STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED

STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED A. PROJECT IDENTIFICATION 1. Applicant/CON Action Number Halifax Hospital Medical Center (CON #9956) 303 W. Clyde Morris Boulevard Daytona Beach, Florida 32115 Authorized Representative: Mr. William J. Griffin (386) 322-4771 Adventist Health System/Sunbelt Inc. (CON #9957) 601 East Rollins Street Orlando, Florida 32803 Authorized Representative: Mr. Richard E. Morrison (407) 647-4400 2. Service District/Subdistrict Organ Transplantation Service Planning Area Three (includes District 7, District 9 excluding Palm Beach County, and includes Lake (District 3) and Volusia Counties (District 4). B. PUBLIC HEARING A public hearing was not held or requested. However, letters of support were submitted by the applicants proposing to establish adult pancreas transplantation programs, as discussed below. Letters of Support Halifax Hospital Medical Center (CON #9956) included two letters of support. One letter each was received from Tim Jankiewicz, Executive Director of TransLife Organ Procurement Organization and Dr. Sajid Latif, M.D. of Halifax Medical Center. Mr. Jankiewics states that TransLife supports the establishment of a pancreas transplant program

by Halifax Medical Center and will allocate pancreas organs to the facility in accordance with organ allocation policies as established by the Organ Procurement and Transplant Network and the United Network for Organ Sharing. Adventist Health System/Sunbelt, Inc. (CON #9957) included seven letters of support with one letter from a transplant recipient indicating distance to be a problem. Four letters were received from TransLife Organ Procurement Organization: Robert A. Metzger, M.D., Medical Director, Michael Angelis, M.D., Surgical Transplant Director, Bobby Nibhanupudy, M.D., Transplant Surgeon, and Tim Jankiewicz, Executive Director. Also in support of Adventist Health System/Sunbelt, Inc. are Joseph W. Warren, M.D., Nephrology Associates of Central Florida, and George Burke, M.D., Professor of Surgery, University of Miami, Director, Kidney and Kidney Pancreas Transplant Programs. C. PROJECT SUMMARY Halifax Hospital Medical Center (CON #9956) (Halifax)proposes to establish an adult pancreas transplant program in Transplant Service Area 3. Halifax is an existing provider of tertiary services. It operates a Level II neonatal intensive care unit (NICU). It also operates an adult open heart surgical service and is a Level II state-certified trauma center. The development of a pancreas transplant program will operate in conjunction with and compliment the medical center s CON approved kidney transplant program. The hospital projects that $150,000 will be spent in recruiting and other pre-opening costs and anticipates the program, if approved, to become operational on July 1, 2007. Recruiting costs include not only recruitment proper, but the cost of pre-opening orientation and training for existing staff and new hires. The equipment necessary to support the flushing and transport of grafts has been acquired already in connection with the implementation of the applicant s kidney transplant program. Project costs are projected to total $207,925 and do not include any construction costs. Halifax Medical Center is a Medicaid disproportionate share hospital and has agreed to provide a minimum of five percent of its pancreas transplant procedures to uninsured patients. The applicant also agrees to condition award of the CON upon implementing programs to assist in funding immunosuppressant drugs for indigent and uninsured pancreas transplant patients. These programs will range from working with drug manufacturers to secure favorable purchase prices for such drugs to direct subsidy. The applicant further agrees to implement programs to 2

support indigent patients in meeting compliance criteria for pancreas transplantation. Adventist Health System/Sunbelt, Inc. (CON #9957) (Adventist) proposes to establish an adult pancreas transplant program at the main campus, Florida Hospital - Orlando in Transplant Service Area 3. Like co-batched applicant, Halifax, the applicant is also a provider of tertiary care services. Unlike co-batched Halifax, the applicant operates a number of acute care hospitals throughout central Florida. The tertiary services offered at its main campus include: Levels II and III NICU, comprehensive medical rehabilitation, adult and pediatric kidney transplant, adult and pediatric bone marrow transplant and is approved for a pediatric liver transplant program. Florida Hospital Orlando also provides adult open heart surgery. Unlike Halifax, Florida Hospital Orlando is not a state certified trauma center. The proposed program will complement the existing kidney transplant program. The pancreas transplant program, if approved, is to be operational by June 1, 2007 and project costs total $106,425 and include no construction. The applicant states that because of its operational adult kidney transplant program, Florida Hospital has all of the necessary equipment for pancreas transplant at the Orlando facility. The applicant states that it does not wish to accept any conditions predicated upon award of the CON. D. REVIEW PROCEDURE The evaluation process is structured by the certificate of need review criteria found in Section 408.035, Florida Statutes. These criteria form the basis for the goals of the review process. The goals represent desirable outcomes to be attained by successful applicants who demonstrate an overall compliance with the criteria. Analysis of an applicant's capability to undertake the proposed project successfully is conducted by assessing the responses provided in the application, and independent information gathered by the reviewer. Applications are analyzed to identify strengths and weaknesses in each proposal. If more than one application is submitted for the same type of project in the same district (subdistrict), applications are comparatively reviewed to determine which applicant best meet the review criteria. Section 59C-1.010(2) (b), Florida Administrative Code, allows no application amendment information subsequent to the application being 3

