development of cap standards for digital pathology that would be important for cap accreditation of...
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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, 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
Pathology Visions 2010
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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