MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 - Germany

This page is part of the MII IG Kerndatensatz-Modul Onkologie (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Ressourcenprofil: MII PR Onkologie Her2neu Status

Offizielle URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-mamma-her2neu-status Version: 2027.0.0-ballot.1
Active Stand: 2026-09-15 Maschinenlesbarer Name: MII_PR_Onko_Mamma_Her2neu_Status

Dieses Profil beschreibt den Her2neu Status einer pathologisch untersuchten Probe beim Mamma-Karzinom in der Onkologie

Inhalt

Das Her2neu Status Profil dokumentiert den diagnostischen Her2neu Status einer pathologisch untersuchten Probe beim Mammakarzinom. Her2neu (auch HER2 oder ERBB2) ist ein wichtiger prognostischer und prädiktiver Biomarker, der über die Eignung für eine anti-HER2-gerichtete Therapie entscheidet.

Der Her2neu Status basiert auf der immunhistochemischen (IHC) Färbung und bei bestimmten Befunden zusätzlich auf der In-situ-Hybridisierung (ISH, z.B. FISH oder CISH). Die Bestimmung folgt den ASCO/CAP-Guidelines und den Vorgaben der S3-Leitlinie Mammakarzinom.

Klinischer Hintergrund

Die Her2neu-Bestimmung ist essentiell für die Therapieplanung beim Mammakarzinom:

  • HER2-positive Tumoren (ca. 15-20% der Mammakarzinome) profitieren von anti-HER2-Therapien wie Trastuzumab, Pertuzumab oder T-DM1
  • HER2-low Tumoren zeigen eine niedrige HER2-Expression und können von neueren Therapien wie Trastuzumab-Deruxtecan profitieren (basierend auf den DESTINY-Breast04/06 Studien)
  • HER2-negative Tumoren erhalten keine anti-HER2-gerichtete Therapie

Her2neu Bestimmung nach ASCO/CAP

Die Her2neu-Bestimmung erfolgt mehrstufig:

her2neu-1

Abbildung 1: Her2neu Bestimmungsalgorithmus nach ASCO/CAP Guidelines. Die initiale IHC-Färbung führt bei 2+ Befunden zur ISH-Testung.

her2neu-2

Abbildung 2: Interpretation der Her2neu-Ergebnisse und Klassifikation in HER2-positiv, HER2-low, HER2-ultralow und HER2-negativ.

IHC-Scores:

  • 3+: Starke, komplette Membranfärbung in >10% der Tumorzellen → HER2-positiv
  • 2+: Schwache bis moderate, komplette Membranfärbung in >10% der Tumorzellen → ISH-Testung erforderlich
  • 1+: Schwache, inkomplette Membranfärbung in >10% der Tumorzellen → HER2-low (bei ISH-negativ bzw. ohne ISH)
  • 0: Keine Färbung oder Membranfärbung in ≤10% der Tumorzellen

ISH-Testung (FISH, CISH, etc.):

  • Positiv: HER2/CEP17-Ratio ≥2,0 oder HER2-Kopienzahl ≥6,0 pro Zelle
  • Negativ: HER2/CEP17-Ratio <2,0 und HER2-Kopienzahl <4,0 pro Zelle
  • Equivocal: Grenzwertige Befunde, die eine Nachtestung erfordern

Das Modul Molekulares Tumorboard bietet feingranulärereProfile zur Abbildung der IHC- und ISH-Datenpunkte innerhalb eines molekularpathologisch Befundberichts.

