Development of CAP Standards for Digital Pathology That Would be Important for

CAP Accreditation of Pathology Labs as We Transition Into a Digital Era

Keith J. Kaplan, MDCarolinas Pathology Group

What is CAP Accreditation? CAP Laboratory Accreditation Program (LAP) is an internationally recognized

program and the only one of its kind that utilizes teams of practicing laboratory professionals and inspectors

Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care.

Deemed status from CMS and recognized by JCAHO

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What is CAP Accreditation? The goal of the CAP LAP is to improve patient safety by advancing the

quality of pathology and laboratory services through education, standard setting and ensuring laboratories meet or exceed regulatory requirements

CAP Website Sept 2010

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What is CAP Accreditation? Best Practices

Where and how does this apply to digital pathology?

How will standards enable digital pathology adoption?

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Accreditation Checklists Blueprint for up-to-date quality practices for laboratories

Incorporate the development and support of pathologists and continually evolve to reflect current technology

Provide a solid foundation, specify detailed requirements and serve as a tool used by inspectors to evaluate the laboratory

Act as a guideline for development of policies, procedures and processes to help ensure accurate, reliable laboratory test results

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Checklist examples GEN.41770 Glassware Cleaning

Appropriate documented procedures for handling and cleaning glassware

ANP.11500 Specimen Identity Identity of every specimen is maintained at all times during processing and

examination

ANP.24300 CJD Special Handling Documented procedures for special handing from cases in which CJD is suspected

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CAP Informatics Committee circa March 2008 Bruce A. Beckwith, MD (Chair)

Walter H. Henricks, MD (Vice-chair)

David L. Booker, MD

James H. Brassel, MD

Victor B. Brodsky, MD

William J. Castellani, MD

Keith J. Kaplan, MD

Ronald W. McLawhon, MD, PhD

Liron Pantanowitz, MD

John Sinard, MD, PhD

Ronald S. Weinstein, MD

Jeffrey Korman (CAP Staff)

Bryce Gilmore (CAP Staff)

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Digital PathologyDigital Data Set/Whole slide image

Telepathology

Image analysis & CAD

ResearchEducation

Imaging & Archiving

Virtual microscopy

PACS signout Virtual IHC Consultation

Diagnosis Consultation

Targeted therapies

Image based

searches

Reporting Links to images Digital archive

Undergraduate GME/CME

TMA Comparative analysis

Content rich data sets

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What other standards are needed? Clinical implications

“It’s what you do with the information that matters”

Technical implications “Create an environment for managing multi-gigabyte images” Autostainers, coverslippers, LIS, PACS

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Clinical standards Workflow driven

Right patient, right image, right time – appropriate links to information

Morphometric analysis (image analysis) Approved (validated) platforms # of fields/regions

Quality assurance and quality control Gross photograph images recorded and integrated with WSI/viewing Specimen containers for QC

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Factors for consideration Diagnostic accuracy

Quality of image handling (orientation, focusing)

Workflow Influence of turn around time/time to diagnosis (image transfer) Influence of system stability Influence of user support (training, support, helpdesk)

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Factors for consideration Reliability

System(s) reliability (total break down) Access control and data security (access without loss or misuse)

Medicolegal factors

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Technical standards DICOM standard facilitates interoperability between scanners, image

storage systems and viewers

Image compression that would not compromise pathologists’ ability to diagnose

Image fidelity from scanner to monitor

Storage standards – HIPAA, redundancy, back up

Storage standards – length of storage

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Factors for consideration Quality of equipment (PCs, monitors, scanners)

Quality of monitor images (resolution, color, contrast)

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Regulatory standards FDA panel Oct 2009

Medicolegal implication

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Medicolegal standards Market forces are changing and insurers are responding to the market

Assistance in working with insurers to meet standards of care

Risk of using technology vs. Not using technology

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Pathology Visions 2010