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Important Information about the CLIA Proficiency Testing Final Rule

Million Hearts Model (Innovative health care for every heart)Clinical Laboratory Improvement Amendments (CLIA)
Welcome to the CMS CLIA Communications Update!

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-F [ https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to ]) final rule became effective on July 11, 2024; however, it will not be implemented until January 1, 2025.

Today, we updated our Proficiency Testing (PT) and PT Referral brochure on our CLIA Brochures [ https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/brochures ] website to assist laboratories in preparing for the new regulations. The brochure will help laboratories complete PT enrollment and place orders with their PT providers for 2025. This guidance will inform laboratories of the upcoming changes necessary for compliance prior to the January 1, 2025 implementation date.

For more information, visit the CMS CLIA Program website [ https://links-2.govdelivery.com/CL0/https:%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FLegislation%2FCLIA%2Findex%3Fredirect=%2Fclia/1/010101930d1471f4-eb13a694-0c89-4470-9914-d9b917900819-000000/n3srrj3BBIMw_HxtB5YSNo9VqK1oDYtpmshxfIoL1lY=378 ]

Centers for Medicare & Medicaid Services


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