Montana 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 QCOR (See below)
- CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
MontanaDepartment of Health and Human Services, Public Health Division. Clinical Laboratories.
(1) Under CLIA, a facility is a laboratory if it performs even one test 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 the health of, human beings.” This includes tests categorized as waived complexity tests. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service aren’t considered laboratories.
A CLIA certificate is not required for:
- Forensic testing
- Blood draws
- Specimen collections
- Drug testing for purposes of employment; unless employment drug testing is done and individual treatment is offered or made available, then a CLIA certificate is required.
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.