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Validating Whole Slide Imaging for Diagnostic Purposes in Pathology

Background

The US Food and Drug Administration has approved select digital whole slide imaging (WSI) systems for primary diagnoses in surgical pathology, ushering in new applications for digital pathology. The "Validating Whole Slide Imaging for Diagnostic Purposes in Pathology: Guideline Update” helps pathologists and laboratories confirm diagnostic accuracy and equivalence with light microscopy of whole slide imaging (WSI) systems before they are actually used for diagnostic purposes.

We convened an expert panel of pathologists, histotechnologists, and a methodologist to develop the 2021 guideline update. Adhering to the National Academy of Medicine guideline standards and now using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the update offers three strong recommendations and nine good practice statements, which largely reaffirm the original guideline recommendations.

Validation of WSI is crucial to ensure the quality and consistency of diagnostic performance based on digitized slides. For patients, this could mean receiving their pathologic diagnosis more quickly with the same quality test results and thereby possibly receiving treatment sooner. The guideline update is available as an early online release in Archives of Pathology & Laboratory Medicine.

Scope

Assess evidence published since the release of the original guideline to provide recommendations for validating WSI systems used for diagnostic purposes.

Key Questions

What should be done to validate a whole slide digital imaging system for diagnostic purposes before it is placed in clinical service?

Guideline Information

  • Guideline Status: Complete Recommendations
  • Originally published: December 2013
  • Update published online ahead of print: May 18, 2021

Guideline Tools & Resources

Collaborators

  • American Society for Clinical Pathology
  • Association for Pathology Informatics

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