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

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version 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

Resource Profile: MII PR MTB In Situ Hybridization

Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-insituhybridization Version: 2027.0.0-ballot.1
Active as of 2026-09-15 Computable Name: MII_PR_MTB_Biomarker_InSituHybridization

Molekularer Biomarker - In Situ Hybridization Profil. Unterstützt FISH, CISH und SISH Methoden.

Content

This profile describes a generic representation of results based on molecular pathology in-situ hybridization tests on tissue sections.

The profile supports various ISH methods:

  • FISH (Fluorescence In Situ Hybridization)
  • CISH (Chromogenic In Situ Hybridization)
  • SISH (Silver In Situ Hybridization)

Profile structure

Analogous to the IHC modeling, the following structure was chosen:

  • code: Slicing with spezifisch and generisch
    • Specific: Concrete LOINC or SNOMED code for the test (e.g. 49683-6 ERBB2 gene copy number/Chromosome 17 copy number in Tissue by FISH)
    • Generic: Fallback code 51864006 Nucleic acid hybridization, function (observable entity) if no specific code is available
  • method (mandatory field): Specification of the ISH method from the ValueSet MII_VS_MTB_ISH_Method:
    • 1303773004 - Fluorescence in situ hybridization technique (FISH)
    • 787997001 - Chromogenic in situ hybridization (CISH)
    • 787998006 - Silver in situ hybridization (SISH)
  • value[x]: Supports various result types:
    • valueRatio - for ratio measurements (e.g. HER2/CEP17)
    • valueQuantity - for individual signal counts
    • valueCodeableConcept - for categorical results (positive/negative)

Components for signal counts

For detailed FISH evaluations, the following components are supported:

Component LOINC Description
target-signals 74860-8 Target probe signals per cell nucleus (e.g. ERBB2)
reference-signals 74861-6 Reference probe signals per cell nucleus (e.g. CEP17)
cells-counted 62361-1 Number of cells evaluated
gene-studied 48018-6 Gene studied (HGNC-coded)

This structure is based on the LOINC panel for HER2 FISH (74885-5 ERBB2 gene (HER2) duplication associated observations panel - Tissue by FISH).

The in-situ hybridization, like immunohistochemical results, is linked from the molecular pathology report via DiagnosticReport.result. It can in turn be referenced by diagnostic or therapeutic implications.

Specialized profiles

Specialized child profiles exist for common ISH tests:

  • MII_PR_MTB_INSITUHYBRIDIZATION_HER2 - HER2/ERBB2 FISH with ratio calculation

ValueSet: ISH methods

Search parameters

The following search parameters are relevant for the Oncology module, including in combination:

  1. The search parameter "_id" MUST be supported:

    Examples:

    GET [base]/Observation?_id=12345

    Usage notes: Further information on searching for "_id" can be found in the FHIR base specification - section "Parameters for all resources".

  2. The search parameter "code" MUST be supported:

    Examples:

    GET [base]/Observation?code=http://snomed.info/sct|51864006

    Usage notes: Further information on searching for "code" can be found in the FHIR base specification - section "token".

  3. The search parameter "method" MUST be supported:

    Examples:

    GET [base]/Observation?method=http://snomed.info/sct|1303773004

    Usage notes: Search for the ISH method used (FISH, CISH, SISH).

  4. The search parameter "focus" MUST be supported:

    Examples:

    GET [base]/Observation?focus=Condition/example-mii-mtb-diagnose

    Usage notes: Further information on searching for "focus" can be found in the FHIR base specification - section "reference".

  5. The search parameter "interpretation" MUST be supported:

    Examples:

    GET [base]/Observation?interpretation=http://hl7.org/fhir/uv/genomics-reporting/ValueSet/high-low-codes-vs|high

    Usage notes: Further information on searching for "interpretation" can be found in the FHIR base specification - section "token".

Examples

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..* MII_PR_MTB_Molekularer_Biomarker Measurements and simple assertions
Constraints: obs-6, obs-7, mii-mtb-ish-1
... meta SΣ 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
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... Slices for category S 2..* CodeableConcept Kategorie
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:labCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... coding Σ 1..1 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://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
.... category:mbCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... coding Σ 1..1 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
.... category:geCategory 0..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... coding Σ 1..1 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://terminology.hl7.org/CodeSystem/v2-0074
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: GE
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
... code SΣ 1..1 CodeableConcept Code for In Situ Hybridization examination
Binding: MII VS Molekulare Biomarker (extensible)
.... Slices for coding SΣ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:generisch SΣ 1..1 Coding Generic ISH Code

