description: Molekularer Biomarker - In Situ Hybridization Profil. Unterstützt FISH, CISH und SISH Methoden.
package_name: de.medizininformatikinitiative.kerndatensatz.mtb
derivation: constraint
name: MII_PR_MTB_Biomarker_InSituHybridization
type: Observation
elements:
  interpretation:
    short: Interpretation
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Interpretation}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Interpretation}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Interpretation der ISH Signale. Die Interpretation kann auf Vergleich mit Referenzwerten basieren.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Interpretation of ISH signals. The interpretation can be based on comparison with reference values.}
    mustSupport: true
    index: 16
  method:
    short: FISH | CISH | SISH
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: 'In Situ Hybridization Methode: Fluoreszenz - FISH - Chromogen - CISH - oder Silber - SISH'}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: 'In Situ Hybridization Method: Fluorescence - FISH - Chromogen - CISH - or Silver - SISH'}
    mustSupport: true
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: FISH | CISH | SISH}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: FISH | CISH | SISH}
    binding: {strength: extensible, valueSet: 'https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/ValueSet/mii-vs-mtb-ish-method'}
    index: 17
  valueQuantity:
    short: Quantitatives Ergebnis (z.B. Signalanzahl)
    type: Quantity
    mustSupport: true
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Quantitatives Ergebnis - z.B. Signalanzahl}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Quantitative result - e.g. signal count}
    choiceOf: value
    index: 9
    slicing:
      slices:
        valueQuantity:
          match: {}
          schema:
            short: Quantitatives Ergebnis (z.B. Signalanzahl)
            type: Quantity
            mustSupport: true
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Quantitatives Ergebnis - z.B. Signalanzahl}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: Quantitative result - e.g. signal count}
            choiceOf: value
            index: 9
          min: 0
          max: 1
  value:
    short: Kategorisches Ergebnis (z.B. positiv/negativ)
    mustSupport: true
    choices: [valueCodeableConcept]
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Kategorisches Ergebnis - z.B. positiv/negativ}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Categorical result - e.g. positive/negative}
    index: 14
    slicing:
      slices:
        valueCodeableConcept:
          match: {}
          schema:
            short: Kategorisches Ergebnis (z.B. positiv/negativ)
            mustSupport: true
            choices: [valueCodeableConcept]
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Kategorisches Ergebnis - z.B. positiv/negativ}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: Categorical result - e.g. positive/negative}
            index: 14
          min: 0
          max: 1
  valueRatio:
    short: Ratio-Ergebnis (z.B. HER2/CEP17)
    type: Ratio
    mustSupport: true
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Ratio-Ergebnis - z.B. HER2/CEP17}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Ratio result - e.g. HER2/CEP17}
    choiceOf: value
    index: 12
    slicing:
      slices:
        valueRatio:
          match: {}
          schema:
            short: Ratio-Ergebnis (z.B. HER2/CEP17)
            type: Ratio
            mustSupport: true
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Ratio-Ergebnis - z.B. HER2/CEP17}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: Ratio result - e.g. HER2/CEP17}
            choiceOf: value
            index: 12
          min: 0
          max: 1
  component:
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Untersuchtes Gen}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Gene studied}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Das mit der Target-Sonde untersuchte Gen - z.B. ERBB2}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: The gene studied with the target probe - e.g. ERBB2}
    index: 18
    slicing:
      slices:
        gene-studied:
          match: {}
          schema:
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Untersuchtes Gen}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: Gene studied}
            _definition:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Das mit der Target-Sonde untersuchte Gen - z.B. ERBB2}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: The gene studied with the target probe - e.g. ERBB2}
            index: 18
  code:
    short: Code für In Situ Hybridization Untersuchung
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Code fuer In Situ Hybridization Untersuchung}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Code for In Situ Hybridization examination}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Kodierung fuer In Situ Hybridization. Nach Moeglichkeit sind spezifische Codes zu verwenden. Wenn weder in SNOMED noch LOINC spezifische Codes vorhanden sind ist der generische Code mit Textbeschreibung zu verwenden.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Coding for In Situ Hybridization. Specific codes should be used whenever possible. If no specific codes are available in SNOMED or LOINC use the generic code with text description.}
    index: 1
    elements:
      coding:
        mustSupport: true
        index: 2
        slicing:
          rules: open
          ordered: false
          description: Slice für generischen ISH Code, zusätzliche spezifische Codes via open slicing
          discriminator:
          - {path: $this, type: pattern}
          min: 1
          slices:
            generisch:
              match: {code: '51864006', system: 'http://snomed.info/sct', display: 'Nucleic acid hybridization, function (observable entity)'}
              schema:
                short: Generischer ISH Code
                _definition:
                  extension:
                  - url: http://hl7.org/fhir/StructureDefinition/translation
                    extension:
                    - {url: lang, valueCode: de-DE}
                    - {url: content, valueString: Generischer Code fuer ISH-Untersuchungen. Wird immer angegeben um die Interoperabilitaet zu gewaehrleisten. Zusaetzliche spezifische Codes koennen ueber open slicing hinzugefuegt werden.}
                  - url: http://hl7.org/fhir/StructureDefinition/translation
                    extension:
                    - {url: lang, valueCode: en}
                    - {url: content, valueString: Generic code for ISH examinations. Always provided to ensure interoperability. Additional specific codes can be added via open slicing.}
                mustSupport: true
                _short:
                  extension:
                  - url: http://hl7.org/fhir/StructureDefinition/translation
                    extension:
                    - {url: lang, valueCode: de-DE}
                    - {url: content, valueString: Generischer ISH Code}
                  - url: http://hl7.org/fhir/StructureDefinition/translation
                    extension:
                    - {url: lang, valueCode: en}
                    - {url: content, valueString: Generic ISH Code}
                _required: true
                pattern:
                  type: Coding
                  value: {code: '51864006', system: 'http://snomed.info/sct', display: 'Nucleic acid hybridization, function (observable entity)'}
                index: 3
              min: 1
              max: 1
    required: [coding]
  identifier:
    short: Identifier zur Abgrenzung anderer gleichartiger Untersuchungen
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Identifier zur Abgrenzung anderer gleichartiger Untersuchungen}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Identifier to distinguish from other similar examinations}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Identifier der Untersuchung damit die Untersuchung auch ausserhalb von FHIR eindeutig identifiziert werden kann. Sollte ISH oder aehnliches beinhalten um von anderen Biomarkeruntersuchungen abzugrenzen.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Identifier of the examination so that the examination can be uniquely identified outside of FHIR. Should include ISH or similar to distinguish from other biomarker examinations.}
    mustSupport: true
    index: 0
  valueCodeableConcept:
    short: Kategorisches Ergebnis (z.B. positiv/negativ)
    type: CodeableConcept
    mustSupport: true
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: Kategorisches Ergebnis - z.B. positiv/negativ}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Categorical result - e.g. positive/negative}
    choiceOf: value
    index: 15
    slicing:
      slices:
        valueCodeableConcept:
          match: {}
          schema:
            short: Kategorisches Ergebnis (z.B. positiv/negativ)
            type: CodeableConcept
            mustSupport: true
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Kategorisches Ergebnis - z.B. positiv/negativ}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: Categorical result - e.g. positive/negative}
            choiceOf: value
            index: 15
          min: 0
          max: 1
  focus:
    type: Reference
    refers: ['https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor']
    index: 4
package_version: 2026.0.1
class: profile
kind: resource
url: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-insituhybridization
base: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-molekularer-biomarker
version: 2026.0.1
required: [method]