New and revised laboratory requirements align with updated CMS histocompatibility and personnel regulations

Effective Jan. 1, 2025, The Joint Commission has new and revised requirements for laboratories that align with revisions to Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations:

• Updated histocompatibility requirements in the “Quality System Assessment for Nonwaived Testing” (QSA) chapter of the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB). There are six new and revised standards and 11 new and revised elements of performance (EPs) for Standards QSA.12.01.01 through QSA.12.06.01; Standard QSA.12.07.01 has been deleted.
• Developed three new EPs to address the updated personnel requirements. A complete list of all personnel qualifications is included at 42 CFR 493 Subpart M: Personnel for Nonwaived Testing.

The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final rule on Dec. 28, 2023, updating its regulations related to histocompatibility and personnel requirements, making them effective Dec. 28, 2024.

The Joint Commission’s new and revised requirements will be posted on the Prepublication Standards page, will publish online in the fall 2024 E-dition^® update to the CAM-LAB, and will be included in the hard-copy and PDF versions of the 2025 CAMLAB.

For more information, please contact The Joint Commission’s Standards and Survey Methods.