Maine 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 CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Maine Department of Health and Human Services, Public Health Division. Clinical Laboratories.
https://legislature.maine.gov/statutes/22/title22ch411.pdf
(1) Medical Laboratories
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. There are four CLIA certificate types:
- Certificate of Waiver – Performs simple tests, i.e., covid-19, blood glucose, urine dipstick, urine drug screen, etc.
- Certificate of Provider Performed Microscopy – Medical providers perform exams under the microscope, i.e., urine microscopic, KOH Prep, etc. They can perform waived testing with the PPM certificate
- Certificate of Compliance – Moderate to High complexity laboratory testing. These laboratories are surveyed by individual State surveyors
- Certificate of Accreditation – Moderate to High complexity testing. These laboratories are surveyed by CLIA- approved accrediting agencies (College of American Pathologists, Joint Commission, etc.)
Maine’s State Laboratory Rules and Regulations (PDF)
Applications and Resources:
- Medical Laboratory License Application (PDF)
- Health Screening Laboratory Application (PDF)
- CMS116 new 2022 (PDF)
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.