Indiana 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 Certification QCOR (See below)
- Pay your CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Indiana Health Authority, Public Health Division. Clinical Laboratories.
https://www.in.gov/health/cshcr/acute-and-continuing-care/clinical-laboratory-clia-licensing-and-certification-program/clia-frequently-asked-questions/
(1) Application: http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf
Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate.
(a) The Indiana Department of Health (IDOH) does not license laboratories or laboratory personnel.
(b) IDOH does have Communicable Disease and Universal Precautions rules that must be followed. These rules can be found under Indiana Administrative Code 410 Article 1.
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.