| Applications and appropriate fees should be mailed to:
Phone: (850) 412-4500
The Laboratory Unit administers licensure programs for the following:
All facilities, including physician offices, performing any clinical laboratory testing, are required to obtain a federal Clinical Laboratory Improvement Amendment (CLIA) certificate. All facilities performing non-waived tests, which includes any tests done under a microscope, must also obtain a State of Florida license. The state clinical laboratory license must be issued before the laboratory is authorized to perform testing. The AHCA Laboratory Unit handles applications and changes for both the state laboratory licensure and federal CLIA certification programs. Initial and biennial inspections are required for facilities performing non-waived testing.
Laboratories that only do "waived" testing are issued a Certificate of Wavier by the CLIA program. Applications for the federal Certificate of Waiver must be submitted to the Laboratory Unit at the address above. Effective July 1, 2009, state law changed to no longer require labs doing only waived testing and NOT using a microscope to obtain a State of Florida Certificate of Exemption.
A "waived test" is a test that the federal Centers for Medicare and Medicaid Services (CMS) has determined qualify for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder.
To check to see if a test is "waived", CMS advises that it can be checked on the Food and Drug Administration's web site and provides a PDF file of waived laboratory tests as well.
Any laboratory that uses a microscope in testing or that is performing a test that is not classified as "waived", must seek a "non-waived" laboratory license and CLIA certificate under the specialty or subspecialty of the tests it is performing. State and federal regulations provide guidance for who may and may not perform these tests as well as what laboratories are required to do to perform these tests.
The Laboratory Unit does not license clinical personnel. If you are seeking information about professional licenses, please visit the Department of Health's web site at: http://www.doh.state.fl.us/mqa/ClinLab/.
This web site provides a great deal of information for providers seeking to establish new clinical laboratories as well as those renewing an existing license or needing to notify the agency of a change of ownership and file a change of ownership application. To navigate through the "clinical laboratories" portion of the web site, you will find the "Site Index" to your left very helpful.
- Drug-free Workplace Laboratories
Drug-free Workplace laboratories are specialized forensic toxicology laboratories licensed by the State of Florida for the purpose of performing drug testing for employers within the State. These laboratories may be certified through the Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the Department of Health and Human Services of the Federal Government. Drug-free Workplace laboratories must be CLIA certified in order to qualify for licensure by the State of Florida.
All employers within the State that wish to participate in the "Drug-Free Workplace Program" ( http://www.fldfs.com/WC/pdf/DrugFreeWorkplace_new.pdf 211 KB) sponsored through the Department of Worker's Compensation must contract with a licensed forensic toxicology laboratory to implement their programs.
Regulations for drug-free workplace laboratories are contained in state statutes (see Chapter 112 Part I for the Drug-Free Workplace Act and section 440.102, Florida Statutes for private employers)and rules.
- Multiphasic Health Testing Centers (MHTC)
Multiphasic health testing centers provide two or more limited health testing services that are either performed at the center or involve the sending of specimens to a clinical laboratory. The testing center may be any fixed or mobile facility. Examples of testing services offered are, height and weight determinations, blood pressure testing, limited audio and visual testing and electrocardiograms. Blood and urine specimens may also be obtained on site and delivered to a licensed clinical laboratory for analysis.
- Organ, Tissue and Eye Procurement Organizations
Organ Procurement Organizations (OPOs) are designated for each state through the federal Department of Health and Human Services (DHHS). In Florida, these organizations must also be licensed. The distribution of organs recovered by these organizations is coordinated through the United Network for Organ Sharing (UNOS), a not-for-profit organization regulated through DHHS.
Tissue Banks must be licensed by the State in order to offer services within Florida. Those services may include the recovery, processing, storage and distribution of human tissue. Tissue is distributed to healthcare facilities and practitioners on request for the purpose of transplantation into patients.
Eye Banks must be licensed by the state in order to offer services within Florida. Those services may include the recovery, processing and distribution of eyes or eye tissue. Eyes and eye tissue are distributed to healthcare facilities and practitioners on request for the purpose of transplantation into patients.
In addition to program specific regulations for the clinical laboratory license, drug-free workplace license, multiphasic health testing center and organ, tissue and eye procurement organizations, all licensed programs are regulated under the Health Care Licensing Procedures Act .
Federally certified programs administered by the Laboratory Unit:
- End Stage Renal Disease (ESRD) dialysis facilities.
These facilities are not licensed by the state, but are regulated by the Centers for Medicare and Medicaid Services.