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, MD
Carolinas 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?
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Best Practices
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Where and how does this apply to digital pathology?
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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
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GEN.41770 Glassware Cleaning

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ANP.11500 Specimen Identity

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Appropriate documented procedures for handling and cleaning glassware
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)
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Ronald W. McLawhon, MD, PhD

Walter H. Henricks, MD (Vice-chair)

Liron Pantanowitz, MD

David L. Booker, MD

John Sinard, MD, PhD

James H. Brassel, MD

Ronald S. Weinstein, MD

Victor B. Brodsky, MD

Jeffrey Korman (CAP Staff)

William J. Castellani, MD

Bryce Gilmore (CAP Staff)

Keith J. Kaplan, MD
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Virtual
microscopy
PACS signout
Virtual IHC
Consultation
Imaging &
Archiving
Diagnosis
Consultation
Reporting
Targeted
Digital Pathology therapies
Links to
images
Image
Digital Data Set/Whole slide image
Digital
based
Content
rich
data
sets
archive
searches
Undergraduate TMA
GME/CME
Education
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Telepathology
Comparative
analysis
Research
Image analysis
& CAD
What other standards are needed?

Clinical implications


“It’s what you do with the information that matters”
Technical implications
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“Create an environment for managing multi-gigabyte images”

Autostainers, coverslippers, LIS, PACS
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Clinical standards
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Workflow driven
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Right patient, right image, right time – appropriate links to information

Morphometric analysis (image analysis)

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Approved (validated) platforms
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# of fields/regions
Quality assurance and quality control

Gross photograph images recorded and integrated with WSI/viewing
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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)
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Influence of system stability

Influence of user support (training, support, helpdesk)
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Factors for consideration
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Reliability
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System(s) reliability (total break down)
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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
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Image fidelity from scanner to monitor
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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
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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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