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Federal Certification for Clinical Laboratory (CLIA)

The Laboratory Improvement Section is responsible for protecting the health and safety of individuals who require accurate and timely test results from clinical laboratories.

State Of Michigan Licensure of Clinical Laboratories

At this time, the State of Michigan is not issuing licenses to clinical laboratories. (Updated 1/2013)

 

Clinical Laboratory Improvement Amendments of 1988 (CLIA)

The Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), at 42 CFR 493, define a clinical laboratory as any facility that examines 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. Any facility that meets this definition must have the appropriate CLIA certificate to perform laboratory tests. The four types of CLIA certificates are:

 

  • Certificate of Waiver: Performs tests granted waived status by the FDA. The cost of the certificate is $150.00 every two years.
     
  • Certificate of Microscopy (PPM): This allows the provider to perform microscopic procedures. The laboratory may also perform waived tests under a PPM certificate. The cost of the certificate is $200.00 every two years.
     
  • Certificate of Compliance: A laboratory that performs tests categorized as waived, PPM, and non-waived tests (moderate and/or highly complex). The cost of the certificate is dependent on the number of non-waived tests performed annually.
     
  • Certificate of Accreditation: A laboratory that performs tests categorized as waived, PPM, and non-waived (moderate and/or highly complex) and the laboratory chooses to be accredited by an approved accreditation organization. The cost of the certificate fee (this is in addition to the accreditation fee) is based on the number of tests performed annually.

NOTE: You must have a CLIA certificate even if you perform only one basic test. It does not matter if you charge for the test or not-you must have a CLIA certificate. If you perform a test and do not have a CLIA certificate you will be in violation of federal law.


HOW TO APPLY FOR A CLIA CERTIFICATE

(click the link above)

CLIA OVERVIEW 

 

  • CLIA Certificates are mailed approximately 30 days before the current certificate expires.
  • Payments for CLIA certificates can be made by check payable to: CLIA Laboratory Program

       **WRITE YOUR CLIA NUMBER IN THE MEMO PORTION OF THE CHECK**

  • Payments for CLIA certificates can be mailed to:

CLIA Laboratory Program

PO Box 530882

Atlanta, GA 30353-0882

  • If a laboratory is only collecting a specimen, a CLIA certificate is not required.
  • Changes to a CLIA certificate-all changes need to be in writing. Please include the name of the facility, the address, CLIA number, and the notification will need to be signed by someone with authority to do so.

Certificate of Waiver - submit any changes in writing (address, phone number, or director).

Certificate of PPM or a Certificate of Compliance - submit changes in writing (address or phone number). A change in director requires a new CMS 116 to be completed and submitted with a copy of the director's medical license and credentials.

Certificate of Accreditation - please submit changes in writing. A new CMS 116 with the changes would be preferred.

  • Termination of a CLIA certificate-the laboratory will need to notify our office in writing of the termination including the effective date. 

Complaint Investigations

Complaints against a clinical laboratory or allegations of non-compliance with CLIA regulations may be made verbally, in writing, or anonymously by calling the Bureau of Health Care Services Complaint Hotline at 800-882-6006 or by faxing to 517-241-0093.

 

Contact Information

    

Department of Licensing and Regulatory Affairs

Bureau of Health Care Services
Laboratory Improvement Section

PO Box 30664

Lansing, MI  48909

Phone: 517-241-2648

Fax: 517-241-3354

E-Mail: BHCS-Lab-Section@michigan.gov

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