the cancer based on its extent. When the staging system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a staging system (for example, if the code is SNOMED CT 385388004 Lymphoma stage), then the staging system must be specified in Observation.method.

                                                  ShortThe staging system used.
                                                  Comments

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

                                                  Control0..1
                                                  BindingThe codes SHOULD be taken from Cancer Staging Method Value Set
                                                  (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-method-vs)
                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Obligations
                                                    ObligationsActor
                                                    SHALL:populate-if-knownCreator (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()))
                                                    66. 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()))
                                                    68. 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()))
                                                    70. 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())
                                                    72. 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
                                                    74. 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())
                                                    76. 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())
                                                    78. 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()))
                                                    80. 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()))
                                                    82. 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()))
                                                    84. 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()))
                                                    86. 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()))
                                                    88. 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()))
                                                    90. Observation.hasMember
                                                    Definition

                                                    References to the prognostic factors affecting the stage, for example, the T, N, and M categories.

                                                    ShortPrognostic factors contributing to stage determination.
                                                    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()))
                                                    92. Observation.derivedFrom
                                                    Definition

                                                    US Core Observations, DocumentReference, QuestionnaireResponse or other resource from which this observation value is derived.

                                                    Short(USCDI) US Core Profiles or other resource 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(Observation, US Core DocumentReference Profile, US Core QuestionnaireResponse Profile, ImagingStudy, Media, MolecularSequence)
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    94. Observation.component
                                                    Definition

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

                                                    ShortComponent results
                                                    Comments

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

                                                    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()))
                                                    SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                    • value @ code
                                                    • 96. 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
                                                      98. 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())
                                                      100. 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())
                                                      102. Observation.component.code
                                                      Definition

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

                                                      ShortType of prognostic factor
                                                      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
                                                      BindingThe codes SHOULD be taken from Cancer Staging Prognostic Factors Types
                                                      (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-prognostic-factor-type-vs)
                                                      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()))
                                                      104. Observation.component.value[x]
                                                      Definition

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

                                                      ShortPrognostic factor value
                                                      Comments

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

                                                      Control0..1
                                                      BindingThe codes SHOULD be taken from Cancer Staging Prognostic Factors Value
                                                      (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-prognostic-factor-value-vs)
                                                      TypeCodeableConcept
                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                      Is Modifierfalse
                                                      Summarytrue
                                                      Requirements

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

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      106. 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()))
                                                      108. 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()))
                                                      110. 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()))
                                                      112. Observation.component:ulceration
                                                      Slice Nameulceration
                                                      Definition

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

                                                      ShortPresence of ulceration
                                                      Comments

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

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

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

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        114. Observation.component:ulceration.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
                                                        116. Observation.component:ulceration.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())
                                                        118. Observation.component:ulceration.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())
                                                        120. Observation.component:ulceration.code
                                                        Definition

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

                                                        ShortType of prognostic factor
                                                        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
                                                        BindingThe codes SHOULD be taken from Cancer Staging Prognostic Factors Types
                                                        (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-cancer-staging-prognostic-factor-type-vs)
                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summarytrue
                                                        Requirements

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

                                                        Pattern Value{
                                                          "coding" : [{
                                                            "system" : "http://loinc.org",
                                                            "code" : "105600-1",
                                                            "display" : "Ulceration status [Presence] in Tissue"
                                                          }]
                                                        }
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        122. Observation.component:ulceration.value[x]
                                                        Definition

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

                                                        ShortPrognostic factor value
                                                        Comments

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

                                                        Control0..1
                                                        BindingThe codes SHALL be taken from https://loinc.org/LL4443-9
                                                        (required to https://loinc.org/LL4443-9)
                                                        TypeCodeableConcept
                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summarytrue
                                                        Requirements

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

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        124. Observation.component:ulceration.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()))
                                                        126. Observation.component:ulceration.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()))
                                                        128. Observation.component:ulceration.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()))