Interpretive Diagnostic Error Reduction

All clinical practice guidelines issued by the College of American Pathologists (CAP) Pathology and Laboratory Quality Center for Evidence-Based Guidelines (Center) are reviewed every five years to determine if the original guideline remains current. New evidence—along with the evolving practice environments and digital technologies, including artificial intelligence—has prompted a review of this guideline.

“Timely” review of cases may be prospective or retrospective, but must occur before management is initiated. A review is considered timely if it has been completed (and the diagnosis modified, if necessary) before management has been initiated. A substantially delayed diagnosis would still be considered timely if the treating physician is informed of the anticipated delay due to the need for an external consultant.

As with any clinical evidence-based guideline, laboratories are not required to follow the recommendations. These recommendations may be added to future versions of the CAP Laboratory Accreditation Program (LAP) Checklist; however, they are not currently required by LAP or any regulatory accrediting agency unless as previously defined in CLIA. Nevertheless, laboratories are encouraged to adopt these evidence-based recommendations.

The field of AI is evolving rapidly, and no fixed standards have been established for AI tools—for medicine in general, and anatomic pathology in particular. As regulatory frameworks and clinical evidence mature, baseline standards need to be developed by bodies such as the FDA, CMS, and AMA. These baseline standards may then be translated into day-to-day pathology practice by the CAP.