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: The State of Michigan does not require a state license for clinical laboratory services.

    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.

    ***The CLIA 116 Application was revised in September 2017. Our office will no longer accept previous versions of the application starting October 1, 2018. A link to the updated form can be found here CMS 116 CLIA Application ***

     

How to Make a Complaint

  • 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 Community and Health Systems Complaint Hotline at 800-882-6006 or by email at BCHS-Complaints@michigan.gov.

    Contact Information

    Department of Licensing and Regulatory Affairs
    Bureau of Community and Health Systems - CLIA
    PO Box 30664
    Lansing, MI 48909
    Phone: 517-241-2648
    Fax: 517-241-3354
    E-Mail: BCHS-CLIA@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. *Please note a CLIA Fee increase went into effect 1/7/19.

    • Certificate of Waiver: Performs tests granted waived status by the FDA. The cost of the certificate is $180.00 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 $240.00 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. It is important to include an E-mail address on your application so we are able to send your acknowledgement in a timely manner.  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 BCHS-CLIA@michigan.gov or fax with a cover page to 517-241-3354.

    5.  Upon receipt, the application will be processed and a confirmation letter will be sent to the e-mail or address provided on the CLIA application. Applications are processed within 30 days of receipt.

    6.  After the application has been successfully entered into the federal system, the following Tuesday a fee coupon will be generated by our federal contractor in Baltimore and sent to the facility.

    7.  When payment has been received by the CLIA program and processed by the federal contractor in Baltimore, your CLIA certificate will be mailed out. When the laboratory receives the CLIA certificate, they may start testing and billing for the test(s) performed.

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, the new information and the effective date of the change. This notification should be signed by someone with authority to make changes.

    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.

    Certificate of Provider Performed Microscopy (PPMP) - 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).

    Certificate of Accreditation - **NEW** Our office will no longer be processing laboratory director changes for Certificate of Accreditation labs. These changes must be completed by the laboratory's Accrediting Organization.

    Certificate of Compliance - 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).

    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.

    Changes can be e-mailed to BCHS-CLIA@michigan.gov or faxed with a cover page to 517-241-3354. Always indicate your CLIA number in the subject line of the email or on the cover page.

    Addition of a Test
    To add on a test for a Certificate of Waiver, written notifications is all that is needed. In the notification, please include the CLIA number, the name and address of the facility, the tests that you wish to add, and the effective date. We will put this information into the system. No confirmation letter will be sent for this type of change. Keep a copy of the notification for your records.

    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.

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 the search box 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
         
    • New CLIA Certificates are mailed out approximately two weeks before the current certificate expires. If new certificates are not received before your current certificate expires, contact our office for a validation letter.

How to Terminate your CLIA Certificate

  • Our department just needs written notification. In this notification, please include the CLIA number, the name and address of the facility, the effective date of the termination and the necessary reason why you wish to terminate the CLIA certificate. This notification should be signed by the laboratory director. Once complete the notification can be faxed with a cover page to 517-241-3354 or sent by e-mail to BCHS-CLIA@michigan.gov.

Educational Resources