MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Ressourcenprofil: MII PR MTB Immunohistochemistry - Detaillierte Beschreibungen

Active Stand: 2026-09-15

Definitionen für das mii-pr-mtb-immunohistochemistry-pdl1 ressourcenprofil

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
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
mii-mtb-ihc-1: Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) (code.coding.where(system != 'http://snomed.info/sct' or code != '1234806008').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
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
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
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..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

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

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

A unique identifier assigned to this observation.

ShortBusiness Identifier for observation
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
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
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..*
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(preferred to http://hl7.org/fhir/ValueSet/observation-category)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

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

    Used for filtering what observations are retrieved and displayed.

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

    Used for filtering what observations are retrieved and displayed.

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

    Used for filtering what observations are retrieved and displayed.

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

    Kodierung für Immunhistochemische Untersuchung. Enthält immer den generischen IHC-Code. Nach Möglichkeit sind zusätzlich spezifische Codes zu verwenden. Wenn weder in SNOMED noch LOINC spezifische Codes vorhanden sind, ist über gene-studied das untersuchte Gen anzugeben.


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

    ShortCode für Immunhistochemische UntersuchungType 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
    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
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Observation.code.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..*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

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

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

      Generischer Code für immunhistochemische Untersuchungen. Wird immer angegeben, um die Interoperabilität zu gewährleisten. Zusätzliche spezifische Codes können über open slicing hinzugefügt werden.


      A reference to a code defined by a terminology system.

      ShortGenerischer Immunhistochemischer UntersuchungscodeCode 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*
      TypeCoding
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

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

      Pattern Value{
        "system" : "http://snomed.info/sct",
        "code" : "1234806008",
        "display" : "Observation using immunohistochemistry (observable entity)"
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. 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.

      Control0..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()))
      36. 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..*
      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()))
      38. 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
      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()))
      40. 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
      TypedateTime, Period, Timing, instant
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      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()))
      42. 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
      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()))
      44. Observation.value[x]
      Definition

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

      ShortActual result
      Comments

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

      Control0..1
      This element is affected by the following invariants: 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
      • 46. Observation.value[x]:valueCodeableConcept
        Slice NamevalueCodeableConcept
        Definition

        Ergebnis der immunhistochemischen Untersuchung.


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

        ShortErgebnis der für immunhistochemische UntersuchungActual 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: obs-7
        TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

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

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

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

        ShortHigh, low, normal, etc.
        Comments

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

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

        Codes identifying interpretations of observations.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Requirements

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

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

        Probe


        The specimen that was used when this observation was made.

        ShortProbeSpecimen used for this observation
        Comments

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

        Control0..1
        TypeReference(Specimen, Specimen)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        52. 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..*
        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()))
        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()
        • 54. 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..*
          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()))
          56. 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..*
          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()))
          58. 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..*
          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()))
          60. 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..*
          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
          • 62. Observation.component.modifierExtension
            Definition

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

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

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            64. 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
            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()))
            66. 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..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()))
            68. 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..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

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

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            70. Observation.component: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
            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()))
            72. 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
            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()))
            74. 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..*
            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()))
            76. 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..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

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

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

            Tumor Proportion Score (TPS) - Score für PD-L1-Expression in Tumorzellen. Der TPS ist der Anteil der PD-L1-positiven Tumorzellen im Verhältnis zu den Gesamtzellen. Der TPS wird in Prozent angegeben. Ein TPS von 1% oder mehr gilt als positiv.


            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.

