MII IG Kerndatensatz-Modul Molekulares Tumorboard
2026.0.0 - release Unknown region code '276'

MII IG Kerndatensatz-Modul Molekulares Tumorboard, published by Medizininformatik-Initiative. This guide is not an authorized publication; it is the continuous build for version 2026.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/medizininformatik-initiative/kerndatensatzmodul-molekulares-tumorboard/ and changes regularly. See the Directory of published versions

Resource Profile: MII_PR_MTB_BRCAness - Detailed Descriptions

Active as of 2026-02-09

Definitions for the mii-pr-mtb-brcaness resource profile.

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

0. Observation
Definition

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

ShortMeasurements and simple assertions
Comments

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

Control0..*
Is Modifierfalse
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())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.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
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.


A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control0..*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
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.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
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())
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 areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 10. Observation.identifier
    Definition

    Eindeutige Biomarker-ID im Kontext des NGS-Befundes.


    A unique identifier assigned to this observation.

    ShortBiomarker-ID im Kontext des NGS-BefundesBusiness 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
    Is Modifierfalse
    Must Supporttrue
    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()))
    12. 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()))
    14. Observation.category
    Definition

    Klassifizierung der Beobachtungsart


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

    ShortKategorieClassification 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.

    Control20..*
    This element is affected by the following invariants: ele-1
    BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
    (preferred to http://hl7.org/fhir/ValueSet/observation-category)

    Codes for high level observation categories.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Requirements

    Used for filtering what observations are retrieved and displayed.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ coding
    • 16. Observation.category:labCategory
      Slice NamelabCategory
      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.

      Control10..1*
      This element is affected by the following invariants: ele-1
      BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
      (preferred to http://hl7.org/fhir/ValueSet/observation-category)

      Codes for high level observation categories.

      TypeCodeableConcept
      Is Modifierfalse
      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()))
      18. Observation.category:labCategory.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.

      Control10..1*
      This element is affected by the following invariants: ele-1
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

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

      Pattern Value{
        "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
        "code" : "laboratory"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Observation.category:mbCategory
      Slice NamembCategory
      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.

      Control10..1*
      This element is affected by the following invariants: ele-1
      BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
      (preferred to http://hl7.org/fhir/ValueSet/observation-category)

      Codes for high level observation categories.

      TypeCodeableConcept
      Is Modifierfalse
      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()))
      22. Observation.category:mbCategory.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.

      Control10..1*
      This element is affected by the following invariants: ele-1
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

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

      Pattern Value{
        "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
        "code" : "biomarker-category"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. Observation.category:geCategory
      Slice NamegeCategory
      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|4.0.1
      (preferred to http://hl7.org/fhir/ValueSet/observation-category)

      Codes for high level observation categories.

      TypeCodeableConcept
      Is Modifierfalse
      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()))
      26. Observation.category:geCategory.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.

      Control10..1*
      This element is affected by the following invariants: ele-1
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

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

      Pattern Value{
        "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
        "code" : "GE"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. Observation.code
      Definition

      BRCAness der Tumormutationsmuster


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

      ShortBRCAnessType 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
      BindingUnless not suitable, these codes SHALL be taken from For example codes, see MII VS Molekulare Biomarkerhttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
      (extensible to https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/ValueSet/mii-vs-mtb-molekulare-biomarker)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

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

      Alternate NamesName
      Pattern Value{
        "coding" : [{
          "system" : "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-molekulare-biomarker",
          "code" : "brcaness"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. Observation.subject
      Definition

      Der Patient auf den sich die Beobachtung bezieht


      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.

      ShortPatientWho and/or what the observation is about
      Comments

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

      Control10..1
      This element is affected by the following invariants: ele-1
      TypeReference(Patient, Group, Patient, Group, Device, Location)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      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')))
      32. Observation.focus
      Definition

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

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

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

      Control0..*
      This element is affected by the following invariants: ele-1
      TypeReference(MII PR Onkologie Diagnose Primärtumor, MII PR MTB Diagnose Primärtumor, Resource)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      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')))
      34. Observation.encounter
      Definition

      Der Kontakt in dessen Rahmen die Beobachtung gemacht wurde


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

      ShortKontaktHealthcare 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, Encounter)
      Is Modifierfalse
      Must Supporttrue
      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')))
      36. Observation.effective[x]
      Definition

      Klinisch relevanter Zeitpunkt der Beobachtung


      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.

