What is CLIA certification and what does it mean for your lab?

CLIA stands for Clinical Laboratory Improvement Amendments — the federal law (42 U.S.C. § 263a) that establishes quality standards for all clinical laboratory testing performed on human specimens in the United States. To receive CLIA certification, a laboratory must demonstrate proficiency in personnel qualifications, quality control, proficiency testing, patient test management, and inspections. CLIA-certified laboratories are inspected by the Centers for Medicare & Medicaid Services (CMS) and must meet ongoing proficiency standards. Yenos Analytical LLC in El Dorado Hills, California holds CLIA certification, meaning every OncuraKit sample is analyzed to federal clinical laboratory standards — the same standards applied to hospital laboratories and reference labs.