Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Florida
- Florida still licenses clinical laboratory personnel, which matters once a site moves beyond waived tests.
Does Florida require a state lab license on top of CLIA?
Florida once licensed labs doing nonwaived or microscope-based testing, but AHCA discontinued that licensure program effective July 1, 2018 (Laws of Florida 2018-24). Waived labs never needed it. Chapter 483 Part I now covers clinical laboratory personnel, not labs.
- Does not reach waived-only labs
Citation: Laws of Fla. ch. 2018-24; Fla. Stat. ch. 483, Part I
What does Florida charge?
No state laboratory fee; AHCA says CLIA fees should never be sent to the State of Florida.
Do labs in other states need a Florida 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.
Where does a Florida CMS-116 go?
- Florida Agency for Health Care Administration, Laboratory Licensing Unit
- Email: LABSTAFF@ahca.myflorida.com
- Phone: (850) 412-4500
Opening a testing site in Florida?
We prepare the CMS-116 and any Florida 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.