            ShortTPS-ScoreComponent results
            Comments

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

            Control0..1*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

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

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

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

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

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

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

            Pattern Value{
              "coding" : [{
                "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                "code" : "C184941",
                "display" : "PD-L1 Tumor Proportion Score"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            88. Observation.component:tps-score.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
            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
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 90. Observation.component:tps-score.value[x]:valueQuantity
              Slice NamevalueQuantity
              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
              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()))
              92. Observation.component:tps-score.interpretation
              Definition

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

              ShortHigh, low, normal, etc.
              Comments

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

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

              Codes identifying interpretations of observations.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Requirements

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

              Alternate NamesAbnormal Flag
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              94. Observation.component:cps-score
              Slice Namecps-score
              Definition

              Combined Positive Score (CPS) - Score für PD-L1-Expression in Tumorzellen und Immunzellen. Der CPS ist der Anteil der PD-L1-positiven Tumorzellen und Immunzellen im Verhältnis zu den Gesamtzellen. Der CPS wird in Prozent angegeben. Ein CPS von 1% oder mehr gilt als positiv.


              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.

              ShortCPS-ScoreComponent results
              Comments

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

              Control0..1*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              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()))
              96. Observation.component:cps-score.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

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

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

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

              Pattern Value{
                "coding" : [{
                  "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                  "code" : "C176582",
                  "display" : "PD-L1 Combined Positive Score"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              100. Observation.component:cps-score.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
              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
              Summarytrue
              Requirements

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

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • type @ $this
              • 102. Observation.component:cps-score.value[x]:valueQuantity
                Slice NamevalueQuantity
                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
                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()))
                104. Observation.component:cps-score.interpretation
                Definition

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

                ShortHigh, low, normal, etc.
                Comments

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

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

                Codes identifying interpretations of observations.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summaryfalse
                Requirements

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

                Alternate NamesAbnormal Flag
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                106. Observation.component:ics-score
                Slice Nameics-score
                Definition

                Immune Cell Score (ICS) - Score für PD-L1-Expression in Immunzellen. Der ICS ist der Anteil der PD-L1-positiven Immunzellen im Verhältnis zu den Gesamtzellen. Der ICS wird in Prozent angegeben. Ein ICS von 1% oder mehr gilt als positiv.


                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.

                ShortICS-ScoreComponent results
                Comments

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

                Control0..1*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                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()))
                108. Observation.component:ics-score.modifierExtension
                Definition

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

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

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

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

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

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

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

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

                Pattern Value{
                  "coding" : [{
                    "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                    "code" : "C199175",
                    "display" : "Cells.programmed cell death ligand 1/Viable tumor cells in Tissue by Immune stain"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. Observation.component:ics-score.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
                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
                Summarytrue
                Requirements

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

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • type @ $this
                • 114. Observation.component:ics-score.value[x]:valueQuantity
                  Slice NamevalueQuantity
                  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
                  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()))
                  116. Observation.component:ics-score.interpretation
                  Definition

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

                  ShortHigh, low, normal, etc.
                  Comments

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

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

                  Codes identifying interpretations of observations.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Requirements

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

                  Alternate NamesAbnormal Flag
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  118. Observation.component:tc-score
                  Slice Nametc-score
                  Definition

                  Tumor Cell Score (TC-Score) - Score für PD-L1-Expression in Tumorzellen. Der TC-Score ist der Anteil der PD-L1-positiven Tumorzellen im Verhältnis zu den Gesamtzellen. Der TC-Score wird in Prozent angegeben. Ein TC-Score von 1% oder mehr gilt als positiv.


                  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.

                  ShortTC-Score / TPS-ScoreComponent results
                  Comments

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

                  Control0..1*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  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()))
                  120. Observation.component:tc-score.modifierExtension
                  Definition

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

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

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

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

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

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

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

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

                  Pattern Value{
                    "coding" : [{
                      "system" : "http://loinc.org",
                      "code" : "83053-9",
                      "display" : "Cells.programmed cell death ligand 1/Viable tumor cells in Tissue by Immune stain"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  124. Observation.component:tc-score.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
                  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
                  Summarytrue
                  Requirements

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

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 126. Observation.component:tc-score.value[x]:valueQuantity
                    Slice NamevalueQuantity
                    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
                    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()))
                    128. Observation.component:tc-score.interpretation
                    Definition

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

                    ShortHigh, low, normal, etc.
                    Comments

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

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

                    Codes identifying interpretations of observations.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supporttrue
                    Summaryfalse
                    Requirements

