FHIR Osiris Implementation Guide
2.1.0 - ci-build

FHIR Osiris Implementation Guide - Local Development build (v2.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Expression - Detailed Descriptions

Draft as of 2024-03-21

Definitions for the expression resource profile.

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

0. Observation
2. Observation.extension:strandBias
Slice NamestrandBias
ShortType of the expression value corresponding to the level of data processing
Control0..1
TypeExtension(Gene Expression Data Type) (Extension Type: CodeableConcept)
Must Supporttrue
4. Observation.code
Pattern Value{
  "coding" : [{
    "system" : "http://terminology.hl7.org/CodeSystem/umls",
    "code" : "C0017262"
  }]
}
6. Observation.subject
TypeReference(Oncology Patient)
8. Observation.derivedFrom
Control1..?
SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ reference
  • 10. Observation.derivedFrom:analysis
    Slice Nameanalysis
    ShortAnalysis from which come this observation
    Control1..1
    TypeReference(Sequencing Analysis)
    12. Observation.component
    Control1..?
    SlicingThis element introduces a set of slices on Observation.component. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • pattern @ code
    • 14. Observation.component:actionability
      Slice Nameactionability
      ShortConclusion of the clinicians wether the variant is actionable or not during the Molecular Tumor Board
      Control0..1
      16. Observation.component:actionability.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "93348-1"
        }]
      }
      18. Observation.component:actionability.value[x]
      Typeboolean
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      20. Observation.component:proposed-for-orientation
      Slice Nameproposed-for-orientation
      ShortIs the ClinicalTumorBoardConclusion used to orient the treatment decision ?
      Control0..1
      22. Observation.component:proposed-for-orientation.code
      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/umls",
          "code" : "C0449889"
        }]
      }
      24. Observation.component:proposed-for-orientation.value[x]
      Typeboolean
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      26. Observation.component:pathogenicity
      Slice Namepathogenicity
      ShortConclusion of the biologist on the pathogenicity of the variant before the Molecular Tumor Board
      Control0..1
      28. Observation.component:pathogenicity.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "74019-1"
        }]
      }
      30. Observation.component:pathogenicity.value[x]
      BindingThe codes SHALL be taken from Pathogenicity Value Set
      (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/Pathogenicity)
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      32. Observation.component:gene-studied
      Slice Namegene-studied
      Definition

      HUGO Gene Nomenclature Committee (HGNC) identifier for a gene. List the gene(s) examined in full or in part by the study. If the study addresses multiple genes, these can be recorded in multiple gene studied components. The required coding will use the HGNC gene symbol as the display text and HGNC gene ID as the code.

      ShortGene studied [ID]
      Control0..*
      34. Observation.component:gene-studied.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "48018-6"
        }]
      }
      36. Observation.component:gene-studied.value[x]
      ShortIf no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
      Control1..?
      BindingUnless not suitable, these codes SHALL be taken from HGNC
      (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc)
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      38. Observation.component:gene-expression
      Slice Namegene-expression
      ShortNumerical value for expression
      Control1..1
      40. Observation.component:gene-expression.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "94820-8"
        }]
      }
      42. Observation.component:gene-expression.value[x]
      Typeinteger
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

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

      0. Observation
      Definition

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

      ShortMeasurements and simple assertions
      Comments

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

      Control0..*
      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-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-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-6: A resource should have narrative for robust management (text.`div`.exists())
      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.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())
      obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.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
      This element is affected by the following invariants: ele-1
      Typeuri
      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      4. Observation.extension:strandBias
      Slice NamestrandBias
      Definition

      Type of the expression value corresponding to the level of data processing

      ShortType of the expression value corresponding to the level of data processing
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Gene Expression Data Type) (Extension Type: CodeableConcept)
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      6. 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..*
      This element is affected by the following invariants: ele-1
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Standards StatusNormative (from Normative)
      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())
      SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 8. Observation.status
        Definition

        The status of the result value.

