Attn: Clinical Laboratory Improvement Amendments (CLIA) Providers

Updated Proficiency Testing (PT) and PT Referral brochure

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

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT) Regulations Related to Analytes and Acceptable Performance Final Rule (CMS-3355-F) became effective on July 11, 2024; however, it will not be implemented until January 1, 2025. The Centers for Medicare & Medicaid Services (CMS) issued QSO-22-21-CLIA on July 11, 2022, related to the final PT rule.

CMS updated the PT and PT Referral brochure on their CLIA 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.

Questions

• For questions or concerns relating to QSO-22-21-CLIA, please contact LabExcellence@cms.hhs.gov.
• Read the PT Final Rule in the Federal Registrar: Federal Register :: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.
• Download the CMS Fact Sheet CMS Fact Sheet - CLIA PT Changes about the Final Rule.

For more information, visit the CMS CLIA Program website.

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