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Federal Certification of 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:
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.
(click the link above)
**WRITE YOUR CLIA NUMBER IN THE MEMO PORTION OF THE CHECK**
CLIA Laboratory Program
PO Box 530882
Atlanta, GA 30353-0882
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.
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.
Department of Licensing and Regulatory Affairs
Bureau of Health Care Services
PO Box 30664
Lansing, MI 48909
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