The CapabilityStatement describes all mandatory interactions for a system to be conformant to the Pathology Module of the Medical Informatics Initiative

Logical Model for the graphical reprensentation of the respective Art-Decor Model

This abstract profile collects all common profiling requirements of the pathology observations and serves as the basis for all other observation profiles in this module. As an abstract profile, it cannot be instantiated.

The MII PR Patho Section Grouper profile is an abstract profile that defines the basis for the pathology grouper profiles but is not intended to be instantiated. As DiagnosticReport.result:[grouper-name] for an MII PR Patho Report, the grouper profiles represent the respective observation report section (corresponding to a CDA section) and act as an organizer for these groupings of MII PR Patho Finding.

These are examination results that have to be combined into logical groups ("panels") according to content-related and/or formal requirements, e.g. the respective observations on defined specimens such as the different submitted preparations. This special grouper observation element must be placed before all other observation elements, which are then included as hasMember references to MII PR Patho Finding. MII PR Patho Finding observations in turn reference their "parent observations" via derivedFrom references to SDC QuestionnaireResponses and/or to the respective grouper observations.

The following observation report sections are defined as "panels" of individual examinations:

• MII PR Patho Intraoperative Grouper
• MII PR Patho Macroscopic Grouper
• MII PR Patho Microscopic Grouper
• MII PR Patho Additional Specified Grouper
• MII PR Patho Diagnostic Conclusion Grouper

They are organized in the form of DiagnosticReport.result:[grouper-name] with a grouper function in the MII PR Patho Report and are thus equivalent to the "sections" in CDA. They are characterized by having only an Observation.code but no Observation.value. They group the "panel" observations using the hasMember and/or derivedFrom references or as an Observation.component.

The text (narrative) of these "sections" is represented in the Observation.text element. A complete example of the use of narratives in grouper observations can be found in the Prostate Cancer Spec IG.

These groupers have the Observation.codes

• 83321-0 (Pathology report intraoperative observation in Specimen Document)
• 22634-0 (Pathology report gross observation)
• 22635-7 (Pathology report microscopic observation)
• 100969-5 (Pathology report additional specified observation)
• 22637-3 (Pathology report diagnosis)

If an observation report section contains several submitted specimens (samples), the MII PR Patho findings are assigned to these different specimens via the specimen references of these MII PR Patho findings, specifically the references concerning the "parts".

A grouper for "Clinical Information", 22636-5 (Pathology report relevant history), is not necessary, as the corresponding information is available in the MII PR Patho Service Request under .supportingInfo.

Special case:

• A MII PR Patho Finding as a hasMember construct within one of the above-mentioned groupers for grouping medical content-related problems (corresponds to the CDA problem organizer), e.g. when two different tumor entities are present in one specimen, should be created with the LOINC code 75326-9, Problem; an Observation.value is not required, the grouping problem is represented in the code as Observation.component (e.g. an ICD code (76540-4, Pathology diagnosis ICD code) for a specific entity, a specimen code for a specific specimen (85298-8, Body structure included in specimen), etc.) and the concrete value in the value. The actual examination results for this content-related problem are then represented as MII PR Patho Findings by means of the hasMember construct.

The MII PR Patho Active Problems profile of the List resource represents a list of the patient's diseases and/or problems present at the time of the examination, which reflect the sender's clinical question within the supporting information of the MII PR Patho Service Request profile.

The individual diseases/questions can be represented using the MII PR Patho Problem List Item profile.

The MII PR Patho Additional Specified Grouper profile of the Observation resource represents, as DiagnosticReport.result for an MII PR Patho Report, the respective observation report section "Additional specified observations" (corresponding to this CDA section) and acts as an organizer for the corresponding groupings of MII PR Patho Finding from non-morphological or molecular genetic examinations.

This special grouper observation element must be placed before all other observation elements, which are then included as hasMember references to MII PR Patho Finding. MII PR Patho Finding observations in turn reference their "parent observations" via derivedFrom references to SDC QuestionnaireResponses and/or to the respective grouper observations.

If the observation report section contains several submitted specimens (samples), the MII PR Patho findings are assigned to these different specimens via the specimen references of these MII PR Patho findings, specifically the references concerning the "parts".

For a list and explanation of the FHIR elements see (abstract) MII PR Patho Section Grouper.

With the MII PR Patho Attached Image profile of the Media resource, images embedded in the report, i.e. in the MII PR Patho Report, are described. To include images in MII PR Patho Finding, a reference to an ImagingStudy must be used. This profile should preferably only be used to "illustrate" a pathology report.

This profile MII PR Patho Bundle inherits from Profile - ISiK - BerichtSubsysteme of the specification ISiK - Stufe 5. It serves to aggregate all resources that are part of the document. The first resource in the bundle (Bundle.entry.resource) should always be a Composition.

The profile uses Bundle.type = "document" and a persistent, unique Bundle.identifier. This should correspond to the Composition.identifier, for example an accession number including the version number. Further slices of Bundle.entry are ServiceRequest, Specimen, DiagnosticReport, Observation and Patient, whereby the ServiceRequest and Patient slices are optional. The bundle contains a signature.

