CLIA
Statute
United States
· 1988
CLIA establishes federal quality standards for all laboratory testing performed on human specimens for diagnosis, prevention or treatment. Administered by CMS, it certifies laboratories by test complexity and governs personnel qualifications, proficiency testing, quality control and result reporting. A genomics or diagnostics API returning a clinical result is returning the output of a CLIA-certified process, and the certification travels with the result.
Sectoral regime. It binds the industries below; companies outside them
generally fall outside it.
Regions
Industries
Each links to that industry as a scored cohort — so the question "how ready is this sector for the regime that governs it?" becomes one you can actually look at.