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://snomed.info/sct
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 51864006
...... display 1..1 string Representation defined by the system
Fixed Value: Nucleic acid hybridization, function (observable entity)
...... userSelected 0..1 boolean If this coding was chosen directly by the user
... subject SΣ 0..1 Reference(Patient | Group) Patient
... 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) Kontakt
... effective[x] SΣ 0..1 Zeitpunkt der Beobachtung
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued SΣ 0..1 instant Freigabedatum
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity Quantitative result - e.g. signal count
.... value[x]:valueRatio SΣC 0..1 Ratio Ratio result - e.g. HER2/CEP17
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Categorical result - e.g. positive/negative
... interpretation S 0..* CodeableConcept Interpretation
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... method S 1..1 CodeableConcept FISH | CISH | SISH
Binding: MII VS MTB ISH Method (extensible)
... Slices for derivedFrom SΣ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Abgeleitet von
Slice: Unordered, Open by profile:resolve()
.... derivedFrom:variant Σ 0..* Reference(MII PR MolGen Variante) Variant the biomarker is derived from
.... derivedFrom:genotype Σ 0..* Reference(Genotype) Genotype the biomarker is derived from
.... derivedFrom:haplotype Σ 0..* Reference(Haplotype) Haplotype the biomarker is derived from
... Slices for component SΣ 0..* BackboneElement Komponenten
Slice: Unordered, Open by value: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:gene-studied SΣ 0..* BackboneElement Gene studied
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept 48018-6
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: 48018-6
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
.... component:biomarker-category SΣ 0..* BackboneElement Biomarker-Kategorie
..... 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept cell receptor | antigen | protein | immune stain
Binding: Molecular Biomarker Categories (example)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:labCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:mbCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:geCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.code Base extensible MII VS Molekulare Biomarker 📦2027.0.0-ballot.1 This IG
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.method Base extensible MII VS MTB ISH Method 📦2027.0.0-ballot.1 This IG
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​value[x] Base extensible HUGO Gene Nomenclature Committee Gene Names (HGNC) 📦3.0.0 Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​value[x] Base example Molecular Biomarker Categories 📦3.0.0 Genomics Reporting Implementation Guide v3.0

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()
mii-mtb-ish-1 error Observation Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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 C 0..* MII_PR_MTB_Molekularer_Biomarker Measurements and simple assertions
Constraints: mii-mtb-ish-1
... identifier S 0..1 Identifier Identifier to distinguish from other similar examinations
... code 1..1 CodeableConcept Code for In Situ Hybridization examination
.... Slices for coding S 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:generisch S 1..1 Coding Generic ISH Code
Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 51864006
...... display 1..1 string Representation defined by the system
Fixed Value: Nucleic acid hybridization, function (observable entity)
... focus 0..* Reference(MII PR Onkologie Diagnose Primärtumor) What the observation is about, when it is not about the subject of record
.... value[x]:valueQuantity S 0..1 Quantity Quantitative result - e.g. signal count
.... value[x]:valueRatio S 0..1 Ratio Ratio result - e.g. HER2/CEP17
.... value[x]:valueCodeableConcept S 0..1 CodeableConcept Categorical result - e.g. positive/negative
... interpretation S 0..* CodeableConcept Interpretation
... method S 1..1 CodeableConcept FISH | CISH | SISH
Binding: MII VS MTB ISH Method (extensible)
... Slices for component Content/Rules for all slices
.... component:gene-studied 0..* BackboneElement Gene studied

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.method Base extensible MII VS MTB ISH Method 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
mii-mtb-ish-1 error Observation Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).exists()
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* MII_PR_MTB_Molekularer_Biomarker Measurements and simple assertions
Constraints: obs-6, obs-7, mii-mtb-ish-1
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 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 SΣ 0..1 Identifier Identifier to distinguish from other similar examinations
... 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.
... Slices for category S 2..* CodeableConcept Kategorie
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:labCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... 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 1..1 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://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... category:mbCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... 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 1..1 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... category:geCategory 0..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... 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 1..1 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://terminology.hl7.org/CodeSystem/v2-0074
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: GE
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
... code SΣ 1..1 CodeableConcept Code for In Situ Hybridization examination
Binding: MII VS Molekulare Biomarker (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
.... Slices for coding SΣ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:generisch SΣ 1..1 Coding Generic ISH Code

