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

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

Example Bundle: MII EXA Onko Melanom Bundle

Content

The Melanom bundle example demonstrates the structured assembly of all melanoma-specific FHIR resources in a single transaction bundle. This bundle shows the practical use of the melanoma profiles and how they link to one another in a realistic clinical scenario of a malignant melanoma of the skin.

The bundle implements the transaction pattern and is server-consumable, so that all contained resources can be transmitted as an atomic operation.

Bundle structure

The melanoma bundle comprises the following resources:

Primary resources

  • Patient: melanoma patient (Maria Melanom)
  • Condition: primary tumour diagnosis (C43.9 - malignant neoplasm: skin, unspecified)
  • Encounter: inpatient episode of care

Melanoma-specific Observations

  • Breslow depth: tumour thickness 2.1mm from the granular layer to the deepest invasion (Breslow)
  • Safety margin: minimum distance to the resection margin 5mm (MM1)
  • Ulceration: evidence of ulceration of the epidermis (MM4)
  • LDH: lactate dehydrogenase value 280 U/L as a prognostic marker (LDH)

Bundle-specific characteristics

  • Transaction bundle: server-consumable atomic operation
  • Reference consistency: all individual resources reference the bundle's core resources
  • Complete coverage: all 4 melanoma profiles are included

As a therapeutic resource, the bundle additionally contains the excision on the upper arm as a Procedure.

Clinical scenario

The bundle represents a patient with malignant melanoma with complete histopathological diagnostics and surgical therapy:

Patient characteristics:

  • Diagnosis: C43.9 malignant melanoma of the skin
  • Breslow depth: 2.1mm (prognostically important)
  • Tumour location: skin, unspecified

Histopathological diagnostics:

  • Ulceration: evidence of ulceration of the epidermis
  • LDH: elevated value (280 U/L) as a prognostic marker

Surgical therapy:

  • Excision: with a sufficient safety margin
  • Safety margin: minimum distance 5mm to the resection margin
  • Resection status: R0 resection achieved

Technical implementation

Bundle type and structure

* type = #transaction
  • Transaction bundle: atomic transmission of all resources
  • Server-consumable: all entries carry complete request information

Entry pattern

Each bundle entry contains:

  • fullUrl: unique reference URL
  • resource: the actual FHIR resource
  • request.method: HTTP POST for creation
  • request.url: target resource type

Reference integrity

  • Condition: references the patient via subject
  • Observations: reference both the patient (subject) and the Condition (focus)
  • Procedures: reference the patient (subject) and the Condition (reasonReference)
  • Specimen: references the patient (subject) and the collection procedure

oBDS mapping

The bundle demonstrates the complete representation of the oBDS data fields for malignant melanoma:

Histopathological assessment

Surgical assessment

Laboratory parameters

Use of ValueSets

The bundle shows the practical use of various terminologies:

LOINC

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

SNOMED CT

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

ICD-10-GM

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

oBDS CodeSystems

  • Ulceration: mii-cs-onko-melanom-ulzeration#J "Ja"
  • LDH assessment: mii-cs-onko-melanom-ldh-bewertung#erhoeht "Erhöht"

Individual resource examples

The resources contained in the bundle are also shipped as standalone example instances:

Language: en

Profile: Bundle

Bundle mii-exa-onko-melanom-bundle of type transaction

Entry 1 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Patient/mii-exa-onko-melanom-bundle-patient

Resource Patient:

Language: en

Maria Melanom (no stated gender), DoB Unknown

Request:

POST Patient

Entry 2 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Condition/mii-exa-onko-melanom-diagnose

Resource Condition:

Language: en

Profile: MII PR Onkologie Diagnose Primärtumor version: 2027.0.0-ballot.1

Condition Asserted Date: 2024-01-02

clinicalStatus: Active

verificationStatus: histologische Untersuchung eines Primärtumors

category: Neoplastic disease

code: Bösartiges Melanom der Haut, nicht näher bezeichnet

subject: Maria Melanom (no stated gender), DoB Unknown

encounter: Encounter: status = finished; class = inpatient encounter (ActCode#IMP)

recordedDate: 2024-01-02

Request:

POST Condition

Entry 3 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Encounter/mii-exa-onko-melanom-bundle-encounter

Resource Encounter:

Language: en

status: completed

class: inpatient encounter

subject: Maria Melanom (no stated gender), DoB Unknown

Request:

POST Encounter

Entry 4 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-sicherheitsabstand

Resource Observation:

status: Final

code: Distance of in situ melanoma from closest lateral surgical margin in excised specimen of skin (observable entity)

subject: Maria Melanom (no stated gender), DoB Unknown

focus: Condition Bösartiges Melanom der Haut, nicht näher bezeichnet

encounter: Encounter: status = finished; class = inpatient encounter (ActCode#IMP)

effective: 2024-03-25 10:00:00+0100

value: 5 mm (Details: UCUM codemm = 'mm')

Request:

POST Observation

Entry 5 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-breslow-tiefe

Resource Observation:

status: Final

code: Breslow depth staging for melanoma of skin (observable entity)

subject: Maria Melanom (no stated gender), DoB Unknown

focus: Condition Bösartiges Melanom der Haut, nicht näher bezeichnet

encounter: Encounter: status = finished; class = inpatient encounter (ActCode#IMP)

effective: 2024-03-20 14:30:00+0100

value: 2.1 mm (Details: UCUM codemm = 'mm')

method: Immunohistochemistry procedure

Request:

POST Observation

Entry 6 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-ulzeration

Resource Observation:

status: Final

code: Presence of ulcer in primary malignant melanoma of skin (observable entity)

subject: Maria Melanom (no stated gender), DoB Unknown

focus: Condition Bösartiges Melanom der Haut, nicht näher bezeichnet

encounter: Encounter: status = finished; class = inpatient encounter (ActCode#IMP)

effective: 2024-03-20 14:30:00+0100

value: Ja

method: Immunohistochemistry procedure

Request:

POST Observation

Entry 7 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Observation/mii-exa-onko-melanom-ldh

Resource Observation:

Language: en

Profile: MII PR Onkologie Melanom LDH

status: Final

category: Laboratory

code: Lactate dehydrogenase [Enzymatic activity/volume] in Serum or Plasma by Lactate to pyruvate reaction

subject: Maria Melanom (no stated gender), DoB Unknown

focus: Condition Bösartiges Melanom der Haut, nicht näher bezeichnet

encounter: Encounter: status = finished; class = inpatient encounter (ActCode#IMP)

effective: 2024-03-18 08:30:00+0100

value: 280 U/L (Details: UCUM codeU/L = 'U/L')

interpretation: High

ReferenceRanges

-LowHighText
*135 U/L (Details: UCUM codeU/L = 'U/L')250 U/L (Details: UCUM codeU/L = 'U/L')

135-250 U/L

Request:

POST Observation

Entry 8 - fullUrl = https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/Procedure/mii-exa-onko-melanom-exzision-oberarm

Resource Procedure:

Language: en

Profile: MII PR Onko Melanom Exzision version: 2027.0.0-ballot.1

MII EX Onko Operation Intention: kurativ

status: Completed

category: Surgical procedure

code: Lokale Exzision von erkranktem Gewebe an Haut und Unterhaut: Ohne primären Wundverschluss: Schulter und Axilla

subject: Maria Melanom (no stated gender), DoB Unknown

bodySite: Left upper arm structure

outcome: Kein Residualtumor

Request:

POST Procedure