STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED (954)

Transcription

1 STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED A. PROJECT IDENTIFICATION 1. Applicant/CON Action Number North Broward Hospital District/CON # Southeast 17 th Street Fort Lauderdale, Florida Authorized Representative: Ms. Charlotte C. Mather-Taylor (954) Service District/Subdistrict Organ Transplantation Program Service Area 4 which includes: District 10 (Broward County), District 11 (Miami-Dade and Monroe Counties), District 8 (Collier County only), and District 9 (Palm Beach County only). B. PUBLIC HEARING A public hearing was not held or requested regarding the proposal to establish an adult liver transplantation program in Broward County, District 10, Organ Transplant Service Area 4. However, the applicant submitted 49 unduplicated letters of support in its application (CON #10087, Tab #1). The support letters were submitted in the following order: 12 elected officials, 11 patients, 13 physicians, five other and seven other hospital and staff. Each letter category is briefly described below. The elected officials letters of support were as follows: the Honorable Nan Rich, 34 th District, the Honorable Jeremy Ring, 32 nd District and the Honorable Christopher Smith, 29 th District of The Florida Senate; the Honorable Ellyn Setnor Bogdanoff, District 91, the Honorable Gwyndolen Clarke-Reed, District 92, the Honorable Matt Hudson, District 101, the Honorable Ari Abraham Porth (not dated), District 96, the Honorable Franklin Sands, District 98, the Honorable Perry Thurston, Jr., District 93 and the Honorable James Jim Waldman, District 95 of The Florida House of Representatives; the Honorable Ilene Lieberman,

2 Commissioner, District 1, Broward County Board of County Commissioners and the Honorable John Jack Seiler, Mayor, City of Fort Lauderdale. These letters indicate that Broward General Medical Center s adult liver transplant program has increased access for residents and constituents and that the application should be approved to maintain geographic access for the many and frequent pre and post (often lifetime) transplant services required for successful adult liver transplantation. Commissioner Lieberman states she has first-knowledge of the burden on transplantation patients and their families and has worked to ease this burden by helping to bring transplantations services to Broward County patients. She indicates that Jackson s financial troubles were the reason it decided to close the shared program. Commissioner Lieberman states that Broward General s transplant center has made it easier for residents of Broward, Palm Beach and other counties to receive a transplantation operation, and pre- and post transplantation services. She indicates that she has long supported efforts to build a transplant house on the grounds of Broward General Medical Center and that it is scheduled to be built in The transplant house will serve as a temporary residence for patients and families that need pre and post-care for adult liver transplantation. City of Fort Lauderdale Mayor Seiler states that prior to Broward General Medical Center s adult liver transplant program, uninsured and Medicaid patients in need of this service were facing challenges in obtaining needed follow-up care. The support letters from patients and families expressed genuine thanks and gratitude for the kindness, care and expertise shown at Broward General in the adult liver transplantation program. Four of these 11 support letters were handwritten. One of the 13 physician support letters was signed by 15 physicians of the medical council of Broward General Medical Center 1. Of the remaining 12 physician letters of support, eight were directly affiliated with Broward General Medical Center (some also on the medical council), six were directly affiliated with the University of Miami/Miller School of Medicine and one was a senior executive with the Community Blood Centers of South Florida, Inc. Ernesto Pretto, MD, MPH, Chief, Division of Solid Organ Transplant, Department of Anesthesiology, Jackson Memorial Hospital/University of Miami/Miller School of Medicine, Akin Tekin, MD, Assistant Professor of Surgery, Division of Liver/GI Transplantation, University of Miami/Miller School of Medicine and 1 Though some of these 15 physicians also provided separate letters of support, each physician s support was not counted more than once. 2

