Anatomic Pathology Structured Reports

White Paper: Anatomic Pathology Standard Reports (APSR)

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

Introduction

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.
• Collectively, in clinical research and epidemiology.

Information technology & knowledge engineering offer several solutions for optimizing APR collection and exchange in structuring, coding and standardizing their contents.

Definitions:

Structured report

To be completed

Coded report

To be completed

Standard report

To be completed

Previous approaches

Several studies about reports quality assessment have attempted to outline recommendations delineating the required, preferred, and optional elements that should be included in the APR. These recommendations afford a framework for the creation of an APR containing all of the components that are required or optimal for patient care. [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]
Furthermore, there are several international initiatives intending to define templates for structured reports in anatomic pathology:

• In United States (PERC/CAP): Cancer Protocoles and checklists.
  • 70 cancer checklist in text format, 10 of them in XML schema format.
  • Covered cancer domains: breast, colon, lung and prostat.
  • Coding systems used: SNOMED CT and LOINC.
• In France (INca/FSP/InVS):
  • 24 cancer checklist in text format, 5 of them in CDA format (esophagus, stomach, pancreas, colon and rectum).
  • Coding systems used: ADICAP and CIM-O.
  • Others: INca mandatory items, DM Path.
• CEN TC 251 WI 130.1.1:2003
• Others...

Hypothesis

It is possible to define an information model for structuring and coding AP findings and to provide selection processes in order to render the relevant information to the different healthcare providers in different contexts:

• Essentially for patient care (in or outside hospitals).
• Secondarily for:
  • Clinical research & epidemiology (Cancer registries & Centers for Diseases Control).
  • Tissue banking, biorepositories.
  • Education and training.
  • Others...

Confidentiality, security issues and transmission transactions are out of the scope of this white paper.

Use Cases/contexts

So, anatomic pathology reports (APR) may be designed for multiple uses, essentially in patient care (diagnostic and prognostic information, tumor board) and also in epidemiology (centers for diseases control) and clinical research (cancer registries), etc.
We have to carefully analyse these different contexts (workflow) of producing APR in order to define both templates and IT solution which support these different uses.

APR contexts (Open issue):

• PATIENT CARE
  • Context 1 : anatomic pathology reporting for clinicians
  • Context 2 : anatomic pathology reporting for healthcare networks (e.g tumor board)
• EPIDEMIOLOGY and RESEARCH
  • Context 1 : research in the anatomic pathology field (retrospective studies in AP laboratories)
  • Context 2 : anatomic pathology reporting for public health agencies (cancer registries, Centers for Diseases Control, etc.)
  • Context 3 : anatomic pathology reporting for tissue banking
• TRAINING & EDUCATION
• Others...

Moreover, for each context 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.

• 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

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.

• 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 available format (CDA)
    • 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).

We appreciate your participation: Structured APR Survey
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References

• Error detection in anatomic pathology. Zarbo RJ, Meier FA, Raab SS. Arch Pathol Lab Med 2005;129:1237-1245.
• Evidence-based cellular pathology. Fleming KA. Lancet 2002;359:1149-1150. HL7 Clinical Document Architecture R2, Dolin et al, J Am Med Inform Assoc. 2006;13:30–39. DOI 10.1197/jamia.M1888.
• Interactive exploration of model-based automatically extracted data, Coden et al, Myo Clinic.
• Patient safety and error reduction in surgical pathology. Nakhleh RE. Arch Pathol Lab Med 2008;132:181-185.
• Recommendations for quality assurance and improvement in surgical and autopsy pathology. Association Of Directors Of Anatomic And Surgical Pathology, Nakhleh R, Coffin C, Cooper K. Hum Pathol 2006;37:985-988.
• Reporting guidelines for clinical laboratory reports in surgical pathology, Goldsmith JD, Siegal GP, Suster S, Wheeler TM, Brown RW. Arch Pathol Lab Med. 2008 Oct;132(10):1608-16.
• Surgical Pathology Report recommendations—Goldsmith et al, Arch Pathol Lab Med—Vol 132, October 2008.
• http://www.adicap.asso.fr/
• http://cap.org
• http://code.google.com/p/synoptic-report *http://fr.wikipedia.org/wiki/Classification_internationale_des_maladies
• http://loinc.org/
• http://snomed.org/