Clinical laboratories produce test results that are crucial to providers’ decision-making in ensuring patients receive consistently high-quality care. How do laboratories ensure providers receive consistently accurate test results? Laboratories conduct proficiency testing to meet CMS quality assurance rules, including rules now being updated.

The Proficiency Testing Final Rule, published on July 11, 2022, has an implementation deadline of January 1, 2025, for both proficiency testing (PT) vendors and laboratories.

The final rule was issued for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT) regulations related to analytes and acceptable performance. This final rule implements revised regulations that the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) proposed in 2019 to update CLIA PT regulations.

Laboratories performing microbiology tests that are regulated for proficiency testing are required to test five regulated challenges per test event in each subspecialty. The five subspecialties are Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology. Detection (presence or absence) without identification will require PT for Bacteria, Mycobacteria, Fungi (including dermatophytes), Aerobic Actinomycetes, and Parasites.

To assist laboratories in adapting to the rules changes, Accreditation Commission for Health Care (ACHC) has developed proficiency testing tables that list the new and current CMS-regulated analytes and updated criteria for acceptability.