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Development of quality assurance program for digital pathology by the Korean Society of Pathologists

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Background: Digital pathology (DP) using whole slide imaging is a recently emerging game changer technology that can fundamentally change the way of working in pathology. The Digital Pathology Study Group (DPSG) of the Korean Society of Pathologists (KSP) published a consensus report on the recommendations for pathologic practice using DP. Accordingly, the need for the development and implementation of a quality assurance program (QAP) for DP has been raised. Methods: To provide a standard baseline reference for internal and external QAP for DP, the members of the Committee of Quality Assurance of the KSP developed a checklist for the Redbook and a QAP trial for DP based on the prior DPSG consensus report. Four leading institutes participated in the QAP trial in the first year, and we gathered feedback from these institutes afterwards. Results: The newly developed checklists of QAP for DP contain 39 items (216 score): eight items for quality control of DP systems; three for DP personnel; nine for hardware and software requirements for DP systems; 15 for validation, operation, and management of DP systems; and four for data security and personal information protection. Most participants in the QAP trial replied that continuous education on unfamiliar terminology and more practical experience is demanding. Conclusions: The QAP for DP is essential for the safe implementation of DP in pathologic practice. Each laboratory should prepare an institutional QAP according to this checklist, and consecutive revision of the checklist with feedback from the QAP trial for DP needs to follow.

Abstract

Background: Digital pathology (DP) using whole slide imaging is a recently emerging game changer technology that can fundamentally change the way of working in pathology. The Digital Pathology Study Group (DPSG) of the Korean Society of Pathologists (KSP) published a consensus report on the recommendations for pathologic practice using DP. Accordingly, the need for the development and implementation of a quality assurance program (QAP) for DP has been raised. Methods: To provide a standard baseline reference for internal and external QAP for DP, the members of the Committee of Quality Assurance of the KSP developed a checklist for the Redbook and a QAP trial for DP based on the prior DPSG consensus report. Four leading institutes participated in the QAP trial in the first year, and we gathered feedback from these institutes afterwards. Results: The newly developed checklists of QAP for DP contain 39 items (216 score): eight items for quality control of DP systems; three for DP personnel; nine for hardware and software requirements for DP systems; 15 for validation, operation, and management of DP systems; and four for data security and personal information protection. Most participants in the QAP trial replied that continuous education on unfamiliar terminology and more practical experience is demanding. Conclusions: The QAP for DP is essential for the safe implementation of DP in pathologic practice. Each laboratory should prepare an institutional QAP according to this checklist, and consecutive revision of the checklist with feedback from the QAP trial for DP needs to follow.

참고문헌 (31)

