The Michigan
Department of Licensing and Regulatory Affairs, Bureau of Health Systems 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 Systems
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
Us
Creation/Revision Date:
September 10, 2010
