Attn: Clinical Laboratory Improvement Amendments (CLIA) Providers
Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing-Analytes and Acceptable Performance Final Rule (CMS-3355-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-22-21-CLIA on July 11, 2022. The following summary was provided by CMS.
Memorandum Summary
- Publication of Final Rule: CMS-3355-F was published on July 11, 2022. This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT)-Analytes and Acceptable Performance for laboratories performing moderate or high complexity testing. Specifically, the final rule will: 1) Add or delete regulated analytes under Subpart I of the CLIA regulations; 2) revise PT criteria for acceptable performance; 3) labs performing moderate or high complexity testing along with waived testing, are subject to improper PT referral for the waived testing.
- Effective Dates: These regulations at §§493. 2 and 493.801 through 493.959 were delayed for two years after the memo was published and are effective July 11, 2024, with an implementation date of January 1, 2025. The delayed effective date reflects the timeframe that the Center for Medicare and Medicaid Services (CMS) and the Center for Disease Control (CDC) believe PT programs will need to produce the PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements. The delayed effective date also gives laboratories time to subscribe to PT for the new analytes or microbiology tests.
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