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: SequencingAnalysis - Detailed Descriptions

Draft as of 2024-03-21

Definitions for the sequencing-analysis resource profile.

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

0. Observation
2. Observation.category
4. Observation.category.text
6. Observation.code
8. Observation.subject
10. Observation.focus
12. Observation.effective[x]:effectiveDateTime
Slice NameeffectiveDateTime
TypedateTime
[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
14. Observation.method
Definition

OSIRIS code of the molecular analysis method used.

ShortMethod of analysis
Control1..?
BindingUnless not suitable, these codes SHALL be taken from Analysis Technical Protocol
(extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/TechnicalProtocol)
Must Supporttrue
16. Observation.specimen
ShortParent external accession
TypeReference(Biological Sample)
Must Supporttrue
18. Observation.device
ShortSequencing device used
Control1..?
TypeReference(Sequencing Device)
Must Supporttrue
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:algorithmic-cellularity
    Slice Namealgorithmic-cellularity
    Definition

    Percentage of tumor cells in the tissue sample.

    ShortPercentage of tumor cells
    Control0..1
    24. Observation.component:algorithmic-cellularity.code
    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/umls",
        "code" : "C3260254"
      }]
    }
    26. Observation.component:algorithmic-cellularity.value[x]
    TypeQuantity
    [x] NoteSee Choice of Data Types for further information about how to use [x]
    28. Observation.component:algorithmic-ploidy
    Slice Namealgorithmic-ploidy
    Definition

    DefThe number of complete copies of chromosome sets.inition

    ShortPloidy
    Control0..1
    30. Observation.component:algorithmic-ploidy.code
    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/umls",
        "code" : "C0032246"
      }]
    }
    32. Observation.component:algorithmic-ploidy.value[x]
    [x] NoteSee Choice of Data Types for further information about how to use [x]
    SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • type @ $this
    • 34. Observation.component:algorithmic-ploidy.value[x]:valueCodeableConcept
      Slice NamevalueCodeableConcept
      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from Algorithmic Ploidy
      (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AlgorithmicPloidy)
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      36. Observation.component:number-of-breakpoints
      Slice Namenumber-of-breakpoints
      Definition

      The number of breakpoints resulting from chromosomal rearrangements.

      ShortGenomic complexity
      Control0..1
      38. Observation.component:number-of-breakpoints.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "LA26327-9"
        }]
      }
      40. Observation.component:number-of-breakpoints.value[x]
      TypeQuantity
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      42. Observation.component:date-of-experiment
      Slice Namedate-of-experiment
      Definition

      Date on which the experiment was carried out

      ShortSequencing date
      Control0..1
      44. Observation.component:date-of-experiment.code
      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/umls",
          "code" : "258049002"
        }]
      }
      46. Observation.component:date-of-experiment.value[x]
      TypedateTime
      [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
      48. Observation.component:analytic-pipeline-code
      Slice Nameanalytic-pipeline-code
      Definition

      The name of the software used to analyze the molecular data from the analysis technology. It can be the name of an ad hoc bioinformatics analysis chain or a commercial software.

      ShortName of the analysis software
      Control1..1
      50. Observation.component:analytic-pipeline-code.code
      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/umls",
          "code" : "C0162801"
        }]
      }
      52. Observation.component:analytic-pipeline-code.value[x]
      Typestring
      [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.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
      • 6. 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()))
        8. 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..1*
        This element is affected by the following invariants: ele-1
        BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category
        (preferred to http://hl7.org/fhir/ValueSet/observation-category)

        Codes for high level observation categories.

        TypeCodeableConcept
        Must Supporttrue
        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()))
        10. Observation.category.text
        Definition

        Analysis identifier


        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

        ShortAnalysis codePlain text representation of the concept
        Comments

        Very often the text is the same as a displayName of one of the codings.

        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
        Summarytrue
        Requirements

        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

        Type(s) of confirmatory diagnostic or investigative method(s) used.


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

        ShortInvestigations performedType 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 Analysis Types Value Sethttp://hl7.org/fhir/ValueSet/observation-codes
        (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AnalysisType)
        TypeCodeableConcept
        Must Supporttrue
        Summarytrue
        Requirements

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

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

        The patient, 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)
        Must Supporttrue
        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')))
        16. Observation.focus
        Definition

        Tumor Pathology Event from which the sample was taken


        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.

