CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 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:

1. Certificate of Waiver: Performs tests granted waived status by the Food and Drug Administration (FDA).
2. Certificate of Microscopy: Performs provider performed microscopy procedures and waived tests.
3. Certificate of Accreditation: Performs moderate and/or high complexity tests and is laboratory-accredited by an agency holding CLIA deemed status.
4. Certificate of Compliance: A non-accredited laboratory performing moderate and/or high complexity tests.

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.  

Laboratory Improvement Section

The Laboratory Improvement Section, located within the Michigan Department of Community Health, 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:

• Assuring that clinical laboratories perform all procedures in accordance with the CLIA regulations
• Investigating and taking appropriate corrective actions in response to complaints or deficiencies
• Certifying approximately 6,800 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.

CLIA Certification Application Process

The CMS-116 CLIA Application for Certification  should be completed, signed by the owner or 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

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 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.

Complaint Investigations

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

Contact Information

Additional information about CLIA topics can be found on the CMS CLIA Web Page  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
(517) 241-2648

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