North Dakota 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
North Dakota Health and Human Services, Public Health Division. Clinical Laboratories.
N.D ClinLab
Under CLIA, a 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 examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. This program certifies, inspects and monitors clinical laboratories for compliance of state and federal CLIA regulations, and investigates complaints received to ensure clinical laboratory testing is accurate, effective and reliable. Feel free to contact the program for answers to technical and regulatory questions.
Health Response and Licensure
Health Facilities Unit
1720 Burlington Drive, Suite A
Bismarck ND 58504-7736
Phone: (701) 328-2352
Fax: (701) 328-1890
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.