Anatomic Pathology Structured Reports

Proposed Profile: Anatomic Pathology Structured Reports

• Proposal Editor: Thomas Schrader, Christel Daniel
• Editor: Christel Daniel, Mary Kennedy, Haitham Kussaibi, Bettina Fabiani, Dominique Henin, Antoine Buemi
• Domain: Anatomic Pathology

The Problem

The transaction related to the reporting workflow (PAT3-Order Results Management) of the IHE Anatomic Pathologyt Technical Framework is mainly dedicated to storage and sharing of free text anatomic pathology reports.

Studies about quality assessment of reports provide lists of mandatory items and stress the positive role of checklists to enhance the reporting process [ADASP06, Goldsmith08] According to “evidence-based pathology”, only features that are reproducible and relevant – with demonstrated diagnostic or prognostic significance – should be reported in description [Fleming 02]

There are many initiatives in different countries and/or within standardization bodies (HL7, CEN)aiming at proposing standard structured architecture for anatomic pathology reports.

• CAP (US): Cancer Protocoles and checklists
• SFP/INCa : CRFS, DM Path, InVS (France)
• Royal College (UK)
• CEN TC 251 WI 130.1.1:2003

The obective of this white paper is to collect, analyze and summarize these different initiatives in order to discuss the available technical solutions to store and share structured reports in anatomic pathology and make the recommandation about appropriated solution.

Hypothesis : It is possible to define an information model for structuring and coding AP information and a selection process in order to provide the relevant information to the different healthcare providers for:

• Research in Anatomic Pathology domain.
• Clinical care (in and outside hospitals (tupor bords, health networks, etc)).
• Epidemiological and/or clinical research (Cancer registries & Disease Control Centers)

Confidentiality issues are out of the scope of this white paper

Key Use Case

The anatomic pathology report (APR) documents the pathologic findings in tissues removed from patients. These findings provide diagnostic and prognostic information which can be used individually in patient care or collectively in clinical research and epidemiology.

• PATIENT CARE :
  • Use case 1 : anatomic pathology reporting for clinicians
  • Use case 2 : anatomic pathology reporting for healthcare networks (e.g multidisciplinary meetings in oncology)

• EPIDEMIOLOGY and RESEARCH
  • Use case 1 : research in the anatomic pathology field (retrospective studies in the AP laboratory)
  • Use case 2 : anatomic pathology reporting for public health agencies (cancer registries, disease control centers, etc)
  • Use case 3 : anatomic pathology reporting for tissue banking

Moreover, for each use case we have to consider in synoptic/structured reports the different types of specimens: operative specimens and biopsies in surgical pathology, fluid and FNA specimens in cytopathology, autopsy and tissue micro array (for research).

Standards & Systems

• Reporting guidelines

Goldsmith & al outlined recommendations delineating the required, preferred, and optional elements that should be included in the anatomic pathology report (APR). These recommendations afford a framework for the creation of an APR containing the mandatory and favored components for an optimal patient care. These guidelines, if implemented, will bring uniformity to the reporting of surgical pathology specimens.(Arch Pathol Lab Med. 2008;132:1608–1616).

According to CEN TC 251 WI 130.1.1:2003 a histology report may be divided into sections describing the: macroscopic appearance, microscopic features and the conclusion of the service provider based on these findings. Each of these sections may consist of free-text, measurements (e.g. size, weight etc.) and code values representing the findings. Different healthcare parties may be responsible for different parts of a report. Furthermore, overall responsibility of reviewing and signing-off the reports may be assured by another supervisory healthcare party.

• Available templates
  • CAP-PERC (US): 70 cancer checklist in text format, 8 of them in XML schema format (xsd or rng); for the cancers of breast, colon, lung and prostat; which use SNOMED CT and LOINC as coding system.
  • InCA/SFP (France): 24 cancer checklist in text format, 5 of them in CDA format (esophagus, stomach, pancreas, colon and rectum) which use ADICAP and CIM-O as coding system.

