Ohio 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 CLIA fees at Pay.gov
- Forms CMS115 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Ohio Department of Health, Public Health Division. Clinical Laboratories.
(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.
Generally, each separate location or address is required to have a separate CLIA number. There are exceptions for not-for-profit/government-owned laboratories or hospitals. Call us if you think your organization qualifies for one of these exceptions. You must complete and submit CMS Form 116 to apply for certification as an approved CLIA laboratory.
Ohio Department of Health
Bureau of Survey and Certification
CLIA Program
246 North High Street, 2nd Floor
Columbus, OH 43215
Telephone: (614) 644-1845
Fax: (614) 564-2478
E-mail: CLIA@odh.ohio.gov
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.