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)"

The latest draft of the white paper is downloadable from this folder

Current contributors are:

• Raj C. Dash, MD,
• Riki Merrick,
• Francesca Frexia,
• Francesca Vanzo, ,
• John D Nolan,
• Dan Rutz,
• Nicholas C. 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 Secondary Review / Consultation

There are numerous contexts for consultation requests which have subtle, but important differences. Understanding these contexts and the pertinent variations for workflow are necessary to understand systems design, management, and operations for secondary reviews. (Temp Note: See NCJ's Consultation Workshop ppt from 2015 DPA conf for further details.) Terminology note: we will call the requesting party the requester, and the person fulfilling that request the consultant.

• 1.a. Pathologist requested consults, pre-primary diagnosis.
  • 1.a.1. Intrainstitutional: The pathologist is requesting a second opinion (through digital review) to another pathologist at their institution, either at the same site or another site in their network. In the case where the pathologist was already viewing the slides digitally (primary diagnosis), this would likely be in the same system (i.e. uses synchronous or asynchronous consultation functions within their IMS/PACS). This is likely due to the case being challenging, or otherwise meriting the review of a sub-specialist (or different kind of subspecialist, such as a gyn-specialist requesting the opinion of a dermatopathologist's consultation).
    • Note that this may or may not trigger requests for scans, would not trigger billing for the patient, but may trigger records or documents internal to that organization for tracking consultation between pathologists within the organization.
    • Note that due to the internal nature, it can be assumed the consultant will have access to all electronic documentation (EHR, APLIS, etc.), but that there are likely to be either text based messages and annotations (for asynchronous consultation) and/or verbal communication between requester and consultant in the case of synchronous consultation.
    • Much of the value of this process centers around efficiency (compared to glass slide processes) is in limiting "phone or email tag" issues, maximizing communication ("this ROI is what worries me"), and generally improving organization and documentation of the process.
  • 1.a.2. Interinstitutional: The requester pathologist is requesting consultation from an outside hospital, usually due to the challenge of the case or the need for an external subspecialist.
    • Slides may need to be scanned if the requester was using the microscope. The requester pathologists may only request a subset of the slides to be scanned (i.e. if 9 slides are normal, and 2 are questionable, they may scan and send just the 2 questionable slides to the consultant.) Note that in this context, the scanning processes will likely be considered high priority or rush requests; systems should allow for differences in priority of scan requests.
    • The request to the consultant will be coupled with consultant's summary of the patient's clinical history, notes and questions (i.e. "is this a microfocus of carcinoma?" or "my differential is diagnosis A vs diagnosis B.") along with printed or saved documentation (i.e. preliminary report including items like frozen section or rapid fine needle aspiration interpretations, reports from surgeons or radiology imaging processes, other images from AP processes such as gross images, IF, EM, etc.) and possibly blocks. Inclusion of profiles like APSR here will be highly beneficial, especially if APSR profiles support itemizing both all assets that exist on a case as well as what was sent for consultation.
    • Note that the consulting institution will need to match images to clinical history and documentation. The consulting institution may also have quality control procedures to check image quality, and may need to troubleshoot the process by asking for rescans or other clinical information.
    • There are potentially significant differences in process here based on how image distribution and viewing are intended to function. This may involve uploading WSIs and other data to a thin client host, uploading data to a repository for download to the consultant group, or sending disks (i.e. flash drives or DVDs) with the data.
    • Much of the value proposition in this process revolves around reducing turn-around-time of processes versus mailing glass slides, further coordinating the consultation process (which requires some collaboration between the requesting site and consultant site), and improving on the consultation product to the requester (i.e. requester gets the consultant's report in the end, but can also see annotations or other notes to see in more detail why the consultant interpreted the case in such a way). These value propositions also merit noting that sending physical media can potentially be viewed as "the worst of both worlds" if they require both imaging processes and still have the long shipping time related issues and risks.
• 1.b. Patient Requested second opinion, post-primary diagnosis.
  • These contexts can be generally assumed to be going to a different institution. While there may be less pressure on the original institution for timeliness, the patient may be waiting on making a treatment decision based on the second opinion, so process turn-around-time is still very important. But because the patient is likely requesting the review sent to a specific institution or other pathologist, it should not be assumed that there is a functional telepathology pipeline between the two institutions.
  • If there are no specific instructions accompanying the request (other than send this case X to institution/pathologist Y for second opinion), the onus is on the institution sending the material to gather materials (documents, images, scanned slides) for send out. The original hospital may wish to image some or all cases for such send-outs either to archive such materials (to mitigate risk of slides being damaged or lost in transit by having digital copies), or to prevent such risks by sending WSIs instead.
    • Again, exact processes will vary based on image distribution (i.e. whether WSIs and other clinical data are made available for download, sent via physical media such as DVDs, or other methods).

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:

Use Case #9: Sub-contracting for special analyses on specimens

Contributor: Gunter

Created as an increasing workload will be sub-contracted to special laboratories, e.g. for molecular analyses.

• 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
• Case with all digital assets analysed by the pathologist
• Selection of relevant assets/slides/blocks for consultation or sub-contracting
• Mailing of relevant assets/slides/blocks to external lab
• AP reporting (preliminary)
• Mailing of the (preliminary) report
• Receiving results of consultation / sub-contracted tests
• critical reflexion
• AP reporting (synoptic, final)
• Mailing of the final synoptic report.