Clinical Laboratory Improvement Amendment (CLIA) Frequently Asked Questions

How do I apply for CLIA certificate?

Go to CMS - How to Apply for a CLIA Certificate, Including International Laboratories

How do I renew or make changes to a current certificate?

CLIA is a two-year program. You will receive a bill in the mail. Once the bill is paid, you are automatically renewed.

If you are not located in Minnesota, you need to contact your state's CLIA program.

For the Minnesota Department of Health’s CLIA program, send all changes to the State of Minnesota (include your CLIA number) via one of the following:
Email: health.clia@state.mn.us
Mail:
Minnesota Department of Health
CLIA Program
PO Box 64900
St Paul, MN 55164-0900

For changes in ownership, fill out the Centers for Medicaid and Medicare Services (CMS) 116 form with a cover letter indicating your CLIA number and the effective date.

For a change in laboratory directors include a copy of the director’s qualification documents (refer to question 9).

Where do I find the CMS 116 form?

Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (PDF)

What are the charges for a certificate?

Certificate fee schedules can be found at:

CMS - CLIA - Certificate Fee Schedule (PDF)

In addition, compliance fees are charged based on volume. Information can be found at:

CMS - CLIA - Interpretive Guidelines for Laboratories

Where is my CLIA certificate?

The federal government sends out bills six months to one year prior to the expiration date. You must pay your fee to receive a certificate.

If you paid your fee, the federal government sends out certificates approximately two weeks prior to the expiration date.

May I get a duplicate certificate?

It is important to keep track of your certificate, as lost certificates are not duplicated. You may, however, request a letter of verification by MDH for a lost certificate. You may send your request to the State of Minnesota (include your CLIA number) via one of the following:
Email: health.clia@state.mn.us
Mail:
Minnesota Department of Health
CLIA Program
PO Box 64900
St Paul, MN 55164-0900

When can a new facility begin testing?

As soon as you receive verification payment was received by CMS. You do not need to wait until you receive the certificate, as long as you have verification from MDH that CMS received your payment. You may request verification by calling the CLIA hotline at 651-201-4120 or sending an email to health.clia@state.mn.us.

May we continue testing if a CLIA certificate was not obtained prior to starting testing?

No, you must cease testing until your fee has been paid and you receive verification it was received at CMS by calling the CLIA hotline at 651-201-4120 or sending an email to health.clia@state.mn.us.

What are the qualification requirements for the director of a moderate or high complexity laboratory?

CMS - CLIA - Interpretive Guidelines for Laboratories
Download subpart M (PDF file at the bottom of the page)

What are the requirements for waived tests?

CMS - CLIA - Certificate of Waiver Laboratory Project