Minnesota 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)
- Pay your CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Minnesota Department of Health, Public Health Division. Clinical Laboratories.
https://www.revisor.mn.gov/statutes/2024
The facility must be certified under the Clinical Laboratory Improvement Amendments (CLIA) to enroll as an independent laboratory with Minnesota Health Care Programs (MHCP) and pay a screening fee to MHCP, Medicare, or send proof that the fee was paid to another State Medicaid Authority.
(1) State Agency & Regional Office CLIA Contacts
This page lists CLIA contacts for each state agency. If you have any questions regarding CLIA, contact the appropriate state agency.
Minnesota Department of Health
Health Regulation Division
CLIA Program
PO Box 64900
St Paul, MN 55164-0900
health.clia@state.mn.us
Phone: 651-201-4200
(2) The Quick Start Guide directs laboratories in the processes for:
- Completing the CLIA application form, CMS-116
- Finding the appropriate State Agency to submit the form.
- Receiving the fee coupon
- Paying applicable fees
- Receiving laboratory certificate and beginning testing
- Maintaining the certificate
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.