2024 CAP Checklists to Publish in Fall Due to CLIA Regulatory Changes

Communication Date: March 13, 2024

NOTE: The information below was current at the time of communication. Subsequent CAP changes, if applicable, are not reflected in this eAlert.

On December 28, 2023, the CMS released the Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F). This ruling includes changes to the CLIA regulations addressing personnel qualifications and histocompatibility testing, which will take effect on December 28, 2024.

The CAP is in the process of evaluating the recently announced changes to the CLIA regulations on personnel qualifications and histocompatibility testing to determine if checklist revisions are needed. As a condition of the CAP’s deeming authority under CLIA, the CAP is required to be at least as stringent as the CLIA regulations; however, the CAP may choose to be more stringent in some cases. Until a new Checklist Edition is published, CAP-accredited laboratories must continue to follow the CAP’s published checklist requirements.

2024 Checklist Edition: Fall Publication

To ensure the necessary revisions to the CAP personnel and histocompatibility requirements are incorporated, the CAP expects the 2024 Checklist Edition to publish in the fall.

Learn about the Checklist changes at the November 20 Focus on Compliance webinar, “Staying in Sync: CAP Accreditation Checklist Changes for 2024”. Presenters Stephen Sarewitz, MD, FCAP, and Gregory A. Gagnon, MD, FCAP, will review the rationale for the 2024 requirement changes, identify laboratory/practice improvement opportunities to align with 2024 requirements, and explain how laboratories can use CAP resources to identify changes and compliance solutions.

If you have questions or concerns, please contact the CAP at 800-323-4040 or accred@cap.org.