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Validating Whole Slide Imaging for Diagnostic Purposes in Pathology

We are committed to keeping this guideline up to date. The guideline is currently being updated with expected completion by the end of 2019.

Background

Our 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 WSI system for diagnostic purposes before it is placed in clinical service?" and developed 12 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.
  • A validation study should include at least 60 routine cases per application, comparing intraobserver diagnosis concordance between digitized and glass slides viewed at least two weeks apart.
  • The validation process should confirm that all material present on a glass slide to be scanned is included in the digital image.

WSI technology has several advantages for pathologists. Our guideline helps facilitate the safe use of WSI systems in laboratories employing the technology.

Guideline Information

  • Guideline status: In Review
  • Published online ahead of print: May 1, 2013
  • Originally published: December 2013

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