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:
- The Food and Drug Administration (FDA)
- Center for Medicaid Services (CMS)
- The Centers for Disease Control and Prevention (CDC)
Each agency has a unique role in assuring quality laboratory testing.
Waived tests must:
- be simple
- have a low risk for erroneous results
There are around 120 CLIA-waived analytes. Unfortunately, even with the requirements, this does not mean that waived tests are completely safe. There are potential negative impacts on health that may occur if waived tests are performed inaccurately.
POCT: Point-of-Care Testing
Pharmacies/pharmacists can perform tests if the tests are CLIA-waived and the pharmacy has obtained a Certificate of Waiver (COW). A COW is usually obtained from the State Board of Health.
Bula’s CLIA Frequently Asked Questions with Answers
The CLIA FAQs mostly relate to how to get a Certificate of Waiver (COW) and what is required. While Federal law doesn’t have requirements for the education and training that pharmacists must have to perform tests, a state may. Learn more.