Florida Regulations 59A-1.003: Definitions
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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 Florida Statutes § 382.009, 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 Florida Statutes Chapter 765, or if applicable, Florida Statutes Chapter 406
(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 Florida Statutes § 765.512
(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.
(33) “”Transplant safety”” means the assurance of relative freedom from harmful effect to persons affected, directly or indirectly, by a transplant when administered, taking into consideration the character of the transplant in relation to the condition of the recipient at the time.
(34) “”Transplant physician”” means a licensed practitioner who performs surgical repair or replacement using organs or tissues donated by a living or non-living donor.
Rulemaking Authority Florida Statutes § 765.541(2). Law Implemented 765.541, 765.542 FS. History-New 11-26-92, Amended 8-20-96, 3-21-18.
Terms Used In Florida Regulations 59A-1.003
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- Donor: The person who makes a gift.
- Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
(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 Florida Statutes § 382.009, 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 Florida Statutes Chapter 765, or if applicable, Florida Statutes Chapter 406
(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 Florida Statutes § 765.512
(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.
(33) “”Transplant safety”” means the assurance of relative freedom from harmful effect to persons affected, directly or indirectly, by a transplant when administered, taking into consideration the character of the transplant in relation to the condition of the recipient at the time.
(34) “”Transplant physician”” means a licensed practitioner who performs surgical repair or replacement using organs or tissues donated by a living or non-living donor.
Rulemaking Authority Florida Statutes § 765.541(2). Law Implemented 765.541, 765.542 FS. History-New 11-26-92, Amended 8-20-96, 3-21-18.