Obtaining a CLIA Certificate of Waiver
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, establishing authority to promote standards for certain laboratory testing to ensure the accuracy, reliability, and timeliness of test results regardless of where or by whom the test was performed.
The CLIA requirements are based on the complexity of the test and the type of laboratory where the testing is performed. While every effort has been made to ensure the accuracy of this restatement, this brochure is not a legal document. The official CLIA program requirements are contained in the relevant law, regulations and rulings. Please note that state, local, and accreditation requirements may be more stringent.
What is a laboratory?
Under CLIA, a laboratory is defined as a facility that performs applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.
What is a waived test?
As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews
manufacturer’s applications for test system waiver.
Where can I find a list of waived tests?
For a list of waived tests sorted by analyte name, visit the FDA website at:
CLIA – Currently Waived Analytes
Can I perform tests other than waived tests if I have a Certificate of Waiver?
No, only those tests that are CLIA-waived can be performed by a laboratory with a Certificate of Waiver.
How do I enroll in or apply to the CLIA program?
You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local state agency. Send your completed application to state agency for the state in which your laboratory is located. In Georgia, you can submit the application via email to hfrd.diagnostic@dch.ga.gov.
Georgia contact:
GEORGIA DEPARTMENT PUBLIC HEALTH
Healthcare Facility Regulation Division
Diagnostic Services Unit
2 Peachtree Street, N.W.
Suite 31-447
Atlanta, GA 30303-3142
(404) 657-5700
FAX: (404) 463-4398
Email: hfrd.diagnostic@dch.ga.gov
