CAP releases a new evidence-based guideline

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Twelve practical recommendations are outlined in the guideline, including the following key items:

• 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, assessing intraobserver diagnostic 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.

Currently, the US Food and Drug Administration does not approve WSI systems for primary diagnosis. In that context, this CAP guideline gives current recommendations while preparing its members for wider adoption of digital imaging technology in the future. Pathologists practicing abroad can begin to implement the guideline immediately in concordance with their country’s regulatory guidelines for using WSI in making primary diagnoses.