Clinical Laboratory Services

• 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. Michigan does not have state specific requirements for clinical laboratory testing.

FEDERAL: The State of Michigan follows federal CLIA requirements.

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.

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.

***Due to the COVID-19 Public Health Emergency, our staff are working remotely. Please submit all documents electronically. All completed 116 applications and requests for corrections and/or changes can be emailed to: LARA-BSC-CLIA@michigan.gov. If applicable, please include the assigned CLIA number in the subject line of the email. Documents may also be faxed to 517.763.0214. All documents sent via US Mail will be processed, however, significant delays may occur.***

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

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 $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, a list of all tests being performed is required, as is an estimated test volume.  This is strictly an estimate, and a number must be indicated to process the application.  It is important to include an E-mail address on your application, so we can send your acknowledgement in a timely manner.  For questions regarding the multiple site exception please contact 517-241-2648.

NOTE:  In order to process your application, all CMS-116 required information must be included.  For instance, in Section VI Waived Testing, the instructions require the laboratory to identify the waived testing to be performed and to be as specific as possible. This includes each analyte test system or device used in the laboratory (test name and manufacturer).

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

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

5. Once the application is processed, a confirmation letter will be sent to the e-mail or address provided on the CLIA application. Our office strives to process complete applications 5-7 business days after receipt.

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.

COVID-19 Testing & Reporting Information

For questions related to testing for Schools please contact MDHHS at MDHHS-COVIDTestingSupport@michigan.gov, visit the following website: K-12 School Guidance, or call the MDHHS COVID hotline at: 888-535-6136

For questions on the MDHHS testing program for Adult Foster Care (AFC) Facilities/Homes for Aged (HFA) please contact MDHHS atMDHHS-MSA-COVID19@michigan.gov or call the MDHHS COVID hotline at: 888-535-6136.

SARS-CoV-2 Point of Care Testing and CLIA Certificate of Wavier Applications (CMS FAQ 12-14-20)

How to Report COVID-19 Laboratory Data?

Our sister Agency, The Michigan Department of Health and Human Services (MDHHS) oversees COVID-19 reporting for the State of Michigan. Please visit their website at www.michigan.gov/coronavirus for additional information.

Per MDHHS, all antigen tests administered should be reported to the Antigen Reporting Form. You can find more information and specifics about how to organize and report your data at the following links:

Sample spreadsheet and instructionsMI COVID Antigen Reporting FAQ

Some changes require a CMS 116 CLIA Application to be completed.

Name, Address, Tax ID, Phone Changes
Please notify our department in writing. Written notification includes email, fax, or hard copy. Written notification must include the following:

• Laboratory Name
• CLIA number
• Name of Laboratory Director AND Owner
• The change(s) being made – old information, new information and effective date of the change
• Signature of the Laboratory Director or his/her designee (someone with the authority to make changes)

In lieu of written notification, a new form CMS 116 CLIA Application is also acceptable. The CMS 116 application must be completed in its entirety.

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. In certain instances, an updated CMS-116 may be required if requested.

Certificate of Provider Performed Microscopy (PPMP) -Complete ALL sections of the CMS-116 CLIA application. Please include a copy of the new director’s physical medical license.

Certificate of Accreditation - As of January 2019, 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 a copy of the physical medical license if applicable.

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. Completed 116 applications can be e-mailed to LARA-BSC-CLIA@michigan.gov. Always indicate your CLIA number in the subject line of the email.

Addition of a Test/Specialty

Certificate of Waiver –Laboratories with a CLIA Certificate of Waiver (CoW) can perform any test categorized as CLIA waived or granted Emergency Use Authorization (EUA) for use in a waived setting by the Food and Drug Administration (FDA). CoW labs do not need to notify the State Agency when adding or removing waived tests to their testing menu.

**CoW laboratories do need to notify the State Agency when adding COVID-19 testing to their testing menu. This can be done by completing a CMS 116 CLIA Application form and noting ‘Add COVID Testing’ in the other changes box**

A CoW laboratory is required to notify the State Agency before performing tests that are not categorized/granted EUA for use in the waived setting as a change in certificate type would likely be required.

Certificate of Compliance – Complete and submit a CMS-116 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.

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.

NOTE: A NEW CLIA CERTIFICATE WILL NOT BE ISSUED FOR CHANGES. A CONFIRMATION LETTER WILL BE SENT ONLY FOR REQUESTS TO CHANGE THE LABORATORY DIRECTOR OR FEDERAL TAX IDENTIFICATION NUMBER TO USE IN PLACE OF THE CLIA CERTIFICATE.  For other changes, you will receive an automatic message that it was received and may be contacted if further information needed. 

Addition of a Test/Specialty

Certificate of Waiver--To add on a test for a Certificate of Waiver, only written notifications are needed. In the notification, include the CLIA number, the name and address of the facility, the tests that you wish to add, and the effective date. No confirmation letter will be sent for this type of change. Keep a copy of the notification for your records.

To add on a test for COVID-19 to a valid existing Certificate of Waiver:  If the COVID-19 test has been granted Emergency Use Authorization (EUA) to be performed in a waived setting, you do not have to wait to start testing.  Testing may begin immediately.

Certificate of Compliance--Complete and submit a CMS-116 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.

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.

• Payments can be made by mail to:
  CLIA Laboratory Program
  PO Box 3056
  Portland, OR 97208-3056
  
  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. Type CLIA into the search box
  2. Click the blue ‘Continue’ button located in the CLIA Laboratory User Fees box
  3. Click the blue ‘Continue to the Form’ on the next screen to proceed.
  4. Complete the form as indicated and select continue. A confirmation number will be provided at the end of the transaction. Retain a printed copy of this number for your records.
• 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.

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 sent by e-mail to LARA-BSC-CLIA@michigan.gov.

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.

Department of Licensing and Regulatory Affairs
Bureau of Survey and Certification - CLIA
PO Box 30838
611 W. Ottawa Street, 1st floor
Lansing, MI 48909
CLIA direct line: (517) 241-2648
Bureau main line: (517) 284-0193
Fax: (517) 763-0214
E-Mail: LARA-BSC-CLIA@michigan.gov