        ShortTumor Pathology Event from which the sample was takenWhat 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(Tumor Pathology Event, Resource)
        Must Supporttrue
        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')))
        18. Observation.effective[x]
        Definition

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

        ShortClinically relevant time/time-period for observation
        Comments

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

        Control10..1
        This element is affected by the following invariants: ele-1
        TypedateTime, 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()))
        SlicingThis element introduces a set of slices on Observation.effective[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
        • type @ $this
        • 20. Observation.effective[x]:effectiveDateTime
          Slice NameeffectiveDateTime
          Definition

          Date on which the analysis was done.


          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.

          ShortDate of analysisClinically relevant time/time-period for observation
          Comments

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

          Control10..1
          This element is affected by the following invariants: ele-1
          TypedateTime, 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
          Must Supporttrue
          Summarytrue
          Requirements

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

          Alternate NamesOccurrence
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. 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()))
          24. 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()))
          26. Observation.method
          Definition

          OSIRIS code of the molecular analysis method used.


          Indicates the mechanism used to perform the observation.

          ShortMethod of analysisHow it was done
          Comments

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

          Control10..1
          This element is affected by the following invariants: ele-1
          BindingUnless not suitable, these codes SHALL be taken from For example codes, see Analysis Technical Protocolhttp://hl7.org/fhir/ValueSet/observation-methods
          (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/TechnicalProtocol)
          TypeCodeableConcept
          Must Supporttrue
          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()))
          28. Observation.specimen
          Definition

          The specimen that was used when this observation was made.

          ShortParent external accessionSpecimen 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(Biological Sample, Specimen)
          Must Supporttrue
          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')))
          30. Observation.device
          Definition

          The device used to generate the observation data.

          ShortSequencing device used(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.

          Control10..1
          This element is affected by the following invariants: ele-1
          TypeReference(Sequencing Device, Device, DeviceMetric)
          Must Supporttrue
          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')))
          32. 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
          • 34. 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())
            36. 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()))
            38. 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()))
            40. Observation.component:algorithmic-cellularity
            Slice Namealgorithmic-cellularity
            Definition

            Percentage of tumor cells in the tissue sample.


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

            ShortPercentage of tumor cellsComponent results
            Comments

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

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

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

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

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

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

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            44. Observation.component:algorithmic-cellularity.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" : "C3260254"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            46. Observation.component:algorithmic-cellularity.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
            TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
            [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()))
            48. Observation.component:algorithmic-cellularity.dataAbsentReason
            Definition

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

            ShortWhy the component result is missing
            Comments

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

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

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

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

            TypeCodeableConcept
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            50. Observation.component:algorithmic-ploidy
            Slice Namealgorithmic-ploidy
            Definition

            DefThe number of complete copies of chromosome sets.inition


            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.

            ShortPloidyComponent results
            Comments

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

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

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

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

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

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

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            54. Observation.component:algorithmic-ploidy.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" : "C0032246"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. Observation.component:algorithmic-ploidy.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()))
            SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 58. Observation.component:algorithmic-ploidy.value[x]:valueCodeableConcept
              Slice NamevalueCodeableConcept
              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
              BindingUnless not suitable, these codes SHALL be taken from For codes, see Algorithmic Ploidy
              (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AlgorithmicPloidy)
              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()))
              60. Observation.component:algorithmic-ploidy.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()))
              62. Observation.component:number-of-breakpoints
              Slice Namenumber-of-breakpoints
              Definition

              The number of breakpoints resulting from chromosomal rearrangements.


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

              ShortGenomic complexityComponent 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()))
              64. Observation.component:number-of-breakpoints.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())
              66. Observation.component:number-of-breakpoints.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" : "LA26327-9"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. Observation.component:number-of-breakpoints.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
              TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
              [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()))
              70. Observation.component:number-of-breakpoints.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()))
              72. Observation.component:date-of-experiment
              Slice Namedate-of-experiment
              Definition

              Date on which the experiment was carried out


              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.

              ShortSequencing dateComponent 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()))
              74. Observation.component:date-of-experiment.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())
              76. Observation.component:date-of-experiment.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" : "258049002"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              78. Observation.component:date-of-experiment.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
              TypedateTime, boolean, 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()))
              80. Observation.component:date-of-experiment.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()))
              82. Observation.component:analytic-pipeline-code
              Slice Nameanalytic-pipeline-code
              Definition

              The name of the software used to analyze the molecular data from the analysis technology. It can be the name of an ad hoc bioinformatics analysis chain or a commercial software.


              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.

