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Laboratory and In-Home Services

Ruby Grantham, Acting Manager
Laboratory and In-Home Services Unit

Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
(850) 412-4500
Florida Relay Service (TDD): (800) 955-8771
Fax: (850) 410-1511

 

 

 

 

 

Notices/Updates

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

 

The Laboratory and In-Home Services Unit administers programs for the following:

Clinical Laboratories:

The physical location where examinations on fluids, tissues or cells, taken from the human body are performed to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the identification or assessment of a medical or physical condition.

Non-waived

A clinical laboratory that performs testing other than those which have been determined to qualify for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the federal rules adopted thereunder.

Waived

A test system, assay or examination that the U.S. Department of Health and Human Services has determined meets the CLIA statutory criteria as specified for waiver under section 353(d)(3) of the Public Health Service Act.

End Stage Renal Disease (ESRD) Dialysis Facilities

An entity that provides outpatient maintenance dialysis services, or home dialysis training and support services, or both.  A dialysis facility may be an independent or hospital-based unit that includes a self-care dialysis unit that furnishes only self-dialysis services.

Forensic Toxicology Laboratories

The physical location where examinations are performed on specimens taken from the human body to provide information regarding the presence or absence of drugs or their metabolites for the purpose of promoting a drug free workplace under the provisions of Section 112.0455, F.S. or Section 440.102, F.S.

Home Health Agencies

An agency that provides skilled services (by nurses, therapists, social workers) and/or unskilled services (by home health aides, certified nursing assistants, homemaker, companions) to patients in their homes. A home health agency may also provide staffing to health care facilities on a temporary basis.

Multiphasic Health Testing Centers (MHTC)

Any fixed or mobile facility where specimens are taken from the human body for delivery to registered clinical laboratories for analysis and where certain measurements such as height and weight determinations, blood pressure determinations, limited audio and visual tests, and electrocardiograms are made.

Nurse Registries

An agency that offers health care related contracts for nurses, home health aides, certified nursing assistants, homemakers, and companions in a patient's home and as temporary staff to health care facilities.

Organ Procurement Organizations, Tissue Banks and Eye Banks

Entities engaged in the recovery, processing, storage or distribution of human organs, eyes or tissues to be used for transplantation.