CLIA and Waived Testing in Illinois

Illinois has a state lab law, the Clinical Laboratory and Blood Bank Act (210 ILCS 25), but it stops short of waived testing. Section 1-103 says the Act "applies to clinical laboratories and blood banks, except clinical laboratories operated by the United States Government. In addition, this Act shall not be construed to apply to tests classified as waivered tests under federal regulations adopted for the Clinical Laboratory Improvement Act of 1988." A practice, pharmacy or school clinic in Illinois that runs only waived tests needs its federal Certificate of Waiver and no Illinois license.

So which labs does the Act reach?

The Act defines a clinical laboratory as "a facility which performs laboratory tests or issues reports resulting from such tests and is certified under the Clinical Laboratory Improvement Act of 1988" (210 ILCS 25/2-103). In other words, Illinois builds on the federal certificate rather than issuing its own lab license. The Illinois Department of Public Health (IDPH) is the CLIA State Agency, and its CLIA FAQ describes only federal certificates: Waiver, PPM, Registration, Compliance and Accreditation.

What does IDPH need with a waiver application?

Very little. IDPH: "Applications for certificates of CLIA waived only require the CMS-116 application; however, HOME HEALTH CARE facilities must include a copy of their Illinois Home Health Care License." PPM, Compliance and Accreditation applications add the proposed director's qualifying documents, and IDPH warns that those "will not be processed without these documents."

The application goes to IDPH's Division of Health Care Facilities and Programs. CMS's State Agency list (updated May 2026) gives DPH.CLIA@illinois.gov and (217) 782-6747. IDPH describes the steps as processing the application, a fee coupon from the federal program, payment, and then the certificate, and says the process "takes an average of 4 to 6 weeks." Treat that as IDPH's own average, not a promise: an incomplete form restarts the clock.

Can several practices share one Illinois lab?

IDPH's FAQ answers a question many states never address: whether physicians practicing at the same location can share a CLIA certificate and laboratory. IDPH lets them share if the lab "is located in a common area," two or more solo physicians or group practices "share the expenses necessary to operate the laboratory," one qualified individual directs the testing, and every practice performs only the test categories the shared certificate allows. "Facilities performing tests at a different location and not in the shared laboratory testing area will require their own CLIA certificate." That is a narrow arrangement for practices that genuinely share a lab room, not a way to put separate clinics in different buildings under one number. Each fixed location still needs its own certificate under 42 CFR 493.35(b); see one certificate per site, and the three exceptions.

How does Illinois treat out-of-state labs and specimen collection?

More simply than New York or Pennsylvania. Asked whether an out-of-state lab needs an Illinois certificate or permit to receive and test Illinois specimens, IDPH answers: "No. The requirements are for your facility to be CLIA certified and in good standing; however, you must provide instructions for specimen collection, processing, and a copy of your CLIA certificate to the submitter(s)." A practice that only sends samples elsewhere needs no certificate of its own for that, but "samples can only be sent to a CLIA or state certified laboratory that is in good standing."

IDPH also addresses home health. If a nurse or employee "only assists the patients and provides the patients self-testing result to the doctor, a certificate is not required. If the nurse or employee conducts the test, a certificate is required." For testing at health fairs and screening events, IDPH says Illinois facilities must hold a CLIA certificate and out-of-state facilities must be CLIA certified in their own state. Our post on testing specimens from other states compares Illinois with the stricter states.

Which IDPH numbers should you ignore?

The fee answer on IDPH's FAQ lists a Certificate of Waiver at $180 and PPM at $240 every two years. Those are the pre-2024 CMS fees. CMS raised them in its 2023 fee rule, effective January 27, 2024, and the current CMS fees, as of October 2026, are $248 for a Certificate of Waiver and $297 for PPM. The FAQ also says the fee coupon goes "to your designated mailing address"; since March 1, 2026, CMS sends coupons and certificates only by email. See CLIA fees in 2026.

After approval, what should an Illinois site watch?

• Changes. IDPH publishes its own change request forms, including for test menu changes. A waiver lab must report before it adds any test that is not waived, because testing beyond the certificate is a federal violation.
• Lapses. IDPH says a certificate expired more than six months needs a new CMS-116 marked as a reactivation.
• Nonwaived testing. The moment a site adds a moderate complexity test, the Act's waived-test carve-out no longer covers that work. Read the Act and IDPH's rules before you buy the analyzer.

How do we help Illinois sites?

Our Certificate of Waiver Application is $399 per site: the test list from each kit's instructions, the CMS-116 for your owner or director to review and sign, and the IDPH submission if you want us to send it. You pay CMS from your own emailed coupon. The Illinois requirements page keeps the IDPH contact current.