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

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

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

                    0. Observation
                    2. Observation.effective[x]
                    TypedateTime, Period, Timing, instant
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    4. Observation.specimen
                    Definition

                    Probe

                    ShortProbe
                    6. Observation.component
                    SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ code
                    • 8. Observation.component:tps-score
                      Slice Nametps-score
                      Definition

                      Tumor Proportion Score (TPS) - Score für PD-L1-Expression in Tumorzellen. Der TPS ist der Anteil der PD-L1-positiven Tumorzellen im Verhältnis zu den Gesamtzellen. Der TPS wird in Prozent angegeben. Ein TPS von 1% oder mehr gilt als positiv.

                      ShortTPS-Score
                      Control0..1
                      Must Supporttrue
                      10. Observation.component:tps-score.code
                      Must Supporttrue
                      Pattern Value{
                        "coding" : [{
                          "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                          "code" : "C184941",
                          "display" : "PD-L1 Tumor Proportion Score"
                        }]
                      }
                      12. Observation.component:tps-score.value[x]
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • type @ $this
                      • 14. Observation.component:tps-score.value[x]:valueQuantity
                        Slice NamevalueQuantity
                        Control0..1
                        TypeQuantity
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Must Supporttrue
                        16. Observation.component:tps-score.interpretation
                        Must Supporttrue
                        18. Observation.component:cps-score
                        Slice Namecps-score
                        Definition

                        Combined Positive Score (CPS) - Score für PD-L1-Expression in Tumorzellen und Immunzellen. Der CPS ist der Anteil der PD-L1-positiven Tumorzellen und Immunzellen im Verhältnis zu den Gesamtzellen. Der CPS wird in Prozent angegeben. Ein CPS von 1% oder mehr gilt als positiv.

                        ShortCPS-Score
                        Control0..1
                        Must Supporttrue
                        20. Observation.component:cps-score.code
                        Must Supporttrue
                        Pattern Value{
                          "coding" : [{
                            "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                            "code" : "C176582",
                            "display" : "PD-L1 Combined Positive Score"
                          }]
                        }
                        22. Observation.component:cps-score.value[x]
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • type @ $this
                        • 24. Observation.component:cps-score.value[x]:valueQuantity
                          Slice NamevalueQuantity
                          Control0..1
                          TypeQuantity
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Must Supporttrue
                          26. Observation.component:cps-score.interpretation
                          Must Supporttrue
                          28. Observation.component:ics-score
                          Slice Nameics-score
                          Definition

                          Immune Cell Score (ICS) - Score für PD-L1-Expression in Immunzellen. Der ICS ist der Anteil der PD-L1-positiven Immunzellen im Verhältnis zu den Gesamtzellen. Der ICS wird in Prozent angegeben. Ein ICS von 1% oder mehr gilt als positiv.

                          ShortICS-Score
                          Control0..1
                          Must Supporttrue
                          30. Observation.component:ics-score.code
                          Must Supporttrue
                          Pattern Value{
                            "coding" : [{
                              "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                              "code" : "C199175",
                              "display" : "Cells.programmed cell death ligand 1/Viable tumor cells in Tissue by Immune stain"
                            }]
                          }
                          32. Observation.component:ics-score.value[x]
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • type @ $this
                          • 34. Observation.component:ics-score.value[x]:valueQuantity
                            Slice NamevalueQuantity
                            Control0..1
                            TypeQuantity
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Must Supporttrue
                            36. Observation.component:ics-score.interpretation
                            Must Supporttrue
                            38. Observation.component:tc-score
                            Slice Nametc-score
                            Definition

                            Tumor Cell Score (TC-Score) - Score für PD-L1-Expression in Tumorzellen. Der TC-Score ist der Anteil der PD-L1-positiven Tumorzellen im Verhältnis zu den Gesamtzellen. Der TC-Score wird in Prozent angegeben. Ein TC-Score von 1% oder mehr gilt als positiv.

