MII-Initiative

MII IG Onkologie DE v2026

Bundle Beispiel


Inhalt

Das Melanom Bundle Beispiel demonstriert die strukturierte Zusammenstellung aller Melanom-spezifischen FHIR-Ressourcen in einem einheitlichen Transaktions-Bundle. Dieses Bundle zeigt die praktische Anwendung der Melanom-Profile und deren Verknüpfungen untereinander in einem realistischen klinischen Szenario eines Malignen Melanoms der Haut.

Das Bundle implementiert das Transaction-Pattern und ist server-konsumierbar, wodurch alle enthaltenen Ressourcen als atomare Operation übertragen werden können.


Bundle-Struktur

Das Melanom-Bundle umfasst folgende Ressourcen:

Primäre Ressourcen

  • Patient: Melanom-Patient (Maria Melanom)
  • Condition: Primärtumor-Diagnose (C43.9 - Bösartige Neubildung: Haut, nicht näher bezeichnet)
  • Encounter: Stationärer Behandlungsfall

Melanom-spezifische Observations

  • Breslow-Tiefe: Tumordicke 2.1mm von Granularschicht bis tiefste Invasion (Breslow)
  • Sicherheitsabstand: Minimaler Abstand zum Resektionsrand 5mm (MM1)
  • Ulzeration: Nachweis einer Ulzeration der Epidermis (MM4)
  • LDH: Laktatdehydrogenase-Wert 280 U/L als prognostischer Marker (LDH)

Bundle-spezifische Merkmale

  • Transaction Bundle: Server-konsumierbare atomare Operation
  • Referenz-Konsistenz: Alle Einzelressourcen referenzieren Bundle-Kernressourcen
  • Vollständige Abdeckung: Alle 4 Melanom-Profile sind enthalten

Klinisches Szenario

Das Bundle repräsentiert eine Patientin mit Malignem Melanom mit kompletter histopathologischer Diagnostik und operativer Therapie:

Patientencharakteristika:

  • Diagnose: C43.9 Malignes Melanom der Haut
  • Breslow-Tiefe: 2.1mm (prognostisch wichtig)
  • Tumorlokalisation: Haut, nicht näher bezeichnet

Histopathologische Diagnostik:

  • Ulzeration: Nachweis einer Ulzeration der Epidermis
  • LDH: Erhöhter Wert (280 U/L) als prognostischer Marker

Operative Therapie:

  • Exzision: Mit ausreichendem Sicherheitsabstand
  • Sicherheitsabstand: Minimaler Abstand 5mm zum Resektionsrand
  • Resektionsstatus: R0-Resektion erreicht

Technische Implementation

Bundle-Typ und Struktur

* type = #transaction
  • Transaction Bundle: Atomare Übertragung aller Ressourcen
  • Server-konsumierbar: Alle Entries mit vollständigen Request-Informationen

Entry-Pattern

Jeder Bundle-Entry enthält:

  • fullUrl: Eindeutige Referenz-URL
  • resource: Die eigentliche FHIR-Ressource
  • request.method: HTTP POST für Erstellung
  • request.url: Ziel-Ressourcentyp

Referenz-Integrität

  • Condition: Referenziert Patient über subject
  • Observations: Referenzieren sowohl Patient (subject) als auch Condition (focus)
  • Procedures: Referenzieren Patient (subject) und Condition (reasonReference)
  • Specimen: Referenziert Patient (subject) und Collection-Procedure


oBDS-Zuordnung

Das Bundle demonstriert die vollständige Abbildung der oBDS-Datenfelder für Malignes Melanom:

Histopathologische Bewertung

  • MM2: Breslow-Tiefe → Observation/mii-exa-onko-melanom-breslow-tiefe
  • MM4: Ulzeration → Observation/mii-exa-onko-melanom-ulzeration

Chirurgische Bewertung

  • MM1: Sicherheitsabstand → Observation/mii-exa-onko-melanom-sicherheitsabstand

Laborparameter

  • MM3: Laktatdehydrogenase → Observation/mii-exa-onko-melanom-ldh

ValueSet-Verwendung

Das Bundle zeigt die praktische Anwendung verschiedener Terminologien:

LOINC

  • LDH: 14805-6 "Lactate dehydrogenase activity in Serum or Plasma"

SNOMED CT

  • Breslow-Tiefe: 106243009 "Breslow depth staging for melanoma of skin"
  • Sicherheitsabstand: 396511007 "Distance of in situ melanoma from closest lateral surgical margin"
  • Ulzeration: 97816-3 "Ulceration present in melanoma of skin"

ICD-10-GM

  • Diagnose: C43.9 "Bösartige Neubildung: Haut, nicht näher bezeichnet"

oBDS CodeSystems

  • Ulzeration: mii-cs-onko-melanom-ulzeration#J "Ja"
  • LDH-Bewertung: `mii-cs-onko-melanom-ldh-bewertung#erhoeht" "Erhöht"

