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  4. CAP Opposes Expansion of CLIA Oversight of Personnel, Supports AI Regulation at CLIAC Meeting

At an April 10 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), managed by the Centers for Disease Control and Prevention (CDC), Diana Cardona, MD, MBA, FCAP governor of the board of the CAP, delivered the CAP’s positions on the three topics up for consideration by the committee: Opposition to expansion of CLIA oversight to include preanalytic testing personnel qualification as the CAP has not identified quality or other issues that could be resolved through expansion of regulatory oversight. Support of slowing down or pausing a regulatory framework for Artificial Intelligence (AI) and Machine Learning (ML) that requires verification and validation of AI/ML-based tools and centers the role of the pathologist in clinical decision-making How clinical guidelines and standards such as the CAP Checklist can best be used to improve quality and not be referenced in regulations. The advice and guidance CLIAC provides to the Department of Health and Human Services (HHS) pertains to general issues related to improvement in clinical laboratory quality and laboratory medicine practice. In addition, the committee provides advice and guidance on specific questions related to possible revision of the CLIA standards. Please see the CLIAC Recommendations Table for a full listing of all CLIAC Recommendations and their status.

At an April 10 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), managed by the Centers for Disease Control and Prevention (CDC), Diana Cardona, MD, MBA, FCAP governor of the board of the CAP, delivered the CAP’s positions on the three topics up for consideration by the committee:

The advice and guidance CLIAC provides to the Department of Health and Human Services (HHS) pertains to general issues related to improvement in clinical laboratory quality and laboratory medicine practice. In addition, the committee provides advice and guidance on specific questions related to possible revision of the CLIA standards. Please see the CLIAC Recommendations Table for a full listing of all CLIAC Recommendations and their status.

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