                            ShortTC-Score / TPS-Score
                            Control0..1
                            Must Supporttrue
                            40. Observation.component:tc-score.code
                            Must Supporttrue
                            Pattern Value{
                              "coding" : [{
                                "system" : "http://loinc.org",
                                "code" : "83053-9",
                                "display" : "Cells.programmed cell death ligand 1/Viable tumor cells in Tissue by Immune stain"
                              }]
                            }
                            42. Observation.component:tc-score.value[x]
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • type @ $this
                            • 44. Observation.component:tc-score.value[x]:valueQuantity
                              Slice NamevalueQuantity
                              Control0..1
                              TypeQuantity
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Must Supporttrue
                              46. Observation.component:tc-score.interpretation
                              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..*
                              Is Modifierfalse
                              Summaryfalse
                              Alternate NamesVital Signs, Measurement, Results, Tests
                              Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                              dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                              dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                              dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                              dom-6: A resource should have narrative for robust management (text.`div`.exists())
                              obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
                              obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
                              mii-mtb-ihc-1: Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) (code.coding.where(system != 'http://snomed.info/sct' or code != '1234806008').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).exists())
                              2. Observation.id
                              Definition

                              The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                              ShortLogical id of this artifact
                              Comments

                              The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                              Control0..1
                              Typeid
                              Is Modifierfalse
                              Summarytrue
                              4. Observation.meta
                              Definition

                              The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                              ShortMetadata about the resource
                              Control0..1
                              TypeMeta
                              Is Modifierfalse
                              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
                                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
                                BindingThe codes SHOULD be taken from CommonLanguages
                                (preferred to http://hl7.org/fhir/ValueSet/languages)

                                A human language.

                                Additional BindingsPurpose
                                AllLanguagesMax Binding
                                Typecode
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                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
                                TypeNarrative
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesnarrative, html, xhtml, display
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                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
                                Is Modifierfalse
                                Summaryfalse
                                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..*
                                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())
                                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..*
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                                Summaryfalse
                                Requirements

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

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

                                A unique identifier assigned to this observation.

                                ShortBusiness Identifier for observation
                                NoteThis is a business identifier, not a resource identifier (see discussion)
                                Control0..*
                                TypeIdentifier
                                Is Modifierfalse
                                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
                                Control0..*
                                TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                                Is Modifierfalse
                                Summarytrue
                                Requirements

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

                                Alternate NamesFulfills
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                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..*
                                TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                                Is Modifierfalse
                                Summarytrue
                                Alternate NamesContainer
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                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
                                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..*
                                BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                Codes for high level observation categories.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supporttrue
                                Summaryfalse
                                Requirements

                                Used for filtering what observations are retrieved and displayed.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • 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
                                  BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                  (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                  Codes for high level observation categories.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Summaryfalse
                                  Requirements

                                  Used for filtering what observations are retrieved and displayed.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  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
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  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..*
                                  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.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
                                    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()))
                                    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
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

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

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    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
                                    BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                    (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                    Codes for high level observation categories.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summaryfalse
                                    Requirements

                                    Used for filtering what observations are retrieved and displayed.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    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
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    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..*
                                    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.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
                                      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()))
                                      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
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

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

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      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
                                      BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                      (preferred to http://hl7.org/fhir/ValueSet/observation-category)

                                      Codes for high level observation categories.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Summaryfalse
                                      Requirements

                                      Used for filtering what observations are retrieved and displayed.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      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
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      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..*
                                      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.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
                                        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()))
                                        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
                                        Typestring
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

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

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

                                        Kodierung für Immunhistochemische Untersuchung. Enthält immer den generischen IHC-Code. Nach Möglichkeit sind zusätzlich spezifische Codes zu verwenden. Wenn weder in SNOMED noch LOINC spezifische Codes vorhanden sind, ist über gene-studied das untersuchte Gen anzugeben.