Bundle-Beispiel

{
"resourceType": "Bundle",
"id": "mii-exa-onko-melanom-bundle",
"meta": {
"profile": [
"http://hl7.org/fhir/StructureDefinition/Bundle"
]
},
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko",
"value": "melanom-example-bundle-2024-001"
},
"type": "transaction",
"timestamp": "2024-03-25T10:00:00+01:00",
"entry": [
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Patient/mii-exa-onko-melanom-bundle-patient",
"resourceType": "Patient",
"id": "mii-exa-onko-melanom-bundle-patient",
"name": [
{
"given": [
"Maria"
],
"family": "Melanom"
}
]
},
"request": {
"method": "POST",
"url": "Patient"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Condition/mii-exa-onko-melanom-diagnose",
"resourceType": "Condition",
"id": "mii-exa-onko-melanom-diagnose",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor"
]
},
{
"url": "http://hl7.org/fhir/StructureDefinition/condition-assertedDate",
"valueDateTime": "2024-01-02"
}
],
"coding": [
{
"code": "active",
"system": "http://terminology.hl7.org/CodeSystem/condition-clinical"
}
]
},
"coding": [
{
"code": "confirmed",
"system": "http://terminology.hl7.org/CodeSystem/condition-ver-status"
}
]
},
"code": {
"coding": [
{
"code": "C43.9",
"system": "http://fhir.de/CodeSystem/bfarm/icd-10-gm",
"display": "Bösartige Neubildung: Haut, nicht näher bezeichnet",
"version": "2024"
}
]
},
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"recordedDate": "2024-01-02"
},
"request": {
"method": "POST",
"url": "Condition"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Encounter/mii-exa-onko-melanom-bundle-encounter",
"resourceType": "Encounter",
"id": "mii-exa-onko-melanom-bundle-encounter",
"status": "finished",
"class": {
"code": "IMP",
"system": "http://terminology.hl7.org/CodeSystem/v3-ActCode",
"display": "inpatient encounter"
},
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
}
},
"request": {
"method": "POST",
"url": "Encounter"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-sicherheitsabstand",
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-sicherheitsabstand",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-sicherheitsabstand"
]
},
"code": {
"coding": [
{
"code": "396511007",
"system": "http://snomed.info/sct",
"display": "Distance of in situ melanoma from closest lateral surgical margin in excised specimen of skin (observable entity)"
}
]
},
"unit": "mm",
"system": "http://unitsofmeasure.org",
"code": "mm",
"value": 5
},
"status": "final",
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-25T10:00:00+01:00"
},
"request": {
"method": "POST",
"url": "Observation"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-breslow-tiefe",
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-breslow-tiefe",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-breslow-tiefe"
]
},
"code": {
"coding": [
{
"code": "106243009",
"system": "http://snomed.info/sct",
"display": "Breslow depth staging for melanoma of skin (observable entity)"
}
]
},
"unit": "mm",
"system": "http://unitsofmeasure.org",
"code": "mm",
"value": 2.1
},
"method": {
"coding": [
{
"code": "117617002",
"system": "http://snomed.info/sct",
"display": "Immunohistochemistry procedure"
}
]
},
"status": "final",
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-20T14:30:00+01:00"
},
"request": {
"method": "POST",
"url": "Observation"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-ulzeration",
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-ulzeration",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-ulzeration"
]
},
"code": {
"coding": [
{
"code": "6270001000004106",
"system": "http://snomed.info/sct",
"display": "Presence of ulcer in primary malignant melanoma of skin (observable entity)"
}
]
},
"method": {
"coding": [
{
"code": "117617002",
"system": "http://snomed.info/sct",
"display": "Immunohistochemistry procedure"
}
]
},
"status": "final",
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-20T14:30:00+01:00",
"coding": [
{
"code": "J",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-melanom-ulzeration",
"display": "Ja"
}
]
}
},
"request": {
"method": "POST",
"url": "Observation"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-ldh",
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-ldh",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-ldh"
]
},
{
"coding": [
{
"code": "laboratory",
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"display": "Laboratory"
}
]
}
],
"unit": "U/L",
"system": "http://unitsofmeasure.org",
"code": "U/L",
"value": 280
},
"status": "final",
"code": {
"coding": [
{
"code": "14804-9",
"system": "http://loinc.org",
"display": "Lactate dehydrogenase [Enzymatic activity/volume] in Serum or Plasma by Lactate to pyruvate reaction"
}
]
},
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-18T08:30:00+01:00",
{
"low": {
"value": 135,
"unit": "U/L",
"system": "http://unitsofmeasure.org",
"code": "U/L"
},
"high": {
"value": 250,
"unit": "U/L",
"system": "http://unitsofmeasure.org",
"code": "U/L"
},
"text": "135-250 U/L"
}
],
{
"coding": [
{
"code": "H",
"system": "http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation",
"display": "High"
}
]
}
]
},
"request": {
"method": "POST",
"url": "Observation"
}
},
{
"fullUrl": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Procedure/mii-exa-onko-melanom-exzision-oberarm",
"resourceType": "Procedure",
"id": "mii-exa-onko-melanom-exzision-oberarm",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-exzision"
]
},
{
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-operation-intention",
"coding": [
{
"code": "K",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-intention",
"display": "kurativ"
}
]
}
}
],
"code": {
"coding": [
{
"system": "http://fhir.de/CodeSystem/bfarm/ops",
"code": "5-212.6",
"display": "Exzision und Destruktion von erkranktem Gewebe der Haut und der Unterhaut, Exzision, ohne primären Wundverschluss, Schulter und Axilla",
"version": "2024"
},
{
"system": "http://snomed.info/sct",
"code": "177281002",
"display": "Excision of melanoma (procedure)"
}
]
},
"status": "completed",
"coding": [
{
"code": "387713003",
"system": "http://snomed.info/sct",
"display": "Surgical procedure"
}
]
},
{
"coding": [
{
"code": "368208006",
"system": "http://snomed.info/sct",
"display": "Left upper arm structure"
}
]
}
],
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"performedDateTime": "2024-03-20",
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"outcome": {
"coding": [
{
"code": "R0",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-residualstatus",
"display": "Kein Residualtumor"
}
]
}
},
"request": {
"method": "POST",
"url": "Procedure"
}
}
]
}


