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 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 Pathology Visions 2010

What is CAP Accreditation? Best Practices Where and how does this apply to digital pathology? How will standards enable digital pathology adoption? Pathology Visions 2010

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 Pathology Visions 2010

Checklist examples GEN Glassware Cleaning Appropriate documented procedures for handling and cleaning glassware ANP Specimen Identity Identity of every specimen is maintained at all times during processing and examination ANP CJD Special Handling Documented procedures for special handing from cases in which CJD is suspected Pathology Visions 2010

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) Pathology Visions 2010

Digital Pathology Digital Data Set/Whole slide image Telepathology Image analysis & CAD Research Education 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 Pathology Visions 2010

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 Pathology Visions 2010

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 Pathology Visions 2010

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) Pathology Visions 2010

Factors for consideration Reliability System(s) reliability (total break down) Access control and data security (access without loss or misuse) Medicolegal factors Pathology Visions 2010

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 Pathology Visions 2010

Factors for consideration Quality of equipment (PCs, monitors, scanners) Quality of monitor images (resolution, color, contrast) Pathology Visions 2010

Regulatory standards FDA panel Oct 2009 Medicolegal implication Pathology Visions 2010

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 Pathology Visions 2010