1. (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. (2) Definitions.

   1. (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.).
   2. (b) Organs. Organs as used in this rule include heart, kidney, liver, bone marrow, lung, heart and lung, pancreas and islet cells, and intestines.
   3. (c) Pediatric Patient. A patient under the age of 15 years.
   4. (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.
   5. (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.

   6. (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.

   7. (g) Teaching Hospital. Any hospital which meets the conditions specified in Section 408.07(45), F.S.
   8. (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. (3) Coordination of Services. Applicants for transplantation programs, regardless of the type of transplantation program, shall have:

   1. (a) Staff and other resources necessary to care for the patient’s chronic illness prior to transplantation, during transplantation, and in the post-operative period. Services and facilities for inpatient and outpatient care shall be available on a 24-hour basis.
   2. (b) If cadaveric transplantation will be part of the transplantation program, a written agreement with an organ acquisition center for organ procurement is required. A system by which 24-hour call can be maintained for assessment, management and retrieval of all referred donors, cadaver donors or organs shared by other transplant or organ procurement agencies is mandatory. Applicants for a bone marrow transplantation program are exempt from this requirement.
   3. (c) An age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required.
   4. (d) A clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate.
   5. (e) Written protocols for patient care for each type of organ transplantation program including, at a minimum, patient selection criteria for patient management and evaluation during the pre-hospital, in-hospital, and immediate post-discharge phases of the program.
   6. (f) Detailed therapeutic and evaluative procedures for the acute and long term management of each transplant program patient, including the management of commonly encountered complications.
   7. (g) Equipment for cooling, flushing, and transporting organs. If cadaveric transplants are performed, equipment for organ preservation through mechanical perfusion is necessary. Applicants for a bone marrow transplantation program are exempt from this requirement. This requirement may be met through an agreement with an organ procurement Agency.
   8. (h) An onsite tissue-typing laboratory or a contractual arrangement with an outside laboratory within the State of Florida, which meets the requirements of the American Society of Histocompatibility.
   9. (i) Pathology services with the capability of studying and promptly reporting the patient’s response to the organ transplantation surgery, and analyzing appropriate biopsy material.
   10. (j) Blood banking facilities.
   11. (k) A program for the education and training of staff regarding the special care of transplantation patients.
   12. (l) Education programs for patients, their families and the patient’s primary care physician regarding after-care for transplantation patients.

4. (4) Staffing Requirements. Applicants for transplantation programs, regardless of the type of transplantation program, shall meet the following staffing requirements:

   1. (a) A staff of physicians with expertise in caring for patients with end-stage disease requiring transplantation. The staff shall have medical specialties or sub-specialties appropriate for the type of transplantation program to be established. The program shall employ a transplant physician, and a transplant surgeon, if applicable, as defined by the United Network for Organ Sharing (UNOS) June 1994. The UNOS definitions are incorporated herein by reference. A physician with one year experience in the management of infectious diseases in the transplant patient shall be a member of the transplant team;
   2. (b) A program director who shall have a minimum of 1 year of formal training and 1 year of experience at a transplantation program for the same type of organ transplantation program proposed. Provided, however, that an applicant for a bone marrow transplantation program shall meet the requirements in subsection (9);
   3. (c) A staff with experience in the special needs of children if pediatric transplantations are performed;
   4. (d) A staff of nurses, and nurse practitioners with experience in the care of chronically ill patients and their families;
   5. (e) Contractual agreements with consultants who have expertise in blood banking and are capable of meeting the unique needs of transplant patients on a long term basis;
   6. (f) Nutritionists with expertise in the nutritional needs of transplant patients;
   7. (g) Respiratory therapists with expertise in the needs of transplant patients; and,
   8. (h) Social workers, psychologists, psychiatrists, and other individuals skilled in performing comprehensive psychological assessments, counselling patients, and families of patients, providing assistance with financial arrangements, and making arrangements for use of community resources.
5. (5) Data Reporting Requirements. Facilities with organ transplantation programs shall submit data regarding each transplantation program to the Agency or its designee, 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. (6) Heart Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for a heart transplantation program shall not normally be approved in a service planning area unless the following additional criteria are met.

