ISiK Vitalparameter Implementierungsleitfaden
Version 6.0.0-rc - STU1

Resource Profile: ISiKLaboruntersuchungGFR - Detailed Descriptions

Active as of 2025-12-17

Definitions for the ISiKLaboruntersuchungGFR resource profile.

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

0. Observation
Definition

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

ShortMeasurements and simple assertions
Comments

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

Control0..*
Is Modifierfalse
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())
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.id
Definition

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

Shortserverseitige, interne ID des DatensatzesLogical id of this artifact
Comments

bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.


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
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
4. 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()))
6. Observation.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored
Comments

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

Control0..*
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())
8. Observation.status
Definition

The status of the result value.

ShortStatus der Laboruntersuchungregistered | preliminary | final | amended +
Comments

Begründung MS: Der Status ist unerlässlich für die korrekte Interpretation einer Untersuchung. WICHTIGER Hinweis für Implementierer:

  • Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte final und unknown.
  • Alle client-seitigen Implementierungen MÜSSEN in der Lage sein, sämtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu können, beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status entered-in-error und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.ä.

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
Must Supporttrue
Summarytrue
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

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

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

ShortKategorie der LaboruntersuchungClassification of type of observation
Comments

Begründung MS: Ermöglicht das Filtern, Sortieren und Gruppieren von Befunden. Für Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu befüllen.


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..*
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|4.0.1)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value{
  "coding" : [{
    "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()))
12. Observation.code
Definition

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

ShortGegenstand der Untersuchung (Laborparameter)Type of observation (code / type)
Comments

Begründung MS: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext dokumentiert.


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
BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
(example to http://hl7.org/fhir/ValueSet/observation-codes|4.0.1)

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.

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

A reference to a code defined by a terminology system.

ShortKodierung des LaborparametersCode 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
  • 16. Observation.code.coding:loinc
    Slice Nameloinc
    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..*
    BindingThe codes SHALL be taken from For codes, see ObservationCodesGFR
    (required to https://gematik.de/fhir/isik/ValueSet/ObservationCodesGFR)
    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://loinc.org"
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Observation.code.coding:loinc.system
    Definition

    The identification of the code system that defines the meaning of the symbol in the code.

    ShortSystem, aus dem der Code für den Laborparameter stammt (z. B. LOINC)Identity of the terminology system
    Comments

    The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

    Control10..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Need to be unambiguous about the source of the definition of the symbol.

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

    A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

    ShortCode des Laborparameters entsprechend dem verwendeten SystemSymbol in syntax defined by the system
    Control10..1
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Need to refer to a particular code in the system.

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

    A representation of the meaning of the code in the system, following the rules of the system.

    ShortAnzeige-/Bezeichnungstext für den Laborparameter-CodeRepresentation defined by the system
    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

    A reference to a code defined by a terminology system.

    ShortPrimärer SNOMED CT-Code ohne MethodenbezugCode defined by a terminology system
    Comments

    Motivation 0..1 Kardinalität: Abstrakter SNOMED CT-Code ohne Methodenbezug. Weitere (SCT) Codings mit Methodenbezug sind durch das offene Slicing möglich.


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

    Control0..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" : "80274001"
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. 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
    Must Supporttrue
    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()))
    28. Observation.subject
    Definition

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

    ShortReferenz auf den PatientenWho and/or what the observation is about
    Comments

    Begründung MS: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit.


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

    Control10..1
    TypeReference(Patient, Patient, Group, Device, Location)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Observations have no value if you don't know who or what they're about.

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

    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

    ShortPatienten-LinkLiteral reference, Relative, internal or absolute URL
    Comments

    Begründung MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.


    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

    Control0..1
    This element is affected by the following invariants: ref-1
    Typestring
    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()))
    32. Observation.encounter
    Definition

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

    ShortReferenz auf den AbteilungskontaktHealthcare event during which this observation is made
    Comments

    Begründung MS: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung.


    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()))
    34. Observation.encounter.reference
    Definition

    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

    ShortLiteral reference, Relative, internal or absolute URL
    Comments

    Begründung MS: Die Verlinkung auf eine Encounter-Ressource dient der technischen Zuordnung der Dokumentation zu einem Aufenthalt und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKKontaktGesundheitseinrichtung sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.


    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

    Control0..1
    This element is affected by the following invariants: ref-1
    Typestring
    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()))
    36. Observation.effective[x]
    Definition

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

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

    Begründung Must Support: Das Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen können, wann eine Untersuchung durchgeführt oder ein Zustand beobachtet wurde. Dies ist entscheidend für:

    • die klinische Relevanz des Ergebnisses (z.B. aktueller vs. älterer Befund),
    • Verlaufsauswertungen und Trendanalysen,
    • zeitlich abhängige Entscheidungsunterstützung,
    • eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts.

    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
    TypeChoice of: dateTime, Period, Timing, instant
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    Summarytrue
    Requirements

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

    Alternate NamesOccurrence
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • type @ $this
    • 38. Observation.effective[x]:effectiveDateTime
      Slice NameeffectiveDateTime
      Definition

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

      ShortClinically relevant time/time-period for observation
      Comments

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

      Control0..1
      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()))
      40. Observation.issued
      Definition

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

      ShortZeitpunkt der Verfügbarkeit des UntersuchungsergebnissesDate/Time this version was made available
      Comments

      Begründung MS: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte.


