Florida ended its clinical laboratory license on July 1, 2018, under Laws of Florida 2018-24, and the license never applied to waived-only sites. A Florida testing site now needs only its federal CLIA certificate, sent through AHCA as the State Agency, with the CMS fee paid to CMS. Florida still licenses clinical laboratory personnel.
For years Florida was one of the states where a lab needed two things: a federal CLIA certificate and a state clinical laboratory license from the Agency for Health Care Administration (AHCA). That changed in 2018. AHCA's laboratory page now carries the notice: "Effective July 1, 2018, the Agency will discontinue the licensure program for non-waived laboratories," citing Laws of Florida 2018-24. A Florida testing site today needs its CLIA certificate and no state lab license.
Before the repeal, which labs needed a Florida license?
The state license never reached waived-only sites. AHCA's page still shows the old rule: "Facilities performing any non-waived clinical Laboratory testing or testing using a microscope must also obtain a state clinical Laboratory license before the Laboratory is authorized to perform testing. Tests performed using a microscope are not waived." So the license used to catch nonwaived labs and anyone running provider-performed microscopy, while a practice running only rapid strep, flu, pregnancy and glucose tests needed only the federal waiver.
That sentence is the source of most of the confusion. It sits on the same AHCA page as the discontinuation notice, and older consultant guides copied it. Read the two together: the license described in the first sentence is the one the 2018 law ended.
Where does chapter 483 stand now?
Chapter 483 of the Florida Statutes is titled "Health Testing Services," and in the 2026 statutes its Part I is "Clinical Laboratory Personnel" (sections 483.800 to 483.828). Part II covers medical physicists and Part III genetic counseling. There is no longer a part that licenses laboratories as facilities. The 2018 law removed it.
What does AHCA still do for labs?
AHCA remains Florida's CLIA State Agency. CMS's State Agency list (updated May 2026) names the AHCA Laboratory Licensing Unit, LABSTAFF@ahca.myflorida.com and (850) 412-4500, as the place the CMS-116 goes. AHCA processes the federal application for CMS.
AHCA is also clear about money: "The CLIA program separately bills the Laboratory for payment. CLIA fees should never be sent to the State of Florida." Since March 1, 2026, CMS emails the fee coupon and the certificate, and the lab pays CMS on pay.gov. The current CMS fee for a Certificate of Waiver, as of October 2026, is $248 for two years.
Is there anything Florida-specific left?
Yes, but it attaches to people, not to the lab:
- Clinical laboratory personnel. Florida still licenses clinical laboratory personnel under Part I of chapter 483, and AHCA points professional licensing questions to the Department of Health. A site that moves beyond waived testing into moderate or high complexity work should check which of its testing staff that reaches before hiring or assigning them.
- Who may order and run tests. Practice acts for physicians, nurses, pharmacists and others decide who may order a test and act on its result. A CLIA certificate does not expand anyone's scope of practice.
- One certificate per site. The federal rule still applies in full. Each fixed testing location needs its own certificate unless it fits one of the three exceptions in 42 CFR 493.35(b). A Florida urgent care group with eight clinics files eight applications and pays eight CMS fees. See CLIA for urgent care groups.
Which mistakes do Florida applicants still make?
- Applying for a state license that no longer exists. Some practices still budget for an AHCA lab license after reading an old guide. There is nothing to file.
- Treating microscopy as waived. AHCA's reminder that "Tests performed using a microscope are not waived" is still true under CLIA. Wet mounts and KOH preps need a PPM certificate, not a waiver; see the PPM certificate.
- Sending a check to Tallahassee. CMS bills the lab; the state does not collect CLIA fees.
- Missing the emailed coupon. With paper coupons gone, the address on the CMS-116 is the only way the bill reaches you. Use a business inbox that more than one person reads.
How do we help Florida sites?
We confirm the certificate type from your test menu, prepare the CMS-116 for your owner or director to sign, and send it to AHCA for you if you want. You pay CMS from your own coupon. A single site is $399 under our Certificate of Waiver Application, and groups of ten or more Florida sites are $249 per site. The Florida requirements page has the AHCA contact.
Common questions
- Does Florida still require a clinical laboratory license?
- No. AHCA discontinued the licensure program for nonwaived laboratories effective July 1, 2018. Chapter 483, Part I now covers clinical laboratory personnel, not lab facilities.
- Where do I send a CMS-116 in Florida?
- To AHCA's Laboratory Licensing Unit, which is still Florida's CLIA State Agency. CMS lists LABSTAFF@ahca.myflorida.com and (850) 412-4500.
- Do I pay the CLIA fee to Florida?
- No. AHCA says CLIA fees should never be sent to the State of Florida. CMS emails a fee coupon and the lab pays CMS directly.
- Does Florida license lab staff?
- Yes. Florida still licenses clinical laboratory personnel under Part I of chapter 483, which matters for sites doing moderate or high complexity testing.
Need Help with Your CLIA Certificate?
We prepare your CMS-116 and any state filing for your owner or director to sign, then track your certificate, changes and renewals.