Wisconsin State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certificates (See instructions below)
- Pay CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Wisconsin Department of Health Services, Public Health Division. Clinical Laboratories.
https://docs.legis.wisconsin.gov/code/admin_code/dhs/101/105/42/1
(1) 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.
(2) Online Access to CLIA Certificates
CONTACT INFORMATION
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 dhsdqaclia@
dhs.wisconsin.gov. - Call 608-261-0654.
Mailing address:
DHS Division of Quality AssuranceClinical Laboratory SectionPO Box 2969Madison, WI 53701-2969
- Email dhsdqaclia@
Online Access to CLIA Certificates
CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.