How to Make Changes to your CLIA Certificate Note

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.