APW-EDM White Paper

Foreword

This is the collaborative space of the white paper "Anatomic Pathology Workflow in an Era of Digital Medicine (APW-EDM)"

Current contributors:

• Raj C. Dash, MD,
• Riki Merrick,
• Francesca Frexia,
• Francesca Vanzo, ,
• John D Nolan,
• Dan Rutz,
• Nicholas Jones,
• Gunter Haroske,
• François Macary

Introduction

This document, the IHE PaLM “Anatomic Pathology Workflow in an Era of Digital Imaging” White Paper, describes use cases, data elements, actors, and transactions necessary to support anatomic pathology workflows that leverage digital technologies. Abbreviation for the title is APW-EDM.

This white paper lays out a collection of future integration profiles to address how vended systems for supporting anatomic pathology workflows interact and is intended to replace the former Anatomic Pathology Workflow (APW) profile. The first objective is to better take into account the latest advancements in digital imaging, spanning but not necessarily limited to two primary aspects of anatomic pathology workflow:

• the gross/macroscopic examination leveraging state-of-the art more interoperable imaging modalities,
• the histologic/microscopic examination taking advantage of whole slide imaging technology.

The second objective is to break down the APW profile into a set of smaller, easier to implement building blocks, each of these focusing on one key aspect of the anatomic pathology digital workflow. The expectation is to collect sufficient feedback from all stakehoders of digital pathology (vendors, pathologists, institutions) in order to confirm and/or refine this set of profiles before starting to build them as new supplements to the Pathology and Laboratory Medicine Technical Framework.

Open Issues

• APW-EDM-01: Involve industrial offer for archiving and communication of whole slide images, as well as slide scanner manufacturers
• APW-EDM-02: Check the market for imaging modalities, PACS, and image reviewing and annotating software solutions, supporting the DICOM standard with the DICOM 122 supplement “Specimen Module and Revised Pathology SOP Classes” and the DICOM 145 supplement “Whole Slide Microscopic Image IOD and SOP Classes”

Closed Issues

• APW-EDM-03: Tissue microarrays may break the current specimen model. DICOM does cover this as a use case. Tissue microarrays are not used in clinical care, and so are left out of the scope of the profiles that will be derived from this white paper.

Use Cases

Use Case #1: Image Slides for External Secondary Review

Create digital copies of glass slides to preclude exhausting tissue block for outside slide reviews

• Request for case review from outside facility or patient
• All glass slides reviewed by pathologist and key slides identified
• Key slides digitally imaged
• Original key slides sent out for review
• In future, digital version can be submitted for review
• If additional review request comes in, can reference digital versions and/or wait for original slides
• Usually blocks not sent out by policy

To be refined and continued.

Use Case #2: Immunohistochemistry Positive Control Slides

Creating digital copies of immunohistochemistry positive control slides to preclude the need for creating multiple positive control slides for distribution to pathologists

• Request for IHC stain processed as usual
• Only one IHC positive control run per batch
• IHC positive control slides imaged and saved to network folder
• Positive controls NOT distributed ($$$ savings)
• Glass IHC slides reviewed by pathologist but same positive control reviewed digitally by all pathologists for a given IHC (i.e. only a single cytokeratin positive control slide even if requested across 10 different patient samples)

To be refined and continued.

Use Case #3: Managing Digital Assets for Anatomic Pathology Clinical Workflows

These workflows include for instance, Whole Slide Images for Primary Diagnosis. Creating digital copies of all glass slides for primary diagnosis

• Specimen collected and transported
• Specimen gross exam with possible digital imaging and annotation
• Specimen processing
• Glass slides produced as usual
• All glass slides fed into high volume automated digital scanner
• Scanner tags images requiring manual intervention
• Digital images deposited in network share, VNA, or PACS
• Interface message to LIS sent as each barcode read off slide
• Acknowledgment from LIS indicates case is valid and ready for association with digital slide assets
• Additional message sent when slide digitization completed
• Interface message sent every time slide viewed or annotated

To be refined and continued.

Use Case #4: Sharing and Cooperating on Gross Examination Images

TBD Contributor assigned:

Use Case #5: Incorporation of Legacy Digital Images for Use in APW

TBD Contributor assigned:

Use Case #6: Image Analysis, Machine Learning and In Silico Workflows

TBD Contributor assigned: Contributor assigned:

Use Case #7: Quality Control / Quality Assurance and Error Correction Workflows to Support Digital Pathology

TBD Contributor assigned:

Use Case #8: Digital Pathology in Support of Multidisciplinary Tumor Board Case Reviews

TBD Contributor assigned: