Ruby Grantham, Manager
Laboratory and In-Home Services Unit
Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
Florida Relay Service (TDD): (800) 955-8771
Fax: (850) 410-1511
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.
Effective July 1, 2018, the Agency will discontinue the licensure program for non-waived laboratories.