  1. 남수정, "Introduction to digital pathology and computer-aided pathology", Journal of Pathology and Translational Medicine, 54(2), pp.125~134 (2020), 대한병리학회[DOI]
  2. 정요셉, "Recommendations for pathologic practice using digital pathology: consensus report of the Korean Society of Pathologists", Journal of Pathology and Translational Medicine, 54(6), pp.437~452 (2020), 대한병리학회[DOI]
  3. Canadian Association of Pathologists Telepathology Guidelines Committee, "Guidelines from the Canadian Association of Pathologists for establishing a telepathology service for anatomic pathology using whole-slide imaging", J Pathol Inform, 5, pp.15~ (2014)
  4. College of American Pathologists, "Validating whole slide imaging for diagnostic purposes in pathology" (2013), College of American Pathologists
  5. College of American Pathologists, "Anatomic pathology checklist : CAP accreditation program" (2011), College of American Pathologists
  6. Cross S, "Best practice recommendations for implementing digital pathology", pp.1~43 (2018), The Royal College of Pathologists
  7. Federal Association of German Pathologists Bundesverband deutscher Pathologen (FAGP-BDP), "Guidelines digital pathology for diagnosis on (and reports of) digital images, 2018", Federal Association of German Pathologists Bundesverband deutscher Pathologen (FAGP-BDP), ~ (2018)
  8. Japanese Society of Pathology, "Digital Pathology Assessment Committee : technical standards for digital pathology system for pathologic diagnosis", Japanese Society of Pathology, ~ (2018)
  9. Japanese Society of Pathology, "Digital Pathology Assessment Committee : guidelines for pathologic diagnosis using digital pathology images(clinical questions and answers)", Japanese Society of Pathology, ~ (2019)
  10. Department of In-Vitro Diagnostic Device, Ministry of Food and Drug Safety, "Assessment and approval guideline on the artificial intelligence (AI)-based histopathologic in-vitro diagnostic devices (software)" (2021), Ministry of Food and Drug Safety
  11. Health Insurance Review and Assessment Service, "Reimbursement assessment guideline of innovative medical technology (pathology AI-based technology)" (2021), Health Insurance Review and Assessment Service
  12. Mukhopadhyay S, "Whole slide imaging versus microscopy for primary diagnosis in surgical pathology : a multicenter blinded randomized noninferiority study of 1992 cases(pivotal study)", Am J Surg Pathol, 42, pp.39~52 (2018)
  13. Pantanowitz L, "Validating whole slide imaging for diagnostic purposes in pathology : guideline from the College of American Pathologists Pathology and Laboratory Quality Center", Arch Pathol Lab Med, 137, pp.1710~1722 (2013)
  14. Snead DR, "Validation of digital pathology imaging for primary histopathological diagnosis", Histopathology, 68, pp.1063~1072 (2016)
  15. Fraggetta F, "The importance of eSlide macro images for primary diagnosis with whole slide imaging", J Pathol Inform, 9, pp.46~ (2018)
  16. Chae SW, "Present and future of digital pathology: experience of Kangbuk Samsung Hospital", Proceedings of the 73rd Annual Fall Meeting of The Korean Society of Pathologists (2021), The Korean Society of Pathologists
  17. Han N, "Present and future of digital pathology : experience of National Cancer Center", Proceedings of the 73rd Annual Fall Meeting of The Korean Society of Pathologists, pp.21~ (2021), The Korean Society of Pathologists
  18. Hong SW, "Present and future of digital pathology : experience of Yongin Severance Hospital", Proceedings of the 73rd Annual Fall Meeting of The Korean Society of Pathologists, pp.21~ (2021), The Korean Society of Pathologists
  19. Jang KT, "Present and future of digital pathology : experience of Samsung Medical Center", Proceedings of the 46th Annual Spring Meeting of The Korean Society of Pathologists, pp.17~ (2021), The Korean Society of Pathologists
  20. Jang S, "Present and future of digital pathology: experience of Seoul Asan Medical Center", Proceedings of The 46th Annual Spring Meeting of The Korean Society of Pathologists, pp.21~ (2021)
  21. Jung CK, "Present and future of digital pathology: experience of the Catholic University of Korea St. Mary’s Hospital", Proceedings of The 46th Annual Spring Meeting of The Korean Society of Pathologists, pp.19~ (2021), The Korean Society of Pathologists
  22. Kim S, "Present and future of digital pathology : experience of Yonsei University Severance Hospital", Proceedings of The 46th Annual Spring Meeting of The Korean Society of Pathologists, pp.20~ (2021), The Korean Society of Pathologists
  23. Lee KB, "Present and future of digital pathology: laboratory information system leads whole slide image diagnosis: integration digital pathology with paperless pathology workflow in SNUH", Proceedings of The 46th Annual Spring Meeting of The Korean Society of Pathologists, pp.18~ (2021), The Korean Society of Pathologists
  24. Lee KB, "Preparation of Reimbursement Assessment Guideline of Innovative Medical Technology (pathology AI-based technology)" (2019), Health Insurance Review and Assessment Service
  25. DICOM Standards Committee Working Groups 26, Pathology, "Supplement 145: Whole slide microscopic image IOD and SOP classes" (2010), DICOM
  26. Singh R, "Standardization in digital pathology : Supplement 145 of the DICOM standards", J Pathol Inform, 2, pp.23~ (2011)
  27. Zwonitzer R, "Digital pathology : DICOM-conform draft, testbed, and first results", Comput Methods Programs Biomed, 87, pp.181~188 (2007)
  28. Ailia MJ, "Current trend of artificial intelligence patents in digital pathology: a systematic evaluation of the patent landscape", Cancers(Basel), 14, pp.2400~ (2022)
  29. Alam MR, "Recent applications of artificial intelligence from histopathologic image-based prediction of microsatellite instability in solid cancers : a systematic review", Cancers(Basel), 14, pp.2590~ (2022)
  30. Kim H, "Deep learning-based histopathological segmentation for whole slide images of colorectal cancer in a compressed domain", Sci Rep, 11, pp.22520~ (2021)

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