                                        ShortCode für Immunhistochemische Untersuchung
                                        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
                                        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
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Requirements

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

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

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

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

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

                                        ShortAdditional content defined by implementations
                                        Comments

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

                                        Control0..*
                                        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.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 80. Observation.code.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..*
                                          TypeCoding
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

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

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

                                            Generischer Code für immunhistochemische Untersuchungen. Wird immer angegeben, um die Interoperabilität zu gewährleisten. Zusätzliche spezifische Codes können über open slicing hinzugefügt werden.

                                            ShortGenerischer Immunhistochemischer Untersuchungscode
                                            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
                                            TypeCoding
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Summarytrue
                                            Requirements

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

                                            Pattern Value{
                                              "system" : "http://snomed.info/sct",
                                              "code" : "1234806008",
                                              "display" : "Observation using immunohistochemistry (observable entity)"
                                            }
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            84. Observation.code.text
                                            Definition

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

                                            ShortPlain text representation of the concept
                                            Comments

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

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

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

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            86. 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.

                                            Control0..1
                                            TypeReference(Patient, Group)
                                            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()))
                                            88. 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..*
                                            TypeReference(MII PR Onkologie Diagnose Primärtumor, MII PR MTB Diagnose Primärtumor)
                                            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()))
                                            90. 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
                                            TypeReference(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()))
                                            92. 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
                                            TypedateTime
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supporttrue
                                            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()))
                                            94. 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
                                            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()))
                                            96. Observation.performer
                                            Definition

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

                                            ShortWho is responsible for the observation
                                            Control0..*
                                            TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                                            Is Modifierfalse
                                            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()))
                                            98. 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: 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
                                            • 100. Observation.value[x]:valueCodeableConcept
                                              Slice NamevalueCodeableConcept
                                              Definition

                                              Ergebnis der immunhistochemischen Untersuchung.

                                              ShortErgebnis der für immunhistochemische Untersuchung
                                              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: obs-7
                                              TypeCodeableConcept
                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summarytrue
                                              Requirements

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

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

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

                                              ShortWhy the result is missing
                                              Comments

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

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

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

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

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

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

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              104. 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..*
                                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                              Codes identifying interpretations of observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summaryfalse
                                              Requirements

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

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

                                              Comments about the observation or the results.

                                              ShortComments about the observation
                                              Comments

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

                                              Control0..*
                                              TypeAnnotation
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              Need to be able to provide free text additional information.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              108. 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
                                              BindingFor example codes, see SNOMEDCTBodyStructures
                                              (example to http://hl7.org/fhir/ValueSet/body-site)

                                              Codes describing anatomical locations. May include laterality.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              110. 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
                                              BindingFor example codes, see ObservationMethods
                                              (example to http://hl7.org/fhir/ValueSet/observation-methods)

                                              Methods for simple observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

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

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

                                              Probe

                                              ShortProbe
                                              Comments

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

                                              Control0..1
                                              TypeReference(Specimen)
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              114. 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
                                              TypeReference(Device, DeviceMetric)
                                              Is Modifierfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              116. 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..*
                                              TypeBackboneElement
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                                              118. Observation.referenceRange.id
                                              Definition

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

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

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

                                              ShortAdditional content defined by implementations
                                              Comments

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

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              122. Observation.referenceRange.modifierExtension
                                              Definition

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

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

                                              ShortExtensions that cannot be ignored even if unrecognized
                                              Comments

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

                                              Control0..*
                                              TypeExtension
                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                              Summarytrue
                                              Requirements

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

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

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

                                              ShortLow Range, if relevant
                                              Control0..1
                                              This element is affected by the following invariants: obs-3
                                              TypeQuantity(SimpleQuantity)
                                              Is Modifierfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              126. Observation.referenceRange.high
                                              Definition

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

                                              ShortHigh Range, if relevant
                                              Control0..1
                                              This element is affected by the following invariants: obs-3
                                              TypeQuantity(SimpleQuantity)
                                              Is Modifierfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              128. Observation.referenceRange.type
                                              Definition

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

                                              ShortReference range qualifier
                                              Comments

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

                                              Control0..1
                                              BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                                              (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

                                              Code for the meaning of a reference range.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

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

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

                                              ShortReference range population
                                              Comments

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

                                              Control0..*
                                              BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                                              (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                                              Codes identifying the population the reference range applies to.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              Need to be able to identify the target population for proper interpretation.

