MII-Initiative

MII IG Pathologie-Befund EN v2026

Data sets including descriptions

The official version of the information model for the Pathology Report module can be found on Art-Decor. To standardize the representation, the information model was also mapped as a FHIR Logical Model:

Identifikation1..*Identifier
Status1..1code
Dokumentationsdatum1..1dateTime
Fragestellung0..1string
Anamnese0..*string
Ueberweisungsgrund0..*string
DiagnoseKodiert0..*Reference(Condition)
AuftragsgruppenID0..1Identifier
AuftragsIDAuftraggeber0..1Identifier
AuftragsIDAuftragnehmer0..1Identifier
Status1..1code
Untersuchung0..*CodeableConcept
Einsender0..*Reference(Practitioner | Organization)
Probenentnehmer0..*Reference(Practitioner | Organization)
Probe1..*Reference(Specimen)
ProbenID0..1Identifier
Status0..1code
Probenart1..1CodeableConcept
Laboreingangszeitpunkt0..1dateTime
Entnahmemethode0..1CodeableConcept
Herkunft0..1CodeableConcept
EntnahmeZeitpunkt0..1dateTime
Eigenschaften0..1CodeableConcept
Bearbeitungsprozedur1..1CodeableConcept
Elternprobe1..1Reference(Specimen)
Additive0..*Reference(Substance)
Beschreibung0..1string
ContainerID1..*Identifier
ContainerTyp0..1CodeableConcept
AdditiveCodeableConceptCodeableConcept
AdditiveReferenceReference(Substance)
Text0..1string
Einzelbeobachtung0..*Reference(Observation)
EingebettetesBild0..*Reference(Media)
Text0..1string
Einzelbeobachtung0..*Reference(Observation)
ID1..*id
MakroBild1..*Attachment
Skizze0..*Attachment
Text0..1string
Einzelbeobachtung0..*Reference(Observation)
ID1..*id
MikroBild1..*Attachment
ROI0..*Attachment
Text0..1string
Einzelbeobachtung0..*Reference(Observation)
ID1..*id
ZugehoerigesDokument0..*Attachment
Text0..1string
Einzelbeobachtung0..*Reference(Observation)
ID1..*id
Skizze0..*Attachment
MakroBild0..*Attachment
MikroBild0..*Attachment
ROI0..*Attachment

Data set Art-Decor

It should be noted that the Logical Model is purely aimed at mapping the data elements and describing them. The data types and cardinalities used are not mandatory. This is ultimately determined by the FHIR profiles. For each element within the Logical Model, there is a 1:1 mapping to an element of a specific FHIR resource.


Pathology report

Logical data model
Befundbericht.id Unique identification of the pathology report, usually the accession number (case number), supplemented by the version number
Befundbericht.Identifikator Version-independent identifier of the pathology report, usually the accession number (case number), GUID (Global Unique Identifier) ​​possible
Befundbericht.Versionsnummer Version number of the pathology report
Befundbericht.Status Status of the pathology report (provisional, final)
Befundbericht.Typ Type of clinical document (LOINC 60568-3)
Befundbericht.Status Category of clinical document (LOINC 27898-6)
Befundbericht.Datum Date and time of release of the report
Befundbericht.Titel Title of the report (pathological-anatomical assessment)
Befundbericht.Autor Author of the report
Befundbericht.Freigebender Legally responsible person (Legal Authenticator) for the report
Befundbericht.ZugehörigesDokument Older version of the report

The MII modules Person, Fall and Strukturdaten are used for the data sets Patient, Fall / Case and Verwaltende Organisation / administrative organization. They are therefore not specified further here.


Examination request (Clinical order)

Logical data model Description
Untersuchungsauftrag.Identifikation Identifier of the clinical order
Untersuchungsauftrag.KlinischeInformation Clinical information about the case
Untersuchungsauftrag.Status Status of the order (active, completed)
Untersuchungsauftrag.Einsender Doctor who sends samples from a patient for pathological-anatomical examination and assessment
Untersuchungsauftrag.Probenentnehmer Sample collector who need not be identical to the sender
Untersuchungsauftrag.Präparat Submitted preparation (see preparation/specimen)
Untersuchungsauftrag.Untersuchung Ordered examination(s)

Specimen (Sample)

The MII profile Bioprobe - Core, from the Biobank module, is used as the basis for the specification of the specimen. Usually, the specimen resulting from the clinical collection process is also called sample.

