Development of CAP Standards for Digital Pathology That Would be Important for CAP Accreditation of Pathology Labs as We Transition Into a Digital Era

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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

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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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Virtual microscopy
Telepathology
PACS signout Virtual IHC Consultation
Diagnosis Consultation
Reporting Links to images Digital archive
Targeted therapies Image based searches
Digital Pathology Digital Data Set/Whole slide
image
Image analysis CAD
Imaging Archiving
Content rich data sets
Undergraduate GME/CME
TMA Comparative analysis
Education
Research
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What other standards are needed?

• Clinical implications
• Its 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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