      ShortZeitpunkt der BeobachtungClinically relevant time/time-period for observation
      Comments

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

      Control0..1
      This element is affected by the following invariants: ele-1
      TypeChoice of: dateTime, Period, Timing, instant
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      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()))
      38. Observation.issued
      Definition

      Datum und Uhrzeit der Freigabe


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

      ShortFreigabedatumDate/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
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. 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] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      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.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • type @ $this
      • 42. Observation.value[x]:valueQuantity
        Slice NamevalueQuantity
        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
        TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

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

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

        The value of the measured amount. The value includes an implicit precision in the presentation of the value.

        ShortNumerical value (with implicit precision)
        Comments

        The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

        Control0..1
        Typedecimal
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Precision is handled implicitly in almost all cases of measurement.

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

        How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

        Short< | <= | >= | > - how to understand the value
        Control0..1
        BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

        How the Quantity should be understood and represented.

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

        Meaning if MissingIf there is no comparator, then there is no modification of the value
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. Observation.value[x]:valueQuantity.unit
        Definition

        A human-readable form of the unit.

        ShortUnit representation
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

        Pattern ValueScore
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        50. Observation.value[x]:valueQuantity.system
        Definition

        The identification of the system that provides the coded form of the unit.

        ShortSystem that defines coded unit form
        Control0..1
        This element is affected by the following invariants: qty-3
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need to know the system that defines the coded form of the unit.

        Pattern Valuehttp://unitsofmeasure.org
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        52. Observation.value[x]:valueQuantity.code
        Definition

        A computer processable form of the unit in some unit representation system.

        ShortCoded form of the unit
        Comments

        The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

        Control0..1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

        Pattern Value1
        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 DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

        TypeCodeableConcept
        Is Modifierfalse
        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
        BindingThe codes SHALL be taken from Unless not suitable, these codes SHALL be taken from http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
        (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        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.specimen
        Definition

        The specimen that was used when this observation was made.

        ShortSpecimen used for this observation
        Comments

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

        Control0..1
        This element is affected by the following invariants: ele-1
        TypeReference(Specimen, Specimen)
        Is Modifierfalse
        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')))
        60. Observation.derivedFrom
        Definition

        Referenzen zu anderen Beobachtungen von denen diese abgeleitet ist


        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.

        ShortAbgeleitet vonRelated 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, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
        Is Modifierfalse
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
        SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • profile @ resolve()
        • 62. Observation.derivedFrom:variant
          Slice Namevariant
          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.

          ShortVariant the biomarker is derived fromRelated 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(MII PR MolGen Variante, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          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')))
          64. Observation.derivedFrom:genotype
          Slice Namegenotype
          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.

          ShortGenotype the biomarker is derived fromRelated 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(Genotype, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          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.derivedFrom:haplotype
          Slice Namehaplotype
          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.

          ShortHaplotype the biomarker is derived fromRelated 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(Haplotype, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          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.component
          Definition

          Einzelne Komponenten der Beobachtung


          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.

          ShortKomponentenComponent results
          Comments

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

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

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

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ code
          • 70. 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())
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            72. 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|4.0.1
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. 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|4.0.1
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            Is Modifierfalse
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. Observation.component:gene-studied
            Slice Namegene-studied
            Definition

            Das untersuchte Gen


            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.

            ShortUntersuchtes GenComponent results
            Comments

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

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

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

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

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

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

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

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

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

            Short48018-6Type 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|4.0.1
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

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

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

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

            ShortThe HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.Actual component result
            Comments

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

            Control10..1
            This element is affected by the following invariants: ele-1
            BindingUnless not suitable, these codes SHALL be taken from For codes, see HUGO Gene Nomenclature Committee Gene Names (HGNC)
            (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc-vs)
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. Observation.component:gene-studied.dataAbsentReason
            Definition

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

            ShortWhy the component result is missing
            Comments

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

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

            Control0..1
            This element is affected by the following invariants: ele-1, obs-6
            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            Is Modifierfalse
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            86. Observation.component:biomarker-category
            Slice Namebiomarker-category
            Definition

            Die Kategorie des molekularen Biomarkers


            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.