This profile inherits from Profile - ISiK - BerichtSubsysteme of the specification ISiK - Stufe 5.

The MII PR Patho Composition profile, as a profile of a Composition resource with special constraints for clinical documents, brings together the resources for a complete, text-centric pathology report with the properties of a clinical document. A complete example of a Composition with narratives can be found in the Prostate Cancer Spec IG. This profile is the first entry in a bundle of Bundle.type "document"; the structure and signature of the bundle are described in the MII PR Patho Bundle profile. In addition to the diagnostic report (patho-diagnostic-report) and one or more additional complete reports (additional-diagnostic-report), the observation report sections may optionally also be carried directly as separate sections of the Composition (macroscopy, microscopy, intraoperative, diagnostic conclusion, additional observation); each of these sections references the same grouper as DiagnosticReport.result. Composition and DiagnosticReport may additionally reference each other via the extension composition-diagnosticReportReference and the R5 cross-version extension DiagnosticReport.composition respectively. All of these additions are optional.

The MII PR Patho Diagnostic Conclusion Grouper profile of the Observation resource represents, as DiagnosticReport.result:diagnostic-conclusion-grouper for an MII PR Patho Report, the respective observation report section "Diagnostic conclusion" (corresponding to this CDA section) and acts as an organizer for the corresponding groupings of MII PR Patho Finding.

This special grouper observation element must be placed before all other observation elements, which are then included as hasMember references to MII PR Patho Finding. MII PR Patho Finding observations in turn reference their "parent observations" via derivedFrom references to SDC QuestionnaireResponses and/or to the respective grouper observations.

If the observation report section contains several submitted specimens (samples), the MII PR Patho findings are assigned to these different specimens via the specimen references of these MII PR Patho findings, specifically the references concerning the "parts".

For a list and explanation of the FHIR elements see (abstract) MII PR Patho Section Grouper.

The MII PR Patho Finding profile of the Observation resource maps atomically coded examination results as a hasMember or derivedFrom reference for a profile of the type MII PR Patho Section Grouper. This profile can form nested constructs in order to capture "child observations" that further specify a single observation. Patho findings can be provided by the pathology information system via Questionnaire / QuestionnaireResponse resources (see HL7 Implementation Guide Structured Data Capture), or QuestionnaireResponse resources are referenced. Each MII PR Patho Finding should reference the specimen on which the observation was made.

Special case:

• In the case of a report update, an MII PR Patho Finding with the LOINC code 90004-3 - Clinical significance of updated information serves as the organizer for the update information, which is mapped in the MII PR Patho Diagnostic Conclusion Grouper. For this purpose the focus reference is used to point to the affected MII PR Patho Grouper (observation section). The Observation.value is represented by a ValueSet "ClinicalSignificance" (e.g. LOINC LL4770-5).

For specific Observation constructs, especially from the oncological basic data set (oBDS) - such as TNM, histological tumor type, etc. - the Observation profiles of the MII Extension Module Oncology can also be used. For observations on immunohistochemical stains, in-situ hybridizations, PCR tests, methylation tests and NGS analyses, the Observation profiles of the MII Extension Module Molecular Tumor Board or of the MII Extension Module Molecular Genetic Report should be used.

The MII PR Patho History of Present Illness profile of the List resource represents the description of the medical history by the sender and is part of the "supportingInfo" in the MII PR Patho Service Request profile.

The individual diseases/problems can be represented using the MII PR Patho Problem List Item profile.

The MII PR Patho Intraoperative Grouper profile of the Observation resource represents, as DiagnosticReport.result:intraoperative-grouper for an MII PR Patho Report, the respective observation report section "Intraoperative observation" (corresponding to this CDA section) and acts as an organizer for the corresponding groupings of MII PR Patho Finding.

This special grouper observation element must be placed before all other observation elements, which are then included as hasMember references to MII PR Patho Finding. MII PR Patho Finding observations in turn reference their "parent observations" via derivedFrom references to SDC QuestionnaireResponses and/or to the respective grouper observations.

If the observation report section contains several submitted specimens (samples), the MII PR Patho findings are assigned to these different specimens via the specimen references of these MII PR Patho findings, specifically the references concerning the "parts".

For a list and explanation of the FHIR elements see (abstract) MII PR Patho Section Grouper.

The MII PR Patho Macroscopic Grouper profile of the Observation resource represents, as DiagnosticReport.result:macroscopic-grouper for an MII PR Patho Report, the respective observation report section "Macroscopic assessment" (corresponding to this CDA section) and acts as an organizer for the corresponding groupings of MII PR Patho Finding.

This special grouper observation element must be placed before all other observation elements, which are then included as hasMember references to MII PR Patho Finding. MII PR Patho Finding observations in turn reference their "parent observations" via derivedFrom references to SDC QuestionnaireResponses and/or to the respective grouper observations.

If the observation report section contains several submitted specimens (samples), the MII PR Patho findings are assigned to these different specimens via the specimen references of these MII PR Patho findings, specifically the references concerning the "parts".

For a list and explanation of the FHIR elements see MII PR Patho Section Grouper.

The MII PR Patho Microscopic Grouper profile of the Observation resource represents, as DiagnosticReport.result:microscopic-grouper for an MII PR Patho Report, the respective observation report section "Microscopic assessment" (corresponding to this CDA section) and acts as an organizer for the corresponding groupings of MII PR Patho Finding.

This special grouper observation element must be placed before all other observation elements, which are then included as hasMember references to MII PR Patho Finding. MII PR Patho Finding observations in turn reference their "parent observations" via derivedFrom references to SDC QuestionnaireResponses and/or to the respective grouper observations.

If the observation report section contains several submitted specimens (samples), the MII PR Patho findings are assigned to these different specimens via the specimen references of these MII PR Patho findings, specifically the references concerning the "parts".

For a list and explanation of the FHIR elements see MII PR Patho Section Grouper.

The MII PR Patho Problem List Item profile of the Condition resource represents the individual list entries of the MII PR Patho Active Problems and MII PR Patho History of Present Illness profiles.

The MII PR Patho Report profile of the DiagnosticReport resource represents the complete pathology report without having document properties (see MII-PR-Patho-Composition).

It presents highly structured examination results including human-readable texts (narratives) that belong to "panels" of individual examinations. It collects and organizes pathology findings for complex individual results as well and can reference further information on the examination panel, e.g. clinical information and specimen information. A complete, formatted report text should be part of the MII PR Patho Report. A complete example of a pathology report with narratives can be found in the Prostate Cancer Spec IG.

The most important features of the MII PR Patho Report are:

• the ability to include additional clinical context, e.g. a mix of results from individual observations, images, texts and formatted representations,
• the ability to include information on several specimens (here the specimens submitted by the clinician),
• and the ability to represent a summarizing assessment, the conclusion, as well as one or more conclusion codes that are not identical to the pathology findings.

As an entry in the section "patho-diagnostic-report" of the MII PR Patho Composition profile, the MII PR Patho Report forms the core of a persistent "pathology report" document.

In the table below, elements that are duplicated in the MII PR Patho Composition profile are marked with *.

The MII PR Patho Service Request profile of the ServiceRequest resource represents the description of the clinician's request to the pathology facility. This request is usually non-specific ("histology requested", which corresponds to a request for a consultative assessment), but it can be supplemented by specific questions (e.g. "FISH for Her2", corresponding to a target request). If several specific examinations are to be ordered, a separate MII PR Patho Service Request must be issued for each examination, all of which are grouped together in the ServiceRequest.requisition (corresponding to a placer order group).

An examination request is always linked to one (or more) specimen(s), for which detailed descriptions from the sender may be available. An examination request usually constitutes a case (submission, "accession") of the pathology facility. If a ServiceRequest.requisition is present, it usually constitutes the case (submission, accession). The pathology facility processing the examination request may combine or divide examination requests into one or several cases according to the laboratory-internal requirements.

This profile inherits from Profile - Specimen - Bioprobe - Core It is based on the HL7 domain analysis model (HL7_DAM_SPECIMEN_R2_INFORM_2019APR). Particularly for pathology, this model takes into account the role model of specimens, which are both the subject and the product of laboratory processes. The root element (sample) is specimen material clinically obtained from a patient and corresponds to a part in the pathology workflow. Child elements are blocks and sections, or a cytological preparation. The child specimens (blocks and sections) should always reference at least their direct parent specimen via the element Specimen.parent.

Specimens are referenced in several profiles. In the "pathology report" and in the "individual observations" of the groupers for macroscopy and diagnostic conclusion, the specimens of the submission (parts) should be referenced; in the "individual observations" of the microscopy grouper, the specimens at the stained tissue section level should be referenced.

ValueSet for general LOINC VS binding

ValueSet for the clinical collection method

ValueSet for the categorization of Pathology Report documents

ValueSet for the types a pathology Composition can have

ValueSet for container type based on IHE PaLM's ContainerEntityClassType ValueSet

ValueSet with some of the main Media.modalities needed in the pathological scope

ValueSet containing the recommended vocabulary for describing problems, according to the IHE Patient Care Coordination Technical Framework (Vol. 2)

Specimen processing procedure

ValueSet for the categorization of Pathology Report documents

ValueSet for the report type codes of pathology DiagnosticReports

ValueSet for IHE PaLM APSR's section types

ValueSet for a preferred set of ServiceRequest codes

Canada balsam (substance)

Eosin Y (substance)

Hematoxylin stain (substance)

Microscope slide mounting medium (substance)

Neutral buffered formalin (substance)

Paraffin wax (substance)

Pathology Active Problems List List Example

Example for Attached Image

Breast-conserving excision specimen of the left breast as submitted specimen (part), with wire and suture markings

Pathology History of Present Illness List Example

Location in the breast-conserving excision specimen: left breast, lower outer quadrant, 5 o'clock, 50 mm distal to the nipple

Pathology Problem List Item Example

Pathology Problem List Item Example

Location in the prostatectomy specimen: right apical peripheral zone, posterior, 15 mm proximal to the apex

Radical prostatectomy specimen as submitted specimen (part)