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

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

                                              ShortApplicable age range, if relevant
                                              Control0..1
                                              TypeRange
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              Some analytes vary greatly over age.

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

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

                                              ShortText based reference range in an observation
                                              Control0..1
                                              Typestring
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              136. 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..*
                                              TypeReference(Observation, QuestionnaireResponse, MolecularSequence)
                                              Is Modifierfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              138. 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..*
                                              TypeReference(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()))
                                              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()
                                              • 140. 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..*
                                                TypeReference(MII PR MolGen Variante)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                142. 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..*
                                                TypeReference(Genotype)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                144. 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..*
                                                TypeReference(Haplotype)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                146. 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..*
                                                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
                                                • 148. Observation.component.id
                                                  Definition

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

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

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

                                                  ShortAdditional content defined by implementations
                                                  Comments

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

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  152. Observation.component.modifierExtension
                                                  Definition

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

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

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  Comments

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

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  Requirements

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

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  154. 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
                                                  BindingFor example codes, see LOINCCodes
                                                  (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()))
                                                  156. 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
                                                  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
                                                  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()))
                                                  158. Observation.component.dataAbsentReason
                                                  Definition

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

                                                  ShortWhy the component result is missing
                                                  Comments

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

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

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

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

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

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

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

                                                  ShortHigh, low, normal, etc.
                                                  Comments

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

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

                                                  Codes identifying interpretations of observations.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

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

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

                                                  ShortProvides guide for interpretation of component result
                                                  Comments

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

                                                  Control0..*
                                                  TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  164. 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..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()))
                                                  166. 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
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  168. 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..*
                                                  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())
                                                  170. 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..*
                                                  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())
                                                  172. 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
                                                  BindingFor example codes, see LOINCCodes
                                                  (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()))
                                                  174. 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
                                                  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]
                                                  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()))
                                                  176. 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: obs-6
                                                  BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                  (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  178. 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..*
                                                  BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                  (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                  Codes identifying interpretations of observations.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

                                                  Alternate NamesAbnormal Flag
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  180. 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
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  182. 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..*
                                                  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()))
                                                  184. 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
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  186. 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..*
                                                  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())
                                                  188. 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..*
                                                  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())
                                                  190. 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
                                                  BindingFor example codes, see LOINCCodes
                                                  (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()))
                                                  192. 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
                                                  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]
                                                  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()))
                                                  194. 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: obs-6
                                                  BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                  (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  196. 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..*
                                                  BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                  (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                                                  Codes identifying interpretations of observations.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

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

                                                  Alternate NamesAbnormal Flag
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  198. 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
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Requirements

                                                  Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  200. Observation.component:tps-score
                                                  Slice Nametps-score
                                                  Definition

                                                  Tumor Proportion Score (TPS) - Score für PD-L1-Expression in Tumorzellen. Der TPS ist der Anteil der PD-L1-positiven Tumorzellen im Verhältnis zu den Gesamtzellen. Der TPS wird in Prozent angegeben. Ein TPS von 1% oder mehr gilt als positiv.