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://snomed.info/sct
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 51864006
...... display 1..1 string Representation defined by the system
Fixed Value: Nucleic acid hybridization, function (observable entity)
...... 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 0..1 Reference(Patient | Group) Patient
... 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) Kontakt
... effective[x] SΣ 0..1 Zeitpunkt der Beobachtung
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued SΣ 0..1 instant Freigabedatum
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity Quantitative result - e.g. signal count
.... value[x]:valueRatio SΣC 0..1 Ratio Ratio result - e.g. HER2/CEP17
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Categorical result - e.g. positive/negative
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation S 0..* CodeableConcept Interpretation
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 S 1..1 CodeableConcept FISH | CISH | SISH
Binding: MII VS MTB ISH Method (extensible)
... 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 Low Range, if relevant
.... high C 0..1 SimpleQuantity 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
... Slices for derivedFrom SΣ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Abgeleitet von
Slice: Unordered, Open by profile:resolve()
.... derivedFrom:variant Σ 0..* Reference(MII PR MolGen Variante) Variant the biomarker is derived from
.... derivedFrom:genotype Σ 0..* Reference(Genotype) Genotype the biomarker is derived from
.... derivedFrom:haplotype Σ 0..* Reference(Haplotype) Haplotype the biomarker is derived from
... Slices for component SΣ 0..* BackboneElement Komponenten
Slice: Unordered, Open by value: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:gene-studied SΣ 0..* BackboneElement Gene studied
..... 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 48018-6
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: 48018-6
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (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:biomarker-category SΣ 0..* BackboneElement Biomarker-Kategorie
..... 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept cell receptor | antigen | protein | immune stain
Binding: Molecular Biomarker Categories (example)
..... 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.category:labCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:mbCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:geCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.code Base extensible MII VS Molekulare Biomarker 📦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 extensible MII VS MTB ISH Method 📦2027.0.0-ballot.1 This IG
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:gene-studied.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​value[x] Base extensible HUGO Gene Nomenclature Committee Gene Names (HGNC) 📦3.0.0 Genomics Reporting Implementation Guide v3.0
Observation.component:gene-studied.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​value[x] Base example Molecular Biomarker Categories 📦3.0.0 Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​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()
mii-mtb-ish-1 error Observation Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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: 3 elements
Must-Support: 9 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.code.coding
  • The element 1 is sliced based on the value of Observation.value[x]

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* MII_PR_MTB_Molekularer_Biomarker Measurements and simple assertions
Constraints: obs-6, obs-7, mii-mtb-ish-1
... meta SΣ 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
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... Slices for category S 2..* CodeableConcept Kategorie
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:labCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... coding Σ 1..1 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://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
.... category:mbCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... coding Σ 1..1 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
.... category:geCategory 0..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... coding Σ 1..1 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://terminology.hl7.org/CodeSystem/v2-0074
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: GE
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
... code SΣ 1..1 CodeableConcept Code for In Situ Hybridization examination
Binding: MII VS Molekulare Biomarker (extensible)
.... Slices for coding SΣ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:generisch SΣ 1..1 Coding Generic ISH Code

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://snomed.info/sct
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 51864006
...... display 1..1 string Representation defined by the system
Fixed Value: Nucleic acid hybridization, function (observable entity)
...... userSelected 0..1 boolean If this coding was chosen directly by the user
... subject SΣ 0..1 Reference(Patient | Group) Patient
... 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) Kontakt
... effective[x] SΣ 0..1 Zeitpunkt der Beobachtung
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued SΣ 0..1 instant Freigabedatum
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity Quantitative result - e.g. signal count
.... value[x]:valueRatio SΣC 0..1 Ratio Ratio result - e.g. HER2/CEP17
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Categorical result - e.g. positive/negative
... interpretation S 0..* CodeableConcept Interpretation
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... method S 1..1 CodeableConcept FISH | CISH | SISH
Binding: MII VS MTB ISH Method (extensible)
... Slices for derivedFrom SΣ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Abgeleitet von
Slice: Unordered, Open by profile:resolve()
.... derivedFrom:variant Σ 0..* Reference(MII PR MolGen Variante) Variant the biomarker is derived from
.... derivedFrom:genotype Σ 0..* Reference(Genotype) Genotype the biomarker is derived from
.... derivedFrom:haplotype Σ 0..* Reference(Haplotype) Haplotype the biomarker is derived from
... Slices for component SΣ 0..* BackboneElement Komponenten
Slice: Unordered, Open by value: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:gene-studied SΣ 0..* BackboneElement Gene studied
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code Σ 1..1 CodeableConcept 48018-6
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: 48018-6
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
.... component:biomarker-category SΣ 0..* BackboneElement Biomarker-Kategorie
..... 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept cell receptor | antigen | protein | immune stain
Binding: Molecular Biomarker Categories (example)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:labCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:mbCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:geCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.code Base extensible MII VS Molekulare Biomarker 📦2027.0.0-ballot.1 This IG
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.method Base extensible MII VS MTB ISH Method 📦2027.0.0-ballot.1 This IG
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​value[x] Base extensible HUGO Gene Nomenclature Committee Gene Names (HGNC) 📦3.0.0 Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​value[x] Base example Molecular Biomarker Categories 📦3.0.0 Genomics Reporting Implementation Guide v3.0