Verknüpfungen zu anderen Ressourcen

Das Profil ist eng mit anderen onkologischen Ressourcen verknüpft:

  • verweist über Observation.focus auf die Primärdiagnose (MII_PR_Onko_Diagnose_Primaertumor)
  • verweist über Observation.subject auf die Patientin (Patient-Ressource)
  • kann über Observation.encounter mit einem spezifischen Behandlungsfall verknüpft werden

oBDS-Kontext und duale Kodierung

Das Profil implementiert die oBDS-Datenfelder für den Her2neu Status (Feld M4, Nr. 243) beim Mammakarzinom. Dabei wird eine duale Kodierungsstrategie verwendet, um sowohl der gefrorenen oBDS-Spezifikation als auch den neueren S3-Leitlinien und ASCO/CAP Guidelines gerecht zu werden.

oBDS-Definition (basierend auf Leitlinie 3.0 Spezifikation):

Die oBDS-Kodierung verwendet Buchstaben-Codes, die exakt der publizierten Spezifikation entsprechen:

  • P = Positiv (IHC 3+ oder IHC 2+ und ISH positiv)
  • N = Negativ
  • U = Unbekannt

S3-Leitlinie/ASCO-CAP Definition (aktuelle Leitlinienversion 5.1):

Die moderne Klassifikation berücksichtigt zusätzlich HER2-low und HER2-ultralow Kategorien:

  • HER2-positiv: IHC 3+ oder IHC 2+ und ISH-positiv
  • HER2-low: IHC 1+ oder IHC 2+ und ISH-negativ
  • HER2-ultralow: IHC 0 mit Membranfärbung
  • HER2-negativ: IHC 0 ohne Membranfärbung
  • Equivocal: Grenzwertig, weitere Testung erforderlich

Diese duale Kodierung ermöglicht die Rückwärtskompatibilität mit existierenden oBDS-Registerdaten und gleichzeitig die Vorwärtskompatibilität mit neueren therapeutischen Entwicklungen (z.B. Trastuzumab-Deruxtecan für HER2-low).

Terminologie-Binding

Das Profil verwendet eine duale Kodierungsstrategie mit extensible Binding für valueCodeableConcept. Dies bedeutet, dass Codes aus beiden ValueSets parallel verwendet werden KÖNNEN.

ValueSet: MII VS Onko Mamma Her2neu Status oBDS

Die enthaltenen Codes sind in der Artefaktdarstellung aufgeführt: MII VS Onkologie Mamma Her2neu Status oBDS.

Die enthaltenen Codes sind in der Artefaktdarstellung aufgeführt: MII VS Onkologie Mamma Her2neu Status oBDS.

ValueSet: MII VS Onko Mamma Her2neu Status Leitlinie

Die enthaltenen Codes sind in der Artefaktdarstellung aufgeführt: MII VS Onkologie Mamma Her2neu Status Leitlinie.

Die enthaltenen Codes sind in der Artefaktdarstellung aufgeführt: MII VS Onkologie Mamma Her2neu Status Leitlinie.

Mapping Datensatz zu FHIR

Die Zuordnung der Datensatzfelder ist im logischen Modell dokumentiert: MII LM Onkologie Organspezifische Zusatzmodule.

Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) zu FHIR

Die oBDS-Mappings sind in der Artefaktdarstellung des Profils hinterlegt: MII PR Onkologie Her2neu Status.

Beispiele

mii-exa-onko-mamma-her2neu-status

Usages:

