Florida Administrative Code › 59 - AGENCY FOR HEALTH CARE ADMINISTRATION › 59C - Certificate of Need › Chapter 59C-1 - PROCEDURES FOR THE ADMINISTRATION OF SECTIONS 408.031-408.045, FLORIDA STATUTES, HEALTH FACILITY AND SERVICES DEVELOPMENT ACT › Section 59C-1.044 - Organ Transplantation

Current through Reg. 50, No. 138; July 16, 2024
(1) Agency
				Intent. This rule implements the provision of Section
				408.036(1)(f),
				F.S., which requires the Agency to review the establishment of organ
				transplantation programs under the Certificate of Need program which shall
				include heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and
				islet cells, and intestines. Applications for organ transplantation programs
				shall be reviewed against the applicable review criteria in Section
				408.035, F.S., and the standards
				and need determination criteria set forth in this rule. This rule defines the
				minimum requirements for personnel, equipment, and support services for organ
				transplantation programs. In addition, the rule includes a need methodology for
				the establishment of organ transplantation programs by type. An applicant shall
				apply for each type of organ transplantation program. A separate Certificate of
				Need is required for pediatric organ transplant programs by type. Applicants
				for each type of transplantation program shall meet the requirements specified
				in subsections (3), (4) and (5). Additional requirements for heart
				transplantation programs are specified in subsection (6); for liver
				transplantation programs in subsection (7); for kidney transplantation programs
				in subsection (8); for allogeneic and autologous bone marrow transplantation
				programs in subsection (9); and for lung, heart and lung, pancreas and islet
				cells, and intestines transplants, in subsection (10). The following organ
				transplantation programs shall be restricted to teaching or research hospitals:
				liver, adult allogeneic bone marrow, pediatric allogeneic and autologous bone
				marrow, lung, heart and lung, pancreas and islet cells, and
				intestines.
(2) Definitions.
(a) Bone Marrow Transplantation. Human blood
				precursor cells, stem cells, administered to a patient to restore normal
				hematological and immunological functions following ablative or nonablative
				therapy with curative or life-prolonging intent. Human blood precursor cells
				may be obtained from the patient in an autologous transplant or from a
				medically acceptable related or unrelated donor, and may be derived from bone
				marrow, circulating blood, or a combination of bone marrow and circulating
				blood. If chemotherapy is an integral part of the treatment involving bone
				marrow transplantation, the term "bone marrow transplantation" includes both
				the transplantation and the chemotherapy. (Section
				627.4236(1),
				F.S.).
(b) Organs. Organs as used
				in this rule include heart, kidney, liver, bone marrow, lung, heart and lung,
				pancreas and islet cells, and intestines.
(c) Pediatric Patient. A patient under the
				age of 15 years.
(d) Research
				Hospital. A hospital which devotes clearly defined space, staff, equipment, and
				other resources for research purposes, and has documented teaching affiliations
				with an accredited school of medicine in Florida or another state.
(e) Research Program. An organized program
				that conducts clinical trial research, collects treatment data, assesses
				outcome data, and publishes statistical reports showing research activity and
				findings.
(f) Service Planning
				Area. Planning for organ transplantation programs shall be done on a
				regionalized basis. Certificate of Need applications shall be competitively
				reviewed within each of the four service planning areas delineated below:
1. Service planning area one includes
				District 1, District 2, District 3 excluding Lake County, and District 4
				excluding Volusia County;
2.
				Service planning area two includes District 5, District 6, and District 8
				excluding Collier County;
3.
				Service planning area three includes District 7, District 9 excluding Palm
				Beach County, and includes Lake and Volusia Counties; and,
4. Service planning area four includes
				District 10, District 11, and Collier and Palm Beach
				Counties.
(g) Teaching
				Hospital. Any hospital which meets the conditions specified in Section
				408.07(45),
				F.S.
(h) Transplantation Program.
				The offering of surgical services by a hospital through which one or more types
				of organ transplants are provided to one or more patients; and the offering of
				some or all phases of bone marrow transplantation.