            ShortBiomarker-KategorieComponent results
            Comments

            Component biomarker-category is an optional and repeating field that provides for a categorization of a given biomarker observation. The example 'molecular biomarker ontology' value set provides a categorization of biomarkers along several axes. A given lab test can be associated with more than one category within more than one axis. For example, LOINC code 85337-4 represents Estrogen receptor antigen in tissue by immune stain. It can be categorized by physiologic role of cell receptor and antigen; by molecule type of protein; and by method of immune stain.


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

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

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            88. Observation.component:biomarker-category.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())
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            90. Observation.component:biomarker-category.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|4.0.1
            (example to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

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

            Pattern Value{
              "coding" : [{
                "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                "code" : "biomarker-category"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            92. Observation.component:biomarker-category.value[x]
            Definition

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

            Shortcell receptor | antigen | protein | immune stainActual component result
            Comments

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

            Control10..1
            This element is affected by the following invariants: ele-1
            BindingFor example codes, see For codes, see Molecular Biomarker Categories
            (example to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/molecular-biomarker-category-vs)
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            94. Observation.component:biomarker-category.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|4.0.1
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

            TypeCodeableConcept
            Is Modifierfalse
            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 foundhere

            0. Observation
            2. Observation.identifier
            Definition

            Eindeutige Biomarker-ID im Kontext des NGS-Befundes.

            ShortBiomarker-ID im Kontext des NGS-Befundes
            NoteThis is a business identifier, not a resource identifier (see discussion)
            Must Supporttrue
            4. Observation.code
            Definition

            BRCAness der Tumormutationsmuster

            ShortBRCAness
            Pattern Value{
              "coding" : [{
                "system" : "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-molekulare-biomarker",
                "code" : "brcaness"
              }]
            }
            6. Observation.subject
            Control1..?
            8. Observation.value[x]
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Must Supporttrue
            SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 10. Observation.value[x]:valueQuantity
              Slice NamevalueQuantity
              Control0..1
              TypeQuantity
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Must Supporttrue
              12. Observation.value[x]:valueQuantity.value
              Must Supporttrue
              14. Observation.value[x]:valueQuantity.unit
              Pattern ValueScore
              16. Observation.value[x]:valueQuantity.system
              Pattern Valuehttp://unitsofmeasure.org
              18. Observation.value[x]:valueQuantity.code
              Pattern Value1
              20. Observation.interpretation
              BindingThe codes SHALL be taken from http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs
              (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs)
              Must Supporttrue
              22. Observation.specimen
              Must Supporttrue

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

              0. Observation
              Definition

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

              ShortMeasurements and simple assertions
              Comments

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

              Control0..*
              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
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              6. Observation.meta.id
              Definition

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

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              8. Observation.meta.extension
              Definition

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

              ShortAdditional content defined by implementations
              Comments

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

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 10. Observation.meta.versionId
                Definition

                The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                ShortVersion specific identifier
                Comments

                The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

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

                When the resource last changed - e.g. when the version changed.

                ShortWhen the resource version last changed
                Comments

                This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

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

                A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                ShortIdentifies where the resource comes from
                Comments

                In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

                This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

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

                A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                ShortProfiles this resource claims to conform to
                Comments

                It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                Control0..*
                Typecanonical(StructureDefinition)
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                18. Observation.meta.security
                Definition

                Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

                ShortSecurity Labels applied to this resource
                Comments

                The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                Control0..*
                BindingUnless not suitable, these codes SHALL be taken from All Security Labels
                (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

                Security Labels from the Healthcare Privacy and Security Classification System.

                TypeCoding
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                20. Observation.meta.tag
                Definition

                Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                ShortTags applied to this resource
                Comments

                The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                Control0..*
                BindingFor example codes, see CommonTags
                (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

                Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

                TypeCoding
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                22. 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()))
                24. 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()))
                26. 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()))
                28. 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
                30. 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
                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 areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 32. 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
                  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 areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 34. Observation.identifier
                    Definition

                    Eindeutige Biomarker-ID im Kontext des NGS-Befundes.

