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: Fusion - Detailed Descriptions

Draft as of 2024-03-21

Definitions for the fusion resource profile.

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

0. Observation
2. Observation.extension:spanning-pairs
Slice Namespanning-pairs
ShortNumber of reads pairs spanning the fusion
Control0..1
TypeExtension(Fusion Spanning Pairs) (Extension Type: integer)
Must Supporttrue
4. Observation.extension:spanning-pairs.value[x]
[x] NoteSee Choice of Data Types for further information about how to use [x]
6. Observation.extension:split-reads
Slice Namesplit-reads
ShortNumber of reads containing the fusion point
Control0..1
TypeExtension(Fusion Split Reads) (Extension Type: integer)
Must Supporttrue
8. Observation.extension:split-reads.value[x]
[x] NoteSee Choice of Data Types for further information about how to use [x]
10. Observation.code
ShortType of the fusion event. eg: translocation, readthrough
BindingThe codes SHALL be taken from Fusion Type Value Set
(required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/FusionType)
12. Observation.subject
TypeReference(Oncology Patient)
14. 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
  • 16. Observation.derivedFrom:fusion-molecular-sequences
    Slice Namefusion-molecular-sequences
    ShortFive prime and three prime positions of the fusion
    Control0..2
    TypeReference(5 Prime Molecular Sequence, 3 Prime Molecular Sequence)
    18. Observation.derivedFrom:analysis
    Slice Nameanalysis
    ShortAnalysis from which come this observation
    Control1..1
    TypeReference(Sequencing Analysis)
    20. 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
    • 22. Observation.component:actionability
      Slice Nameactionability
      ShortConclusion of the clinicians wether the variant is actionable or not during the Molecular Tumor Board
      Control0..1
      24. Observation.component:actionability.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "93348-1"
        }]
      }
      26. 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
      28. Observation.component:proposed-for-orientation
      Slice Nameproposed-for-orientation
      ShortIs the ClinicalTumorBoardConclusion used to orient the treatment decision ?
      Control0..1
      30. Observation.component:proposed-for-orientation.code
      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/umls",
          "code" : "C0449889"
        }]
      }
      32. 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
      34. Observation.component:pathogenicity
      Slice Namepathogenicity
      ShortConclusion of the biologist on the pathogenicity of the variant before the Molecular Tumor Board
      Control0..1
      36. Observation.component:pathogenicity.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "74019-1"
        }]
      }
      38. 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]
      40. 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..*
      42. Observation.component:gene-studied.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "48018-6"
        }]
      }
      44. 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]
      46. Observation.component:in-frame
      Slice Namein-frame
      ShortSpecify whether the fusion is in frame
      Control1..1
      48. Observation.component:in-frame.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "95123-6"
        }]
      }
      50. Observation.component:in-frame.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

      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:spanning-pairs
      Slice Namespanning-pairs
      Definition

      Number of reads pairs spanning the fusion

      ShortNumber of reads pairs spanning the fusion
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Fusion Spanning Pairs) (Extension Type: integer)
      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.extension:spanning-pairs.extension
      Definition

      An Extension


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

      ShortExtensionAdditional content defined by implementations
      Comments

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

      Control0..0*
      This element is affected by the following invariants: ele-1
      TypeExtension
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 8. Observation.extension:spanning-pairs.url
        Definition

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

        Shortidentifies the meaning of the extension
        Comments

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

        Control1..1
        Typeuri
        XML FormatIn the XML format, this property is represented as an attribute.
        Fixed Valuehttps://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/spanning-pairs
        10. Observation.extension:spanning-pairs.value[x]
        Definition

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

        ShortValue of extension
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeinteger, date, Meta, Address, Attachment, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
        [x] 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
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        12. Observation.extension:split-reads
        Slice Namesplit-reads
        Definition

        Number of reads containing the fusion point

        ShortNumber of reads containing the fusion point
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeExtension(Fusion Split Reads) (Extension Type: integer)
        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())
        14. Observation.extension:split-reads.extension
        Definition

        An Extension


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

        ShortExtensionAdditional content defined by implementations
        Comments

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

        Control0..0*
        This element is affected by the following invariants: ele-1
        TypeExtension
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 16. Observation.extension:split-reads.url
          Definition

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

          Shortidentifies the meaning of the extension
          Comments

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

          Control1..1
          Typeuri
          XML FormatIn the XML format, this property is represented as an attribute.
          Fixed Valuehttps://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/split-reads
          18. Observation.extension:split-reads.value[x]
          Definition