                                                  ShortTPS-Score
                                                  Comments

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

                                                  Control0..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()))
                                                  202. Observation.component:tps-score.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
                                                  204. Observation.component:tps-score.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())
                                                  206. Observation.component:tps-score.modifierExtension
                                                  Definition

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

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

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  Comments

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

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  Requirements

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

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  208. Observation.component:tps-score.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
                                                  BindingFor example codes, see LOINCCodes
                                                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                  Codes identifying names of simple observations.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Requirements

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

                                                  Pattern Value{
                                                    "coding" : [{
                                                      "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                                                      "code" : "C184941",
                                                      "display" : "PD-L1 Tumor Proportion Score"
                                                    }]
                                                  }
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  210. Observation.component:tps-score.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
                                                  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
                                                  Summarytrue
                                                  Requirements

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

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                  • type @ $this
                                                  • 212. Observation.component:tps-score.value[x]:valueQuantity
                                                    Slice NamevalueQuantity
                                                    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
                                                    TypeQuantity
                                                    [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()))
                                                    214. Observation.component:tps-score.dataAbsentReason
                                                    Definition

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

                                                    ShortWhy the component result is missing
                                                    Comments

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

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

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

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

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Requirements

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

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

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

                                                    ShortHigh, low, normal, etc.
                                                    Comments

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

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

                                                    Codes identifying interpretations of observations.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supporttrue
                                                    Summaryfalse
                                                    Requirements

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

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

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

                                                    ShortProvides guide for interpretation of component result
                                                    Comments

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

                                                    Control0..*
                                                    TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Requirements

                                                    Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    220. Observation.component:cps-score
                                                    Slice Namecps-score
                                                    Definition

                                                    Combined Positive Score (CPS) - Score für PD-L1-Expression in Tumorzellen und Immunzellen. Der CPS ist der Anteil der PD-L1-positiven Tumorzellen und Immunzellen im Verhältnis zu den Gesamtzellen. Der CPS wird in Prozent angegeben. Ein CPS von 1% oder mehr gilt als positiv.

                                                    ShortCPS-Score
                                                    Comments

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

                                                    Control0..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()))
                                                    222. Observation.component:cps-score.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
                                                    224. Observation.component:cps-score.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())
                                                    226. Observation.component:cps-score.modifierExtension
                                                    Definition

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

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

                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                    Comments

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

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                    Summarytrue
                                                    Requirements

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

                                                    Alternate Namesextensions, user content, modifiers
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    228. Observation.component:cps-score.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
                                                    BindingFor example codes, see LOINCCodes
                                                    (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                    Codes identifying names of simple observations.

                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Must Supporttrue
                                                    Summarytrue
                                                    Requirements

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

                                                    Pattern Value{
                                                      "coding" : [{
                                                        "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                                                        "code" : "C176582",
                                                        "display" : "PD-L1 Combined Positive Score"
                                                      }]
                                                    }
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    230. Observation.component:cps-score.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
                                                    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
                                                    Summarytrue
                                                    Requirements

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

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                    • type @ $this
                                                    • 232. Observation.component:cps-score.value[x]:valueQuantity
                                                      Slice NamevalueQuantity
                                                      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
                                                      TypeQuantity
                                                      [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()))
                                                      234. Observation.component:cps-score.dataAbsentReason
                                                      Definition

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

                                                      ShortWhy the component result is missing
                                                      Comments

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

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

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

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

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Requirements

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

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

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

                                                      ShortHigh, low, normal, etc.
                                                      Comments

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

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

                                                      Codes identifying interpretations of observations.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Summaryfalse
                                                      Requirements

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

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

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

                                                      ShortProvides guide for interpretation of component result
                                                      Comments

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

                                                      Control0..*
                                                      TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Requirements

                                                      Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      240. Observation.component:ics-score
                                                      Slice Nameics-score
                                                      Definition

                                                      Immune Cell Score (ICS) - Score für PD-L1-Expression in Immunzellen. Der ICS ist der Anteil der PD-L1-positiven Immunzellen im Verhältnis zu den Gesamtzellen. Der ICS wird in Prozent angegeben. Ein ICS von 1% oder mehr gilt als positiv.