3 Glenn Singer, MD, indicate that Broward General has performed approximately 176 transplant operations since 2004 and that program closure would cause distress to many patients and their families. All physicians state that Broward General is an excellent provider and will continue providing excellent adult liver transplantation procedures and pre and post care services, if the project is approved. David Levi, MD, Professor of Surgery, Division of Liver/GI Transplantation, Medical Director, Life Alliance Organ Recovery Agency, states that project denial would cause significant challenges for residents in Broward, Palm Beach and Collier Counties. Gennaro Selvaggi, MD, Associate Director, Liver Transplant Program at Broward General, Associate Professor of Clinical Surgery, University of Miami/Miller School of Medicine states that in the past three years all but three transplants performed at Broward General were performed on residents of Broward, Palm Beach and Collier Counties and that this solidifies the bond between the local population and Broward General s transplant services. Andreas Tzakis, MD, PhD, Director, Liver Transplant Program, Broward General Medical Center, University of Miami/Miller School of Medicine states that he has been the director of the Jackson Memorial Hospital liver transplant program since 1994 and the corresponding program at Broward General since it opened in 2004 and that he will continue in this capacity. Bruce Lenes, MD, Medical Director, Community Blood Centers of South Florida, Inc. states his organization intends to continue serving the transfusion and blood banking needs of Broward General. Humberto Spezian, Assistant Vice President of Business Services, University of Miami Business Services, states that the University of Miami has been providing physician services to the shared liver transplant program since 2004 and is committed to providing these services under the CON owned by North Broward Hospital District. Mr. Spezian states that a memorandum of understanding between the University of Miami and North Broward Hospital District is nearly complete however, it will not be executed prior to the filing of the District s CON application for the liver transplantation program. The other support letters include: Leslie Cortina, CPA, Executive Director, Life Alliance Organ Recovery Agency, Susan Myers, Ed. S., Director, Broward County Human Services Department and Jon Polenberg, Director, Transplant Foundation, Inc., and two from local residents. Ms. Myers indicates that Broward General has continued to demonstrate a strong commitment to serving low income patients and between October 2006 through September 2009, provided over half (54.1 percent) of the 98 adult liver transplants to low income patients (Medicaid/charity and uninsured). She states that no other program in the state comes close to Broward s level of adult liver transplant services 3

4 to the low income population. Ms. Cortina and Mr. Polenberg indicate that their organizations presently work with Broward General and will continue to do so should the project be approved. The other hospitals and staff letters include two from executives of hospitals in the North Broward Hospital District network: Pauline Grant, MS, MBA, FACHE, Chief Executive Officer, North Broward Medical Center and Calvin Glidewell, FACHE, CEO, Imperial Point Medical Center. Frank Sacco, FACHE, President and Chief Executive Officer, Memorial Healthcare System d/b/a South Broward Hospital District, states that Memorial Healthcare does not hesitate to refer adult liver transplant patients to Broward General and that some of these patients have been low income/uninsured individuals whose lives were saved due to the applicant s commitment to providing world-class health care regardless of ability to pay. Eneida Roldan, MD, MPH, MBA, President and CEO, Jackson Health System, indicates that Jackson Health System is aware of the application and is not opposed to it. C. PROJECT SUMMARY North Broward Hospital District (the applicant) proposes to establish an adult liver transplantation program at Broward General Medical Center, Service Area 4. The applicant indicates that the project will predominantly serve the residents of Broward, Collier and Palm Beach counties. The applicant currently provides adult liver transplantation services through a shared services arrangement with Jackson Memorial Hospital (Miami-Dade County). North Broward Hospital District is a special independent taxing district created pursuant to Chapter 27438, Laws of Florida, Special Acts of 1951, for the purpose of establishing and operating necessary health facilities for citizens of the district. In addition to Broward General, the district s hospital division includes North Broward Medical Center, Imperial Point Medical Center and Coral Springs Medical Center. Broward General Medical Center is a 716-bed facility consisting of 570 acute care beds, 36 Level II NICU beds, 27 Level III NICU beds and 83 adult psychiatric beds. Broward General Medical Center provides Level II Adult Cardiovascular Services and is a designated Primary Stroke Center. Broward General Medical Center is also a state designated Level I trauma center. 2 The estimated total project cost is $1,035,049 with no new construction or renovation involved. The total project cost consists entirely of equipment, project development and start-up costs. 2 Source: Florida Department of Health website at 4

