Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 34 No. 46, November 14, 2008 issue of the Florida Administrative Weekly.

59C-1.044 Organ Transplantation.

(1) Agency Intent. This rule implements the provision of paragraph 408.036(1)(f)~~(k)~~, 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.

(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.

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)~~(49)~~, 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.

(3) through (4) No change.

(5) Data Reporting Requirements. Facilities with organ transplantation programs shall submit data regarding each transplantation program to the agency or its designee, twice a year. The first submission shall be by August 1 of each year, and shall cover the period between January 1 through June 30 of the same calendar year. The second submission shall be by February 1 of each year, and shall cover the period between July 1 through December 31 of the preceding year. The following data shall be provided for each type of organ transplanted:

~~(a) The number of patients by county origin and by zip code.~~

~~(b) The average gross revenue per admission.~~

~~(c) The average length of stay.~~

~~(d) Mortality rates.~~

Within 45 days after the end of each calendar quarter, facilities with organ transplantation programs, shall report to the agency, or its designee, the total number of transplants by organ type which occurred in each month of the quarter.

(6) through (11) No change.

Specific Authority 408.15(8), 408.034(3), (6)~~(5)~~ FS. Law Implemented 408.034(3), 408.035, 408.036(1)(f), ~~(h), (m)~~, 408.032(17), 408.033(1)(b)4., 11. FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11‑9-82, 2-14-83, 4-7-83, 6-9-83, 6‑10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(x), Formerly 10-5.044, Amended 8-24-93,12-13-94,_________.