      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()))
      42. Observation.value[x]
      Definition

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

      ShortFestgestellter (Mess)Wert für den LaborparameterActual result
      Comments

      Begründung MS: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz.


      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 Closed, and can be differentiated using the following discriminators:
      • type @ $this
      • 44. Observation.value[x]:valueQuantity
        Slice NamevalueQuantity
        Definition

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

        ShortMesswert in quantitativer FormActual result
        Comments

        Begründung MS: Standardisierte, codierte Einheiten sind für Vergleichbarkeit, Umrechnung und automatische Plausibilisierung erforderlich.


        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
        BindingThe codes SHALL be taken from For codes, see ObservationUnitsGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
        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()))
        46. Observation.value[x]:valueQuantity.value
        Definition

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

        ShortDer numerische MesswertNumerical value (with implicit precision)
        Comments

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

        Control10..1
        Typedecimal
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Precision is handled implicitly in almost all cases of measurement.

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

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

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

        How the Quantity should be understood and represented.

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

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

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

        A human-readable form of the unit.

        ShortEinheit des Messwertes (z. B. mg/dL)Unit representation
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

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

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

        ShortKodiersystem für die Einheit (UCUM)System that defines coded unit form
        Control10..1
        This element is affected by the following invariants: qty-3
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

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

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

        ShortUCUM-Code der EinheitCoded form of the unit
        Comments

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

        Control10..1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

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

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

        ShortAngabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegtWhy the result is missing
        Comments

        Begründung Must Support: Nicht alle geplanten oder dokumentierten Untersuchungen liefern auch tatsächlich ein Ergebnis. In solchen Fällen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason ermöglicht diese präzise Aussage und verhindert Fehlinterpretationen


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

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

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        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()))
        58. Observation.interpretation
        Definition

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

        ShortInterpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)High, low, normal, etc.
        Comments

        Begründung MS: Unterstützt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen.


        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|4.0.1)

        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()))
        60. Observation.note
        Definition

        Comments about the observation or the results.

        ShortFreitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors)Comments about the observation
        Comments

        Begründung MS: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare.


        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
        Must Supporttrue
        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()))
        62. Observation.method
        Definition

        Indicates the mechanism used to perform the observation.

        ShortHow it was done
        Comments

        Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System die Information NICHT abbilden.

        Motivation zum eingeschränkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden können unterschiedliche Resultate liefern. Die Methode ist daher für Transparenz und Vergleichbarkeit entscheidend. Da diese Information aktuell häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird.


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

        Control0..1
        BindingFor example codes, see ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
        (example to http://hl7.org/fhir/ValueSet/observation-methods|4.0.1)

        Methods for simple observations.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        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()))
        64. Observation.specimen
        Definition

        The specimen that was used when this observation was made.

        ShortSpecimen used for this observation
        Comments

        Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System die Information NICHT abbilden.

        Motivation zum eingeschränkten MS: Die Probe (z. B. Serum, Urin) ist zentral für die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend. Da die Information aktuell jedoch häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird


        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()))
        66. Observation.specimen.reference
        Definition

        A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

        ShortLiteral reference, Relative, internal or absolute URL
        Comments

        Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

        Control0..1
        This element is affected by the following invariants: ref-1
        Typestring
        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()))
        68. Observation.specimen.identifier
        Definition

        An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

        ShortLogical reference, when literal reference is not known
        Comments

        When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

        When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

        Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

        Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        TypeIdentifier
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        70. Observation.specimen.identifier.use
        Definition

        The purpose of this identifier.

        Shortusual | official | temp | secondary | old (If known)
        Comments

        Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

        Control0..1
        BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
        (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

        Identifies the purpose for this identifier, if known .

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

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

        Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

        ShortThe namespace for the identifier value
        Comments

        Identifier.system is always case sensitive.

        Control10..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

        ExampleGeneral: http://www.acme.com/identifiers/patient
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        74. Observation.specimen.identifier.value
        Definition

        The portion of the identifier typically relevant to the user and which is unique within the context of the system.

        ShortThe value that is unique
        Comments

        If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

        Control10..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        ExampleGeneral: 123456
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        76. Observation.device
        Definition

        The device used to generate the observation data.

        ShortVerwendetes Gerät oder Instrument zur Durchführung der Untersuchung(Measurement) Device
        Comments

        Begründung Must Support: Das verwendete Mess- oder Analysegerät kann einen entscheidenden Einfluss auf die Genauigkeit, Validität und Vergleichbarkeit von Untersuchungsergebnissen haben.


        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
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        78. Observation.referenceRange
        Definition

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

        ShortReferenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte)Provides guide for interpretation
        Comments

        Begründung MS: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes


        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
        Must Supporttrue
        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())
        obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
        80. 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())
        82. 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).