              ShortName of the analysis softwareComponent 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()))
              84. Observation.component:analytic-pipeline-code.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

              Control0..*
              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.component:analytic-pipeline-code.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" : "C0162801"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              88. Observation.component:analytic-pipeline-code.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
              Typestring, dateTime, boolean, 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()))
              90. Observation.component:analytic-pipeline-code.dataAbsentReason
              Definition

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

              ShortWhy the component result is missing
              Comments

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

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

              Control0..1
              This element is affected by the following invariants: 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.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
                • 18. Observation.identifier
                  Definition

                  A unique identifier assigned to this observation.

                  ShortBusiness Identifier for observation
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..*
                  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()))
                  20. Observation.basedOn
                  Definition

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

                  ShortFulfills plan, proposal or order
                  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')))
                  22. Observation.partOf
                  Definition

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

                  ShortPart of referenced event
                  Comments

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

                  Control0..*
                  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')))
                  24. 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()))
                  26. 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..1
                  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
                  Must Supporttrue
                  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()))
                  28. Observation.category.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.category.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.category.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 32. Observation.category.coding
                    Definition

                    A reference to a code defined by a terminology system.

                    ShortCode defined by a terminology system
                    Comments

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

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

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

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

                    Analysis identifier

                    ShortAnalysis code
                    Comments

                    Very often the text is the same as a displayName of one of the codings.

                    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
                    Summarytrue
                    Requirements

                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

                    Type(s) of confirmatory diagnostic or investigative method(s) used.

                    ShortInvestigations performed
                    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 Analysis Types Value Set
                    (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AnalysisType)
                    TypeCodeableConcept
                    Must Supporttrue
                    Summarytrue
                    Requirements

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

                    Alternate NamesName
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    38. 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)
                    Must Supporttrue
                    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')))
                    40. Observation.focus
                    Definition

                    Tumor Pathology Event from which the sample was taken

                    ShortTumor Pathology Event from which the sample was taken
                    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(Tumor Pathology Event)
                    Must Supporttrue
                    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')))
                    42. 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')))
                    44. Observation.effective[x]
                    Definition

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

                    ShortClinically relevant time/time-period for observation
                    Comments

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

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypedateTime
                    [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()))
                    SlicingThis element introduces a set of slices on Observation.effective[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
                    • type @ $this
                    • 46. Observation.effective[x]:effectiveDateTime
                      Slice NameeffectiveDateTime
                      Definition

                      Date on which the analysis was done.

                      ShortDate of analysis
                      Comments

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

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      TypedateTime
                      [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
                      Must Supporttrue
                      Summarytrue
                      Requirements

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

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

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

                      ShortDate/Time this version was made available
                      Comments

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

                      Control0..1
                      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()))
                      50. 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')))
                      52. Observation.value[x]
                      Definition

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

                      ShortActual result
                      Comments

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

                      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()))
                      54. 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()))
                      56. 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()))
                      58. 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()))
                      60. 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()))
                      62. Observation.method
                      Definition

                      OSIRIS code of the molecular analysis method used.

                      ShortMethod of analysis
                      Comments

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

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      BindingUnless not suitable, these codes SHALL be taken from Analysis Technical Protocol
                      (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/TechnicalProtocol)
                      TypeCodeableConcept
                      Must Supporttrue
                      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()))
                      64. Observation.specimen
                      Definition

                      The specimen that was used when this observation was made.

                      ShortParent external accession
                      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(Biological Sample)
                      Must Supporttrue
                      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')))
                      66. Observation.device
                      Definition

                      The device used to generate the observation data.

                      ShortSequencing device used
                      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.

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      TypeReference(Sequencing Device)
                      Must Supporttrue
                      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')))
                      68. 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())
                      70. 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.
                      72. 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
                      • 74. 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())
                        76. 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())
                        78. 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())
                        80. 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()))
                        82. 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()))
                        84. 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))
                        86. 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()))
                        88. 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')))
                        90. Observation.derivedFrom
                        Definition

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

                        ShortRelated measurements the observation is made from
                        Comments

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

                        Control0..*
                        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')))
                        92. 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
                        • 94. 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.
                          96. 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
                          • 98. 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())
                            100. 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()))
                            102. 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()))
                            104. 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()))
                            106. 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()))
                            108. 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.

                            110. Observation.component:algorithmic-cellularity
                            Slice Namealgorithmic-cellularity
                            Definition

                            Percentage of tumor cells in the tissue sample.

                            ShortPercentage of tumor cells
                            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()))
                            112. Observation.component:algorithmic-cellularity.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.
                            114. Observation.component:algorithmic-cellularity.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
                            • 116. Observation.component:algorithmic-cellularity.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())
                              118. Observation.component:algorithmic-cellularity.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" : "C3260254"
                                }]
                              }
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              120. Observation.component:algorithmic-cellularity.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
                              TypeQuantity
                              [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()))
                              122. Observation.component:algorithmic-cellularity.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()))
                              124. Observation.component:algorithmic-cellularity.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()))
                              126. Observation.component:algorithmic-cellularity.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.