deemed complete. The burden of proof to entitlement of a certificate rests with the applicant. As such, the applicant is responsible for the representations in the application. This is attested to as part of the application in the Certification of the Applicant. As part of the fact-finding, the consultant, Cheslyn Green analyzed the application in its entirety with consultation from the Economic Analyst, Ryan Fitch who evaluated the financial data as part of the application. E. CONFORMITY OF PROJECT WITH REVIEW CRITERIA The following indicate the level of conformity of the proposed project with the criteria and application content requirements found in Florida Statutes, sections 408.035, and 408.037; applicable rules of the State of Florida, Chapter 59C-1 and 59C-2, Florida Administrative Code; and Local Health Plans. 1. Fixed Need Pool a. Does the project proposed respond to need as published by a fixed need pool? Or does the project proposed seek beds or services in excess of the fixed need pool? ss. 59C-1.008(2), Florida Administrative Code. There is no fixed need pool publication for pancreas transplant programs. Therefore, it is the applicant's responsibility to demonstrate the need for the project, including a projection of the expected number of adult pancreatic transplants that will be performed. There are presently no operational adult pancreas transplant programs in Organ Transplant Service Area (OTSA) 3. As noted at the beginning of this review, OTSA 3 includes District 7, District 9 excluding Palm Beach County, and Lake (District 3) and Volusia Counties (District 4). Both co-batched applicants agree that some portion of the patients they expect to serve in this program will have either had a kidney transplant or need to have both a kidney and pancreas transplant. As noted earlier, both Halifax and Florida Hospital Orlando offer adult kidney transplantation services. Data reported to the Agency for the most recent reporting period, July 1, 2005 though June 30,. 2006 show the following: Florida Adult Kidney Transplantation Program Utilization July 2005 June 2006 Hospital OTSA District Total Procedures 4

Shands at Uof F 1 3 127 St. Luke s 1 4 101 Shands Jacksonville 1 4 55 Tampa General 2 6 203 SW Florida RMC 2 8 38 Florida Hospital Orlando 3 7 145 Jackson Memorial 4 11 198 TOTAL 867 Source: AHCA Utilization Data for Pediatric and Adult Organ Transplantation Programs for July 1, 2005 June 30, 2006 Florida Adult Pancreas Transplantation Program Utilization July 2005 June 2006 Hospital OTSA District Total Procedures Shands at Uof F 1 3 11 St. Luke s 1 4 21 Tampa General 2 6 16 Jackson Memorial 4 11 21 TOTAL 69 Source: AHCA Utilization Data for Pediatric and Adult Organ Transplantation Programs for July 1, 2005 June 30, 2006 Data reported to the Agency show that significantly fewer adult pancreas transplants are performed annually than adult kidney transplants. All adult pancreas transplant providers are also adult kidney transplant providers, but not all adult kidney transplant providers perform adult pancreas transplantation. Data further show that of the two co-batched applicants, Florida Hospital Orlando is the only operational kidney transplant provider during the most recent reporting period and that it preformed among the highest number of adult transplants, with Tampa General and Jackson Memorial performing more. 5

Transplants (Adult) Performed July, 2001 - June 2006 For Kidney Transplants in Florida Based on Agency For Health Care Administration (AHCA) data As of January 5, 2007 July 01 June 02 July 02 June 03 July 03 June 04 July 04 June 05 July 05 June 06 Organ Type Total Kidney Shands Hospital at the University of Florida 102 96 117 112 127 554 St. Luke s Hospital 66 72 92 83 101 414 Shands Jacksonville Medical Center 48 53 46 60 55 262 Tampa General Hospital Southwest Florida Regional Medical Center Bert Fish Medical Center (Terminated 7/27/05) Florida Hospital Orlando Jackson Memorial Hospital Cleveland Clinic Hospital (Terminated 12/31/04) 181 186 155 204 203 929 14 21 31 37 38 141 11 13 13 55 0 92 127 97 117 138 145 624 160 140 181 191 198 870 19 21 22 0 0 62 All Centers Total 728 699 774 880 867 3948 Source: Agency for Health Care Administration Adult Organ Transplantation Program Utilization July 2001- June 2006 Transplants Performed July, 2001 June, 2006 For Pancreas in Florida Based on Agency For Health Care Administration Data as of February 16, 2007 Organ Type July 01 July 02 July 03 July 04 July 05 Total June 02 June 03 June 04 June 05 June 06 Pancreas Shands Hospital at the University of Florida 24 23 30 23 11 111 St. Luke s Hospital 9 16 18 13 21 77 Tampa General Hospital (Operational 1/29/01) 25 30 14 8 16 93 Jackson Memorial 37 36 32 23 21 149 Hospital All Centers Total 95 105 94 67 69 430 Source: Agency for Health Care Administration Adult Organ Transplantation Program Utilization July 2001- June 2006 Historic data also show that unlike kidney transplants, there are not a large number of pancreas transplants preformed in Florida. An examination of other states on the OPTN website reveals a similar pattern. 6