                    ShortBiomarker-ID im Kontext des NGS-Befundes
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeIdentifier
                    Must Supporttrue
                    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()))
                    36. 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')))
                    38. 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')))
                    40. 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()))
                    42. Observation.category
                    Definition

                    Klassifizierung der Beobachtungsart

                    ShortKategorie
                    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.

                    Control2..*
                    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()))
                    SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ coding
                    • 44. Observation.category:labCategory
                      Slice NamelabCategory
                      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.

                      Control1..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
                      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()))
                      46. Observation.category:labCategory.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.
                      48. Observation.category:labCategory.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
                      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 areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 50. Observation.category:labCategory.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.

                        Control1..1
                        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.

                        Pattern Value{
                          "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                          "code" : "laboratory"
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        52. Observation.category:labCategory.text
                        Definition

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

                        ShortPlain text representation of the concept
                        Comments

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

                        Control0..1
                        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()))
                        54. Observation.category:mbCategory
                        Slice NamembCategory
                        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.

                        Control1..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
                        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()))
                        56. Observation.category:mbCategory.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.
                        58. Observation.category:mbCategory.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
                        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 areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 60. Observation.category:mbCategory.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.

                          Control1..1
                          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.

                          Pattern Value{
                            "system" : "http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                            "code" : "biomarker-category"
                          }
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          62. Observation.category:mbCategory.text
                          Definition

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

                          ShortPlain text representation of the concept
                          Comments

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

                          Control0..1
                          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()))
                          64. Observation.category:geCategory
                          Slice NamegeCategory
                          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
                          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()))
                          66. Observation.category:geCategory.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.
                          68. Observation.category:geCategory.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
                          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 areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 70. Observation.category:geCategory.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.

                            Control1..1
                            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.

                            Pattern Value{
                              "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
                              "code" : "GE"
                            }
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            72. Observation.category:geCategory.text
                            Definition

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

                            ShortPlain text representation of the concept
                            Comments

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

                            Control0..1
                            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()))
                            74. Observation.code
                            Definition

                            BRCAness der Tumormutationsmuster

                            ShortBRCAness
                            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
                            BindingUnless not suitable, these codes SHALL be taken from MII VS Molekulare Biomarker
                            (extensible to https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/ValueSet/mii-vs-mtb-molekulare-biomarker)
                            TypeCodeableConcept
                            Must Supporttrue
                            Summarytrue
                            Requirements

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

                            Alternate NamesName
                            Pattern Value{
                              "coding" : [{
                                "system" : "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-molekulare-biomarker",
                                "code" : "brcaness"
                              }]
                            }
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            76. Observation.subject
                            Definition

                            Der Patient auf den sich die Beobachtung bezieht

                            ShortPatient
                            Comments

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

                            Control1..1
                            This element is affected by the following invariants: ele-1
                            TypeReference(Patient, Group)
                            Must Supporttrue
                            Must Support TypesNo must-support rules about the choice of types/profiles
                            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')))
                            78. Observation.focus
                            Definition

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

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

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

                            Control0..*
                            This element is affected by the following invariants: ele-1
                            TypeReference(MII PR Onkologie Diagnose Primärtumor, MII PR MTB Diagnose Primärtumor)
                            Must Supporttrue
                            Must Support TypesNo must-support rules about the choice of types/profiles
                            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')))
                            80. Observation.encounter
                            Definition

                            Der Kontakt in dessen Rahmen die Beobachtung gemacht wurde

                            ShortKontakt
                            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)
                            Must Supporttrue
                            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')))
                            82. Observation.effective[x]
                            Definition

                            Klinisch relevanter Zeitpunkt der Beobachtung

                            ShortZeitpunkt der Beobachtung
                            Comments

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

                            Control0..1
                            This element is affected by the following invariants: ele-1
                            TypeChoice of: dateTime, Period, Timing, instant
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Must Support TypesNo must-support rules about the choice of types/profiles
                            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()))
                            84. Observation.issued
                            Definition