                              128. Observation.component:algorithmic-ploidy
                              Slice Namealgorithmic-ploidy
                              Definition

                              DefThe number of complete copies of chromosome sets.inition

                              ShortPloidy
                              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()))
                              130. Observation.component:algorithmic-ploidy.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.
                              132. Observation.component:algorithmic-ploidy.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
                              • 134. Observation.component:algorithmic-ploidy.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())
                                136. Observation.component:algorithmic-ploidy.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" : "C0032246"
                                  }]
                                }
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                138. Observation.component:algorithmic-ploidy.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()))
                                SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
                                • type @ $this
                                • 140. Observation.component:algorithmic-ploidy.value[x]:valueCodeableConcept
                                  Slice NamevalueCodeableConcept
                                  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
                                  BindingUnless not suitable, these codes SHALL be taken from Algorithmic Ploidy
                                  (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AlgorithmicPloidy)
                                  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()))
                                  142. Observation.component:algorithmic-ploidy.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()))
                                  144. Observation.component:algorithmic-ploidy.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()))
                                  146. Observation.component:algorithmic-ploidy.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.

                                  148. Observation.component:number-of-breakpoints
                                  Slice Namenumber-of-breakpoints
                                  Definition

                                  The number of breakpoints resulting from chromosomal rearrangements.

                                  ShortGenomic complexity
                                  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()))
                                  150. Observation.component:number-of-breakpoints.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.
                                  152. Observation.component:number-of-breakpoints.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
                                  • 154. Observation.component:number-of-breakpoints.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())
                                    156. Observation.component:number-of-breakpoints.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" : "LA26327-9"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    158. Observation.component:number-of-breakpoints.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
                                    TypeQuantity
                                    [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()))
                                    160. Observation.component:number-of-breakpoints.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()))
                                    162. Observation.component:number-of-breakpoints.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()))
                                    164. Observation.component:number-of-breakpoints.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.

                                    166. Observation.component:date-of-experiment
                                    Slice Namedate-of-experiment
                                    Definition

                                    Date on which the experiment was carried out

                                    ShortSequencing date
                                    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()))
                                    168. Observation.component:date-of-experiment.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.
                                    170. Observation.component:date-of-experiment.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
                                    • 172. Observation.component:date-of-experiment.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())
                                      174. Observation.component:date-of-experiment.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" : "258049002"
                                        }]
                                      }
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      176. Observation.component:date-of-experiment.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
                                      TypedateTime
                                      [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()))
                                      178. Observation.component:date-of-experiment.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()))
                                      180. Observation.component:date-of-experiment.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()))
                                      182. Observation.component:date-of-experiment.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.

                                      184. Observation.component:analytic-pipeline-code
                                      Slice Nameanalytic-pipeline-code
                                      Definition

                                      The name of the software used to analyze the molecular data from the analysis technology. It can be the name of an ad hoc bioinformatics analysis chain or a commercial software.

                                      ShortName of the analysis software
                                      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()))
                                      186. Observation.component:analytic-pipeline-code.id
                                      Definition

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

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

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

                                      ShortAdditional content defined by implementations
                                      Comments

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

                                      Control0..*
                                      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
                                      • 190. Observation.component:analytic-pipeline-code.modifierExtension
                                        Definition

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

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

                                        ShortExtensions that cannot be ignored even if unrecognized
                                        Comments

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

                                        Control0..*
                                        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())
                                        192. Observation.component:analytic-pipeline-code.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" : "C0162801"
                                          }]
                                        }
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        194. Observation.component:analytic-pipeline-code.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
                                        Typestring
                                        [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()))
                                        196. Observation.component:analytic-pipeline-code.dataAbsentReason
                                        Definition

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

                                        ShortWhy the component result is missing
                                        Comments

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

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

                                        Control0..1
                                        This element is affected by the following invariants: 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()))
                                        198. Observation.component:analytic-pipeline-code.interpretation
                                        Definition

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

                                        ShortHigh, low, normal, etc.
                                        Comments

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

                                        Control0..*
                                        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()))
                                        200. Observation.component:analytic-pipeline-code.referenceRange
                                        Definition

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

                                        ShortProvides guide for interpretation of component result
                                        Comments

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

                                        Control0..*
                                        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.