   1. (a) Staffing Requirements. An applicant for a heart transplantation program shall have the following program personnel and services:

      1. A board-certified or board eligible adult cardiologist; or, in the case of a pediatric heart transplantation program, a board-certified or board eligible pediatric cardiologist;

      2. An anesthesiologist experienced in both open heart surgery and heart transplantation; and,

      3. A one bed isolation room in an age-appropriate intensive care unit.

   2. (b) Need Determination. An application for a Certificate of Need to establish a heart transplantation program shall not normally be approved in a service area unless:

      1. Each existing heart transplantation provider in the applicable service area performed a minimum of 24 heart transplants in the most recent calendar year preceding the application deadline for new programs, and no other heart transplantation program has been approved for the same service planning area;

      2. The application contains documentation that a minimum of 12 heart transplants per year will be performed within 2 years of Certificate of Need approval. Such documentation shall include, at a minimum, the number of hearts procured by Florida hospitals during the most recent calendar year, and an estimate of the number of patients in the service planning area who would meet commonly-accepted criteria identifying potential heart transplant recipients;

      3. The application includes documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 500 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated patient caseload for open heart surgery was at or exceeded 150 for the calendar year preceding the Certificate of Need application deadline; and,

      4. An application for a pediatric heart transplantation program shall include documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 200 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated cardiac open heart surgery caseload was at or exceeded 125 for the calendar year preceding the Certificate of Need application deadline.

7. (7) Liver Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for a liver transplantation program shall not normally be approved unless the following additional criteria are met:

   1. (a) An applicant for a Certificate of Need to establish a liver transplantation program must be a teaching hospital or research hospital with training programs relevant to liver transplantation.

   2. (b) Coordination of Services. The following services shall be available in the hospital, or through contractual arrangements:

      1. A department of gastroenterology, including clinics, and adequately equipped procedure rooms;

      2. Radiology services to provide complex biliary procedures, including transhepathic cholangiography, protal venography and arteriography;

      3. A laboratory with the capability of performing and promptly reporting the results of liver function tests as well as required chemistry, hematology, and virology tests; and,

      4. A patient convalescent unit for further monitoring of patient progress for approximately one month post-hospital discharge following liver transplantation.

   3. (c) Staffing Requirements. In addition to the general staffing requirements for all transplantation programs, program staff for liver transplantation programs shall be trained in the care of patients with hepatic diseases, and liver transplantation.

   4. (d) Need Determination.

      1. The application includes documentation that a minimum of five liver transplants will be performed within 2 years of Certificate of Need approval. Such evidence shall include, at a minimum, the number of livers procured in the state during the most recent calendar year, and an estimate of the number of patients in the service delivery area who would meet commonly-accepted criteria identifying potential liver transplant recipients. The caseload estimate shall be based on the number of persons with end-stage hepatic diseases in the service planning area, for which death due to the disease is likely to occur within 1 year without the transplantation.

      2. The application includes documentation that the new liver transplantation program improves patient access.

8. (8) Kidney Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), a Certificate of Need for a new kidney transplantation program shall not normally be approved unless the following additional criteria are met:

   1. (a) Coordination of Services.

      1. Inpatient services shall be available which shall include renal dialysis, and pre- and post operative care. There shall be 24-hour availability of onsite dialysis under the supervision of a board-certified or board eligible nephrologist. If pediatric patients are served, a separate pediatric dialysis unit shall be established.

      2. Outpatient services shall be available which shall include renal dialysis services and ambulatory renal clinic services.

      3. Ancillary services shall include pre-dialysis, dialysis, and post transplantation nutritional services; bacteriologic, biochemical, and pathological services; radiologic services; and nursing services with the capability of monitoring and support during dialysis and assisting in home care including vascular access, and home dialysis management, when applicable.

