The CAP’s evidence-based guideline, “VALIDATING WHOLE SLIDE IMAGING FOR DIAGNOSTIC PURPOSES IN PATHOLOGY,” serves as a practical guide for pathologists and laboratories to confirm the accuracy and concordance of their own whole slide imaging (WSI) systems for diagnostic work while ensuring the digital tool is being used properly for its intended clinical use.
The panel addressed the key question of “What should be done to validate a whole slide digital imaging system for diagnostic purposes before it is placed in clinical service?” and developed twelve practical recommendations, including these key points:
- Validation of the entire WSI system, involving pathologists trained to use the system, should be performed in a manner which emulates the laboratory’s actual clinical environment.
- It is recommended that such a validation study include at least 60 routine cases per application, comparing intraobserver diagnosis concordance between digitized and glass slides viewed at least two weeks apart.
- It is important that the validation process confirms that all material present on a glass slide to be scanned is included in the digital image.
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