Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, setting quality standards for all lab testing. CLIA ensures the accuracy, reliability, and timeliness of patient test results, regardless of where the test is performed. The CLIA regulations are based on the complexity of the test method. That means the more complicated the test, the more stringent the requirements. The type of CLIA certificate a lab must have depends on the type of testing the lab performs.
Under CLIA, a clinical laboratory is defined as a facility that performs 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 the assessment of health of human beings. These exams also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. If a facility performs tests for these purposes, regardless of whether there is reimbursement for such tests, it is considered a laboratory according to the definition by CLIA. Therefore, it must obtain and maintain CLIA certification. Facilities only collecting or preparing specimens (or both) - or only serving as a mailing service and not performing testing on patient specimens - are not considered clinical laboratories.
Although CLIA is a federal program administered by CMS (Centers for Medicare & Medicaid Services), state agencies are responsible for overseeing labs and maintaining CLIA labs’ certification records. State agencies process CLIA applications, renewals, updates, and requests for certificate copies. In addition, state agencies inspect and monitor clinical labs for compliance of federal CLIA regulations. They also investigate complaints to ensure testing is accurate, effective, and reliable.
At the Wisconsin Department of Health Services (DHS), we can answer questions about clinical laboratories, including CLIA applications and technical questions.
Contact the Division of Quality Assurance (DQA):
- Email firstname.lastname@example.org.
- Call 608-261-0654.
- Mailing address:
DHS Division of Quality AssuranceClinical Laboratory SectionPO Box 2969Madison, WI 53701-2969