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Keith J. Kaplan, MD Carolinas Pathology Group

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?.

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Keith J. Kaplan, MD Carolinas Pathology Group

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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 Pathology Visions 2010

  7. Pathology Visions 2010

  8. Pathology Visions 2010

  9. Pathology Visions 2010

  10. 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

  11. Pathology Visions 2010

  12. 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 Imaging & Archiving Image analysis & CAD Content rich data sets Undergraduate GME/CME TMA Comparative analysis Education Research Pathology Visions 2010

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

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

  19. Regulatory standards • FDA panel Oct 2009 • Medicolegal implication Pathology Visions 2010

  20. 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

  21. Pathology Visions 2010

  22. Pathology Visions 2010

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