Overview

The Laboratory Certification Program works to ensure Ohioans receive accurate, cost-effective clinical laboratory testing as a part of their health care. Clinical laboratory testing directly or indirectly affects every Ohio resident from pre-cradle to grave.

Each year, the program inspects and monitors more than 13,400 clinical laboratories located in ambulances, ambulatory surgical centers, ancillary test sites, assisted living facilities, blood banks, community clinics, comprehensive outpatient rehab facilities, end stage renal disease dialysis facilities, federally qualified health centers, health fairs, health maintenance organizations, home health agencies, hospice facilities, hospitals, independent laboratories, industrial facilities, insurance facilities, intermediate care facilities for individuals with developmental disabilities, mobile laboratories, pharmacies, physicians’ offices, plasmapheresis centers, prisons, public health laboratories, rural health clinics, schools/student health services, skilled nursing facilities, tissue banks, and universities.

The program monitors the performance of approximately 13,400 laboratories and investigates clinical laboratory complaints it receives.

Services

The program monitors all clinical laboratories for compliance to federal (42 Code of Federal Regulations Part 493) Clinical Laboratory Improvement Amendments of 1988 (CLIA)) and state requirements (Ohio Revised Code Chapter 3725 Plasmapheresis Centers). The program conducts on-site inspections for compliance, monitors accuracy and reliability of testing via proficiency review of testing scores/reports, investigates complaints and answers both regulatory and technical questions related to clinical laboratories.

New Applications

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.

Mailing Address:

Ohio Department of Health
Bureau of Survey and Certification

CLIA Program
246 North High Street, 2^nd Floor
Columbus, OH 43215

Telephone: (614) 644-1845
Fax: (614) 564-2478

E-mail: CLIA@odh.ohio.gov