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

          ShortValue of extension
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeinteger, date, Meta, Address, Attachment, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
          [x] 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
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. 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
          • 22. 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()))
            24. Observation.code
            Definition

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

            ShortType of the fusion event. eg: translocation, readthroughType 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
            BindingThe codes SHALL be taken from For example codes, see Fusion Type Value Sethttp://hl7.org/fhir/ValueSet/observation-codes
            (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/FusionType)
            TypeCodeableConcept
            Summarytrue
            Requirements

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

            Alternate NamesName
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. 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')))
            28. 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()))
            30. 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()))
            32. 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
            • 34. Observation.derivedFrom:fusion-molecular-sequences
              Slice Namefusion-molecular-sequences
              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.

              ShortFive prime and three prime positions of the fusionRelated measurements the observation is made from
              Comments

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

              Control0..2*
              This element is affected by the following invariants: ele-1
              TypeReference(5 Prime Molecular Sequence, 3 Prime Molecular Sequence, 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')))
              36. 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')))
              38. Observation.component
              Definition

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

              ShortComponent results
              Comments

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

              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
              • 40. Observation.component.modifierExtension
                Definition

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

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

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

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

                Control0..*
                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())
                42. 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()))
                44. 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()))
                46. 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()))
                48. 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())
                50. 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()))
                52. 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()))
                54. 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()))
                56. 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()))
                58. 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())
                60. 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()))
                62. 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()))
                64. 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()))
                66. 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()))
                68. 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())
                70. 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()))
                72. 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()))
                74. 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()))
                76. 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()))
                78. 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())
                80. 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()))
                82. 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()))
                84. 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()))
                86. Observation.component:in-frame
                Slice Namein-frame
                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.

                ShortSpecify whether the fusion is in frameComponent 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()))
                88. Observation.component:in-frame.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())
                90. Observation.component:in-frame.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" : "95123-6"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                92. Observation.component:in-frame.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()))
                94. Observation.component:in-frame.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:spanning-pairs
                  Slice Namespanning-pairs
                  Definition

                  Number of reads pairs spanning the fusion

                  ShortNumber of reads pairs spanning the fusion
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeExtension(Fusion Spanning Pairs) (Extension Type: integer)
                  Must Supporttrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  18. Observation.extension:spanning-pairs.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.
                  20. Observation.extension:spanning-pairs.extension
                  Definition

                  An Extension

                  ShortExtension
                  Control0..0
                  This element is affected by the following invariants: ele-1
                  TypeExtension
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 22. Observation.extension:spanning-pairs.url
                    Definition

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

                    Shortidentifies the meaning of the extension
                    Comments

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

                    Control1..1
                    Typeuri
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Fixed Valuehttps://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/spanning-pairs
                    24. Observation.extension:spanning-pairs.value[x]
                    Definition

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

                    ShortValue of extension
                    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
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    26. Observation.extension:split-reads
                    Slice Namesplit-reads
                    Definition

                    Number of reads containing the fusion point

                    ShortNumber of reads containing the fusion point
                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeExtension(Fusion Split Reads) (Extension Type: integer)
                    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())
                    28. Observation.extension:split-reads.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.
                    30. Observation.extension:split-reads.extension
                    Definition

                    An Extension

                    ShortExtension
                    Control0..0
                    This element is affected by the following invariants: ele-1
                    TypeExtension
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 32. Observation.extension:split-reads.url
                      Definition

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

                      Shortidentifies the meaning of the extension
                      Comments

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

                      Control1..1
                      Typeuri
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Fixed Valuehttps://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/split-reads
                      34. Observation.extension:split-reads.value[x]
                      Definition

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

                      ShortValue of extension
                      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
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      36. 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
                      • 38. 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()))
                        40. 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')))
                        42. 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')))
                        44. 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()))
                        46. 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()))
                        48. Observation.code
                        Definition

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

                        ShortType of the fusion event. eg: translocation, readthrough
                        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
                        BindingThe codes SHALL be taken from Fusion Type Value Set
                        (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/FusionType)
                        TypeCodeableConcept
                        Summarytrue
                        Requirements

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

                        Alternate NamesName
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        50. 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')))
                        52. 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')))
                        54. 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')))
                        56. 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()))
                        58. 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()))
                        60. 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')))
                        62. 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()))
                        64. Observation.dataAbsentReason
                        Definition

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

                        ShortWhy the result is missing
                        Comments

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

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

                        Control0..1
                        This element is affected by the following invariants: 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()))
                        66. Observation.interpretation
                        Definition

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

                        ShortHigh, low, normal, etc.
                        Comments

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

                        Control0..*
                        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()))
                        68. Observation.note
                        Definition

                        Comments about the observation or the results.

