The 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.

A. NAME OF LICENSE OR APPROVAL:

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 Requirements

Appropriate Federal CLIA certification.

 3.  Application Submission Requirements

Completed BHS-LAB-950

 4.  Procedures and Time-Frame for Obtaining Permit or Approval

Completed application per MLARA request after processing of new CLIA certification.

 5.  Operational Requirements

Completed BHS-LAB-950

 6.  Fees

No license fee, at this time.

 7.  Appeal Process

MCL 333.20166

 8.  Public Input Opportunities

N/A

E. Contact Information:

Contact CLIA

Revised:  September 2013