        Shortregistered | 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
        This element is affected by the following invariants: ele-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
        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()))
        10. Observation.code
        Definition

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

        ShortType of observation (code / type)
        Comments

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

        Control1..1
        This element is affected by the following invariants: ele-1
        BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
        (example to http://hl7.org/fhir/ValueSet/observation-codes)

        Codes identifying names of simple observations.

        TypeCodeableConcept
        Summarytrue
        Requirements

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

        Alternate NamesName
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/umls",
            "code" : "C0017262"
          }]
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        12. Observation.subject
        Definition

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

        ShortWho and/or what the observation is about
        Comments

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

        Control0..1
        This element is affected by the following invariants: ele-1
        TypeReference(Oncology Patient, Patient, Group, Device, Location)
        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()))
        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
        14. Observation.value[x]
        Definition

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

        ShortActual result
        Comments

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

        Control0..1
        This element is affected by the following invariants: ele-1, obs-7
        TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
        [x] NoteSee Choice of Data Types for further information about how to use [x]
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

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

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. 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: ele-1, obs-6
        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

        TypeCodeableConcept
        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()))
        18. Observation.derivedFrom
        Definition

        The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

        ShortRelated measurements the observation is made from
        Comments

        All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

        Control10..*
        This element is affected by the following invariants: ele-1
        TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
        SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • pattern @ reference
        • 20. Observation.derivedFrom:analysis
          Slice Nameanalysis
          Definition

          The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

          ShortAnalysis from which come this observationRelated measurements the observation is made from
          Comments

          All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

          Control10..1*
          This element is affected by the following invariants: ele-1
          TypeReference(Sequencing Analysis, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
          22. 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.

          Control10..*
          This element is affected by the following invariants: ele-1
          TypeBackboneElement
          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 are unordered and Open, and can be differentiated using the following discriminators:
          • pattern @ code
          • 24. 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..*
            This element is affected by the following invariants: ele-1
            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())
            26. Observation.component.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            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()))
            28. 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: ele-1, obs-6
            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            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()))
            30. Observation.component:actionability
            Slice Nameactionability
            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.

            ShortConclusion of the clinicians wether the variant is actionable or not during the Molecular Tumor BoardComponent results
            Comments

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

            Control0..1*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            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()))
            32. Observation.component:actionability.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..*
            This element is affected by the following invariants: ele-1
            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())
            34. Observation.component:actionability.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Summarytrue
            Requirements

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

            Pattern Value{
              "coding" : [{
                "system" : "http://loinc.org",
                "code" : "93348-1"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            36. Observation.component:actionability.value[x]
            Definition

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

            ShortActual component result
            Comments

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

            Control0..1
            This element is affected by the following invariants: ele-1
            Typeboolean, dateTime, string, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            38. Observation.component:actionability.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: ele-1, obs-6
            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            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()))
            40. Observation.component:proposed-for-orientation
            Slice Nameproposed-for-orientation
            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.

            ShortIs the ClinicalTumorBoardConclusion used to orient the treatment decision ?Component results
            Comments

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

            Control0..1*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            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()))
            42. Observation.component:proposed-for-orientation.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..*
            This element is affected by the following invariants: ele-1
            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())
            44. Observation.component:proposed-for-orientation.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Summarytrue
            Requirements

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

            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/umls",
                "code" : "C0449889"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            46. Observation.component:proposed-for-orientation.value[x]
            Definition

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

            ShortActual component result
            Comments

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

            Control0..1
            This element is affected by the following invariants: ele-1
            Typeboolean, dateTime, string, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            48. Observation.component:proposed-for-orientation.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: ele-1, obs-6
            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            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()))
            50. Observation.component:pathogenicity
            Slice Namepathogenicity
            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.

