Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Illinois
- IDPH lets two or more solo practices or groups share one certificate for a lab in a common area under one director, if they meet its shared-lab criteria.
- A certificate expired more than six months needs a new CMS-116 marked as a reactivation.
Does Illinois require a state lab license on top of CLIA?
The Illinois Clinical Laboratory and Blood Bank Act defines a clinical laboratory as a CLIA-certified facility and "shall not be construed to apply to tests classified as waivered tests" under CLIA. IDPH's CLIA FAQ asks Illinois labs only for a CLIA certificate. No separate state laboratory license was found.
- Does not reach waived-only labs
Citation: 210 ILCS 25/1-103, 2-103
Who is exempt in Illinois?
The Act excludes federal labs, and it does not apply to CLIA-waived tests at all.
Citation: 210 ILCS 25/1-103
What does Illinois charge?
No state laboratory fee; the lab pays only the CMS certificate fee.
Do labs in other states need a Illinois license to test its specimens?
IDPH says an out-of-state lab needs no Illinois certificate or permit to test Illinois specimens; it must be CLIA certified and give submitters its collection instructions and a copy of its certificate.
Does Illinois add a form to the CMS-116?
IDPH publishes its own CLIA certificate change request forms for later changes, including test menu changes.
Where does a Illinois CMS-116 go?
- Illinois Department of Public Health, Division of Health Care Facilities and Programs
- Email: DPH.CLIA@illinois.gov
- Phone: (217) 782-6747
Opening a testing site in Illinois?
We prepare the CMS-116 and any Illinois filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.