The Laboratory Improvement Section,
located within the State of Michigan Department of Community Health (MDCH), Bureau of Health Systems, serves to protect the health and safety of individuals who require accurate and timely test results from clinical laboratories.
The Section is responsible for:
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Assuring that clinical laboratories perform all procedures in accordance with the
Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and
State laboratory licensure requirements
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Investigating and taking appropriate corrective actions in response to complaints or deficiencies
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Certifying approximately 7,100 clinical laboratories, of which approximately 400 non-accredited laboratories are surveyed on a biennial basis, 700 accredited laboratories are eligible for validation surveys and another 4,000 waiver laboratories are eligible for certificate of waiver surveys
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Implementing State licensure of laboratories (effective in late 2008) in accordance with the Michigan Public Health Code
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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 Community Health
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 (FAQ) page for periodic updates. (Last updated 7/2/08)
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:
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Examinations are always performed personally by the individual desiring the information
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A laboratory is operated by an individual or a group of not more than 5 individuals licensed to practice medicine, osteopathic medicine and surgery, dentistry, or podiatry who performs clinical laboratory tests or procedures personally or through his or her employees only as an adjunct to the treatment of the licensees patients
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A laboratory is operated by a college, university or school approved by the department of education that is conducted for the training of its students, if the result of an examination performed in the clinical laboratory is not used in the diagnosis and treatment of disease
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A laboratory operated by the federal government
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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 Community Health (MDCH) 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 Community Health
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:
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Certificate of Waiver:
Performs tests granted waived status by the Food and Drug Administration (FDA)
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Certificate of Microscopy:
Performs provider performed microscopy procedures and waived tests
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Certificate of Accreditation:
Performs moderate and/or high complexity tests and is laboratory-accredited by an agency holding CLIA deemed status
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Certificate of Compliance:
A non-accredited laboratory performing moderate and/or high complexity tests
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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 Community Health
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:
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Certificate of Compliance:
Documentation that the laboratory director meets education and experience requirements
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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
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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 70948
Charlotte, North Carolina 28272-0948
Payment should be made by check to the "CLIA Laboratory Program." Indicate the CLIA certificate number on the check.
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