            ShortConclusion of the biologist on the pathogenicity of the variant before the Molecular Tumor BoardComponent results
            Comments

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

            Control0..1*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            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()))
            52. Observation.component:pathogenicity.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..*
            This element is affected by the following invariants: ele-1
            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())
            54. Observation.component:pathogenicity.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Summarytrue
            Requirements

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

            Pattern Value{
              "coding" : [{
                "system" : "http://loinc.org",
                "code" : "74019-1"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. Observation.component:pathogenicity.value[x]
            Definition

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

            ShortActual component result
            Comments

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

            Control0..1
            This element is affected by the following invariants: ele-1
            BindingThe codes SHALL be taken from For codes, see Pathogenicity Value Set
            (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/Pathogenicity)
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            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()))
            58. Observation.component:pathogenicity.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: ele-1, obs-6
            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            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()))
            60. Observation.component:gene-studied
            Slice Namegene-studied
            Definition

            HUGO Gene Nomenclature Committee (HGNC) identifier for a gene. List the gene(s) examined in full or in part by the study. If the study addresses multiple genes, these can be recorded in multiple gene studied components. The required coding will use the HGNC gene symbol as the display text and HGNC gene ID as the code.


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

            ShortGene studied [ID]Component results
            Comments

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

            Control0..*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            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()))
            62. Observation.component:gene-studied.modifierExtension
            Definition

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

            Control0..*
            This element is affected by the following invariants: ele-1
            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())
            64. Observation.component:gene-studied.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Summarytrue
            Requirements

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

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

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

            ShortIf no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.Actual component result
            Comments

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

            Control10..1
            This element is affected by the following invariants: ele-1
            BindingUnless not suitable, these codes SHALL be taken from For codes, see HGNC
            (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc)
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            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()))
            68. Observation.component:gene-studied.dataAbsentReason
            Definition

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

            ShortWhy the component result is missing
            Comments

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

            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

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

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

            TypeCodeableConcept
            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()))
            70. Observation.component:gene-expression
            Slice Namegene-expression
            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.

            ShortNumerical value for expressionComponent results
            Comments

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

            Control10..1*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            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()))
            72. Observation.component:gene-expression.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..*
            This element is affected by the following invariants: ele-1
            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())
            74. Observation.component:gene-expression.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Summarytrue
            Requirements

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

            Pattern Value{
              "coding" : [{
                "system" : "http://loinc.org",
                "code" : "94820-8"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. Observation.component:gene-expression.value[x]
            Definition

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

            ShortActual component result
            Comments

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

            Control0..1
            This element is affected by the following invariants: ele-1
            Typeinteger, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, time, Range, CodeableConcept
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            78. Observation.component:gene-expression.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: ele-1, obs-6
            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            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()))

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

            0. Observation
            Definition

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

            ShortMeasurements and simple assertions
            Comments

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

            Control0..*
            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-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-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-6: A resource should have narrative for robust management (text.`div`.exists())
            dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.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())
            obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
            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
            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
            This element is affected by the following invariants: ele-1
            TypeMeta
            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
            This element is affected by the following invariants: ele-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
            This element is affected by the following invariants: ele-1
            BindingThe codes SHOULD be taken from CommonLanguages
            (preferred to http://hl7.org/fhir/ValueSet/languages)

            A human language.

            Additional BindingsPurpose
            AllLanguagesMax Binding
            Typecode
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            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
            This element is affected by the following invariants: ele-1
            TypeNarrative
            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
            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..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Standards StatusNormative (from Normative)
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on Observation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 16. Observation.extension:strandBias
              Slice NamestrandBias
              Definition

              Type of the expression value corresponding to the level of data processing

              ShortType of the expression value corresponding to the level of data processing
              Control0..1
              This element is affected by the following invariants: ele-1
              TypeExtension(Gene Expression Data Type) (Extension Type: CodeableConcept)
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              18. Observation.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..*
              This element is affected by the following invariants: ele-1
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
              Standards StatusNormative (from Normative)
              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())
              SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 20. 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..*
                This element is affected by the following invariants: ele-1
                TypeIdentifier
                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()))
                22. 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
                Comments

                References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                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()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                24. 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..*
                This element is affected by the following invariants: ele-1
                TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                Summarytrue
                Alternate NamesContainer
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                26. Observation.status
                Definition

                The status of the result value.

                Shortregistered | 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
                This element is affected by the following invariants: ele-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
                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()))
                28. Observation.category
                Definition

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

                ShortClassification of type of observation
                Comments

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

                Control0..*
                This element is affected by the following invariants: ele-1
                BindingThe codes SHOULD be taken from ObservationCategoryCodes
                (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                Codes for high level observation categories.

