What is “CLIA” and why is it important?Updated 4 months ago

“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services. For many Americans, the accuracy of clinical laboratory test results can be a life or death matter. If glucose tests are not performed correctly, a patient could receive an incorrect insulin dose and sustain potentially dangerous consequences. If your cholesterol is high and the laboratory results are reported as normal, you may not receive the care necessary to prevent a heart attack. Having confidence in lab test standards and accuracy can make a big impact on your choice in getting genetic testing.

The CLIA program grants five types of laboratory certificates:

1.    Certificate of Waiver (CoW)

2.    Certificate for Provider-Performed Microscopy Procedures (PPMP)

3.    Certificate of Registration (COR)

4.    Certificate of Compliance (COC)

5.    Certificate of Accreditation (COA)