Lexology January 3, 2025
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024, the final rule on PT Regulations Related to Analytes and Acceptable Performance (CMS-3355-F), issued by the Centers for Medicare & Medicaid Services (CMS), was not implemented until January 1, 2025.
PT and the rules around PT referral form a critical safety net for ensuring trust and accuracy in patient diagnostics. This is true not just for traditional labs, but also for a broad spectrum of healthcare providers, including hospitals, digital health companies, and telehealth providers offering at-home testing solutions. Behind the convenience and accessibility of modern clinical laboratory...
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