                TypeCodeableConcept
                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

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

                ShortType of observation (code / type)
                Comments

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

                Control1..1
                This element is affected by the following invariants: ele-1
                BindingFor example codes, see LOINCCodes
                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                Codes identifying names of simple observations.

                TypeCodeableConcept
                Summarytrue
                Requirements

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

                Alternate NamesName
                Pattern Value{
                  "coding" : [{
                    "system" : "http://terminology.hl7.org/CodeSystem/umls",
                    "code" : "C0017262"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                32. Observation.subject
                Definition

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

                ShortWho and/or what the observation is about
                Comments

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

                Control0..1
                This element is affected by the following invariants: ele-1
                TypeReference(Oncology Patient)
                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()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                34. Observation.focus
                Definition

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

                ShortWhat the observation is about, when it is not about the subject of record
                Comments

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

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeReference(Resource)
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                36. Observation.encounter
                Definition

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

                ShortHealthcare 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
                This element is affected by the following invariants: ele-1
                TypeReference(Encounter)
                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()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                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". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                ShortClinically relevant time/time-period for observation
                Comments

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

                Control0..1
                This element is affected by the following invariants: ele-1
                TypeChoice of: dateTime, Period, Timing, instant
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                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

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

                ShortDate/Time this version was made available
                Comments

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

                Control0..1
                This element is affected by the following invariants: ele-1
                Typeinstant
                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

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

                ShortWho is responsible for the observation
                Comments

                References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                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()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                44. Observation.value[x]
                Definition

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

                ShortActual result
                Comments

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

                Control0..1
                This element is affected by the following invariants: ele-1, obs-7
                TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

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

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

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

                ShortHigh, low, normal, etc.
                Comments

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

                Control0..*
                This element is affected by the following invariants: ele-1
                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
                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()))
                50. 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..*
                This element is affected by the following invariants: ele-1
                TypeAnnotation
                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()))
                52. Observation.bodySite
                Definition

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

                ShortObserved body part
                Comments

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

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

                Control0..1
                This element is affected by the following invariants: ele-1
                BindingFor example codes, see SNOMEDCTBodyStructures
                (example to http://hl7.org/fhir/ValueSet/body-site)

                Codes describing anatomical locations. May include laterality.

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

                Indicates the mechanism used to perform the observation.

                ShortHow it was done
                Comments

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

                Control0..1
                This element is affected by the following invariants: ele-1
                BindingFor example codes, see ObservationMethods
                (example to http://hl7.org/fhir/ValueSet/observation-methods)

                Methods for simple observations.

                TypeCodeableConcept
                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()))
                56. Observation.specimen
                Definition

                The specimen that was used when this observation was made.

                ShortSpecimen 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
                This element is affected by the following invariants: ele-1
                TypeReference(Specimen)
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                58. Observation.device
                Definition

                The device used to generate the observation data.

                Short(Measurement) Device
                Comments

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

                Control0..1
                This element is affected by the following invariants: ele-1
                TypeReference(Device, DeviceMetric)
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                60. Observation.referenceRange
                Definition

                Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

                ShortProvides guide for interpretation
                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..*
                This element is affected by the following invariants: ele-1
                TypeBackboneElement
                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())
                62. 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
                XML FormatIn the XML format, this property is represented as an attribute.
                64. 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..*
                This element is affected by the following invariants: ele-1
                TypeExtension
                Standards StatusNormative (from Normative)
                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.referenceRange.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 66. 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..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

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

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

                  The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                  Control0..1
                  This element is affected by the following invariants: ele-1, obs-3
                  TypeQuantity(SimpleQuantity)
                  Is Modifierfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                  sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
                  70. 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
                  Comments

                  The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                  Control0..1
                  This element is affected by the following invariants: ele-1, obs-3
                  TypeQuantity(SimpleQuantity)
                  Is Modifierfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                  sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
                  72. 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
                  This element is affected by the following invariants: ele-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
                  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()))
                  74. 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..*
                  This element is affected by the following invariants: ele-1
                  BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                  (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                  Codes identifying the population the reference range applies to.