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()
mii-mtb-ish-1 error Observation Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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 C 0..* MII_PR_MTB_Molekularer_Biomarker Measurements and simple assertions
Constraints: mii-mtb-ish-1
... identifier S 0..1 Identifier Identifier to distinguish from other similar examinations
... code 1..1 CodeableConcept Code for In Situ Hybridization examination
.... Slices for coding S 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:generisch S 1..1 Coding Generic ISH Code
Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 51864006
...... display 1..1 string Representation defined by the system
Fixed Value: Nucleic acid hybridization, function (observable entity)
... focus 0..* Reference(MII PR Onkologie Diagnose Primärtumor) What the observation is about, when it is not about the subject of record
.... value[x]:valueQuantity S 0..1 Quantity Quantitative result - e.g. signal count
.... value[x]:valueRatio S 0..1 Ratio Ratio result - e.g. HER2/CEP17
.... value[x]:valueCodeableConcept S 0..1 CodeableConcept Categorical result - e.g. positive/negative
... interpretation S 0..* CodeableConcept Interpretation
... method S 1..1 CodeableConcept FISH | CISH | SISH
Binding: MII VS MTB ISH Method (extensible)
... Slices for component Content/Rules for all slices
.... component:gene-studied 0..* BackboneElement Gene studied

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.method Base extensible MII VS MTB ISH Method 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
mii-mtb-ish-1 error Observation Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).exists()

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* MII_PR_MTB_Molekularer_Biomarker Measurements and simple assertions
Constraints: obs-6, obs-7, mii-mtb-ish-1
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 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 SΣ 0..1 Identifier Identifier to distinguish from other similar examinations
... 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.
... Slices for category S 2..* CodeableConcept Kategorie
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:labCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... 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 1..1 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://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... category:mbCategory 1..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... 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 1..1 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... category:geCategory 0..1 CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
..... 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 1..1 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://terminology.hl7.org/CodeSystem/v2-0074
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: GE
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
... code SΣ 1..1 CodeableConcept Code for In Situ Hybridization examination
Binding: MII VS Molekulare Biomarker (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
.... Slices for coding SΣ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:generisch SΣ 1..1 Coding Generic ISH Code

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://snomed.info/sct
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 51864006
...... display 1..1 string Representation defined by the system
Fixed Value: Nucleic acid hybridization, function (observable entity)
...... 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 0..1 Reference(Patient | Group) Patient
... 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) Kontakt
... effective[x] SΣ 0..1 Zeitpunkt der Beobachtung
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued SΣ 0..1 instant Freigabedatum
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity Quantitative result - e.g. signal count
.... value[x]:valueRatio SΣC 0..1 Ratio Ratio result - e.g. HER2/CEP17
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept Categorical result - e.g. positive/negative
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation S 0..* CodeableConcept Interpretation
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 S 1..1 CodeableConcept FISH | CISH | SISH
Binding: MII VS MTB ISH Method (extensible)
... 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 Low Range, if relevant
.... high C 0..1 SimpleQuantity 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
... Slices for derivedFrom SΣ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Abgeleitet von
Slice: Unordered, Open by profile:resolve()
.... derivedFrom:variant Σ 0..* Reference(MII PR MolGen Variante) Variant the biomarker is derived from
.... derivedFrom:genotype Σ 0..* Reference(Genotype) Genotype the biomarker is derived from
.... derivedFrom:haplotype Σ 0..* Reference(Haplotype) Haplotype the biomarker is derived from
... Slices for component SΣ 0..* BackboneElement Komponenten
Slice: Unordered, Open by value: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:gene-studied SΣ 0..* BackboneElement Gene studied
..... 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 48018-6
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: 48018-6
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (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:biomarker-category SΣ 0..* BackboneElement Biomarker-Kategorie
..... 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://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: biomarker-category
....... display 0..1 string Representation defined by the system
....... 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] Σ 1..1 CodeableConcept cell receptor | antigen | protein | immune stain
Binding: Molecular Biomarker Categories (example)
..... 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.category:labCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:mbCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:geCategory Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.code Base extensible MII VS Molekulare Biomarker 📦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 extensible MII VS MTB ISH Method 📦2027.0.0-ballot.1 This IG
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:gene-studied.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​value[x] Base extensible HUGO Gene Nomenclature Committee Gene Names (HGNC) 📦3.0.0 Genomics Reporting Implementation Guide v3.0
Observation.component:gene-studied.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component:gene-studied.​interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​value[x] Base example Molecular Biomarker Categories 📦3.0.0 Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component:biomarker-category.​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()
mii-mtb-ish-1 error Observation Entweder muss ein spezifischer Code oder gene-studied angegeben werden (Either a specific code or gene-studied must be provided) code.coding.where(system != 'http://snomed.info/sct' or code != '51864006').exists() or component.where(code.coding.where(system = 'http://loinc.org' and code = '48018-6').exists()).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: 3 elements
Must-Support: 9 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.code.coding
  • The element 1 is sliced based on the value of Observation.value[x]

 

Other representations of profile: CSV, Excel, Schematron