It is noted that unlike other hospital programs, transplant services are reliant on donors and patients are often placed on waiting lists. Utilization data, whether current or historic, is primarily an indication of the number of donors. Although wait lists are an indicator of need, without available donors, they are not by themselves a predictor of utilization. OPTN Wait Current Florida Wait List Registrants as of January 5, 2007 Kidney Pancreas Kidney/Pancreas All Time 2,679 16 90 < 30 Days 132 2 5 30 to < 90 Days 221 3 16 90 Days to < 6 Months 355 5 22 6 Months to < 1 Year 508 0 15 1 Year to < 2 Years 659 2 12 2 Years to < 3 Years 310 2 10 3 Years to < 5 Years 272 1 7 5 or More Years 222 1 3 Source: http://www.optn.org/latestdata/rptdata.asp As shown in the chart above, although a large percentage of kidney transplant patients do not also need a pancreas transplant, more patients need a kidney/pancreas transplant than pancreas alone. Florida Pancreas Donors Recovered January 1, 2001- October 31, 2006 2006 2005 2004 2003 2002 2001 All Donor Types 91 123 130 116 111 132 Deceased Donor 91 123 130 116 111 132 Living Donor 0 0 0 0 0 0 Source: http://www.optn.org/latestdata/rptdata.asp The most recently reported 12-month pancreas transplant data shows that a total of 69 pancreas transplants were preformed in Florida as of June 30, 2006. Donor/patient matches are also a factor in transplant services. However, it is noted that there were 123 pancreas donors in 2005 and 91 as of October 31, 2006. According to the data reported to the Agency (calendar year 2005), 84 percent of pancreas transplants performed in Florida were performed for Florida residents. OTSA 3 residents had 11 pancreas transplants, representing 13.6 percent of all pancreas transplants performed in Florida. Without a pancreas transplant provider located in OTSA 3, all pancreas transplants for OTSA 3 residents were performed either at Shands in OTSA 1 (eight patients), Jackson Memorial Hospital in OTSA 4 (two patients), or Tampa General Hospital in OTSA 2 (one patient). 7

Adult Pancreas Transplants by Patient Residence Year Ended December 31, 2005 Service Area Transplants Performed Percent of Total 1 12 14.8% 2 18 22.2% 3 11 13.6% 4 27 33.3% Out-of-State 13 16.0% Total 81 100.0% Source: Florida Center for Health Information and Policy Analysis database, DRGs 512 and 513 Note: Nine other pancreas transplants occurred for patients who were coded to other DRGs. According to Adventist, during 2005 and 2006 at its main Florida Hospital campus, 40 patients were referred to Florida Hospital s TransLife for kidney transplant who would have potentially benefited from a simultaneous kidney-pancreas (SPK) transplant: Five patients received a kidney transplant only; of these patients, two could have received a SPK transplant had a pancreas transplant program been available locally. Three patients left the area for a kidney and pancreas simultaneous transplant. Twenty-two patients are listed with UNOS and are waiting for a kidney to become available. Of these 22 patients eight would have been candidates for a SPK transplant. Seven patients moved away. Three patients expired. Out of a total of 40 patients referred for kidney transplant, 13 would have been candidates for SPK. Only three of these 13 patients actually received a SPK. Halifax Hospital Medical Center (CON #9956) is projecting five pancreas transplants in year two and three pancreas transplants in year one. In view of the limited number of pancreas transplants projected by the applicant, and the desirability of performing simultaneous kidney/pancreas transplants, the applicant's need projections appear reasonable. However, the applicant did not demonstrate that patients requiring a pancreatic transplant are experiencing difficulty in accessing this service. Adventist Health System/Sunbelt, Inc. (CON #9957) projects that it will perform 10 pancreas transplants in its second year of operation and expects to perform five in its first year. Florida Hospital based its utilization numbers on a number of factors: the absence of a pancreas transplant provider in the service area, the number of OTSA 3 residents who sought SPK (simultaneous kidney-pancreas transplants) in other areas of the state and the high-volume kidney transplant program at 8

Florida Hospital 1. In view of the limited number of pancreas transplants projected by the applicant, and the desirability of performing simultaneous kidney/pancreas transplants, the applicant's need projections appear reasonable. b. Applications for the establishment of new adult pancreas and islet cell transplantation programs shall not normally be approved unless the following criteria are met: 1. The applicant is a teaching or research hospital with training programs relevant to the type of organ transplantation program proposed to be established preceding the application deadline, and no additional program has been approved for the same service planning area. (Rule 59C-1.044(10)(a)). Neither Halifax Hospital Medical Center (CON #9956) nor Florida Hospital (CON #9957) are teaching or research hospitals per statutory definition 408.07(45) which states a teaching hospital means any Florida hospital officially affiliated with an accredited Florida medical school which exhibits activity in the area of graduate medical education as reflected by at least seven different graduate medical education programs accredited by the Accreditation Council for Graduate Medical Education or the Council on Postdoctoral Training of American Osteopathic Association and the presence of 100 or more full-time equivalent resident physicians. There are currently six teaching hospitals throughout the state of Florida: Shands Hospital at the University of Florida in Gainesville, Shands Jacksonville Medical Center in Jacksonville, Tampa General Hospital in Tampa, Orlando Regional Medical Center in Orlando, Jackson Memorial Hospital in Miami and Mount Sinai Medical Center, also in Miami. Halifax Hospital Medical Center (CON #9956) states that it has a Family Medicine Residency Program which provides academic graduate medical education for 24 family medicine physicians, and fellowship training for one sports medicine fellow. 1 Refer to CON #9957 for additional factors, pg. 17 9