                                                      ShortICS-Score
                                                      Comments

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

                                                      Control0..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()))
                                                      242. Observation.component:ics-score.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
                                                      244. Observation.component:ics-score.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())
                                                      246. Observation.component:ics-score.modifierExtension
                                                      Definition

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

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

                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                      Comments

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

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                      Summarytrue
                                                      Requirements

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

                                                      Alternate Namesextensions, user content, modifiers
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      248. Observation.component:ics-score.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
                                                      BindingFor example codes, see LOINCCodes
                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                      Codes identifying names of simple observations.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supporttrue
                                                      Summarytrue
                                                      Requirements

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

                                                      Pattern Value{
                                                        "coding" : [{
                                                          "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem-ncit.html",
                                                          "code" : "C199175",
                                                          "display" : "Cells.programmed cell death ligand 1/Viable tumor cells in Tissue by Immune stain"
                                                        }]
                                                      }
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      250. Observation.component:ics-score.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
                                                      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
                                                      Summarytrue
                                                      Requirements

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

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                      • type @ $this
                                                      • 252. Observation.component:ics-score.value[x]:valueQuantity
                                                        Slice NamevalueQuantity
                                                        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
                                                        TypeQuantity
                                                        [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()))
                                                        254. Observation.component:ics-score.dataAbsentReason
                                                        Definition

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

                                                        ShortWhy the component result is missing
                                                        Comments

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

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

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

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

                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Summaryfalse
                                                        Requirements

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

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

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

                                                        ShortHigh, low, normal, etc.
                                                        Comments

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

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

                                                        Codes identifying interpretations of observations.

                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summaryfalse
                                                        Requirements

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

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

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

                                                        ShortProvides guide for interpretation of component result
                                                        Comments

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

                                                        Control0..*
                                                        TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                        Is Modifierfalse
                                                        Summaryfalse
                                                        Requirements

                                                        Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        260. Observation.component:tc-score
                                                        Slice Nametc-score
                                                        Definition

                                                        Tumor Cell Score (TC-Score) - Score für PD-L1-Expression in Tumorzellen. Der TC-Score ist der Anteil der PD-L1-positiven Tumorzellen im Verhältnis zu den Gesamtzellen. Der TC-Score wird in Prozent angegeben. Ein TC-Score von 1% oder mehr gilt als positiv.

                                                        ShortTC-Score / TPS-Score
                                                        Comments

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

                                                        Control0..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()))
                                                        262. Observation.component:tc-score.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
                                                        264. Observation.component:tc-score.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())
                                                        266. Observation.component:tc-score.modifierExtension
                                                        Definition

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

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

                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                        Comments

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

                                                        Control0..*
                                                        TypeExtension
                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                        Summarytrue
                                                        Requirements

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

                                                        Alternate Namesextensions, user content, modifiers
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                        268. Observation.component:tc-score.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
                                                        BindingFor example codes, see LOINCCodes
                                                        (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                                        Codes identifying names of simple observations.

                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summarytrue
                                                        Requirements

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

                                                        Pattern Value{
                                                          "coding" : [{
                                                            "system" : "http://loinc.org",
                                                            "code" : "83053-9",
                                                            "display" : "Cells.programmed cell death ligand 1/Viable tumor cells in Tissue by Immune stain"
                                                          }]
                                                        }
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        270. Observation.component:tc-score.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
                                                        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
                                                        Summarytrue
                                                        Requirements

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

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                        • type @ $this
                                                        • 272. Observation.component:tc-score.value[x]:valueQuantity
                                                          Slice NamevalueQuantity
                                                          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
                                                          TypeQuantity
                                                          [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()))
                                                          274. Observation.component:tc-score.dataAbsentReason
                                                          Definition

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

                                                          ShortWhy the component result is missing
                                                          Comments

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

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

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

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

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Summaryfalse
                                                          Requirements

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

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

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

                                                          ShortHigh, low, normal, etc.
                                                          Comments

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

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

                                                          Codes identifying interpretations of observations.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supporttrue
                                                          Summaryfalse
                                                          Requirements

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

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

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

                                                          ShortProvides guide for interpretation of component result
                                                          Comments

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

                                                          Control0..*
                                                          TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                          Is Modifierfalse
                                                          Summaryfalse
                                                          Requirements

                                                          Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

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