   2. (b) Staffing Requirements for Adult Kidney Transplantation Programs.

      1. The kidney transplantation program shall be under the direction of a physician with experience in physiology, immunology and immuno-suppressive therapy relevant to kidney transplantation.

      2. The transplant surgeon shall be board-certified in surgery or a surgical subspecialty, and shall have a minimum of 18 months training in a transplant center.

      3. The transplant team performing kidney transplantation shall include physicians who are board-certified or board-eligible in the areas of Anesthesiology, Nephrology, Psychiatry, Vascular Surgery, and Urology.

      4. Additional support personnel which shall be available include a nephrology nurse with experience in nursing care of patients with permanent kidney failure, and a renal dietician.

      5. A laboratory with the capability of performing and promptly reporting bacteriologic, biochemical and pathologic analysis.

      6. An anesthesiologist experienced in kidney transplantation.

   3. (c) Staffing Requirements for Pediatric Kidney Transplantation Programs. Applicants for a kidney transplantation program which will serve pediatric patients shall have the following staffing:

      1. A medical director who is sub-board-certified or sub-board-eligible in pediatric nephrology.

      2. A dialysis unit head nurse with special training and expertise in pediatric dialysis.

      3. Nurse staffing at a nurse to patient ratio of 1 to 1 in the pediatric dialysis unit.

      4. A registered dietician with expertise in nutritional needs of children with chronic renal disease.

      5. A surgeon with experience in pediatric renal transplantation.

      6. A radiology service with specialized equipment for obtaining x-rays on pediatric patients.

      7. Education services to include home and hospital programs to ensure minimal interruption in school education.

   4. (d) Need Determination. Applications for the establishment of new kidney transplantation programs shall not normally be approved unless the following need criteria are met:

      1. Each existing kidney transplantation provider in the applicable service area performed a minimum of 30 kidney transplants in the most recent calendar year preceding the application deadline, and no additional program has been approved for the same service planning area;

      2. If pediatric kidney transplants will be performed, each existing pediatric kidney transplant program performed a minimum of 10 pediatric kidney transplants during the calendar year preceding the application deadline, and no additional program has been approved for the same service planning area;

      3. The application shall include documentation that a minimum of fifteen kidney transplants per year will be performed within 2 years of program operation. Such documentation shall include, at a minimum, the number of kidneys procured in the state during the most recent calendar year, and an estimate of the number of patients who would meet commonly-accepted criteria identifying potential kidney transplant recipients. This estimate shall be based on the number of patients on dialysis within the same service planning area; and,

      4. If pediatric kidney transplants will be performed, the application shall include documentation that a minimum of 5 pediatric kidney transplants per year will be performed within two years of Certificate of Need approval.

9. (9) Allogeneic and Autologous Bone Marrow Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for new bone marrow programs shall not normally be approved unless the following additional requirements and criteria are met.

   1. (a) Pediatric Allogeneic and Autologous Bone Marrow Transplantation Programs. Pediatric allogeneic and autologous bone marrow transplantation programs shall be limited to teaching and research hospitals with training programs relevant to pediatric bone marrow transplantation. All applicants shall meet the requirements specified in subparagraph 1., below. Applicants for allogeneic programs shall meet the additional requirements specified in subparagraph 2., below:

      1. Requirements for Pediatric Allogeneic and Autologous Transplantation Programs;

      a. Applicants shall be able to project that at least 10 pediatric transplants will be performed each year. If both allogeneic and autologous pediatric transplants are performed, at least 10 of each shall be projected. New units shall be able to project the minimum volume for the third year of operation;

      b. A program director who is a board certified hematologist or oncologist with experience in the treatment and management of pediatric acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in pediatric bone marrow transplantation;

      c. Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program;

      d. An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications;

      e. Age appropriate inpatient transplantation units for post-transplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of 2 beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders;

      f. A radiation therapy division onsite which is capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation. The division shall be under the direction of a board certified radiation oncologist;

      g. An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include outcome monitoring and long-term patient follow-up; and;

      h. An established research-oriented oncology program.

