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. For a full list of available versions, see the Directory of published versions

Resource Profile: MII PR Onkologie Her2neu Status

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

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

Content

The HER2/neu Status Profile documents the diagnostic HER2/neu status of a pathologically examined specimen in breast cancer. HER2/neu (also HER2 or ERBB2) is an important prognostic and predictive biomarker that determines eligibility for anti-HER2-targeted therapy.

The HER2/neu status is based on immunohistochemical (IHC) staining and, for certain findings, additionally on in situ hybridization (ISH, e.g. FISH or CISH). Determination follows the ASCO/CAP guidelines and the requirements of the S3 guideline on breast cancer.

Clinical background

HER2/neu determination is essential for therapy planning in breast cancer:

  • HER2-positive tumors (approx. 15-20% of breast cancers) benefit from anti-HER2 therapies such as trastuzumab, pertuzumab or T-DM1
  • HER2-low tumors show low HER2 expression and may benefit from newer therapies such as trastuzumab deruxtecan (based on the DESTINY-Breast04/06 trials)
  • HER2-negative tumors do not receive anti-HER2-targeted therapy

HER2/neu determination according to ASCO/CAP

HER2/neu determination is a multi-step process:

her2neu-1

Figure 1: HER2/neu determination algorithm according to ASCO/CAP guidelines. The initial IHC staining leads to ISH testing for 2+ findings.

her2neu-2

Figure 2: Interpretation of HER2/neu results and classification into HER2-positive, HER2-low, HER2-ultralow and HER2-negative.

IHC scores:

  • 3+: Strong, complete membrane staining in >10% of tumor cells → HER2-positive
  • 2+: Weak to moderate, complete membrane staining in >10% of tumor cells → ISH testing required
  • 1+: Weak, incomplete membrane staining in >10% of tumor cells → HER2-low (if ISH-negative or without ISH)
  • 0: No staining or membrane staining in ≤10% of tumor cells

ISH testing (FISH, CISH, etc.):

  • Positive: HER2/CEP17 ratio ≥2.0 or HER2 copy number ≥6.0 per cell
  • Negative: HER2/CEP17 ratio <2.0 and HER2 copy number <4.0 per cell
  • Equivocal: Borderline findings that require retesting

The Molecular Tumor Board module offers more fine-grained profiles for representing the IHC and ISH data points within a molecular pathology findings report.

The profile is closely linked to other oncology resources:

  • refers via Observation.focus to the primary diagnosis (MII_PR_Onko_Diagnose_Primaertumor)
  • refers via Observation.subject to the patient (Patient resource)
  • can be linked via Observation.encounter to a specific treatment case

oBDS context and dual coding

The profile implements the oBDS data fields for the HER2/neu status (field M4, no. 243) in breast cancer. A dual coding strategy is used to accommodate both the frozen oBDS specification and the newer S3 guidelines and ASCO/CAP guidelines.

oBDS definition (based on guideline 3.0 specification):

The oBDS coding uses letter codes that correspond exactly to the published specification:

  • P = Positive (IHC 3+ or IHC 2+ and ISH positive)
  • N = Negative
  • U = Unknown

S3 guideline/ASCO-CAP definition (current guideline version 5.1):

The modern classification additionally takes into account the HER2-low and HER2-ultralow categories:

  • HER2-positive: IHC 3+ or IHC 2+ and ISH-positive
  • HER2-low: IHC 1+ or IHC 2+ and ISH-negative
  • HER2-ultralow: IHC 0 with membrane staining
  • HER2-negative: IHC 0 without membrane staining
  • Equivocal: Borderline, further testing required

This dual coding enables backward compatibility with existing oBDS registry data while also enabling forward compatibility with newer therapeutic developments (e.g. trastuzumab deruxtecan for HER2-low).

Terminology binding

The profile uses a dual coding strategy with extensible binding for valueCodeableConcept. This means that codes from both ValueSets MAY be used in parallel.

ValueSet: MII VS Onko Mamma Her2neu Status oBDS

The codes it contains are listed in the artefact view: MII VS Onkologie Mamma Her2neu Status oBDS.

The codes it contains are listed in the artefact view: MII VS Onkologie Mamma Her2neu Status oBDS.

ValueSet: MII VS Onko Mamma Her2neu Status Leitlinie

The codes it contains are listed in the artefact view: MII VS Onkologie Mamma Her2neu Status Leitlinie.

The codes it contains are listed in the artefact view: MII VS Onkologie Mamma Her2neu Status Leitlinie.

Mapping dataset to FHIR

The mapping of the dataset fields is documented in the logical model: MII LM Onkologie Organspezifische Zusatzmodule.

Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) to FHIR

The oBDS mappings are recorded in the artefact view of this profile: MII PR Onkologie Her2neu Status.

Examples

mii-exa-onko-mamma-her2neu-status

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

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()

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()

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

Key Elements View

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 View

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 ViewView

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()

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

 

Other representations of profile: CSV, Excel, Schematron