You can also check for usages in the FHIR IG Statistics

Formale Ansichten des Profilinhalts

Beschreibung von Profilen, Differentials, Snapshots und deren Repräsentationen.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... code SΣ 1..1 CodeableConcept Her2neu Status
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 48676-1
..... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Interpretation] in Tissue
..... userSelected 0..1 boolean If this coding was chosen directly by the user
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... focus SΣ 0..* Reference(MII PR Onkologie Diagnose Primärtumor) What the observation is about, when it is not about the subject of record
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... value[x] SΣC 1..1 CodeableConcept Actual result
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:All Slices Content/Rules for all slices
...... code SΣ 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionOBDS SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status oBDS (extensible)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-obds
...... code SΣ 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionLeitlinie SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status Leitlinie (extensible)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-leitlinie
...... code SΣ 1..1 code Symbol in syntax defined by the system
... Slices for component SΣ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... component:IHCScore SΣ 0..1 BackboneElement Component results
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 85319-2
....... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Presence] in Breast cancer specimen by Immune stain
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma Her2neu IHC Score (extensible)
.... component:ISHResult SΣ 0..1 BackboneElement Component results
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 96893-3
....... display 1..1 string Representation defined by the system
Fixed Value: ERBB2 gene duplication in Tumor by FISH
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma ISH Ergebnis (extensible)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x].​coding:DefinitionOBDS Base extensible MII VS Onkologie Mamma Her2neu Status oBDS 📦2027.0.0-ballot.1 This IG
Observation.value[x].​coding:DefinitionLeitlinie Base extensible MII VS Onkologie Mamma Her2neu Status Leitlinie 📦2027.0.0-ballot.1 This IG
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​value[x] Base extensible MII VS Onkologie Mamma Her2neu IHC Score 📦2027.0.0-ballot.1 This IG
Observation.component:ISHResult.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​value[x] Base extensible MII VS Onkologie Mamma ISH Ergebnis 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

Diese Struktur ist abgeleitet von Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... code S 1..1 CodeableConcept Her2neu Status
.... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 48676-1
..... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Interpretation] in Tissue
... subject S 1..1 Reference(Patient) Who and/or what the observation is about
... encounter S 0..1 Reference(Encounter) Healthcare event during which this observation is made
... value[x] S 1..1 CodeableConcept Actual result
.... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:All Slices Content/Rules for all slices
...... code S 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionOBDS S 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status oBDS (extensible)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-obds
...... code S 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionLeitlinie S 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status Leitlinie (extensible)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-leitlinie
...... code S 1..1 code Symbol in syntax defined by the system
... Slices for component S 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:IHCScore S 0..1 BackboneElement Component results
..... code 1..1 CodeableConcept Type of component observation (code / type)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 85319-2
....... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Presence] in Breast cancer specimen by Immune stain
..... value[x] S 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma Her2neu IHC Score (extensible)
.... component:ISHResult S 0..1 BackboneElement Component results
..... code 1..1 CodeableConcept Type of component observation (code / type)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 96893-3
....... display 1..1 string Representation defined by the system
Fixed Value: ERBB2 gene duplication in Tumor by FISH
..... value[x] S 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma ISH Ergebnis (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.value[x].​coding:DefinitionOBDS Base extensible MII VS Onkologie Mamma Her2neu Status oBDS 📦2027.0.0-ballot.1 This IG
Observation.value[x].​coding:DefinitionLeitlinie Base extensible MII VS Onkologie Mamma Her2neu Status Leitlinie 📦2027.0.0-ballot.1 This IG
Observation.component:IHCScore.​value[x] Base extensible MII VS Onkologie Mamma Her2neu IHC Score 📦2027.0.0-ballot.1 This IG
Observation.component:ISHResult.​value[x] Base extensible MII VS Onkologie Mamma ISH Ergebnis 📦2027.0.0-ballot.1 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code SΣ 1..1 CodeableConcept Her2neu Status
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 48676-1
..... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Interpretation] in Tissue
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... focus SΣ 0..* Reference(MII PR Onkologie Diagnose Primärtumor) What the observation is about, when it is not about the subject of record
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] Σ 0..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 1..1 CodeableConcept Actual result
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:DefinitionOBDS SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status oBDS (extensible)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-obds
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:DefinitionLeitlinie SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status Leitlinie (extensible)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-leitlinie
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
.... high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... Slices for component SΣ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
..... value[x] Σ 0..1 Actual component result
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueRatio Ratio
...... valueSampledData SampledData
...... valueTime time
...... valueDateTime dateTime
...... valuePeriod Period
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result
.... component:IHCScore SΣ 0..1 BackboneElement Component results
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 85319-2
....... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Presence] in Breast cancer specimen by Immune stain
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma Her2neu IHC Score (extensible)
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result
.... component:ISHResult SΣ 0..1 BackboneElement Component results
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 96893-3
....... display 1..1 string Representation defined by the system
Fixed Value: ERBB2 gene duplication in Tumor by FISH
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma ISH Ergebnis (extensible)
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Observation.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Observation.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x].​coding:DefinitionOBDS Base extensible MII VS Onkologie Mamma Her2neu Status oBDS 📦2027.0.0-ballot.1 This IG
Observation.value[x].​coding:DefinitionLeitlinie Base extensible MII VS Onkologie Mamma Her2neu Status Leitlinie 📦2027.0.0-ballot.1 This IG
Observation.dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📍4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​value[x] Base extensible MII VS Onkologie Mamma Her2neu IHC Score 📦2027.0.0-ballot.1 This IG
Observation.component:IHCScore.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​value[x] Base extensible MII VS Onkologie Mamma ISH Ergebnis 📦2027.0.0-ballot.1 This IG
Observation.component:ISHResult.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

