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- CAP Advocates for Streamlining Regulatory Requirements and Accreditation at CLIAC Meeting
On November 8-9, the Centers for Disease Control and Prevention (CDC) hosted meetings for the Clinical Laboratory Improvement Advisory Committee (CLIAC) and invited the CAP to provide input. CAP members Diana Cardona, MD, MBA, FCAP, and Michael Datto, MD, PhD, FCAP, testified and presented on behalf of the organization. Dr. Cardona testified with the CAP response to the final report from the CLIAC Regulatory Assessment Workgroup[T(1] , highlighting positions on efforts to modernize CLIA oversight of histology, Proficiency Testing (PT) in the total testing process, and regulations to support remote sign out. Dr. Datto’s presentation on the Top 10 Accreditation Deficiencies[T(2] explored the accreditation challenges laboratories face, the root causes for citations, and recommended changes including streamlining regulatory and workforce requirements, as well as encouraging the use of technology to reduce burden on laboratory staff. The committee discussed areas such as electronic testing reporting within CLIA regulations that potentially need to be modified to address recent regulatory changes (eg, compliance with the ONCE Information Blocking Regulations). CLIAC also discussed and passed several recommendations, but the agency has yet to make final determinations on whether it will take action. Link to Accreditation 2022 PPT [T(1] Link to Top 10 Deficiencies PPT [T(2]
On November 8-9, the Centers for Disease Control and Prevention (CDC) hosted meetings for the Clinical Laboratory Improvement Advisory Committee (CLIAC) and invited the CAP to provide input. CAP members Diana Cardona, MD, MBA, FCAP, and Michael Datto, MD, PhD, FCAP, testified and presented on behalf of the organization.
Dr. Cardona testified with the CAP response to the final report from the CLIAC Regulatory Assessment Workgroup, highlighting positions on efforts to modernize CLIA oversight of histology, Proficiency Testing (PT) in the total testing process, and regulations to support remote sign out. Dr. Datto’s presentation on the Top 10 Accreditation Deficiencies explored the accreditation challenges laboratories face, the root causes for citations, and recommended changes including streamlining regulatory and workforce requirements, as well as encouraging the use of technology to reduce burden on laboratory staff.
The committee discussed areas such as electronic testing reporting within CLIA regulations that potentially need to be modified to address recent regulatory changes (eg, compliance with the ONCE Information Blocking Regulations). CLIAC also discussed and passed several recommendations, but the agency has yet to make final determinations on whether it will take action.