                            Datum und Uhrzeit der Freigabe

                            ShortFreigabedatum
                            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
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            86. 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')))
                            88. 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] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Must Support TypesNo must-support rules about the choice of types/profiles
                            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.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • type @ $this
                            • 90. Observation.value[x]:valueQuantity
                              Slice NamevalueQuantity
                              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
                              TypeQuantity
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Must Supporttrue
                              Summarytrue
                              Requirements

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

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

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

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              94. Observation.value[x]:valueQuantity.extension
                              Definition

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

                              ShortAdditional content defined by implementations
                              Comments

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

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on Observation.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 96. Observation.value[x]:valueQuantity.value
                                Definition

                                The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                ShortNumerical value (with implicit precision)
                                Comments

                                The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                Control0..1
                                Typedecimal
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Requirements

                                Precision is handled implicitly in almost all cases of measurement.

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

                                How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                Short< | <= | >= | > - how to understand the value
                                Control0..1
                                BindingThe codes SHALL be taken from QuantityComparator
                                (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                How the Quantity should be understood and represented.

                                Typecode
                                Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                Meaning if MissingIf there is no comparator, then there is no modification of the value
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                100. Observation.value[x]:valueQuantity.unit
                                Definition

                                A human-readable form of the unit.

                                ShortUnit representation
                                Control0..1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                                Pattern ValueScore
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                102. Observation.value[x]:valueQuantity.system
                                Definition

                                The identification of the system that provides the coded form of the unit.

                                ShortSystem that defines coded unit form
                                Control0..1
                                This element is affected by the following invariants: qty-3
                                Typeuri
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Need to know the system that defines the coded form of the unit.

                                Pattern Valuehttp://unitsofmeasure.org
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                104. Observation.value[x]:valueQuantity.code
                                Definition

                                A computer processable form of the unit in some unit representation system.

                                ShortCoded form of the unit
                                Comments

                                The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                                Control0..1
                                Typecode
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                Pattern Value1
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                106. 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()))
                                108. 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
                                BindingThe codes SHALL be taken from http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs
                                (required to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs)
                                TypeCodeableConcept
                                Must Supporttrue
                                Requirements

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

                                Alternate NamesAbnormal Flag
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                110. Observation.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()))
                                112. 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()))
                                114. Observation.method
                                Definition

                                Indicates the mechanism used to perform the observation.

                                ShortHow it was done
                                Comments

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

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

                                Methods for simple observations.

                                TypeCodeableConcept
                                Requirements

                                In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

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

                                The specimen that was used when this observation was made.

                                ShortSpecimen used for this observation
                                Comments

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

                                Control0..1
                                This element is affected by the following invariants: ele-1
                                TypeReference(Specimen)
                                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')))
                                118. Observation.device
                                Definition

                                The device used to generate the observation data.

                                Short(Measurement) Device
                                Comments

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

                                Control0..1
                                This element is affected by the following invariants: ele-1
                                TypeReference(Device, DeviceMetric)
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                120. 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())
                                122. 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.
                                124. 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
                                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 areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 126. 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())
                                  128. 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())
                                  130. 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())
                                  132. 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()))
                                  134. 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()))
                                  136. 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))
                                  138. 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()))
                                  140. 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')))
                                  142. Observation.derivedFrom
                                  Definition

                                  Referenzen zu anderen Beobachtungen von denen diese abgeleitet ist

                                  ShortAbgeleitet von
                                  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)
                                  Must Supporttrue
                                  Must Support TypesNo must-support rules about the choice of types/profiles
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                  SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • profile @ resolve()
                                  • 144. Observation.derivedFrom:variant
                                    Slice Namevariant
                                    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.

                                    ShortVariant the biomarker is derived 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(MII PR MolGen Variante)
                                    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')))
                                    146. Observation.derivedFrom:genotype
                                    Slice Namegenotype
                                    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.

                                    ShortGenotype the biomarker is derived 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(Genotype)
                                    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')))
                                    148. Observation.derivedFrom:haplotype
                                    Slice Namehaplotype
                                    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.