        ShortUntergrenze des ReferenzbereichsLow Range, if relevant
        Control0..1
        This element is affected by the following invariants: obs-3
        BindingThe codes SHALL be taken from For codes, see ObservationUnitsGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
        TypeQuantity(SimpleQuantity)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        84. Observation.referenceRange.low.value
        Definition

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

        ShortNumerical value (with implicit precision)
        Comments

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

        Control10..1
        Typedecimal
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Precision is handled implicitly in almost all cases of measurement.

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

        Not allowed to be used in this context


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

        Short< | <= | >= | > - how to understand the value
        Control0..01
        BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

        How the Quantity should be understood and represented.

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

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

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

        A human-readable form of the unit.

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

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

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

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

        ShortSystem that defines coded unit form
        Control10..1
        This element is affected by the following invariants: qty-3
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

        Pattern Valuehttp://unitsofmeasure.org
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        92. Observation.referenceRange.low.code
        Definition

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

        ShortCoded form of the unit
        Comments

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

        Control10..1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        94. 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).

        ShortObergrenze des ReferenzbereichsHigh Range, if relevant
        Control0..1
        This element is affected by the following invariants: obs-3
        BindingThe codes SHALL be taken from For codes, see ObservationUnitsGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
        TypeQuantity(SimpleQuantity)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        96. Observation.referenceRange.high.value
        Definition

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

        ShortNumerical value (with implicit precision)
        Comments

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

        Control10..1
        Typedecimal
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Precision is handled implicitly in almost all cases of measurement.

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

        Not allowed to be used in this context


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

        Short< | <= | >= | > - how to understand the value
        Control0..01
        BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
        (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

        How the Quantity should be understood and represented.

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

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

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

        A human-readable form of the unit.

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

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

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

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

        ShortSystem that defines coded unit form
        Control10..1
        This element is affected by the following invariants: qty-3
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

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

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

        ShortCoded form of the unit
        Comments

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

        Control10..1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

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

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        106. 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.

        ShortArt des Referenzbereichs (z. B. normal, kritisch)Reference 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 ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaning|4.0.1
        (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning|4.0.1)

        Code for the meaning of a reference range.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        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()))
        108. Observation.referenceRange.type.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

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

        Control0..*
        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()))
        110. Observation.referenceRange.type.coding.system
        Definition

        The identification of the code system that defines the meaning of the symbol in the code.

        ShortIdentity of the terminology system
        Comments

        The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

        Control10..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to be unambiguous about the source of the definition of the symbol.

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

        A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

        ShortSymbol in syntax defined by the system
        Control10..1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to refer to a particular code in the system.

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

        A representation of the meaning of the code in the system, following the rules of the system.

        ShortRepresentation defined by the system
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        116. Observation.referenceRange.type.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
        Must Supporttrue
        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()))
        118. 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.

        ShortFür wen der Referenzbereich gilt (z. B. Geschlecht, Alter)Reference 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 ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliesto|4.0.1
        (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto|4.0.1)

        Codes identifying the population the reference range applies to.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        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()))
        120. Observation.referenceRange.appliesTo.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortKodierte Angabe zur ZielgruppeCode defined by a terminology system
        Comments

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

        Control0..*
        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()))
        122. Observation.referenceRange.appliesTo.coding.system
        Definition

        The identification of the code system that defines the meaning of the symbol in the code.

        ShortIdentity of the terminology system
        Comments

        The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

        Control10..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to be unambiguous about the source of the definition of the symbol.

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

        A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

        ShortSymbol in syntax defined by the system
        Control10..1
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to refer to a particular code in the system.

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

        A representation of the meaning of the code in the system, following the rules of the system.

        ShortRepresentation defined by the system
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

        ShortAltersbereich, für den der Referenzbereich giltApplicable age range, if relevant
        Control0..1
        TypeRange
        Is Modifierfalse
        Must Supporttrue
        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()))
        132. Observation.referenceRange.age.low
        Definition

        The low limit. The boundary is inclusive.

        ShortLow limit
        Comments

        If the low element is missing, the low boundary is not known.

        Control0..1
        TypeQuantity(SimpleQuantity)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        134. Observation.referenceRange.age.high
        Definition

        The high limit. The boundary is inclusive.

        ShortHigh limit
        Comments

        If the high element is missing, the high boundary is not known.

        Control0..1
        TypeQuantity(SimpleQuantity)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        136. 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".

        ShortFreitextbeschreibung des ReferenzbereichsText 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
        Must Supporttrue
        Summaryfalse
        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.code
        4. Observation.code.coding:loinc
        Slice Nameloinc
        BindingThe codes SHALL be taken from ObservationCodesGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationCodesGFR)
        6. Observation.code.coding:snomed
        Slice Namesnomed
        ShortPrimärer SNOMED CT-Code ohne Methodenbezug
        Comments

        Motivation 0..1 Kardinalität: Abstrakter SNOMED CT-Code ohne Methodenbezug. Weitere (SCT) Codings mit Methodenbezug sind durch das offene Slicing möglich.