                  TypeCodeableConcept
                  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()))
                  76. 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
                  Comments

                  The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeRange
                  Requirements

                  Some analytes vary greatly over age.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  rng-2: If present, low SHALL have a lower value than high (low.empty() or high.empty() or (low <= high))
                  78. 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
                  Comments

                  Note that FHIR strings SHALL NOT exceed 1MB in size

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  80. Observation.hasMember
                  Definition

                  This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

                  ShortRelated resource that belongs to the Observation group
                  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..*
                  This element is affected by the following invariants: ele-1
                  TypeReference(Observation, QuestionnaireResponse, MolecularSequence)
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                  82. Observation.derivedFrom
                  Definition

                  The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                  ShortRelated measurements the observation is made from
                  Comments

                  All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

                  Control1..*
                  This element is affected by the following invariants: ele-1
                  TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                  SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • pattern @ reference
                  • 84. Observation.derivedFrom:analysis
                    Slice Nameanalysis
                    Definition

                    The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                    ShortAnalysis from which come this observation
                    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.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Sequencing Analysis)
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    86. 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.

                    Control1..*
                    This element is affected by the following invariants: ele-1
                    TypeBackboneElement
                    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 are unordered and Open, and can be differentiated using the following discriminators:
                    • pattern @ code
                    • 88. 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
                      XML FormatIn the XML format, this property is represented as an attribute.
                      90. 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..*
                      This element is affected by the following invariants: ele-1
                      TypeExtension
                      Standards StatusNormative (from Normative)
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on Observation.component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 92. 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..*
                        This element is affected by the following invariants: ele-1
                        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())
                        94. Observation.component.code
                        Definition

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

                        ShortType of component observation (code / type)
                        Comments

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

                        Control1..1
                        This element is affected by the following invariants: ele-1
                        BindingFor example codes, see LOINCCodes
                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                        Codes identifying names of simple observations.

                        TypeCodeableConcept
                        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()))
                        96. Observation.component.value[x]
                        Definition

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

                        ShortActual component result
                        Comments

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

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                        [x] NoteSee Choice of Data Types for further information about how to use [x]
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Requirements

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

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        98. 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: ele-1, 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
                        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()))
                        100. 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..*
                        This element is affected by the following invariants: ele-1
                        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
                        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()))
                        102. 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..*
                        TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                        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.

                        104. Observation.component:actionability
                        Slice Nameactionability
                        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.

                        ShortConclusion of the clinicians wether the variant is actionable or not during the Molecular Tumor Board
                        Comments

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

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeBackboneElement
                        Summarytrue
                        Requirements

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

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        106. Observation.component:actionability.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
                        XML FormatIn the XML format, this property is represented as an attribute.
                        108. Observation.component:actionability.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..*
                        This element is affected by the following invariants: ele-1
                        TypeExtension
                        Standards StatusNormative (from Normative)
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        SlicingThis element introduces a set of slices on Observation.component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 110. Observation.component:actionability.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..*
                          This element is affected by the following invariants: ele-1
                          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())
                          112. Observation.component:actionability.code
                          Definition

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

                          ShortType of component observation (code / type)
                          Comments

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

                          Control1..1
                          This element is affected by the following invariants: ele-1
                          BindingFor example codes, see LOINCCodes
                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                          Codes identifying names of simple observations.

                          TypeCodeableConcept
                          Summarytrue
                          Requirements

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

                          Pattern Value{
                            "coding" : [{
                              "system" : "http://loinc.org",
                              "code" : "93348-1"
                            }]
                          }
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          114. Observation.component:actionability.value[x]
                          Definition

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

                          ShortActual component result
                          Comments

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

                          Control0..1
                          This element is affected by the following invariants: ele-1
                          Typeboolean
                          [x] NoteSee Choice of Data Types for further information about how to use [x]
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

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

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          116. Observation.component:actionability.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: ele-1, 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
                          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()))
                          118. Observation.component:actionability.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..*
                          This element is affected by the following invariants: ele-1
                          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
                          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()))
                          120. Observation.component:actionability.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..*
                          TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                          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.