                                    ShortHaplotype the biomarker is derived 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(Haplotype)
                                    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')))
                                    150. Observation.component
                                    Definition

                                    Einzelne Komponenten der Beobachtung

                                    ShortKomponenten
                                    Comments

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

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

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

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ code
                                    • 152. 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.
                                      154. 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
                                      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 areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 156. 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())
                                        158. 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()))
                                        160. 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] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        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()))
                                        162. 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()))
                                        164. 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()))
                                        166. Observation.component.referenceRange
                                        Definition

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

                                        ShortProvides guide for interpretation of component result
                                        Comments

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

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

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

                                        Das untersuchte Gen

                                        ShortUntersuchtes Gen
                                        Comments

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

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

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

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

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

                                        ShortAdditional content defined by implementations
                                        Comments

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

                                        Control0..*
                                        This element is affected by the following invariants: ele-1
                                        TypeExtension
                                        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 areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 174. Observation.component:gene-studied.modifierExtension
                                          Definition

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

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

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

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

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

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

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

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

                                          Short48018-6
                                          Comments

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

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

                                          Codes identifying names of simple observations.

                                          TypeCodeableConcept
                                          Summarytrue
                                          Requirements

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

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

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

                                          ShortThe HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
                                          Comments

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

                                          Control1..1
                                          This element is affected by the following invariants: ele-1
                                          BindingUnless not suitable, these codes SHALL be taken from HUGO Gene Nomenclature Committee Gene Names (HGNC)
                                          (extensible to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc-vs)
                                          TypeCodeableConcept
                                          [x] NoteSeeChoice of Data Typesfor 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()))
                                          180. Observation.component:gene-studied.dataAbsentReason
                                          Definition

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

                                          ShortWhy the component result is missing
                                          Comments

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

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

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

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

                                          TypeCodeableConcept
                                          Requirements

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

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          182. Observation.component:gene-studied.interpretation
                                          Definition

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

                                          ShortHigh, low, normal, etc.
                                          Comments

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

                                          Control0..*
                                          This element is affected by the following invariants: ele-1
                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                          Codes identifying interpretations of observations.

                                          TypeCodeableConcept
                                          Requirements

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

                                          Alternate NamesAbnormal Flag
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          184. Observation.component:gene-studied.referenceRange
                                          Definition

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

                                          ShortProvides guide for interpretation of component result
                                          Comments

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

                                          Control0..*
                                          TypeSeettp://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.

                                          186. Observation.component:biomarker-category
                                          Slice Namebiomarker-category
                                          Definition

                                          Die Kategorie des molekularen Biomarkers

                                          ShortBiomarker-Kategorie
                                          Comments

                                          Component biomarker-category is an optional and repeating field that provides for a categorization of a given biomarker observation. The example 'molecular biomarker ontology' value set provides a categorization of biomarkers along several axes. A given lab test can be associated with more than one category within more than one axis. For example, LOINC code 85337-4 represents Estrogen receptor antigen in tissue by immune stain. It can be categorized by physiologic role of cell receptor and antigen; by molecule type of protein; and by method of immune stain.

                                          Control0..*
                                          This element is affected by the following invariants: ele-1
                                          TypeBackboneElement
                                          Must Supporttrue
                                          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()))
                                          188. Observation.component:biomarker-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.
                                          190. Observation.component:biomarker-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
                                          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 areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 192. Observation.component:biomarker-category.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())
                                            194. Observation.component:biomarker-category.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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs",
                                                "code" : "biomarker-category"
                                              }]
                                            }
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            196. Observation.component:biomarker-category.value[x]
                                            Definition

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

                                            Shortcell receptor | antigen | protein | immune stain
                                            Comments

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

                                            Control1..1
                                            This element is affected by the following invariants: ele-1
                                            BindingFor example codes, see Molecular Biomarker Categories
                                            (example to http://hl7.org/fhir/uv/genomics-reporting/ValueSet/molecular-biomarker-category-vs)
                                            TypeCodeableConcept
                                            [x] NoteSeeChoice of Data Typesfor 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()))
                                            198. Observation.component:biomarker-category.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()))
                                            200. Observation.component:biomarker-category.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()))
                                            202. Observation.component:biomarker-category.referenceRange
                                            Definition

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

                                            ShortProvides guide for interpretation of component result
                                            Comments

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

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