5 Schedule C includes the following conditions: North Broward Hospital District will continue to honor the condition in place regarding CON #9593 for the existing shared services program calling for development and implementation of a marketing plan, with slight geographic modification. North Broward Hospital District will continue its marketing and medical community outreach activities with an emphasis on Collier, Palm Beach and Broward Counties. The marketing program has been successfully developed and implemented to support the existing program. It will be modified to make clear that the program at Broward General Medical Center is an independent program, but will otherwise continue Broward General Medical Center's efforts to inform the medical community of the availability, accessibility, and admission policies of the program. Broward General Medical Center will continue to provide an annual written summary of marketing and outreach activities to the Agency. Likewise, North Broward Hospital District will continue to strive to meet the needs of all patients regardless of geographic residence or ability to pay. In furtherance of this goal, North Broward Hospital District will perform liver transplants on all patients who are placed on the UNOS Liver Transplant List of Florida Organ Transplant Region IV originating in Collier, Palm Beach and Broward Counties, if an organ match is found and if the patient remains medically able to undergo the transplant. North Broward Hospital District is committed to addressing the needs of all patients who present or inquire at Broward General Medical Center. This condition highlights our commitment to the previously underserved portions of Service Area 4. Compliance will be demonstrated, as is currently the case, through UNOS waiting list data, and through Broward General Medical Center admissions and discharge data. The Agency notes the following pertinent conditions from CON #9593: Develop and implement a marketing plan directed to the medical community in Collier, Palm Beach and Monroe Counties within Florida Organ Transplant Region IV. 5

6 Perform liver transplants on all patients who are placed on the UNOS Liver Transplant List of Florida Organ Transplant Region IV, if an organ match is found and the patient remains medically able to undergo the transplant. Should the project be approved, the applicant s proposed conditions would be reported in the annual condition compliance report as required by Rule 59C (3) Florida Administrative Code. D. REVIEW PROCEDURE The evaluation process is structured by the certificate of need review criteria found in Section , 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(3)(b), Florida Administrative Code, allows no application amendment information subsequent to the application being 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, Steve Love analyzed the application in its entirety with consultation from the financial analyst Derron Hillman, who evaluated the financial data. 6

7 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 , and ; applicable rules of the State of Florida, Chapter 59C-1 and 59C-2, Florida Administrative Code. 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? Rule 59C-1.008(2), Florida Administrative Code. There is no fixed need pool publication for adult liver 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 liver transplants that will be performed in the first years of operation. Service Area 4 includes Districts 10 and 11, Collier County in District 8 and Palm Beach County in District 9. The Service Area has one operational adult liver transplant program, the Broward General Medical Center shared service arrangement with Jackson Memorial Hospital (Miami-Dade County). There are no CON approved programs. Data reported to the Agency by the local health councils for Calendar Year 2009 show the following adult liver transplant utilization by facility: Florida Adult Liver Transplantation Program Utilization January 2009 December 2009 Hospital Service Area District Total Procedures Shands at Univ. of Florida (UF) 3 40 Mayo Clinic Tampa General Hospital Florida Hospital-Orlando Broward General Med. Center* Jackson Memorial Hospital* TOTAL 526 Source: Florida Adult Organ Transplantation Program Utilization data published April 2, *Shared program with Jackson Memorial Hospital. Mayo Clinic and Jackson Memorial Hospital are performing the highest number of adult liver transplants in the state. Broward General Medical Center s program, which is completing the least number of adult liver 7

8 transplants, has a shared program arrangement with Jackson Memorial Hospital. Jackson Memorial is located approximately 26.3 miles south of Broward General. The two next closest programs to Broward General are Florida Hospital-Orlando and Tampa General Hospital who together completed 159 adult liver transplants during Shands Hospital at the University of Florida completed 40 procedures. Florida Hospital-Orlando is approximately 217 miles 3 distant from the applicant. Below is a five-year chart to account for adult liver transplantations performed from calendar year 2005 through As shown, the cumulative totals for the facilities are consistent with the totals for calendar year 2009 in that Mayo Clinic and Jackson Memorial Hospital performed the highest number of adult liver transplants in the state. Broward General Medical Center performed the fewest number of adult liver transplantations, with an average of 30 procedures each year. Adult Liver Transplantation Procedures CY Facility/Organ Transplant Service Area TOTAL Shands Hospital at UF (Service Area 1) Mayo Clinic/St. Luke s Hospital (Service Area 1)* Tampa General Hospital (Service Area 2) Florida Hospital-Orlando (Service Area 3)** Broward General Medical Center (Service Area 4)*** Jackson Memorial Hospital (Service Area 4)*** State Total ,631 Source: Florida Adult Organ Transplantation Program Utilization data for above indicated years. Notes: *Mayo Clinic licensed former St. Luke s Hospital program effective 4/12/2008. **Florida Hospital-Orlando s adult liver transplant program became operational 6/3/07. ***Shared program with Jackson Memorial Hospital. It is noted that unlike other hospital programs, transplant services are reliant upon 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

