REVISED: Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F)

July 10, 2024
Revisions to QSO-22-21-CLIA originally released on July 11, 2022.

The Centers for Medicare and Medicaid Services (CMS) posted memo QSO-24-15-CLIA on July 8, 2024.

The memo was addressed to State Survey Agency Directors from Director, Quality, Safety & Oversight Group (QSOG).

Memorandum Summary:

·       Publication of Final Rule: CMS-3355-F was published on July 11, 2022. This final rule implements revised regulations to update those that the Centers for Medicare & Medicaid Services (CMS) has identified as unnecessary, obsolete, or excessively burdensome on laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

·       Effective Date: The regulations §§ 493.2 and 493.801 through 493.959 are effective two years after publication in the Federal Register [July 11, 2024]; amendments to 42 CFR
§§ 493.20 and 493.25 related to laboratories performing tests of moderate complexity and high complexity testing that also perform waived testing and proficiency testing enrollment will be effective 30 days after the publication date of this final rule, and are effective August 10, 2022.

·       This revision updates the table found on page 4 of this memo to correctly list two analytes, Cancer antigen (CA) 125 and Carcinoembryonic antigen (CEA), under Endocrinology (§§ 493.933).

·       This revision also corrects the reported units for CEA from “ng/dL” to “ng/mL”. The units were previously revised in the Federal Register, and this memo reflects the revision on page 9.

CMS memo

Read the full memo PDF