For this post, I invited the folks from Bula Intelligence back on to give us some legal background on CLIA waivers; after, we'll look at the business side of it and how to make POC testing a reality in your pharmacy.
Clinical Laboratory Improvement Amendments (CLIA) was passed by Congress for non-research laboratory testing in 1988.
It establishes quality standards for laboratories to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test is performed.
CLIA regulations apply to laboratory testing in all settings. If a facility in the United States is performing laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease, they are regulated by CLIA.
The three federal agencies responsible for CLIA:
Each agency has a unique role in assuring quality laboratory testing.