According to Adventist Health System/Sunbelt, Inc. (CON #9957), Florida Hospital serves as a teaching hospital for family practice medicine, offers a minimally invasive surgery fellowship, and a rotation in kidney transplantation for surgical residents from the Orlando Regional Medical Center. Florida Hospital also plans to expand its teaching program to include a Surgical Residency Program in July 2007. 2. Applicants have established interactive programs of basic and applied research in organ failure, transplantation, immunoregulatory responses, and related biology. Halifax Hospital Medical Center (CON #9956) does not have the above listed programs established. Its response to this criteria related entirely to cancer research, including cancer drug research. The applicant indicates that the medical center has a 20-year history of conducting cancer clinical research and is affiliated with the Easter Cooperative Oncology Group (ECOG) through the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa and is a full membership with the National Surgical Adjuvant Breast and Bowel Project. Adventist Health System/Sunbelt, Inc. (CON #9957) states that Florida Hospital s TransLife is currently involved in multi-center and single-center clinical research studies, such as the following: Open label, comparative, controlled single-center trial to assess risks and benefits of steroid elimination versus steroid therapy after renal transplantation. An open label, prospective, randomized, controlled, multi-center study assessing fixed dose versus concentration controlled Cellcep regimens for patients following a single organ renal transplantation in combination with full-dose and reduced-dose calcineurin inhibitors. Long-term outcomes of living renal transplants induced with thymoglobulin. Randomized double-blind, controlled multi-center study of the efficacy and safety of valganciclovir verses oral ganciclovir for the prevention of cytomegalovirus in heart, liver and kidney allograft recipients. 10

2. Agency Rule Criteria Chapter 59C-1.044, Florida Administrative Code, contains criteria and standards by which the department is to review the establishment of organ transplantation programs under the certificate of need program. Appropriate areas addressed by the rule and the applicant's responses to these criteria are as follows: a. Coordination of Services. Chapter 59C-1.044(3), Florida Administrative Code. Applicants for transplantation programs, regardless of the type of transplantation program, shall have: 1. 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. Halifax Hospital Medical Center (CON #9956) states that care for the patient in the pre-operative phase is provided by the hospital and by the patient s physician. According to the applicant Nephrology Consultants, PA is the largest nephrology practice group in Volusia County, managing a large volume of kidney failure and pancreas failure patients, including approximately 450 dialysis patients. The applicant states that the hospital has the in-house resources to perform all of the diagnostic and laboratory procedures necessary to qualify patients as candidates for transplantation. The hospital s social services and nursing resources in the kidney/pancreas transplant center will be available to patients and their families to assist in dealing with the personal and psychological issues that result from living with a chronic medical condition, practical issues of paying for medications, transportation and lodging, and vocational rehabilitation. Nurse coordinators will be involved in pre-transplant screening and remain involved throughout the transplant and post-transplant phases. Halifax Medical Center pledges the continuous participation of a dedicated transplant team that can provide patients and families with continuity. 11

Adventist Health System/Sunbelt, Inc. (CON #9957) asserts that Florida Hospital has a significant number of staff and facilities capable of providing the resources necessary to care for the patient s chronic illness prior to transplantation, during transplantation, and in the postoperative period. Services and facilities for inpatient and outpatient care are currently available to meet these needs on a 24-hour basis for the kidney transplant program and will continue to serve these needs in the future. Florida Hospital also states that the pancreas transplant program will be integrated with the existing kidney transplant program. Both pre-transplant and posttransplant services will be provided in the operating rooms, recovery, surgical ICU, and 38-bed transplant unit. The pancreas transplant program will have the 24-hour availability of transplant nurses and physicians currently available to the kidney transplant program. 2. 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. Halifax Hospital Medical Center (CON #9956) states it currently partners with Translife for their organ donation services, and proposes to continue to do so for its kidney transplant service. A 24-hour call system is already in place and Halifax Medical Center states that it has provided Translife with many patients for organ donation in the past; Translife also has arrangements with physician groups that come to Halifax for organ harvesting. The applicant has provided a copy of the contract with Translife in Appendix H of the CON application. Adventist Health System/Sunbelt, Inc. (CON #9957), Florida Hospital, has a written agreement with the organ acquisition center for organ procurement, which was provided with the application. As specified in the agreement, Florida Hospital s TransLife (the OPO) is a department of Florida Hospital and will respond to calls from hospital personnel within 20 minutes of notification. A 24-hour call 12

