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Clinical Laboratory LicenseThe Michigan Department of Licensing & Regulatory Affairs, Bureau of Health Care Services, Health Facilities Division, CLIA issues licenses to all clinical laboratories performing testing in the State of Michigan. A "clinical laboratory" is any facility which examines human blood, tissue and fluid specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
Health Facility License -- Clinical Laboratory B. STATUTORY AUTHORITY: Public Act 368 of 1978, as amended C. APPLICABLE REGULATION: Rules Administered by the Bureau of Health Care Services R325.2301-2369 D. SUMMARY OF LICENSE/APPROVAL PROCESS: 1. Applicability (activities that require the license)A facility that analyzes human specimens for the purpose of diagnosing, preventing or treating disease. 2. Pre-Application RequirementsAppropriate Federal CLIA certification. 3. Application Submission RequirementsCompleted BHS-LAB-950 4. Procedures and Time-Frame for Obtaining Permit or ApprovalCompleted application per MLARA request after processing of new CLIA certification. 5. Operational RequirementsCompleted BHS-LAB-950 6. FeesNo license fee, at this time. 7. Appeal ProcessMCL 333.20166 8. Public Input OpportunitiesN/A
Revised: September 2013
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