Diese Struktur ist abgeleitet von Observation

Summary

Mandatory: 2 elements(5 nested mandatory elements)
Must-Support: 16 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.value[x].coding
  • The element 1 is sliced based on the value of Observation.component

Schlüsselelemente-Ansicht

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... code SΣ 1..1 CodeableConcept Her2neu Status
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 48676-1
..... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Interpretation] in Tissue
..... userSelected 0..1 boolean If this coding was chosen directly by the user
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... focus SΣ 0..* Reference(MII PR Onkologie Diagnose Primärtumor) What the observation is about, when it is not about the subject of record
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... value[x] SΣC 1..1 CodeableConcept Actual result
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:All Slices Content/Rules for all slices
...... code SΣ 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionOBDS SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status oBDS (extensible)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-obds
...... code SΣ 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionLeitlinie SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status Leitlinie (extensible)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-leitlinie
...... code SΣ 1..1 code Symbol in syntax defined by the system
... Slices for component SΣ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... component:IHCScore SΣ 0..1 BackboneElement Component results
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 85319-2
....... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Presence] in Breast cancer specimen by Immune stain
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma Her2neu IHC Score (extensible)
.... component:ISHResult SΣ 0..1 BackboneElement Component results
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 96893-3
....... display 1..1 string Representation defined by the system
Fixed Value: ERBB2 gene duplication in Tumor by FISH
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma ISH Ergebnis (extensible)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x].​coding:DefinitionOBDS Base extensible MII VS Onkologie Mamma Her2neu Status oBDS 📦2027.0.0-ballot.1 This IG
Observation.value[x].​coding:DefinitionLeitlinie Base extensible MII VS Onkologie Mamma Her2neu Status Leitlinie 📦2027.0.0-ballot.1 This IG
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​value[x] Base extensible MII VS Onkologie Mamma Her2neu IHC Score 📦2027.0.0-ballot.1 This IG
Observation.component:ISHResult.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​value[x] Base extensible MII VS Onkologie Mamma ISH Ergebnis 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