system is currently in place for the assessment, management, and retrieval of all referred donors, cadaver donors, or organs shared by other transplant programs or organ procurement agencies. The OPO operates in conformance with the requirements of the Organ Procurement and Transplantation Network and the Joint Commission on Accreditation of Health Care Organizations. Florida Hospital is currently authorized for kidney, bone marrow, and liver transplantation. 3. An age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required. Halifax Hospital Medical Center (CON #9956) states there are currently two adult intensive care units: intensive medical care with 32 beds, many of which are private; and intensive surgical care with 32 beds, many of which are also private. The intensive medical care unit has four private rooms that have Laminar Flow. These rooms will be available to kidney/pancreas transplant patients to minimize infection risk. Adventist Health System/Sunbelt, Inc. (CON #9957) states that following transplantation patients will be transferred to the adult surgical intensive care unit, which is the same unit currently utilized by patients in the kidney transplant program. The surgical ICU currently has the ability to offer prolonged reverse isolation, if needed. 4. A clinical review committee for evaluation and decisionmaking regarding the suitability of a transplant candidate. Halifax Hospital Medical Center (CON #9956) states it will impanel a clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate. The committee will include the transplant surgeon, nephrologist, laboratory, and nursing staff. The function will be to review patient histories and test results to verify that the candidate is suitable for transplant. 13

Adventist Health System/Sunbelt Inc. (CON #9957) states after thorough evaluation, adult pancreas transplant candidates will be reviewed at the weekly Patient Review Committee which will include transplant surgeons, nephrologists, a social worker, a financial coordinator, clinical transplant coordinators, and a nurse practitioner. Once approved by the committee, they will be placed on the waiting list, registered with the local OPO. Florida Hospital s pre-transplant coordinators will update medical information on all listed candidates periodically, and the program will reevaluate listed patients based on OPTN guidelines and the severity of illness. 5. 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. Halifax Hospital Medical Center (CON #9956) provided information regarding written protocols for organ transplantation. These protocols included evaluation process policy and procedure, pre-surgery preparation policy, post-surgery hospitalization management policy, and post-transplant care policy. Adventist Health System/Sunbelt, Inc. (CON #9957) provided a draft protocol for patient care for the Pancreas Transplant Guide. This protocol was modeled after similar protocols developed and utilized by Florida Hospital transplant surgeons while performing pancreas transplants in other institutions. Protocols include identification of patient selection criteria for patient management and evaluation during pre-hospital, in-hospital, and immediate post-discharge phases of the program. 6. Detailed therapeutic and evaluative procedures for the acute and long-term management of each transplant program patient, including the management of commonly encountered complications. Halifax Hospital Medical Center (CON #9956) states it will develop the above mentioned procedures in its kidney/pancreas transplant program. The medical center will hire an experienced clinical nurse specialist/renal transplant coordinator to manage the kidney/pancreas 14

transplant program. The kidney/pancreas transplant center will offer a multi-disciplinary approach to patient care during the qualification, waiting period, inpatient episode and posttransplant phases of care. Adventist Health System/Sunbelt, Inc. (CON #9957) has included in its application, the draft Pancreas Transplant Guide which provides therapeutic and evaluative procedures for the acute and long-term management of each adult pancreas transplant program patient including the management of commonly encountered complications. Also for patients who may require specialized acute or post-acute facilities, either while they wait for their transplant or posttransplant, Florida Hospital has an inpatient rehabilitation unit and a long-term care hospital. Adventist Health System has a nursing home division that has skilled and long-term care nursing facilities accessible to Florida Hospital. 7. Equipment for cooling, flushing, and transporting organs. If cadaveric transplants are performed, equipment for organ preservation through mechanical perfusion is necessary. This requirement may be met through an agreement with an organ procurement agency. Halifax Hospital Medical Center (CON #9956) states that it will equip its program with all equipment necessary to transport and preserve cadaveric organs. It will also hire and/or train staff in the proper use of such equipment. Translife will be used for the procurement of cadaveric organs. Adventist Health System/Sunbelt, Inc. (CON #9957) states that Florida Hospital s organ procurement organization, Florida Hospital s Translife, provides the necessary equipment and personnel to recover solid organs for transplantation. 15

8. An on-site 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. Halifax Hospital Medical Center (CON #9956) states Translife currently uses Florida Hospital in Orlando for tissue typing and cross matching. Florida Hospital s laboratory is ASHI certified. Adventist Health System/Sunbelt, Inc. (CON #9957) states that Florida Hospital has a tissue-typing laboratory which meets the requirements of the American Society for Histocompatibility. State of Florida AHCA licensure and evidence of CAP accreditation are provided in the application. 9. Pathology services with the capability of studying and promptly reporting the patient's response to the organ transplantation surgery, and analyzing appropriate biopsy material. Halifax Hospital Medical Center (CON #9956) states that it has a full-service pathology service headed by Dr. Lora Shehi and Dr. William Douglass. The department has five full-time anatomical and clinical pathologists all with specialty training. Adventist Health System/Sunbelt, Inc. (CON #9957) Florida Hospital s pathology department asserts that it is fully qualified to meet the needs of the pancreas transplant programs and specifically in the analysis of biopsy materials. The department works closely with the kidney transplant program. 10. Blood banking facilities. Halifax Hospital Medical Center (CON #9956) states that its blood bank offers a full-range of services. The laboratory is supervised by a certified specialist in blood banking and is directed by Dr. Lora Shehi. The applicant has included a copy of the medical center s blood and blood components supply agreement with Central Florida Blood Bank. 16