                        ShortComments about the observation
                        Comments

                        May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

                        Control0..*
                        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()))
                        70. Observation.bodySite
                        Definition

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

                        ShortObserved body part
                        Comments

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

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

                        Control0..1
                        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()))
                        72. Observation.method
                        Definition

                        Indicates the mechanism used to perform the observation.

                        ShortHow it was done
                        Comments

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

                        Control0..1
                        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()))
                        74. 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')))
                        76. 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')))
                        78. 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())
                        80. Observation.referenceRange.id
                        Definition

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

                        ShortUnique id for inter-element referencing
                        Control0..1
                        Typestring
                        XML FormatIn the XML format, this property is represented as an attribute.
                        82. Observation.referenceRange.extension
                        Definition

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

                        ShortAdditional content defined by implementations
                        Comments

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

                        Control0..*
                        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
                        • 84. Observation.referenceRange.modifierExtension
                          Definition

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

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

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

                          Control0..*
                          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())
                          86. Observation.referenceRange.low
                          Definition

                          The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

                          ShortLow Range, if relevant
                          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())
                          88. Observation.referenceRange.high
                          Definition

                          The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

                          ShortHigh Range, if relevant
                          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())
                          90. Observation.referenceRange.type
                          Definition

                          Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                          ShortReference range qualifier
                          Comments

                          This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                          Control0..1
                          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()))
                          92. Observation.referenceRange.appliesTo
                          Definition

                          Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                          ShortReference range population
                          Comments

                          This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                          Control0..*
                          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()))
                          94. Observation.referenceRange.age
                          Definition

                          The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

                          ShortApplicable age range, if relevant
                          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))
                          96. Observation.referenceRange.text
                          Definition

                          Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

                          ShortText based reference range in an observation
                          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()))
                          98. 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')))
                          100. Observation.derivedFrom
                          Definition

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

                          ShortRelated measurements the observation is made from
                          Comments

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

                          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
                          • 102. Observation.derivedFrom:fusion-molecular-sequences
                            Slice Namefusion-molecular-sequences
                            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.

                            ShortFive prime and three prime positions of the fusion
                            Comments

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

                            Control0..2
                            This element is affected by the following invariants: ele-1
                            TypeReference(5 Prime Molecular Sequence, 3 Prime Molecular Sequence)
                            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')))
                            104. 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')))
                            106. 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
                            • 108. 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.
                              110. 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
                              • 112. 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())
                                114. 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()))
                                116. 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()))
                                118. 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()))
                                120. 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()))
                                122. 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.

                                124. 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()))
                                126. 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.
                                128. 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
                                • 130. 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())
                                  132. 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()))
                                  134. 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()))
                                  136. 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()))
                                  138. 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()))
                                  140. 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.

                                  142. 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()))
                                  144. 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.
                                  146. 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
                                  • 148. 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())
                                    150. 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()))
                                    152. 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()))
                                    154. 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()))
                                    156. 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()))
                                    158. 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.

                                    160. 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()))
                                    162. 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.
                                    164. 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
                                    • 166. 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())
                                      168. 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()))
                                      170. 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()))
                                      172. 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()))
                                      174. 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()))
                                      176. 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.

                                      178. 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()))
                                      180. 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.
                                      182. 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
                                      • 184. 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())
                                        186. 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()))
                                        188. 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()))
                                        190. 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()))
                                        192. 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()))
                                        194. 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.

                                        196. Observation.component:in-frame
                                        Slice Namein-frame
                                        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.

                                        ShortSpecify whether the fusion is in frame
                                        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()))
                                        198. Observation.component:in-frame.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.
                                        200. Observation.component:in-frame.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
                                        • 202. Observation.component:in-frame.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())
                                          204. Observation.component:in-frame.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" : "95123-6"
                                            }]
                                          }
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          206. Observation.component:in-frame.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()))
                                          208. Observation.component:in-frame.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()))
                                          210. Observation.component:in-frame.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()))
                                          212. Observation.component:in-frame.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.