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.
CLIA
Statute United States
Referenced in API Evangelist papers
This regulation shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this regulation in the context of a real sector.
The State of Biotechnology APIs
Named by 19 of 999 biotechnology companies — the certification that separates a research result from a clinical one, and a distinction almost none of them expose in the API response.
