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LARA - MI Department of Licensing and Regulatory Affairs | LARA MI Department of Licensing and Regulatory Affairs | LARA
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Federal Certification for Clinical Laboratory (CLIA)

The Laboratory Improvement Section is responsible for protecting the health and safety of individuals who require accurate and timely test results from clinical laboratories.

STATE:  At this time, the State of Michigan is not issuing licenses to clinical laboratories. (Updated 05-2014)

FEDERAL:  The federal CLIA program is still in effect.

Clinical Laboratory Improvement Amendments of 1988 (CLIA)

The Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), at 42 CFR 493, define a clinical laboratory as any facility that examines materials derived from the human body for the purpose of providing information 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. If a facility is only collecting specimens, a CLIA certificate is not required.

NOTE: You must have a CLIA certificate even if you perform only one basic test. It does not matter if you charge for the test or not-you must have a CLIA certificate. If you perform a test and do not have a CLIA certificate you will be in violation of federal law.

HOW TO APPLY FOR A NEW CLIA CERTIFICATE

HOW TO MAKE CHANGES TO YOUR CLIA CERTIFICATE

HOW TO MAKE PAYMENTS FOR YOUR CLIA CERTIFICATE

 

Complaint Investigations

Complaints against a clinical laboratory or allegations of non-compliance with CLIA regulations may be made verbally, in writing, or anonymously made by calling the Bureau of Health Care Services Complaint Hotline at 800-882-6006 or by faxing to 517-241-0093.

 

Contact Information

Department of Licensing and Regulatory Affairs
Bureau of Health Care Services
Laboratory Improvement Section
PO Box 30664
Lansing, MI 48909
Phone: 517-241-2648
Fax: 517-241-3354
E-Mail: BHCS-Lab-Section@michigan.gov  

 

HOW TO APPLY FOR A NEW CLIA CERTIFICATE

1.  Determine which type of CLIA certificate is needed. There are four types of CLIA certificates. 

  • Certificate of Waiver: Performs tests granted waived status by the FDA. The cost of the certificate is $150.00 every two years. 
  • Certificate of Microscopy (PPM): This allows the provider and only the provider to use a microscope to perform microscopic procedures (KOH Wet Mount, Urine Sediment Exam, etc.). The laboratory may also perform waived tests under a PPM certificate. The cost of the certificate is $200.00 every two years. 
  • Certificate of Compliance: A laboratory that performs tests categorized as waived, PPM, and non-waived tests (moderate and/or highly complex). The cost of the certificate is dependent on the number of non-waived tests performed annually. 
  • Certificate of Accreditation: A laboratory that performs tests categorized as waived, PPM, and non-waived (moderate and/or highly complex) and the laboratory chooses to be accredited by an approved accreditation organization. The cost of the certificate fee (this is in addition to the accreditation fee) is based on the number of tests performed annually. 

2.  Complete all sections of the CMS 116 CLIA Application. On page 3 of the application, you are required to list the tests that you are going to perform and indicate an estimated test volume.  This is strictly an estimate.  A number must be indicated before we are able to complete the application process. 

For questions regarding the multiple site exception please contact 517-241-2648.

3.  Provide the necessary director credentials: 

  • Certificate of Waiver - no director credentials are required
  • Certificate of Provider Performed - please provide a copy of the director’s medical license (the one that is hung on the wall).
  • Certificate of Compliance - please provide a copy of the director’s medical license (the one that is hung on the wall) and other qualifying information.
  • Certificate of Accreditation - please provide a copy of the director’s medical license (the one that is hung on the wall) and other qualifying information 

4.  Once complete, please e-mail to BHCS-Lab-Section@michigan.gov or fax with a cover page to 517-241-3354.


5.  Once the application is processed (3-5 business days) a confirmation letter will be sent to the e-mail or address provided on the CLIA application.


6.  The following Tuesday, a fee coupon will be generated by our federal contractor and sent to the facility.


7.  Once payment has been received by the CLIA program, the laboratory is able to start testing and billing for the test performed.

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HOW TO MAKE CHANGES TO YOUR CLIA CERTIFICATE 

  • Name, Address, Tax ID, Phone/Fax Changes
    Please notify our department in writing. Include the CLIA number, the old information and then the new information and the effective date of the change. This notification should be signed by someone with authority to make changes. Changes can be e-mailed to BHCS-Lab-Section@michigan.gov or faxed with a cover page to 517-241-3354.

     
  • Laboratory Director Changes

    Certificate of Waiver
    - please notify us in writing. Include the CLIA number, the name and address of the facility, the old director/new director and the effective date of the change. This notification must be signed by the new laboratory director. This notification can be e-mailed to BHCS-Lab-Section@michigan.gov or faxed with a cover page to 517-241-3354.

    Certificate of Provider Performed Microscopy (PPMP) or Certificate of Accreditation -
    You must complete all sections of the CMS-116 CLIA application. Please include a copy of the new director’s medical license (the one that is hung on the wall). This change can be e-mailed to BHCS-Lab-Section@michigan.gov or faxed with a cover page to 517-241-3354.

    Certificate of Compliance must complete all sections of the CMS-116 CLIA application. Please include a copy of the new director’s credentials and medical license (the one that is hung on the wall). This change can be e-mailed to BHCS-Lab-Section@michigan.gov or faxed with a cover page to 517-241-3354.

               
  • Certificate Type Changes
    For all certificate type changes, all sections of the CMS 116 CLIA Application must be completed and signed by the laboratory director. This change can be e-mailed to BHCS-Lab-Section@michigan.gov or faxed with a cover page to 517-241-3354.

NOTE: A NEW CLIA CERTIFICATE WILL NOT BE ISSUED FOR CHANGES. A CONFIRMATION LETTER WILL BE SENT THAT IS TO BE USED IN PLACE OF THE CLIA CERTIFICATE.

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HOW TO MAKE PAYMENTS FOR YOUR CLIA CERTIFICATE

  • Payments can be made by mail to:

    CLIA Laboratory Program
    PO Box 530882
    Atlanta, GA 30353-0882

    Make check payable to “CLIA Laboratory Program” and write the CLIA number on the memo line.
  • Online payments can be made at www.pay.gov.
    It will be listed under:
    1. Select "Make a Payment"
    2. Scroll down until you reach "2" and in teh search boxy type "CLIA", then click on search
    3. The screen should say "CLIA Laboratory User Fees", click on "continue to form"
    4. Continue to form
    5. Complete the requested information
       
  • CLIA Certificates will be mailed out approximately 30 days before your current certificate expires.

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