      2. Additional Requirements for Pediatric Allogeneic Transplantation Programs:

      a. A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements;

      b. An onsite laboratory equipped for the evaluation and cryopreservation of bone marrow;

      c. An age appropriate patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence; and,

      d. An age appropriate outpatient unit for close supervision of discharged patients.

   2. (b) Adult Allogeneic Bone Marrow Transplantation Programs. Adult allogeneic bone marrow transplantation programs shall be limited to teaching and research hospitals. Applicants shall meet the following requirements:

      1. Applicants shall be able to project that at least 10 adult allogeneic transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation;

      2. A program director who is a board certified hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation;

      3. Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program;

      4. An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications;

      5. Inpatient transplantation units for post-transplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of 2 beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders;

      6. A radiation therapy division onsite which is capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation. The division shall be under the direction of a board certified radiation oncologist;

      7. A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements;

      8. An onsite laboratory equipped for the evaluation and cryopreservation of bone marrow;

      9. An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include outcome monitoring and long-term patient follow-up;

      10. An established research-oriented oncology program;

      11. A patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence; and,

      12. An outpatient unit for close supervision of discharged patients.

   3. (c) Adult Autologous Bone Marrow Transplantation Programs. Adult autologous bone marrow transplantation programs can be established at teaching hospitals or research hospitals; or at community hospitals having a research program, or who are affiliated with a research program, as defined in this rule. Applicants shall meet the following requirements:

      1. Applicants shall be able to project that at least 10 adult autologous transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation;

      2. A program director who is a board certified or board eligible hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation, or have at least 1 year of documented experience in performing autologous bone marrow transplantation;

      3. Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program;

      4. An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients;

      5. Inpatient transplantation units for post-transplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of 2 beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders;

      6. A radiation therapy division onsite which is capable of sub-lethal x-irradiation and total lymphoid irradiation. The division shall be under the direction of a board certified radiation oncologist;

      7. An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital; or the applicant may enter into an agreement with an outpatient provider having a research program, as defined in this rule. Under the agreement, the outpatient research program may perform specified outpatient phases of adult autologous bone marrow transplantation, including blood screening tests, mobilization of stem cells, stem cell rescue, chemotherapy, and reinfusion of stem cells; and,

      8. An established research-oriented oncology program.

   4. (d) Grandfathering Provisions for Hospitals Without Certificate of Need Approval. Hospitals that prior to March 1, 1993, operated a bone marrow transplantation program, as defined in this rule, without Certificate of Need approval, shall provide written documentation to the Agency that they meet the applicable requirements of subsections (3), (4) and (9) of this rule. Hospitals that meet the requirements shall be authorized to continue to provide the service.

10. (10) Transplantation Programs for Lung, Heart and Lung, Pancreas and Islet Cells, and Intestines. In addition to meeting the requirements specified in subsections (3), (4) and (5), Certificate of Need applications for the establishment of new transplantation programs involving lung, heart and lung, pancreas and islet cells or intestines shall not normally be approved unless the following additional criteria are met:

    1. (a) The applicant is a teaching or research hospital with training programs relevant to the type of organ transplantation program proposed to be established; and,
    2. (b) Applicants have established interactive programs of basic and applied research in organ failure, transplantation, immunoregulatory responses, and related biology.
11. (11) Pediatric transplant programs with a valid CON at a Medicaid designated transplant center may perform transplants for patients under the age of 21. In case of conflict between provisions in this rule, the provisions of this subsection shall prevail.

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(f), 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), 10-5.044, Amended 8-24-93, 12-13-94, 7-6-09, 4-18-18.