New Hampshire 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 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
New Hampshire Department of Health and Human Services, Public Health Division. Clinical Laboratories.
https://oregon.public.law/rules/oar_333-024-0012#d-for-any-person-other-than-a-physician-or-clinician-to-direct
(1) 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 the health of human beings.” This program certifies, inspects and monitors clinical labs for compliance of federal CLIA regulations, and investigates complaints received to ensure clinical laboratory testing is accurate, effective and reliable.
(2) 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). 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.)
(3) 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.