Obtain Certification for a Clinical Laboratory (Improvements Amendments of 1988 (CLIA) Laboratory

Purpose: This procedure describes the steps necessary to become certified as a CLIA laboratory. Rules governing the certification of all clinical laboratories are contained in the Code of Federal Regulations (CFR) at 42 CFR Part 493—Laboratory Regulations. The regulations require a CLIA certificate for "...any facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of 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."

The Centers for Medicare and Medicaid Services (CMS) charges fees based on the types of certificates and the annual test volume.

Contacts: For questions regarding any part of this process, please contact the appropriate section of the North Carolina Division of Health Service Regulation:

Clinical Laboratories (CLIA) Branch 919-855-4620

Procedures:

  1. Facilities wishing to be CLIA certified must download an application packet from the CMS website.
    1. The facility completes all required information and returns it to CLIA Certification
    2. CLIA fees are billed and payable to the Centers for Medicare and Medicaid Services (CMS). Do not send any money with the application.
    3. CLIA identification numbers will be assigned and testing may begin on the day the application is received and keyed into the CMS CLIA Database by the CLIA Certification Section.
    4. Applicable on-site inspections will be scheduled at least 3 months after the laboratory opens.
    5. Recommendations for certification will be made to the Atlanta CMS office effective the date the laboratory meets all applicable Conditions of the CLIA regulations.
    6. Certificates will be mailed from the CMS central office in Baltimore.