COMPLAINT INVESTIGATIONS
Complaints against clinical laboratories and allegations of non-compliance with CLIA regulations and State licensure requirements may be made verbally, in writing, or anonymously by calling the Bureau of Health System's Complaint Hotline Number 1‑800-882-6006 or by faxing to (517) 241-0093.

CONTACT INFORMATION
Additional information about clinical laboratory regulatory requirements can be found at the links below or by contacting the Laboratory Improvement Section at:

Michigan Department of Licensing and Regulatory Affairs
Bureau of Health Systems, Division of Licensing and Certification
Laboratory Improvement Section
P.O. Box 30664, Lansing, Michigan 48909
Telephone: (517) 241-2648
E-mail: DCH-BHS-LAB@MICHIGAN.GOV

FREQUENTLY ASKED QUESTIONS
Be sure to check our Clinical Laboratory Frequently Asked Questions (FAQs) page for periodic updates.  (Last updated 02/27/2012)

STATE OF MICHIGAN LICENSURE OF CLINICAL LABORATORIES
The Michigan Public Health Code, Act 368 of 1978, Article 17, defines a clinical laboratory as a facility patronized by, or at the direction of, a physician, health officer, or other person authorized by law to obtain information for the diagnosis, prevention, or treatment of disease or the assessment of a medical condition by the microbiological, serological, histological, hematological, immunohematological, biophysical, cytological, pathological, or biochemical examination of materials derived from the human body except where:

Any facility that meets this definition must be licensed as a Clinical Laboratory by the State of Michigan, even if they do not seek reimbursement for the laboratory testing.

All clinical laboratories performing testing in the State of Michigan must submit an application for laboratory licensure. The Michigan Department of Licensing and Regulatory Affairs (LARA) Laboratory Improvement Section will review the application and determine whether the laboratory is subject to State licensure.

Clinical laboratories subject to State Licensure must also be CLIA certified.

STATE LICENSURE APPLICATION PROCESS
The Application for Laboratory Licensure  (BHS-LAB-950) must be completed by responding to all questions, signed by the owner or laboratory director, and submitted to the Laboratory Improvement Section at:

Michigan Department of Licensing and Regulatory Affairs
Bureau of Health Systems, Division of Licensing & Certification
Laboratory Improvement Section
P.O. Box 30664, Lansing, Michigan 48909
Fax: 517-241-3354
E-mail  DCH-BHS-LAB@MICHIGAN.GOV

NO CLINICAL LABORATORY STATE LICENSURE FEE INFORMATION IS AVAILABLE AT THIS TIME.

STATE OF MICHIGAN CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) OVERVIEW
The Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), at 42 CFR 493 define a clinical laboratory as any facility that examines human specimens 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 certificate types are:

All suppliers and providers that perform laboratory testing must hold the appropriate valid CLIA certificate and meet the applicable CLIA requirements for the testing offered, even if they do not seek reimbursement for the testing.

Some CLIA certified laboratories may also be subject to laboratory licensure  per the Michigan Public Health Code.

CLIA CERTIFICATION APPLICATION PROCESS
The CLIA Application for Certification (CMS-116) must be completed, signed by the owner or laboratory director, and submitted to the Laboratory Improvement Section at:

Michigan Department of Licensing and Regulatory Affairs
Bureau of Health Systems, Division of Licensing & Certification
Laboratory Improvement Section
P.O. Box 30664, Lansing, Michigan 48909
Fax: 517-241-3354
E-mail:  DCH-BHS-LAB@MICHIGAN.GOV

In addition to the completed application, the following information must be included with the certification request:

▪	Certificate of Compliance: Documentation that the laboratory director meets education and experience requirements
▪	Certificate of Accreditation: Documentation that the laboratory director meets education and experience requirements AND documentation of a request for laboratory accreditation from an accrediting agency holding CLIA deemed status

Laboratories will receive an acknowledgement letter from the Laboratory Improvement Section and a fee coupon from the Center for Medicare and Medicaid Services (CMS) 1‑2 weeks after application processing is completed. The fee coupon should be included with the CLIA payment and submitted to:
CLIA Laboratory Program
P.O. Box 530882
Atlanta, GA 30353-0882

Payment should be made by check to the "CLIA Laboratory Program." Write your CLIA idenitification number under the memo section on the front of the check.