Adventist Health System/Sunbelt (CON #9957) indicates that Florida Hospital currently has a working relationship with Florida s Blood Center. 11. A program for the education and training of staff regarding the special care of transplantation patients. Halifax Hospital Medical Center (CON #9956) states that it intends to hire an experienced clinical nurse specialist to manage the kidney/pancreas transplant program. This manager will be responsible for training and hiring of nursing and technical staff trained in transplant surgical issues as well as the post-operative care of transplant patients. Halifax Medical Center plans to institute a multidisciplinary team approach to the care and management of its transplant patients. This approach will involve participation from representatives of not only surgical and nursing disciplines, but psychiatry, pharmacy, social services, and nutritional services. Adventist Health System/Sunbelt, Inc. (CON #9957) states that Florida Hospital s Translife offers extensive ongoing continuing education training for both new staff and existing staff working in all phases of the transplant program. In the pancreas transplant program, the clinical transplant coordinators will be responsible for providing continuing education to the nurses on the transplant unit. All of the transplant coordinators are certified clinical transplant coordinators (CCTCs). 12. Education programs for patients, their families and the patient's primary care physician regarding after-care for transplantation patients. Halifax Hospital Medical Center (CON #9956) states it will recruit a clinical specialist with experience in renal/pancreas transplantation who will serve as the initial renal/pancreas transplant coordinator. Halifax Medical also plans to establish a renal/pancreas transplant clinic for patients to be followed both pre and post-transplant. The clinic will provide extensive educational programming for both the pre and post-transplant episodes of care. 17

According to Adventist Health System/Sunbelt, Inc. (CON #9957), Florida Hospital, all candidates for transplant and their families are provided written materials, on-site education, assigned to a clinical pre-transplant coordinator, and encouraged throughout the pre and post-transplant process to continue to learn and ask questions about the pre and post-transplant care. The patients education about after-transplant care begins at their first visit as a potential candidate for a pancreas transplant and continues for a lifetime. b. Staffing Requirements. Applicants for transplantation programs, regardless of the type of transplantation program, shall meet the following staffing requirements. Chapter 59C- 1.044(4), Florida Administrative Code. 1. 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. A physician with one-year experience in the management of infectious diseases in the transplant patient shall be a member of the transplant team. Halifax Hospital Medical Center (CON #9956) states it will be compliant with this Rule criterion. Adventist Health System/Sunbelt, Inc. (CON #9957) provides detail, stating Florida Hospital currently has two transplant surgeons on its medical staff. Dr. Michael Angelis and Dr. Bobby Nibhanupudy are both ASTS multi-organ trained transplant surgeons. Dr. Angelis and Dr. Nibhanupudy previously met the OPTN/UNOS criteria for pancreas transplant program directors. Their curriculum vitae were provided in the application. Dr. Angelis has performed over 30 pancreas transplants. Dr. Angelis also completed a two-year fellowship in multi-organ transplants (small bowel, kidney, liver, and pancreas) between 1998 and 2000 at the University of Miami/Jackson Memorial Hospital, the pancreas transplant program in OTSA 4. In addition, Dr. Tom Chin, who is the liver transplant director at Florida Hospital, is an abdominal transplant surgeon, including pancreas, kidney, and liver. Dr. Chin meets current 18

OPTN/UNOS criteria and will be the pancreas transplant program surgical director. A curriculum vitae for Dr. Chin was also provided in the application. Dr. U. Desai, a nephrologist, meets current OPTN/UNOS criteria and will serve as the pancreas transplant medical director. 2. A program director who shall have a minimum one year formal training and one year of experience at a transplantation program for the same type of organ transplantation program proposed. Halifax Hospital Medical Center (CON #9956) states that it is in the process of recruiting a transplant surgeon for its kidney transplant program. Upon approval, the transplant surgeon will serve as the medical director of the pancreas transplant program. The applicant states that the transplant surgeon will have at least one year of formal training and one year of experience at a pancreas transplantation program. Adventist Health System/Sunbelt, Inc. (CON #9957) states that Dr. Tom Chin, who is the liver transplant director at Florida Hospital and who is an abdominal transplant surgeon will serve as the surgical director for the pancreas transplant program. 3. A staff with experience in the special needs of children if pediatric transplantations are performed. This criterion is not applicable for both applicants. The current applications are for adult pancreas transplant programs. 4. A staff of nurses, and nurse practitioners with experience in the care of chronically ill patients and their families. Halifax Hospital Medical Center (CON #9956) states it will hire an experienced RN renal/pancreas transplant coordinator with experience in patient care and education. 19