• Format
  • HL7 CDAr2
  • DICOM SR
  • HL7 v3 : Domaines Laboraory, Specimen, Observation

• Coding Systems
  • SNOMED
  • LOINC
  • ADICAP
  • ICD-O

• Maintaining and sharing value sets

ITI Sharing Value Sets integration profile is a technical solution that aims to define, manage, mainain and share the value sets corresponding to coded items. Defining and sharing value sets or the transactions defined within the IHE Anatomic Patology TF espacially the value sets related to specimen identification and description and to specific anatmic pathology observation and/or diagnostic codes.

• • HL7 v2.5 transactions (MSH, PID, PV1, OCR, OBR, OBX, SPM) : Placer Order Management, Filler Order management, Order Result Management, Procedure Scheduled and update. SPM segment: Specimen Type, Specimen Additives, Specimen Roles, Specimen Availability.
  • DICOM transactions : Specimen module : Container Types, Container component Types, Anatomic Pathology Specimen Types, Breast Tissue Specimen Types, Specimen Collection Procedures, Specimen Sampling Procedures, Specimen Stains, Specimen Prepartion Types, Specimen Fixative, Specimen Embedding Material.

Methodes

• Action plan
  • Analysis
    • Modeling the reporting workflow in and outside of the AP lab
    • Collecting and analyzing different structured architecture & coding processes for AP reporting in different contexts (patient care & research) & countries
    • Analyzing the available coding systems (SNOMED, LOINC, ICD-O and ADICAP).
  • Design
    • Proposing templates (information models) & define the value sets for coded items for a subset of the available SFP CRFS & CAP synoptics (e.g digestive (colon, esophage,stomach, pancreas), gynecological, breast, ENT, lung and urological cancers)
    • Validating these templates by pathologists and public health organisms (cancer registries, disease control centers, screening organisms, etc)
    • Specifying an architecture, actors and transactions for implementing the reporting workflow in and outside AP lab
    • Identifying the technical solution to store and share structured anatomic pathology reports (HL7 v2/v3, XDS – CDA – DICOM SR)
    • Defining selection and filtering processes that regulate the deliverance of relevant information into the different healthcare providers.

Discussion

• Open issues:
  • Medical consensus is not easy to achieve at regional/national/international level about important features that should be reported as well as the vocabulary and/or code system to use.
  • Standard information models (templates) are not available.
  • "International" code systems are mainly available in English and their coverage of APRs content has not been formally evaluated
  • Structured reports may be built from different sources(APIS, post processing station ("evidence" creation), etc). A crucial issue is to identify a technical solution to handle templates of structured reports including findings and their evidences. It should be possible to link each observation or finding to the specimen source (part(s) (Box ID) for macroscopic findings, tissue item (Slide ID) for microscopic findings)).
  • Moreover it must be possible to link each observation or finding to an image(s) or a region of interest of image(s) acquired from the specimen source. Complex diagnostic structured reports include numeric quantitative measurement, images or graphs, image annotation and links between image (and/or evidence) information and textual information.
  • Structured reports may be designed for multiple uses : not only in patient care but also in clinical research, cancer registries, cancer multi-disciplinary meetings, etc. We have to carefully analyse these different contexts of producing structured reports (workflow) in order to define both templates and IT solution to support these different uses.

Survey: International initiatives

We collect the different initiatives related to anatomic pathology reporting in different contexts (patient care (anatomic pathology reporting to clinicians, to health networks, to personal electronic healthcare record, etc), epidemiology (control disease centres, cancer registries, screening organisms, etc), biomedical research (clinical trials, research in anatomic pathology) and in different countries. We investigate for the regulatory aspects (security and confidentiality), organizational aspects, medical aspect (content, structure and coding of the anatomic pathology report) and technical aspects (architecture, formats and transactions).

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