Attn: Clinical Laboratory Improvement Amendments (CLIA) Providers

Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F)

The Division of Quality Assurance is sending this message as part of our commitment to Collaboration, Innovations and Quality.

The Centers for Medicare & Medicaid Services (CMS) issued QSO-24-03-CLIA on December 28, 2023. The following summary was provided by CMS.

Memorandum Summary

• Publication of Final Rule: CMS-3326-F was published on December 28, 2023. This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. Specifically, the final rule will: 1) implement a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees; 2) amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes; and 3) amend the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate.
• Effective Dates: These regulations are effective January 27, 2024, except for instruction 3, amending § 493.2; instructions 14 through 19, amending §§ 493.945, 493.1273, 493.1274, 493.1278, 493.1359, and 493.1405; instruction 20 removing § 493.1406; instructions 21 through 30, amending §§ 493.1407, 493.1411, 493.1417, 493.1423, 493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461; instruction 31 removing § 493.1462; and instructions 32 through 36, amending §§ 493.1463, 493.1469, 493.1483, 493.1483, 493.1489, and 493.1491, which are effective December 28, 2024.

Questions

• For questions or concerns relating to QSO-24-03-CLIA, please contact LabExcellence@cms.hhs.gov.
• For more information, visit the CMS CLIA Program website.
• QSO Memos are posted on the S&C website: https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states-and-cms-locations
• Admin Info memos are posted on the S&C website: https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/administrative-information-memos-states-and-regions

Resources to Improve Quality of Care

Check out CMS’s new Quality in Focus interactive video series. The series of 10–15 minute videos are tailored to provider types and aim to reduce the deficiencies most commonly cited during the CMS survey process, like infection control and accident prevention. Reducing these common deficiencies increases the quality of care for people with Medicare and Medicaid.

Learn to:

• Understand surveyor evaluation criteria
• Recognize deficiencies
• Incorporate solutions into your facility’s standards of care

See the Quality, Safety, & Education Portal Training Catalog and select Quality in Focus.

Please do not reply directly to this email message. If you have a question about this information, email the Division of Quality Assurance.