Florida licenses both the laboratory and the people working in it. If your lab is in Florida — or if you're an out-of-state lab receiving specimens drawn in Florida — you need a Florida license on top of your CLIA certificate.

State agency

Florida Agency for Health Care Administration (AHCA) — the agency that licenses clinical laboratories in Florida. Laboratory personnel are licensed separately by the Florida Board of Clinical Laboratory Personnel within the Department of Health.

License types

  • Clinical laboratory license (non-waived testing) — the full license for labs performing moderate- and high-complexity testing.
  • Waived testing — labs performing only waived tests follow a lighter registration path.
  • Out-of-state license — required if your lab is outside Florida but receives specimens drawn in Florida. State law is explicit: a Florida lab may not send a Florida-drawn specimen to an out-of-state lab unless that lab holds a Florida license.

How to apply

File the Health Care Licensing Application for Clinical Laboratory (AHCA Form 3170-2004) with the licensing addendum (AHCA Form 3110-1024). The package requires: evidence that the laboratory director is qualified, Level 2 background screening for the administrator and financial officer, and proof of registration with the Florida Department of State. Applications submitted without payment are returned — starter checks and temporary checks are not accepted.

Forms

Application forms — file through the AHCA Online Licensing portal; current paper forms and instructions on the HQA applications for licensure page.

  • Form CMS-116 — CLIA Application for Certification (PDF) — federal application included in the state packet; CLIA fees are billed separately and never sent to Florida.
  • AHCA Form 3170-2004 (Health Care Licensing Application — Clinical Laboratory) — the state application; get the current version from the HQA applications page.
  • AHCA Form 3110-1024 (Health Care Licensing Application Addendum) — required addendum filed with the application; same page.

Inspection preparedness — have these ready before the surveyors arrive:

  • Form CMS-116 — CLIA Application for Certification (PDF) — surveyors verify the specialties, sites, and director on file match current operations.
  • Form CMS-209 — Laboratory Personnel Report (PDF) — current personnel roster; surveyors require it up to date.
  • ACC 212 — CLIA lab test menu — the lab's controlled test menu listing every test by specialty; surveyors cross-check it against the certificate.
  • AHCA does not publish a public laboratory survey checklist; inspections are conducted under Chapter 483, Florida Statutes — read the statute to know what surveyors enforce.
  • Level 2 background screening is required for the administrator and financial officer before licensure — start it early; applications without it stall.
  • Generic CLIA Laboratory Test Menu & Methods form (PDF) — a blank, print-ready test menu any lab can use for inspection readiness; prepared by Zilgene.

Fees

Biennial licensure fees are set by test volume and accreditation status. Labs accredited by an approved accreditation organization (CAP, COLA, Joint Commission, and others) pay $100 biennially — including out-of-state labs. Non-accredited labs performing non-waived testing pay on a volume-based scale, from $400 (up to 2,000 tests/year) to $3,919 (over 1,000,000 tests/year). All fees are nonrefundable; confirm against the current AHCA fee schedule before filing. Note: CLIA fees are billed separately by the CLIA program and must never be sent to the State of Florida.

Personnel requirements

Florida licenses clinical laboratory personnel individually — no one may perform a clinical laboratory examination or report results without a personnel license (the healing-arts-practitioner exemption aside). License categories include director, supervisor, technologist, and technician, with specialty categories for technologists (e.g., generalist, blood banking, cytology, molecular pathology). Florida also offers an interstate endorsement pathway (MOBILE) for personnel already licensed in another state.

Inspection

AHCA inspects licensed laboratories. It may accept inspection reports from accrediting organizations in lieu of conducting its own state licensure inspection, and can conduct a full inspection where no accrediting survey has occurred within the previous 24 months.

Renewal and changes

Licenses renew on a biennial cycle. Report changes to the information in your application — ownership, director, location — within the timeframes the statutes and rules require; a change in ownership triggers a new license application filed before the change takes effect.

How Florida differs from federal CLIA

  • Separate state lab license required in addition to the CLIA certificate.
  • Out-of-state labs need Florida licensure to receive Florida-drawn specimens.
  • Individual personnel licensure through the Board of Clinical Laboratory Personnel.
  • Level 2 background screening for the administrator and financial officer, repeated every five years.

Official links

Last verified: October 2026