        Control0..1
        Pattern Value{
          "system" : "http://snomed.info/sct",
          "code" : "80274001"
        }
        8. Observation.value[x]:valueQuantity
        Slice NamevalueQuantity
        BindingThe codes SHALL be taken from ObservationUnitsGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
        TypeQuantity
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        10. Observation.referenceRange
        12. Observation.referenceRange.low
        BindingThe codes SHALL be taken from ObservationUnitsGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
        14. Observation.referenceRange.high
        BindingThe codes SHALL be taken from ObservationUnitsGFR
        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)

        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())
        2. Observation.id
        Definition

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

        Shortserverseitige, interne ID des Datensatzes
        Comments

        bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

        Control0..1
        Typeid
        Is Modifierfalse
        Must Supporttrue
        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
        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.

          ShortEindeutiger Name der serverseitigen Version des Datensatzes
          Comments

          Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

          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.

          ShortZeitpunkt der letzten Änderung
          Comments

          Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

          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
          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|4.0.1)

          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
          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.

          ShortStatus der Laboruntersuchung
          Comments

          Begründung MS: Der Status ist unerlässlich für die korrekte Interpretation einer Untersuchung. WICHTIGER Hinweis für Implementierer:

          • Alle server-seitigen Implementierungen MÜSSEN in der Lage sein, die systemintern möglichen Statuswerte korrekt in FHIR abzubilden, mindestens jedoch die Werte final und unknown.
          • Alle client-seitigen Implementierungen MÜSSEN in der Lage sein, sämtliche Status-Codes zu interpretieren und dem Anwender in angemessener Form darstellen zu können, beispielsweise durch Ausblenden/Durchstreichen von Prozeduren mit dem status entered-in-error und Ausgrauen von Untersuchungen, die noch nicht stattgefunden haben, o.ä.
          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
          Must Supporttrue
          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

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

          ShortKategorie der Laboruntersuchung
          Comments

          Begründung MS: Ermöglicht das Filtern, Sortieren und Gruppieren von Befunden. Für Laboruntersuchungen ist die Kategorie zwingend mit dem entsprechenden Code (z. B. LOINC-Kategorie „laboratory“) zu befüllen.

          Control1..*
          BindingThe codes SHOULD be taken from ObservationCategoryCodes
          (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Pattern Value{
            "coding" : [{
              "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()))
          44. Observation.code
          Definition

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

          ShortGegenstand der Untersuchung (Laborparameter)
          Comments

          Begründung MS: Der Code identifiziert, was gemessen wurde, und ist damit das zentrale Element der Observation. Ohne .code ist kein eindeutiger sowie maschinell auswertbarer klinischer Kontext dokumentiert.

          Control1..1
          BindingFor example codes, see LOINCCodes
          (example to http://hl7.org/fhir/ValueSet/observation-codes|4.0.1)

          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.

          Alternate NamesName
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. 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
          48. 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
          • 50. Observation.code.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortKodierung des Laborparameters
            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
            • 52. Observation.code.coding:loinc
              Slice Nameloinc
              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..*
              BindingThe codes SHALL be taken from ObservationCodesGFR
              (required to https://gematik.de/fhir/isik/ValueSet/ObservationCodesGFR)
              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://loinc.org"
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              54. Observation.code.coding:loinc.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
              56. Observation.code.coding:loinc.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.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 58. Observation.code.coding:loinc.system
                Definition

                The identification of the code system that defines the meaning of the symbol in the code.

                ShortSystem, aus dem der Code für den Laborparameter stammt (z. B. LOINC)
                Comments

                The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                Control1..1
                Typeuri
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Requirements

                Need to be unambiguous about the source of the definition of the symbol.

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

                The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                ShortVersion of the system - if relevant
                Comments

                Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                NoteThis is a business version Id, not a resource version Id (see discussion)
                Control0..1
                Typestring
                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()))
                62. Observation.code.coding:loinc.code
                Definition

                A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                ShortCode des Laborparameters entsprechend dem verwendeten System
                Control1..1
                Typecode
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Requirements

                Need to refer to a particular code in the system.

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

                A representation of the meaning of the code in the system, following the rules of the system.

                ShortAnzeige-/Bezeichnungstext für den Laborparameter-Code
                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Requirements

                Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

                Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                ShortIf this coding was chosen directly by the user
                Comments

                Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

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

                A reference to a code defined by a terminology system.

                ShortPrimärer SNOMED CT-Code ohne Methodenbezug
                Comments

                Motivation 0..1 Kardinalität: Abstrakter SNOMED CT-Code ohne Methodenbezug. Weitere (SCT) Codings mit Methodenbezug sind durch das offene Slicing möglich.

                Control0..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" : "80274001"
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. 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
                Must Supporttrue
                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()))
                72. Observation.subject
                Definition

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

                ShortReferenz auf den Patienten
                Comments

                Begründung MS: Die Verknüpfung zur Patientin oder zum Patienten ist zwingend notwendig für jegliche klinische Verwertbarkeit.

                Control1..1
                TypeReference(Patient)
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                Observations have no value if you don't know who or what they're about.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                74. Observation.subject.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
                76. Observation.subject.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.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 78. Observation.subject.reference
                  Definition

                  A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                  ShortPatienten-Link
                  Comments

                  Begründung MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

                  Control0..1
                  This element is affected by the following invariants: ref-1
                  Typestring
                  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()))
                  80. Observation.subject.type
                  Definition

                  The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                  The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                  ShortType the reference refers to (e.g. "Patient")
                  Comments

                  This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                  Control0..1
                  BindingUnless not suitable, these codes SHALL be taken from ResourceType
                  (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

                  Aa resource (or, for logical models, the URI of the logical model).