The medical center currently provides dialysis services through a contractual arrangement with Gambro Healthcare and is implementing in-house capabilities. The hospital currently has a staff of nurses and nurse practitioners with experience in the care and treatment of chronically and acutely ill patients. Adventist Health System/Sunbelt, Inc. (CON #9957), Florida Hospital, states that the transplantation program will have access to nurses and nurse practitioners with experience in the care of chronically ill patients and the support of their families. 5. 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. Halifax Hospital Medical Center (CON #9956): The applicant s blood bank is affiliated with Central Florida Blood Bank and can provide a full compliment of products and components as related to transplant. The department also has an on-site blood irradiator for blood and component irradiation for immunocompromised transfusion recipients. Adventist Health System/Sunbelt, Inc. (CON #9957) states that Florida s Blood Center currently has an ongoing relationship with Florida Hospital. Florida Hospital s Translife has an excellent working relationship with Florida s Blood Center, including working together to determine blood need for the liver transplant program. Florida Hospital states it has the ability to meet the need for blood products by the proposed program. 6. Nutritionists with expertise in the nutritional needs of transplant patients. Halifax Hospital Medical Center (CON #9956) states that nutritional services assessments will be performed by a dietician registered with the American Dietetic Association and licensed by and in the State of Florida with at least one year of hands-on experience in renal dietetics. Adventist Health system/sunbelt, Inc. (CON #9957) states that Florida Hospital will not need to expand its nutrition department in order to provide this program. 20

7. Respiratory therapists with expertise in the needs of transplant patients. Halifax Hospital Medical Center (CON #9956) indicates that it has a large respiratory therapy department. Staff members with experience in the care of transplant patients currently serve on the medical center s staff. Adventist Health System/Sunbelt, Inc. (CON #9957) states that respiratory therapists at Florida Hospital have experience in the current transplant programs. The respiratory therapists are primarily involved with the needs of transplant patients during their inpatient stay. The respiratory therapists presently provide care to immunosuppressed transplanted patients. 8. Social workers, psychologists, psychiatrists, and other individuals skilled in performing comprehensive psychological assessments, counseling patients, and families of patients, providing assistance with financial arrangements, and making arrangements for use of community resources. Halifax Hospital Medical Center (CON #9956) commits to providing an extensive and qualified staff of social workers, psychologists, and psychiatrists trained and competent to provide the services referenced in this rule criterion. Halifax also provides a comprehensive array of medical services, including inpatient psychiatric services. Halifax Medical Center is chartered to provide medical care and services to indigent populations in its service area. The applicant also states it commitment to providing funding or sources of funding for the cost of immunosuppressant drugs for its patients. Adventist Health System/Sunbelt, Inc. (CON #9957) states that social workers, psychologists, and psychiatrists are available to provide support and assessments to patients and their families who are seeking transplantation. All potential transplantation patients are assessed by social workers. Services of psychologists, psychiatrists, and others such as addition specialists are available as deemed appropriate by the patient, their family, or the transplant team. Although financial evaluation will be completed as part of the pre-assessment process for pancreas transplant 21

patient. Social workers and financial counselors will work closely with the patient and their family prior to transplantation, during their inpatient stay, and also during the post-transplant follow-up care. Neither of the applicants discussed the availability of patient/family housing during the time period the patient/family is waiting for a transplant or waiting for return to home. There is no indication that either hospital provides leased apartments within close proximity to the transplant center. c. 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. 1. The number of patients by county origin and zip code 2. The average gross revenue per admission. 3. The average length of stay. Halifax Hospital Medical Center (CON #9956) states it will comply with all reporting requirements. Adventist Health System/Sunbelt, Inc. (CON #9957) states that as an existing transplant provider Florida Hospital currently complies with the organ transplant data reporting requirements and will continue to do so in both existing transplant programs and the proposed adult pancreas transplant program. 22

3. Statutory Review Criteria a. Is need for the project evidenced by the availability, quality of care, efficiency, accessibility and extent of utilization of existing health care facilities and health services in the applicant's service area? ss. 408.035(1), (2), (5), and (7), Florida Statutes. Access There is currently no adult pancreas transplant service provider in Organ Transplant Area 3 (OTSA) which is comprised of 10 counties: Volusia, Lake, Seminole, Orange, Osceola, Brevard, Indian River, Okeechobee, St. Lucie, and Martin. The four existing Florida pancreas transplant providers are located in OTSA 1 (St. Luke s and Shands at UF), OTSA 2 (Tampa General), and OTSA 4 (Jackson Memorial Hospital). According to the AHCA inpatient data base (calendar year 2005), 84 percent of pancreas transplants performed in Florida were performed for Florida residents. OTSA 3 residents had 11 pancreas transplants, representing 13.6 percent of all pancreas transplants performed in 23

