Florida Administrative Code › 59 - AGENCY FOR HEALTH CARE ADMINISTRATION › 59A - Health Facility and Agency Licensing › Chapter 59A-1 - CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS, TISSUE BANKS, AND EYE BANKS (IN MEMORY OF CHARLES ARLEIGH LINCOLN, PH.D.) › Section 59A-1.003 - Definitions

Current through Reg. 50, No. 138; July 16, 2024
For the purpose of this section the word, phrase, or
				  term:
(1) "Adverse reaction" means the
				patient's unfavorable physical response to the transplantation of an organ or
				tissue with regard to the transmission of infections of other diseases of
				potential danger.
(2) "Allograft"
				means the transplantation of tissue or organ taken from one individual of the
				same species as the recipient but with different hereditary factors.
(3) "Brain death" means the determination of
				death in accordance with Section
				382.009, F.S., where there is
				the irreversible cessation of the functioning of the entire brain, including
				the brain stem.
(4) "Certificate"
				means a license to operate as an organ procurement organization, tissue bank,
				or eye bank which is issued by the Agency for Health Care
				Administration.
(5) "Clean,
				non-sterile" means the use of methods and techniques that reduce gross
				contamination.
(6) "Consent" means
				authorization or permission to procure organ(s) or tissue(s) from a non-living
				donor which is obtained only under circumstances that provide the prospective
				donor or donor's next of kin sufficient opportunity to consider whether or not
				to agree to such donation and that minimize the possibility of coercion or
				undue influence.
(7) "Container
				(final container)" means the immediate unit, bottle, vial, ampule, tube, or
				other receptacle containing grafts as distributed.
(8) "Coordinators" means registered nurses,
				physicians' assistants, or other medically trained personnel who assist in the
				medical management of organ donors or in the surgical retrieval of
				organs.
(9) "Designee" means one
				who has been assigned a duty or duties, and who has the necessary training and
				educational qualifications to act on behalf of an agency director or medical
				director of an agency.
(10)
				"Distribution" means the shipment and delivery of final container grafts for
				recipient use.
(11) "Donation"
				means the free and voluntary gift of one or more organs or tissues for the
				purpose of transplant surgery.
(12)
				"Donor" means a medically acceptable person where appropriate permissions have
				been obtained to procure organ(s) and tissue(s) according to the provisions of
				Chapter 765, F.S., or if applicable, Chapter 406, F.S.
(13) "Facilities" means any area used for
				retrieval, processing, testing, storage, or distribution of organs, tissues,
				and tissue components.
(14) "Graft"
				means a piece of skin, bone, or other tissue to be transplanted to another
				place on the human body.
(15)
				"Gross autopsy" means the anatomical examination of a body without microscopic
				examination.
(16) "Indirect
				supervision" means the direction that is provided to coordinators and other
				staff under protocols expressly approved by the licensed physician medical
				director. The medical director or his physician designee shall always be
				available, in person or by telephone, to provide medical direction and
				consultation.
(17) "Label" means
				written, printed, or graphic matter on the container or package or any such
				matter clearly visible through the immediate carton, receptacle, or
				wrapper.
(18) "Next of kin" means
				the person or persons most closely related to a deceased individual as
				designated by Section
				765.512, F.S.
(19) "Organ" means a body part such as a
				heart, kidneys, pancreas, liver, lungs, that requires vascular
				reanastomosis.
(20) "Organ
				Procurement and Transplantation Network (OPTN)" means the corporation under the
				Public Health Service Act that approves transplant programs to ensure that all
				organ donors meet minimum standards and requirements.
(21) "Package" means the immediate carton,
				receptacle, or wrapper, including all labeling matter therein and thereon, and
				the contents of the one or more enclosed containers.
(22) "Preservation" means the proper
				combination of conditions that serve to protect organs from decay during
				established periods.
(23)
				"Procedure" means a series of activities followed in a regular and definite
				order.
(24) "Processing" means the
				procedure employed after organ or tissue retrieval and before storage of the
				final container material; includes identification of the organ or tissue, organ
				or tissue treatment, preparation of components from such organ or tissue,
				testing, labeling, and associated record-keeping.
(25) "Procure" means the removal of
				transplantable organs or tissues for the benefit of one or more
				patients.
(26) "Procurement" as it
				applies to an OPO and eye bank means the retrieval, processing or distribution
				of organs and eye tissues; procurement as it applies to a tissue bank means the
				retrieval, processing, storage or distribution of tissues.
(27) "Quality assurance" means the monitoring
				procedures that ensure and document that the entire agency (e.g., facilities,
				personnel, methods, practices, and records) conforms with these
				standards.
(28) "Quality control"
				means laboratory tests and procedures for measuring or monitoring properties of
				organs and tissues essential to the evaluation of their safety or
				usefulness.
(29) "Retrieval" means
				the excision of organs or tissues from a donor's body.
(30) "Storage" means the proper combination
				of conditions that serve to protect tissues from decay during established
				periods.
(31) "Tissue" means any
				non-visceral collection of human cells and their associated intercellular
				substances.
(32) "Tissue bank"
				means a public or private entity which is involved in at least one of the
				following activities:
a) retrieving,
				processing, storing, or distributing viable or nonviable human tissues to
				clinicians who are not involved in the procurement process;
b) retrieving, processing, and storing human
				tissues in one institution and making these tissues available to clinicians in
				other institutions; or
c)
				retrieving, processing, and storing human tissues for individual depositors and
				releasing these tissues to clinicians at the depositor's request.
				Establishments such as transplantation centers and other hospitals which store
				tissue only for a short term pending scheduled surgery within the same facility
				but do not otherwise participate in the retrieving, processing, or distribution
				of tissue would not be regulated under these provisions.