                  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()))
                  82. Observation.subject.identifier
                  Definition

                  An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                  ShortLogical reference, when literal reference is not known
                  Comments

                  When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                  When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                  Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                  Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  84. Observation.subject.display
                  Definition

                  Plain text narrative that identifies the resource in addition to the resource reference.

                  ShortText alternative for the resource
                  Comments

                  This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                  Control0..1
                  Typestring
                  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()))
                  86. 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(Resource)
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  88. Observation.encounter
                  Definition

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

                  ShortReferenz auf den Abteilungskontakt
                  Comments

                  Begründung MS: Dient der Einordnung in den klinischen Verlauf und ermöglicht Kontextinformationen wie Aufnahmediagnose oder behandelnde Abteilung.

                  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()))
                  90. Observation.encounter.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
                  92. Observation.encounter.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.encounter.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 94. Observation.encounter.reference
                    Definition

                    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                    ShortLiteral reference, Relative, internal or absolute URL
                    Comments

                    Begründung MS: Die Verlinkung auf eine Encounter-Ressource dient der technischen Zuordnung der Dokumentation zu einem Aufenthalt und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKKontaktGesundheitseinrichtung sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

                    Control0..1
                    This element is affected by the following invariants: ref-1
                    Typestring
                    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.encounter.type
                    Definition

                    The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                    The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                    ShortType the reference refers to (e.g. "Patient")
                    Comments

                    This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                    Control0..1
                    BindingUnless not suitable, these codes SHALL be taken from ResourceType
                    (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

                    Aa resource (or, for logical models, the URI of the logical model).

                    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()))
                    98. Observation.encounter.identifier
                    Definition

                    An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                    ShortLogical reference, when literal reference is not known
                    Comments

                    When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                    When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                    Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                    Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..1
                    TypeIdentifier
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    100. Observation.encounter.display
                    Definition

                    Plain text narrative that identifies the resource in addition to the resource reference.

                    ShortText alternative for the resource
                    Comments

                    This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                    Control0..1
                    Typestring
                    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()))
                    102. Observation.effective[x]
                    Definition

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

                    ShortZeitpunkt der Untersuchung
                    Comments

                    Begründung Must Support: Das Element effective[x] ist zentral, um die Beobachtung - insbesondere bei Laborbefunden - zeitlich korrekt einzuordnen. Es stellt sicher, dass Systeme erkennen können, wann eine Untersuchung durchgeführt oder ein Zustand beobachtet wurde. Dies ist entscheidend für:

                    • die klinische Relevanz des Ergebnisses (z.B. aktueller vs. älterer Befund),
                    • Verlaufsauswertungen und Trendanalysen,
                    • zeitlich abhängige Entscheidungsunterstützung,
                    • eine valide Anzeige im zeitlichen Kontext des Patientenaufenthalts.
                    Control0..1
                    TypeChoice of: dateTime, Period, Timing, instant
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Must Support TypesNo must-support rules about the choice of types/profiles
                    Summarytrue
                    Requirements

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

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

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

                      ShortClinically relevant time/time-period for observation
                      Comments

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

                      Control0..1
                      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()))
                      106. Observation.issued
                      Definition

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

                      ShortZeitpunkt der Verfügbarkeit des Untersuchungsergebnisses
                      Comments

                      Begründung MS: Relevant zur Nachvollziehbarkeit und Validierung von Befunden, z.B. wann eine Entscheidung darauf basierte.

                      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()))
                      108. 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()))
                      110. Observation.value[x]
                      Definition

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

                      ShortFestgestellter (Mess)Wert für den Laborparameter
                      Comments

                      Begründung MS: Der gemessene Wert stellt die zentrale Aussage der Observation dar. Ohne value besitzt die Observation keine medizinische Relevanz.

                      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 Closed, and can be differentiated using the following discriminators:
                      • type @ $this
                      • 112. Observation.value[x]:valueQuantity
                        Slice NamevalueQuantity
                        Definition

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

                        ShortMesswert in quantitativer Form
                        Comments

                        Begründung MS: Standardisierte, codierte Einheiten sind für Vergleichbarkeit, Umrechnung und automatische Plausibilisierung erforderlich.

                        Control0..1
                        This element is affected by the following invariants: obs-7
                        BindingThe codes SHALL be taken from ObservationUnitsGFR
                        (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
                        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()))
                        114. Observation.value[x]:valueQuantity.id
                        Definition

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

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

                          ShortDer numerische Messwert
                          Comments

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

                          Control1..1
                          Typedecimal
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          Precision is handled implicitly in almost all cases of measurement.

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

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

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

                          How the Quantity should be understood and represented.

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

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

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

                          A human-readable form of the unit.

