How to Make Changes to your 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. 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 Microscopy - please provide a copy of the director’s medical license.
  • Certificate of Compliance - please provide a copy of the director’s medical license and other qualifying information.
  • Certificate of Accreditation - please provide a copy of the director’s medical license and other qualifying information

4.  Once complete, please e-mail to BCHS-CLIA@michigan.gov.

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. 

6.  After the application has been successfully entered into the federal system, a fee coupon will be generated the following Tuesday. Fee coupons and CLIA certificates are printed and mailed by a federal contractor located in Oregon. Fee coupons are mailed no later than the Friday of the week they are generated.

7.  When payment has been processed, the new CLIA certificate will be printed and mailed from Oregon via US Mail. Once the laboratory receives the CLIA certificate, they may start testing and billing for the test(s) performed.