Michigan

Michigan Licensing and Regulatory Affairs, Public Health Division. Clinical Laboratories. 
https://www.legislature.mi.gov/Laws/MCL?objectName=mcl-445-161

(1) The State of Michigan does not require a state license for clinical laboratory services. Michigan does not have state specific requirements for clinical laboratory testing.

(2) The State of Michigan follows federal CLIA requirements.

(3) If a facility is only collecting specimens, a CLIA certificate is not required.

(4) A CLIA certificate is required even if only one test is performed, regardless of whether payment is received for the test. Performing testing without a CLIA certificate is a violation of federal law.

(a) The Quick Start Guide directs laboratories in the processes for:

• Completing the CLIA application form, CMS-116
• Finding the appropriate State Agency to submit the form.
• Receiving the fee coupon
• Paying applicable fees
• Receiving laboratory certificate and beginning testing
• Maintaining the certificate

(b) 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/or other qualifying information.
• Certificate of Accreditation – please provide a copy of the director’s medical license and/or other qualifying information.

Send the completed application by e-mail to LARA-BSC-CLIA@michigan.gov. Once the application is processed, a confirmation letter will be sent to the e-mail or address provided on the CLIA application. Applications take 5-7 business days after receipt.

NOTE: 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.

Certificate of Accreditation—Notify the accreditation program no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both.

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.