Einzelne Ressourcen-Beispiele

Patient

{
"resourceType": "Patient",
"id": "mii-exa-onko-melanom-bundle-patient",
"name": [
{
"given": [
"Maria"
],
"family": "Melanom"
}
]
}

Primärtumor-Condition

{
"resourceType": "Condition",
"id": "mii-exa-onko-melanom-diagnose",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor"
]
},
{
"url": "http://hl7.org/fhir/StructureDefinition/condition-assertedDate",
"valueDateTime": "2024-01-02"
}
],
"coding": [
{
"code": "active",
"system": "http://terminology.hl7.org/CodeSystem/condition-clinical"
}
]
},
"coding": [
{
"code": "confirmed",
"system": "http://terminology.hl7.org/CodeSystem/condition-ver-status"
}
]
},
"code": {
"coding": [
{
"code": "C43.9",
"system": "http://fhir.de/CodeSystem/bfarm/icd-10-gm",
"display": "Bösartige Neubildung: Haut, nicht näher bezeichnet",
"version": "2024"
}
]
},
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"recordedDate": "2024-01-02"
}

Breslow-Tiefe

{
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-breslow-tiefe",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-breslow-tiefe"
]
},
"code": {
"coding": [
{
"code": "106243009",
"system": "http://snomed.info/sct",
"display": "Breslow depth staging for melanoma of skin (observable entity)"
}
]
},
"unit": "mm",
"system": "http://unitsofmeasure.org",
"code": "mm",
"value": 2.1
},
"method": {
"coding": [
{
"code": "117617002",
"system": "http://snomed.info/sct",
"display": "Immunohistochemistry procedure"
}
]
},
"status": "final",
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-20T14:30:00+01:00"
}

Sicherheitsabstand

{
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-sicherheitsabstand",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-sicherheitsabstand"
]
},
"code": {
"coding": [
{
"code": "396511007",
"system": "http://snomed.info/sct",
"display": "Distance of in situ melanoma from closest lateral surgical margin in excised specimen of skin (observable entity)"
}
]
},
"unit": "mm",
"system": "http://unitsofmeasure.org",
"code": "mm",
"value": 5
},
"status": "final",
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-25T10:00:00+01:00"
}

Ulzeration

{
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-ulzeration",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-ulzeration"
]
},
"code": {
"coding": [
{
"code": "6270001000004106",
"system": "http://snomed.info/sct",
"display": "Presence of ulcer in primary malignant melanoma of skin (observable entity)"
}
]
},
"method": {
"coding": [
{
"code": "117617002",
"system": "http://snomed.info/sct",
"display": "Immunohistochemistry procedure"
}
]
},
"status": "final",
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-20T14:30:00+01:00",
"coding": [
{
"code": "J",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-melanom-ulzeration",
"display": "Ja"
}
]
}
}

LDH

{
"resourceType": "Observation",
"id": "mii-exa-onko-melanom-ldh",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-melanom-ldh"
]
},
{
"coding": [
{
"code": "laboratory",
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"display": "Laboratory"
}
]
}
],
"unit": "U/L",
"system": "http://unitsofmeasure.org",
"code": "U/L",
"value": 280
},
"status": "final",
"code": {
"coding": [
{
"code": "14804-9",
"system": "http://loinc.org",
"display": "Lactate dehydrogenase [Enzymatic activity/volume] in Serum or Plasma by Lactate to pyruvate reaction"
}
]
},
"subject": {
"reference": "Patient/mii-exa-onko-melanom-bundle-patient"
},
"reference": "Encounter/mii-exa-onko-melanom-bundle-encounter"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-melanom-diagnose"
}
],
"effectiveDateTime": "2024-03-18T08:30:00+01:00",
{
"low": {
"value": 135,
"unit": "U/L",
"system": "http://unitsofmeasure.org",
"code": "U/L"
},
"high": {
"value": 250,
"unit": "U/L",
"system": "http://unitsofmeasure.org",
"code": "U/L"
},
"text": "135-250 U/L"
}
],
{
"coding": [
{
"code": "H",
"system": "http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation",
"display": "High"
}
]
}
]
}