Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology
Publication Date: May 27, 2021
Last Updated: March 14, 2022
Recommendations
The validation process should include a sample set of at least 60 cases for one application, or use case (eg, hematoxylin-eosin–stained sections of fixed tissue, frozen sections, hematology), that reflect the spectrum and complexity of specimen types and diagnoses likely to be encountered during routine practice. The validation should include another 20 cases to cover additional applications such as immunohistochemistry or other special stains if these applications are relevant to an intended use and were not included in the 60 cases mentioned above. (Strong)
610
The validation study should establish diagnostic concordance between digital and glass slides for the same observer (ie, intraobserver variability). If concordance is less than 95%, laboratories should investigate and attempt to remedy the cause. (Strong)
610
A washout period of at least 2 weeks should occur between viewing digital and glass slides. (Strong)
610
Recommendation Grading
Overview
Title
Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology
Authoring Organizations
American Society for Clinical Pathology
College of American Pathologists
Publication Month/Year
May 27, 2021
Last Updated Month/Year
August 29, 2024
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Health Care Settings
Ambulatory, Hospital
Intended Users
Physician, epidemiology infection prevention, nurse, nurse practitioner, physician assistant
Scope
Assessment and screening, Diagnosis
Diseases/Conditions (MeSH)
D010336 - Pathology
Keywords
guideline, Imaging Systems, Validating Whole Slide
Supplemental Methodology Resources
Methodology
Number of Source Documents
55
Literature Search Start Date
December 31, 2011
Literature Search End Date
June 25, 2018