Non-Waived Laboratories

*If you are seeking information about professional licenses, please visit the Department of Health's web site at: http://floridasclinicallabs.gov/.

All facilities, including physician offices, performing any clinical Laboratory testing, are required to obtain a federal Clinical Laboratory Improvement Amendment (CLIA) certificate. 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. To determine whether a test is waived, see the List of Waived Tests at the federal web site: http://www.cms.hhs.gov/CLIA/10_Categorization_of_Tests.asp, which provides CLIA categorizations.

The CLIA program separately bills the Laboratory for payment. CLIA fees should never be sent to the State of Florida.

Notices/Updates

Effective July 1, 2018, the Agency will discontinue the licensure program for non-waived laboratories.

• Discontinuation of the Non-waived Laboratory Licensure Program
• Laws of Florida 2018-24

Help Aids

• How to Calculate Test Volumes and/or Fees
• Program Overview Brochure [630KB, PDF]
• Lab Director Infos
• Quality Assurance

Resources

• CMS CLIA web site
• CMS Lab Look-up
• Federal CLIA information, includes application (FORM CMS-116)
• FDA web site to check the complexity of a test
• List of Provider-performed Microscopy and Waived Tests with CPT codes