                          ShortEinheit des Messwertes (z. B. mg/dL)
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

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

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

                          ShortKodiersystem für die Einheit (UCUM)
                          Control1..1
                          This element is affected by the following invariants: qty-3
                          Typeuri
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

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

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

                          ShortUCUM-Code der Einheit
                          Comments

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

                          Control1..1
                          Typecode
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

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

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

                          ShortAngabe eines Grundes weshalb kein Ergebniss der Laboruntersuchung vorliegt
                          Comments

                          Begründung Must Support: Nicht alle geplanten oder dokumentierten Untersuchungen liefern auch tatsächlich ein Ergebnis. In solchen Fällen ist es wichtig, nicht nur auf das Fehlen eines Wertes zu reagieren, sondern den Grund strukturiert anzugeben. dataAbsentReason ermöglicht diese präzise Aussage und verhindert Fehlinterpretationen

                          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|4.0.1)

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

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supporttrue
                          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()))
                          130. Observation.interpretation
                          Definition

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

                          ShortInterpretation oder Bewertung des Messergebnisses (z.B. „hoch“, „niedrig“, „normal“)
                          Comments

                          Begründung MS: Unterstützt die klinische Interpretation, insbesondere bei komplexen Parametern und automatisierten Auswertungen.

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

                          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()))
                          132. Observation.note
                          Definition

                          Comments about the observation or the results.

                          ShortFreitextnotiz oder Kommentar zur Beobachtung (z. B. Hinweise des Labors)
                          Comments

                          Begründung MS: Dient zur Dokumentation abweichender Umstände, Freitextbefundung oder ergänzender Laborkommentare.

                          Control0..*
                          TypeAnnotation
                          Is Modifierfalse
                          Must Supporttrue
                          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()))
                          134. 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|4.0.1)

                          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()))
                          136. Observation.method
                          Definition

                          Indicates the mechanism used to perform the observation.

                          ShortHow it was done
                          Comments

                          Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der zugrundeliegenden Methode, so MUSS dieses System die Information NICHT abbilden.

                          Motivation zum eingeschränkten MS: Die Untersuchungsmethode einer Laboruntersuchung ist eine relevante medizinische Information: Unterschiedliche Methoden können unterschiedliche Resultate liefern. Die Methode ist daher für Transparenz und Vergleichbarkeit entscheidend. Da diese Information aktuell häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird.

                          Control0..1
                          BindingFor example codes, see ObservationMethods
                          (example to http://hl7.org/fhir/ValueSet/observation-methods|4.0.1)

                          Methods for simple observations.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supporttrue
                          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()))
                          138. Observation.specimen
                          Definition

                          The specimen that was used when this observation was made.

                          ShortSpecimen used for this observation
                          Comments

                          Einschränkung der übergreifenden MS-Definition: Verfügt ein bestätigungsrelevantes System nicht über die Datenstruktur zur Hinterlegung der Laboruntersuchung zugrundeliegenden Probe, so MUSS dieses System die Information NICHT abbilden.

                          Motivation zum eingeschränkten MS: Die Probe (z. B. Serum, Urin) ist zentral für die korrekte Bewertung des Ergebnisses. Die Unterscheidung von Materialtypen ist oft diagnostisch ausschlaggebend. Da die Information aktuell jedoch häufig nicht übergeben wird, wird das MS eingeschränkt. Es ist dennoch wünschenswert, dass die Probe in der Zukunft übergeben wird

                          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()))
                          140. Observation.specimen.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
                          142. Observation.specimen.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.specimen.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 144. Observation.specimen.reference
                            Definition

                            A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                            ShortLiteral reference, Relative, internal or absolute URL
                            Comments

                            Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                            Control0..1
                            This element is affected by the following invariants: ref-1
                            Typestring
                            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()))
                            146. Observation.specimen.type
                            Definition

                            The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                            The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                            ShortType the reference refers to (e.g. "Patient")
                            Comments

                            This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                            Control0..1
                            BindingUnless not suitable, these codes SHALL be taken from ResourceType
                            (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

                            Aa resource (or, for logical models, the URI of the logical model).

                            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()))
                            148. Observation.specimen.identifier
                            Definition

                            An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                            ShortLogical reference, when literal reference is not known
                            Comments

                            When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                            When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                            Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                            Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                            NoteThis is a business identifier, not a resource identifier (see discussion)
                            Control0..1
                            TypeIdentifier
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            150. Observation.specimen.identifier.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
                            152. Observation.specimen.identifier.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.specimen.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 154. Observation.specimen.identifier.use
                              Definition

                              The purpose of this identifier.

                              Shortusual | official | temp | secondary | old (If known)
                              Comments

                              Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                              Control0..1
                              BindingThe codes SHALL be taken from IdentifierUse
                              (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

                              Identifies the purpose for this identifier, if known .

                              Typecode
                              Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

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

                              A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                              ShortDescription of identifier
                              Comments

                              This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                              Control0..1
                              BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
                              (extensible to http://hl7.org/fhir/ValueSet/identifier-type|4.0.1)

                              A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Requirements

                              Allows users to make use of identifiers when the identifier system is not known.

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

                              Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

                              ShortThe namespace for the identifier value
                              Comments

                              Identifier.system is always case sensitive.

