Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Iowa
- Iowa's State Agency requires the person listed as laboratory director to sign page 5 of the CMS-116; an owner's signature alone is not accepted there.
Does Iowa require a state lab license on top of CLIA?
Iowa's CLIA program, run by the State Hygienic Laboratory under contract with the state and CMS, describes only federal CLIA certificates. No separate state laboratory license is described.
- Does not reach waived-only labs
What does Iowa charge?
No state laboratory fee; the lab pays only the CMS certificate fee.
Do labs in other states need a Iowa license to test its specimens?
No state laboratory license was found, so a lab in another state needs nothing from this state to test its specimens beyond its own CLIA certificate.
Does Iowa add a form to the CMS-116?
PPM, Compliance and Accreditation applicants include the director's qualifications and current Iowa license, when applicable, with the CMS-116.
Where does a Iowa CMS-116 go?
- Iowa CLIA Laboratory Program, State Hygienic Laboratory at the University of Iowa
- Email: shl-clia@uiowa.edu
- Phone: (319) 335-4500
Opening a testing site in Iowa?
We prepare the CMS-116 and any Iowa 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.