Differential-Ansicht

Diese Struktur ist abgeleitet von Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... code S 1..1 CodeableConcept Her2neu Status
.... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 48676-1
..... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Interpretation] in Tissue
... subject S 1..1 Reference(Patient) Who and/or what the observation is about
... encounter S 0..1 Reference(Encounter) Healthcare event during which this observation is made
... value[x] S 1..1 CodeableConcept Actual result
.... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:All Slices Content/Rules for all slices
...... code S 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionOBDS S 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status oBDS (extensible)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-obds
...... code S 1..1 code Symbol in syntax defined by the system
..... coding:DefinitionLeitlinie S 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status Leitlinie (extensible)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-leitlinie
...... code S 1..1 code Symbol in syntax defined by the system
... Slices for component S 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:IHCScore S 0..1 BackboneElement Component results
..... code 1..1 CodeableConcept Type of component observation (code / type)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 85319-2
....... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Presence] in Breast cancer specimen by Immune stain
..... value[x] S 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma Her2neu IHC Score (extensible)
.... component:ISHResult S 0..1 BackboneElement Component results
..... code 1..1 CodeableConcept Type of component observation (code / type)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 96893-3
....... display 1..1 string Representation defined by the system
Fixed Value: ERBB2 gene duplication in Tumor by FISH
..... value[x] S 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma ISH Ergebnis (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.value[x].​coding:DefinitionOBDS Base extensible MII VS Onkologie Mamma Her2neu Status oBDS 📦2027.0.0-ballot.1 This IG
Observation.value[x].​coding:DefinitionLeitlinie Base extensible MII VS Onkologie Mamma Her2neu Status Leitlinie 📦2027.0.0-ballot.1 This IG
Observation.component:IHCScore.​value[x] Base extensible MII VS Onkologie Mamma Her2neu IHC Score 📦2027.0.0-ballot.1 This IG
Observation.component:ISHResult.​value[x] Base extensible MII VS Onkologie Mamma ISH Ergebnis 📦2027.0.0-ballot.1 This IG

Snapshot-AnsichtView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code SΣ 1..1 CodeableConcept Her2neu Status
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 48676-1
..... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Interpretation] in Tissue
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... focus SΣ 0..* Reference(MII PR Onkologie Diagnose Primärtumor) What the observation is about, when it is not about the subject of record
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] Σ 0..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 1..1 CodeableConcept Actual result
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:DefinitionOBDS SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status oBDS (extensible)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-obds
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:DefinitionLeitlinie SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Mamma Her2neu Status Leitlinie (extensible)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-mamma-her2neu-status-leitlinie
...... version Σ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
.... high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... Slices for component SΣ 0..* BackboneElement Component results
Slice: Unordered, Open by pattern:code
.... component:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
..... value[x] Σ 0..1 Actual component result
...... valueQuantity Quantity
...... valueCodeableConcept CodeableConcept
...... valueString string
...... valueBoolean boolean
...... valueInteger integer
...... valueRange Range
...... valueRatio Ratio
...... valueSampledData SampledData
...... valueTime time
...... valueDateTime dateTime
...... valuePeriod Period
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result
.... component:IHCScore SΣ 0..1 BackboneElement Component results
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 85319-2
....... display 1..1 string Representation defined by the system
Fixed Value: HER2 Ag [Presence] in Breast cancer specimen by Immune stain
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma Her2neu IHC Score (extensible)
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result
.... component:ISHResult SΣ 0..1 BackboneElement Component results
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 96893-3
....... display 1..1 string Representation defined by the system
Fixed Value: ERBB2 gene duplication in Tumor by FISH
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... value[x] SΣ 0..1 CodeableConcept Actual component result
Binding: MII VS Onkologie Mamma ISH Ergebnis (extensible)
..... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
..... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Observation.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Observation.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x].​coding:DefinitionOBDS Base extensible MII VS Onkologie Mamma Her2neu Status oBDS 📦2027.0.0-ballot.1 This IG
Observation.value[x].​coding:DefinitionLeitlinie Base extensible MII VS Onkologie Mamma Her2neu Status Leitlinie 📦2027.0.0-ballot.1 This IG
Observation.dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📍4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​value[x] Base extensible MII VS Onkologie Mamma Her2neu IHC Score 📦2027.0.0-ballot.1 This IG
Observation.component:IHCScore.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component:IHCScore.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​value[x] Base extensible MII VS Onkologie Mamma ISH Ergebnis 📦2027.0.0-ballot.1 This IG
Observation.component:ISHResult.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component:ISHResult.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

Diese Struktur ist abgeleitet von Observation

Summary

Mandatory: 2 elements(5 nested mandatory elements)
Must-Support: 16 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.value[x].coding
  • The element 1 is sliced based on the value of Observation.component

 

Weitere Repräsentationen des Profils: CSV, Excel, Schematron