                              Control1..1
                              Typeuri
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Summarytrue
                              Requirements

                              There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                              ExampleGeneral: http://www.acme.com/identifiers/patient
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              160. Observation.specimen.identifier.value
                              Definition

                              The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                              ShortThe value that is unique
                              Comments

                              If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                              Control1..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Summarytrue
                              ExampleGeneral: 123456
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              162. Observation.specimen.identifier.period
                              Definition

                              Time period during which identifier is/was valid for use.

                              ShortTime period when id is/was valid for use
                              Control0..1
                              TypePeriod
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              164. Observation.specimen.identifier.assigner
                              Definition

                              Organization that issued/manages the identifier.

                              ShortOrganization that issued id (may be just text)
                              Comments

                              The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                              Control0..1
                              TypeReference(Organization)
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              166. Observation.specimen.display
                              Definition

                              Plain text narrative that identifies the resource in addition to the resource reference.

                              ShortText alternative for the resource
                              Comments

                              This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                              Control0..1
                              Typestring
                              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()))
                              168. Observation.device
                              Definition

                              The device used to generate the observation data.

                              ShortVerwendetes Gerät oder Instrument zur Durchführung der Untersuchung
                              Comments

                              Begründung Must Support: Das verwendete Mess- oder Analysegerät kann einen entscheidenden Einfluss auf die Genauigkeit, Validität und Vergleichbarkeit von Untersuchungsergebnissen haben.

                              Control0..1
                              TypeReference(Device, DeviceMetric)
                              Is Modifierfalse
                              Must Supporttrue
                              Must Support TypesNo must-support rules about the choice of types/profiles
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              170. 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.

                              ShortReferenzbereich zur Interpretation des Messergebnisses (z. B. Normalwerte)
                              Comments

                              Begründung MS: Referenzbereiche erlauben die sofortige klinische Bewertung eines Wertes

                              Control0..*
                              TypeBackboneElement
                              Is Modifierfalse
                              Must Supporttrue
                              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())
                              172. 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
                              174. 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())
                              176. 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())
                              178. 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).

                              ShortUntergrenze des Referenzbereichs
                              Control0..1
                              This element is affected by the following invariants: obs-3
                              BindingThe codes SHALL be taken from ObservationUnitsGFR
                              (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
                              TypeQuantity(SimpleQuantity)
                              Is Modifierfalse
                              Must Supporttrue
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              180. Observation.referenceRange.low.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
                              182. Observation.referenceRange.low.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.referenceRange.low.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 184. Observation.referenceRange.low.value
                                Definition

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

                                ShortNumerical value (with implicit precision)
                                Comments

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

                                Control1..1
                                Typedecimal
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Requirements

                                Precision is handled implicitly in almost all cases of measurement.

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

                                Not allowed to be used in this context

                                Short< | <= | >= | > - how to understand the value
                                Control0..0
                                BindingThe codes SHALL be taken from QuantityComparator
                                (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                How the Quantity should be understood and represented.

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

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

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

                                A human-readable form of the unit.

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

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

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

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

                                ShortSystem that defines coded unit form
                                Control1..1
                                This element is affected by the following invariants: qty-3
                                Typeuri
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Requirements

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

                                Pattern Valuehttp://unitsofmeasure.org
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                192. Observation.referenceRange.low.code
                                Definition

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

                                ShortCoded form of the unit
                                Comments

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

                                Control1..1
                                Typecode
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Requirements

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

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                194. 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).

                                ShortObergrenze des Referenzbereichs
                                Control0..1
                                This element is affected by the following invariants: obs-3
                                BindingThe codes SHALL be taken from ObservationUnitsGFR
                                (required to https://gematik.de/fhir/isik/ValueSet/ObservationUnitsGFR)
                                TypeQuantity(SimpleQuantity)
                                Is Modifierfalse
                                Must Supporttrue
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                196. Observation.referenceRange.high.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
                                198. Observation.referenceRange.high.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.referenceRange.high.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 200. Observation.referenceRange.high.value
                                  Definition

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

                                  ShortNumerical value (with implicit precision)
                                  Comments

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

                                  Control1..1
                                  Typedecimal
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

                                  Precision is handled implicitly in almost all cases of measurement.

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

                                  Not allowed to be used in this context

                                  Short< | <= | >= | > - how to understand the value
                                  Control0..0
                                  BindingThe codes SHALL be taken from QuantityComparator
                                  (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                  How the Quantity should be understood and represented.

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

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

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

                                  A human-readable form of the unit.

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

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

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

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

                                  ShortSystem that defines coded unit form
                                  Control1..1
                                  This element is affected by the following invariants: qty-3
                                  Typeuri
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

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

                                  Pattern Valuehttp://unitsofmeasure.org
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  208. Observation.referenceRange.high.code
                                  Definition

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

                                  ShortCoded form of the unit
                                  Comments

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

                                  Control1..1
                                  Typecode
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

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

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  210. 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.

                                  ShortArt des Referenzbereichs (z. B. normal, kritisch)
                                  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|4.0.1)

                                  Code for the meaning of a reference range.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supporttrue
                                  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()))
                                  212. Observation.referenceRange.type.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
                                  214. Observation.referenceRange.type.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.referenceRange.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 216. Observation.referenceRange.type.coding
                                    Definition

                                    A reference to a code defined by a terminology system.

