Making Changes to your CLIA Certificate
You are required to notify the Illinois Department of Public Health - CLIA Program within 30 days of changes to your CLIA certificate. The table below shows the requirements for making changes to your CLIA certificate, and the forms needed. These forms are available on this website. Note it is not the Department’s policy to reissue certificates for changes in facility name, address, director or ownership.
| I NEED TO: | WHAT FORM DO I USE? | ANYTHING ELSE? |
|---|---|---|
| Change our physical or mailing address | Name-Address-Director Change Form | No |
| Change the name of our facility (our tax ID will not change) |
Name-Address-Director Change Form | No |
| Change the name of our facility (our tax ID will also change) |
If there will be a lab director change with the change in ownership, a letter of release from the previous owner or lab director, releasing the CLIA number to the new owner, is required | |
| Change the name of our lab director | Name-Address-Director Change Form (the new lab director must sign the form, or the request will not be processed) | Qualifying documentation of the new director is required for Certificates of PPMP, Compliance, and Accreditation; personnel qualifications can be found on this website under the Application and Information tab |
| Upgrade/downgrade our CLIA Certificate to a Certificate of PPMP or a Certificate of Waiver | Certificate Type Change Form | No |
| Upgrade/downgrade our CLIA to a Certificate of Compliance or a Certificate of Accreditation | CMS-116 | If the change in certificate requires the lab director to also change, qualifying documentation of the new director is required; personnel qualifications can be found on this website under the Application and Information tab |
| Add or remove a specialty/subspecialty or test/assay, to/from my Certificate of Compliance or Certificate of Accreditation | Specialty/Subspecialty and Test/Assay Change Form | No |
| Add or remove a test to/from my Certificate of Waiver or Certificate of PPMP | Written notification from lab director | No |
| Reactivate a terminated CLIA certificate (terminated less than six months) |
There is no reactivation form; payment instructions can be found on this website under the FAQs tab | No |
| Reactivate a terminated CLIA certificate (terminated greater than six months) |
CMS-116, marked as a reactivation, with CLIA number included | Any necessary laboratory director qualifying documentation; personnel qualifications can be found on this website under the Application and Information tab |
| Request a new Multiple Site CLIA Certificate | CMS-116 (refer to page 2, Section V – Multiple Sites; you may attach additional pages if you are adding more than two locations) |
If you are applying for Multiple Site exception #2, you must include a copy of your Not-For-Profit Federal 501(c)(3) Tax Determination Letter |
| Add or remove a site from my existing Multiple Site CLIA Certificate | Written notification from lab director, including CLIA number, site name, address, phone number and tests performed at the site | No |
| Request a Temporary Testing endorsement for my CLIA Certificate | Written notification from lab director | No |