THE PROGRESS OF DIGITAL PATHOLOGY DURING THE COVID-19 PANDEMIC IN JAPAN
Junya Fukuoka, Andrey Bychkov · Journal of Pathology Informatics · 2022
Background: In 2013, the College of American Pathologists (CAP) published a guideline on validating whole slide imaging (WSI) systems for diagnostic purposes.The CAP, in collaboration with the Association for Pathology Informatics (API) and American Society for Clinical Pathology (ASCP), assembled an expert panel (EP) to update the guideline.Methods: The objective of the EP was to assess evidence published following release of the 2013 guideline and provide updated recommendations for validating WSI systems used for diagnostic purposes.A systematic review of literature published between 2012 and 2019 providing information on what needs to be done to validate WSI systems was conducted.Using the Grading of Recommendations Assessment Development and Evaluation (GRADE) approach, the EP reassessed and updated the original guideline recommendations based on information generated during the data extraction phase.Results: The above process generated 3 strong recommendations and 9 good practice statements which were subjected to a 3-week open comment period, review by an internal advisory panel, an external expert review panel and review by CAP legal representation.The final guideline was released online in Archives of Pathology and Laboratory Medicine on May 11, 2021.Conclusion: Literature released following publication of the 2013 guideline re-affirms the use of a validation set of at least 60 cases, establishing intraobserver concordance between WSI and glass slide diagnoses and a 2-week washout period between WSI and glass slide review.If concordance is b 95%, a detailed review should be undertaken to identify and correct systematic problems before WSI is used for patient care.