                                    ShortCode defined by a terminology system
                                    Comments

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

                                    Control0..*
                                    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()))
                                    218. Observation.referenceRange.type.coding.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
                                    220. Observation.referenceRange.type.coding.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.referenceRange.type.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 222. Observation.referenceRange.type.coding.system
                                      Definition

                                      The identification of the code system that defines the meaning of the symbol in the code.

                                      ShortIdentity of the terminology system
                                      Comments

                                      The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                                      Control1..1
                                      Typeuri
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Need to be unambiguous about the source of the definition of the symbol.

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

                                      The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                      ShortVersion of the system - if relevant
                                      Comments

                                      Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                      NoteThis is a business version Id, not a resource version Id (see discussion)
                                      Control0..1
                                      Typestring
                                      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()))
                                      226. Observation.referenceRange.type.coding.code
                                      Definition

                                      A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                      ShortSymbol in syntax defined by the system
                                      Control1..1
                                      Typecode
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Need to refer to a particular code in the system.

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

                                      A representation of the meaning of the code in the system, following the rules of the system.

                                      ShortRepresentation defined by the system
                                      Control0..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

                                      Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                      ShortIf this coding was chosen directly by the user
                                      Comments

                                      Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                                      This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      232. Observation.referenceRange.type.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
                                      Must Supporttrue
                                      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()))
                                      234. 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.

                                      ShortFür wen der Referenzbereich gilt (z. B. Geschlecht, Alter)
                                      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|4.0.1)

                                      Codes identifying the population the reference range applies to.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supporttrue
                                      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()))
                                      236. Observation.referenceRange.appliesTo.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
                                      238. Observation.referenceRange.appliesTo.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.referenceRange.appliesTo.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 240. Observation.referenceRange.appliesTo.coding
                                        Definition

                                        A reference to a code defined by a terminology system.

                                        ShortKodierte Angabe zur Zielgruppe
                                        Comments

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

                                        Control0..*
                                        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()))
                                        242. Observation.referenceRange.appliesTo.coding.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.referenceRange.appliesTo.coding.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.referenceRange.appliesTo.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 246. Observation.referenceRange.appliesTo.coding.system
                                          Definition

                                          The identification of the code system that defines the meaning of the symbol in the code.

                                          ShortIdentity of the terminology system
                                          Comments

                                          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

                                          Control1..1
                                          Typeuri
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          Need to be unambiguous about the source of the definition of the symbol.

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

                                          The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                          ShortVersion of the system - if relevant
                                          Comments

                                          Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                          NoteThis is a business version Id, not a resource version Id (see discussion)
                                          Control0..1
                                          Typestring
                                          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()))
                                          250. Observation.referenceRange.appliesTo.coding.code
                                          Definition

                                          A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                          ShortSymbol in syntax defined by the system
                                          Control1..1
                                          Typecode
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          Need to refer to a particular code in the system.

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

                                          A representation of the meaning of the code in the system, following the rules of the system.

                                          ShortRepresentation defined by the system
                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

                                          Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                          ShortIf this coding was chosen directly by the user
                                          Comments

                                          Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                                          This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          256. Observation.referenceRange.appliesTo.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
                                          Must Supporttrue
                                          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()))
                                          258. 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.

                                          ShortAltersbereich, für den der Referenzbereich gilt
                                          Control0..1
                                          TypeRange
                                          Is Modifierfalse
                                          Must Supporttrue
                                          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()))
                                          260. Observation.referenceRange.age.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
                                          262. Observation.referenceRange.age.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.referenceRange.age.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 264. Observation.referenceRange.age.low
                                            Definition

                                            The low limit. The boundary is inclusive.

                                            ShortLow limit
                                            Comments

                                            If the low element is missing, the low boundary is not known.

                                            Control0..1
                                            TypeQuantity(SimpleQuantity)
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            266. Observation.referenceRange.age.high
                                            Definition

                                            The high limit. The boundary is inclusive.

                                            ShortHigh limit
                                            Comments

                                            If the high element is missing, the high boundary is not known.

                                            Control0..1
                                            TypeQuantity(SimpleQuantity)
                                            Is Modifierfalse
                                            Must Supporttrue
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            268. 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".

                                            ShortFreitextbeschreibung des Referenzbereichs
                                            Control0..1
                                            Typestring
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supporttrue
                                            Summaryfalse
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            270. 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()))
                                            272. Observation.derivedFrom
                                            Definition

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

                                            ShortRelated measurements the observation is made from
                                            Comments

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

                                            Control0..*
                                            TypeReference(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()))
                                            274. Observation.component
                                            Definition

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

                                            ShortComponent results
                                            Comments

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

                                            Control0..*
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            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()))
                                            276. 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
                                            278. 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())
                                            280. 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())
                                            282. 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|4.0.1)

                                            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()))
                                            284. 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()))
                                            286. 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|4.0.1)

                                            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()))
                                            288. 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|4.0.1)

                                            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()))
                                            290. 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()))