                          122. Observation.component:proposed-for-orientation
                          Slice Nameproposed-for-orientation
                          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.

                          ShortIs the ClinicalTumorBoardConclusion used to orient the treatment decision ?
                          Comments

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

                          Control0..1
                          This element is affected by the following invariants: ele-1
                          TypeBackboneElement
                          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()))
                          124. Observation.component:proposed-for-orientation.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
                          XML FormatIn the XML format, this property is represented as an attribute.
                          126. Observation.component:proposed-for-orientation.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..*
                          This element is affected by the following invariants: ele-1
                          TypeExtension
                          Standards StatusNormative (from Normative)
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Observation.component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 128. Observation.component:proposed-for-orientation.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..*
                            This element is affected by the following invariants: ele-1
                            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())
                            130. Observation.component:proposed-for-orientation.code
                            Definition

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

                            ShortType of component observation (code / type)
                            Comments

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

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            BindingFor example codes, see LOINCCodes
                            (example to http://hl7.org/fhir/ValueSet/observation-codes)

                            Codes identifying names of simple observations.

                            TypeCodeableConcept
                            Summarytrue
                            Requirements

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

                            Pattern Value{
                              "coding" : [{
                                "system" : "http://terminology.hl7.org/CodeSystem/umls",
                                "code" : "C0449889"
                              }]
                            }
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            132. Observation.component:proposed-for-orientation.value[x]
                            Definition

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

                            ShortActual component result
                            Comments

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

                            Control0..1
                            This element is affected by the following invariants: ele-1
                            Typeboolean
                            [x] NoteSee Choice of Data Types for further information about how to use [x]
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

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

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            134. Observation.component:proposed-for-orientation.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: ele-1, 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
                            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()))
                            136. Observation.component:proposed-for-orientation.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..*
                            This element is affected by the following invariants: ele-1
                            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
                            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()))
                            138. Observation.component:proposed-for-orientation.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..*
                            TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                            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.

                            140. Observation.component:pathogenicity
                            Slice Namepathogenicity
                            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.

                            ShortConclusion of the biologist on the pathogenicity of the variant before the Molecular Tumor Board
                            Comments

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

                            Control0..1
                            This element is affected by the following invariants: ele-1
                            TypeBackboneElement
                            Summarytrue
                            Requirements

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

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            142. Observation.component:pathogenicity.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
                            XML FormatIn the XML format, this property is represented as an attribute.
                            144. Observation.component:pathogenicity.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..*
                            This element is affected by the following invariants: ele-1
                            TypeExtension
                            Standards StatusNormative (from Normative)
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on Observation.component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 146. Observation.component:pathogenicity.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..*
                              This element is affected by the following invariants: ele-1
                              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())
                              148. Observation.component:pathogenicity.code
                              Definition

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

                              ShortType of component observation (code / type)
                              Comments

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

                              Control1..1
                              This element is affected by the following invariants: ele-1
                              BindingFor example codes, see LOINCCodes
                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                              Codes identifying names of simple observations.

                              TypeCodeableConcept
                              Summarytrue
                              Requirements

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

                              Pattern Value{
                                "coding" : [{
                                  "system" : "http://loinc.org",
                                  "code" : "74019-1"
                                }]
                              }
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              150. Observation.component:pathogenicity.value[x]
                              Definition

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

                              ShortActual component result
                              Comments

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

                              Control0..1
                              This element is affected by the following invariants: ele-1
                              BindingThe codes SHALL be taken from Pathogenicity Value Set
                              (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/Pathogenicity)
                              TypeCodeableConcept
                              [x] NoteSee Choice of Data Types for further information about how to use [x]
                              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()))
                              152. Observation.component:pathogenicity.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: ele-1, 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
                              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()))
                              154. Observation.component:pathogenicity.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..*
                              This element is affected by the following invariants: ele-1
                              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
                              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()))
                              156. Observation.component:pathogenicity.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..*
                              TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                              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.