Logical data model Description
Probe Organ or part of an organ or a collection thereof or tissue or cells that are sent in for processing and assessment and from which further specimens can be created through specimen processing
Probe.Identifikation Identification of the specimen / sample
Probe.Probenherkunft Location of the body part from which the sample comes
Probe.Entnahme-/Abnahmezeitpunkt Date and time of sample collection
Probe.Laboreingangszeitpunkt Date and time of specimen receipt
Probe.Entnahmeprozedur Procedure for specimen collection
Probe.Bearbeitungsprozedur Procedure for sample/specimen processing
Probe.Bearbeitungsprozedur.Additiv Additive used for sample/specimen processing
Probe.Probenidentifikation.ProbenID ID of the Specimen, can be identical to the accession number
Probe.Probenidentifikation.ParentID ID of the parent Specimen from which the Specimen to be processed / examined originates
Probe.Container Specimen container in the broadest sense: submission container, tissue cassette, paraffin block, slide, etc.
Probe.Container.Typ Type of container
Probe.Container.Additiv Additive in the container
Probe.Beobachtung Observation of the sample

Observation report sections

The observation report sections / Beobachtungsberichtabschnitte listed in the Art-Decor scheme all have the same following logical data elements, which only differ in their specific content.

Logical data model Description
Beobachtungsberichtabschnitt.Identifikation Identifier of the report section
Beobachtungsberichtabschnitt.Text Text of an observation in the report section
Beobachtungsberichtabschnitt.Pathologisch-anatomische Einzelbeobachtung Semantically annotated (coded) unit of a generic pathological-anatomical observation in the report section
Beobachtungsberichtabschnitt.Eingebettetes Bild Image embedded in the findings report section

The observation report section Proben/Technische Bearbeitung from the CDA profile APSR is represented by sample information from the LIS. This contains a list of all samples that were sent by the sender and processed in the laboratory into assessable (stained section) preparations, so that each assessable object can have a clear assignment of its production process.

The text section should be structured according to:

  • Specimen ID / Proben-ID
  • Parent specimen ID / Elternproben-ID
  • Collection procedure / Entnahmeprozedur
  • Processing procedure / Bearbeitungsprozedur

for the sample levels part, block, stained section (sample part, stained smear, each for cytological preparations).

The observation report section Clinical information / Klinische Informationen from the CDA profile APSR is fully included in the examination request and can be taken from it.


Generic pathological-anatomical observation

The generic pathological-anatomical observations represent the "atomic" codable data elements in the pathology report. They describe specific findings on morphological characteristics and results of measurements, may include images or describe regions of interest in images to which further observations refer.

Generic pathological-anatomical observations can also be used in nested constructs with organizer properties.

Logical data model Description
Generische Pathologisch-anatomische Einzelbeobachtung.Identifikation Identifier of the generic pathological-anatomical observation
Generische Pathologisch-anatomische Einzelbeobachtung.Text Display text of a coded observation
Generische Pathologisch-anatomische Einzelbeobachtung.Code Code of the generic pathological-anatomical observation
Generische Pathologisch-anatomische Einzelbeobachtung.Status Status of the generic pathological-anatomical observation (provisional/active, final)
Generische Pathologisch-anatomische Einzelbeobachtung.Datum Date and time of the generic pathological-anatomical observation
Generische Pathologisch-anatomische Einzelbeobachtung.Wert Value (measured value or code value) of the generic pathological-anatomical observation
Generische Pathologisch-anatomische Einzelbeobachtung.Interpretation Coded interpretation of the value in terms of its relationship to threshold values
Generische Pathologisch-anatomische Einzelbeobachtung.Methode Coded method of observation (e.g. Macroscopy, microscopy, etc.)
Generische Pathologisch-anatomische Einzelbeobachtung.Durchführender Person who or device which carried out the observation
Generische Pathologisch-anatomische Einzelbeobachtung.Autor Author of the observation (pathologist, device)
Generische Pathologisch-anatomische Einzelbeobachtung.Informant Person who contributed to the observation
Generische Pathologisch-anatomische Einzelbeobachtung.Probe Specimen on which the observation was made (from submission sample up to stained section possible)
Generische Pathologisch-anatomische Einzelbeobachtung.Unterbeobachtung Further contributing observation (e.g. score values, TNM components, etc.)
Generische Pathologisch-anatomische Einzelbeobachtung.EingebettetesBild Image to illustrate the observation
Generische Pathologisch-anatomische Einzelbeobachtung.RegionOfInterest Region of interest to which the observation refers (e.g. tumor portion in the tissue section for which, for example, Ki-67 was determined)
Generische Pathologisch-anatomische Einzelbeobachtung.Kommentar Comment on the observation
Generische Pathologisch-anatomische Einzelbeobachtung.Referenz Reference to an external document or an external observation, e.g. made by molecular pathology