Florida. Without a pancreas transplant provider located in OTSA 3, all pancreas transplants for OTSA 3 residents were performed either at Shands in OTSA 1 (eight patients), Jackson Memorial Hospital in OTSA 4 (two patients), or Tampa General Hospital in OTSA 2 (one patient). Adult Pancreas Transplants by Patient Residence Year Ended December 31, 2005 Service Area Transplants Performed Percent of Total 1 12 14.8% 2 18 22.2% 3 11 13.6% 4 27 33.3% Out-of-State 13 16.0% Total 81 100.0% Source: Florida Center for Health Information and Policy Analysis database, DRGs 512 and 513 Note: Nine other pancreas transplants occurred for patients who were coded to other DRGs. Halifax is projecting five procedures in year two and Florida Hospital is projecting 10 procedures by year two. Pancreas transplants per facility over the past five years have varied. Both Halifax and Adventist s projections indicate they expect to operate small programs, with Halifax being the smaller of the two. Although neither applicant demonstrated that patients needing this service were unable to obtain it, the establishment of an adult pancreas transplant program in connection with an existing kidney transplant program in OTSA 3 will improve access to these services, including geographic access. As shown above several patients received a pancreas transplant in OTSA 4, at Jackson Memorial Hospital in Miami, Florida. Unlike its co-batched applicant Adventist, Halifax has agreed to ensure care is provided to the medically indigent. Access to care for the medically needy will be improved with the implementation of a program at Halifax. If approved, Halifax will be awarded the CON with the following conditions: 1. A minimum of five percent of its pancreas transplant procedures to uninsured patients. 2. Implementation of programs to assist in funding immunosuppressant drugs for indigent and uninsured pancreas transplant patients ranging from working with drug manufacturers to secure favorable purchase prices for such drugs to direct subsidy. The applicant will annually provide evidence, including dollar amounts and a list of manufacturers it has worked with, of its assistance in funding this program. 24

3. Implementation of programs to support indigent patients in meeting compliance criteria for pancreas transplantation. The applicant will provide evidence that these programs have been implemented and report of indigent patients it has successfully helped to meet compliance criteria for pancreas transplantation annually. Quality of Care Both applicants are approved to operate adult kidney transplant programs. Kidney and pancreas transplant surgery is often done simultaneously. The ability of a kidney transplant provider to also provide pancreas transplants is expected to improve care provided to the patient. Need for the project is evidenced by the availability, quality of care, efficiency, accessibility and extent of utilization of existing health care facilities and health services in the applicant's service area. b. Does the applicant have a history of providing quality of care? Has the applicant demonstrated the ability to provide quality care? Is the applicant a Gold Seal Program nursing facility that is proposing to add beds to and existing nursing home? ss. 408.035(3), 408.035(10), Florida Statutes. Florida Hospital has had 27 confirmed complaints. Halifax has had one confirmed complaint and two confirmed complaints without deficiency. Halifax Hospital Medical Center (CON #9956) is accredited by the Joint Commission of Accreditation of Health Care Organizations (JCAHO) and has received the following awards and recognitions for its services: Distinguished Hospital Award for Clinical Excellence in January of 2004 for the second consecutive year placing Halifax in the top 3.4 percent of all acute care hospitals in the country in terms of overall excellence across a broad array of services. Solucient 100 Top Hospitals: National Benchmarks for Success, study in the teaching hospital category. Solucient recognizes hospitals that have achieved excellence in quality of care, operational efficiency, financial performance and adaptation to environmental change. 25

Leading Consumer Choice Hospital: Selection as a pilot site for the Joint Commission on Accreditation of Healthcare Organization project to develop Technical Implementation Guide for the 15 voluntary consensus standards for nursing-sensitive care performance measures. The medical center also has an active and successful performance improvement program in place that is designed to produce measurable improvements in quality of services and consumer satisfaction. Adventist Health System/Sunbelt, Inc. (CON #9957) states that it received the U.S. Department of Health and Human Services (HHS) Medal of Honor for Organ Donation. Florida Hospital has also received accreditation from the Joint Commission on Accreditation of Healthcare Organization and College of American Pathology Accreditation. In addition, Adventist Health System/Sunbelt, Inc. has received numerous awards recognizing its high quality of care. Examples are as follows: One of America s Best Hospitals. Florida Hospital has been recognized eight years in a row (1999-2006) by U.S. News and World Report as One of America s best Hospitals for clinical specialties. Medicare Leader: Florida Hospital is the largest provider of Medicare services in the nation. (2004) Hospital of the Future: The Wall Street Journal named Florida Hospital the Hospital of the Future (1999) Hospital of the 21 st Century: Florida Hospital Celebration Health received the Premier Patient Services Innovator Award as The Model for Healthcare Delivery in the 21 st century. Top Cardiac Center: Modern Healthcare named Florida Hospital one of the Top 100 Hospitals for Cardiac Care (2002) c. What resources, including health manpower, management personnel, and funds for capital and operating expenditures, are available for project accomplishment and operation Halifax Hospital Medical Center (CON #9956) is applying to establish an adult pancreas transplant center in Organ Transplant Service Area 3. The financial impact of the project will include the project cost of $207,925 and year two incremental operating costs of $432,838. The audited financial statements of the applicant for the periods ending September 30, 2004 and 2005 were analyzed for the purpose of 26