                              158. Observation.component:gene-studied
                              Slice Namegene-studied
                              Definition

                              HUGO Gene Nomenclature Committee (HGNC) identifier for a gene. List the gene(s) examined in full or in part by the study. If the study addresses multiple genes, these can be recorded in multiple gene studied components. The required coding will use the HGNC gene symbol as the display text and HGNC gene ID as the code.

                              ShortGene studied [ID]
                              Comments

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

                              Control0..*
                              This element is affected by the following invariants: ele-1
                              TypeBackboneElement
                              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()))
                              160. Observation.component:gene-studied.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              XML FormatIn the XML format, this property is represented as an attribute.
                              162. Observation.component:gene-studied.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

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

                              Control0..*
                              This element is affected by the following invariants: ele-1
                              TypeExtension
                              Standards StatusNormative (from Normative)
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on Observation.component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 164. Observation.component:gene-studied.modifierExtension
                                Definition

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

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

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

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

                                Control0..*
                                This element is affected by the following invariants: ele-1
                                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())
                                166. Observation.component:gene-studied.code
                                Definition

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

                                ShortType of component observation (code / type)
                                Comments

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

                                Control1..1
                                This element is affected by the following invariants: ele-1
                                BindingFor example codes, see LOINCCodes
                                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                Codes identifying names of simple observations.

                                TypeCodeableConcept
                                Summarytrue
                                Requirements

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

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

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

                                ShortIf no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
                                Comments

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

                                Control1..1
                                This element is affected by the following invariants: ele-1
                                BindingUnless not suitable, these codes SHALL be taken from HGNC
                                (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc)
                                TypeCodeableConcept
                                [x] NoteSee Choice of Data Types for further information about how to use [x]
                                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()))
                                170. Observation.component:gene-studied.dataAbsentReason
                                Definition

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

                                ShortWhy the component result is missing
                                Comments

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

                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                Control0..1
                                This element is affected by the following invariants: ele-1, 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
                                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()))
                                172. Observation.component:gene-studied.interpretation
                                Definition

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

                                ShortHigh, low, normal, etc.
                                Comments

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

                                Control0..*
                                This element is affected by the following invariants: ele-1
                                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
                                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()))
                                174. Observation.component:gene-studied.referenceRange
                                Definition

                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                ShortProvides guide for interpretation of component result
                                Comments

                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                Control0..*
                                TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                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.

                                176. Observation.component:gene-expression
                                Slice Namegene-expression
                                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.

                                ShortNumerical value for expression
                                Comments

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

                                Control1..1
                                This element is affected by the following invariants: ele-1
                                TypeBackboneElement
                                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()))
                                178. Observation.component:gene-expression.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
                                XML FormatIn the XML format, this property is represented as an attribute.
                                180. Observation.component:gene-expression.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..*
                                This element is affected by the following invariants: ele-1
                                TypeExtension
                                Standards StatusNormative (from Normative)
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on Observation.component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 182. Observation.component:gene-expression.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..*
                                  This element is affected by the following invariants: ele-1
                                  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())
                                  184. Observation.component:gene-expression.code
                                  Definition

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

                                  ShortType of component observation (code / type)
                                  Comments

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

                                  Control1..1
                                  This element is affected by the following invariants: ele-1
                                  BindingFor example codes, see LOINCCodes
                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                  Codes identifying names of simple observations.

                                  TypeCodeableConcept
                                  Summarytrue
                                  Requirements

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

                                  Pattern Value{
                                    "coding" : [{
                                      "system" : "http://loinc.org",
                                      "code" : "94820-8"
                                    }]
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  186. Observation.component:gene-expression.value[x]
                                  Definition

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

                                  ShortActual component result
                                  Comments

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

                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typeinteger
                                  [x] NoteSee Choice of Data Types for further information about how to use [x]
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Requirements

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

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  188. Observation.component:gene-expression.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: ele-1, 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
                                  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()))
                                  190. Observation.component:gene-expression.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..*
                                  This element is affected by the following invariants: ele-1
                                  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
                                  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()))
                                  192. Observation.component:gene-expression.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..*
                                  TypeSee ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                  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.