9 Organ Procurement and Transplantation Network (OPTN) Current Florida Wait List Registrants as of July 13, 2010 Liver Total 367 < 30 Days to < 90 Days Days to < 6 Months 47 6 Months to < 1 Year 48 1 Year to < 2 Years 43 2 Years to < 3 Years 36 3 Years to < 5 Years 48 5 or More Years 50 Source: asp Donor/patient matches are also a factor in transplant services. The chart below contains the most recent five-year volume of liver donations by Florida residents. Florida Liver Donors Recovered January 1, December 31, All Donor Types Deceased Donor Living Donor Source: asp As shown above there were 437 liver donors in Florida Center for Health Information and Policy Analysis data indicates there were a total of 472 adult liver transplants performed at Florida Hospitals in CY Therefore, the total procedures (472) exceeded the donors (437) by 35 in calendar year Agency data indicates that 394 of 472 (or percent) of the adult patients (15 years of age or older) receiving liver transplants performed in Florida in CY 2009 were Florida residents 4. Service Area 4 residents accounted for 107 of the 394 procedures, or percent. Below is a chart to account for these totals. 4 DRGs 005 and 006 as reported in the Florida Center for Health Information and Policy Analysis database for CY There were 526 total adult liver transplant procedures reported to the local health councils for CY Some variation in the patient data is to be expected. 9

10 Adult Liver Transplants at Florida Hospitals by Patient Residence Calendar Year 2009 Service Area Transplants Performed Percent of Total % % % % Out-of-State % Total % Source: Florida Center for Health Information and Policy Analysis CY 2009 database, DRGs 005 & 006. Service Area 4 residents generally do not migrate outside their home service area for this service. Below is a chart to account for these procedures. Service Area 4 Resident Facility Selection Adult Liver Transplantation Procedures CY 2009 Facility/Organ Transplant Service Area Patient Total Patient Percent Shands Hospital at UF (Service Area 1) % Mayo Clinic (Service Area 1) % Tampa General Hospital (Service Area 2) % Florida Hospital-Orlando (Service Area 3) % Broward General Medical Center (Service Area 4)* % Jackson Memorial Hospital (Service Area 4)* % Service Area 4 Total % Source: Florida Center for Health Information and Policy Analysis CY 2009 database, DRGs 005 and 006. *Shared program with Jackson Memorial Hospital. The above chart indicates that 99 of the 107 (or percent) of Service Area 4 residents/patients who had liver transplants remained in Service Area 4 for the procedure (most often Jackson Memorial Hospital and second most often Broward General Medical Center). Broward General Medical Center s service to Area 4 residents consisted of 14 Broward County residents, five Palm Beach, and one each from Collier and Monroe counties. Forty-one Miami-Dade County residents sought liver transplants and 40 of these were obtained at Jackson Memorial. Jackson Memorial served 22 Broward County, 11 Palm Beach, three Collier and two Monroe County residents. Mayo Clinic s two patients were residents of Palm Beach County. Tampa General served two Broward County residents, one Collier and one Miami-Dade resident. While the tables above indicate Jackson Memorial Hospital realized the highest number of applicable procedures in 2009 of Service Area 4 adult liver transplant providers (78 of 107 procedures), the table below reflects the proportionate Medicaid/Medicaid HMO patient count and patient days for these services. 10

11 Service Area 4 Residents Adult Liver Transplantation Procedures CY 2009 All Payers Total Patient Count Medicaid/ Medicaid HMO Patient Count All Payers Total Patient Days Medicaid/ Medicaid HMO Patient Days Facility Percent Percent Broward General Medical Center* % % Jackson Memorial Hospital* % % Other % % Total % % Source: Florida Center for Health Information and Policy Analysis CY 2009 database using DRGs 005 & 006. *Shared program with Jackson Memorial Hospital. As shown above, in calendar year 2009, the applicant absorbed a proportionately higher percentage rate of Medicaid/Medicaid HMO Service Area 4 residents needing liver transplants. Agency data indicates that Broward General Medical Center provided 15 of its 24 total liver transplants (includes three patients from outside the service area) to Medicaid/Medicaid HMO patients 5. The applicant expects to perform 34 adult liver transplants in the first year of operation (ending September 30, 2011) and 37 in the second year of operation (ending September 30, 2012). Broward General averaged approximately 33 transplants a year during CY 2007 through CY 2009, so the proposed volume is reasonable. The applicant estimates that 16 transplants will be provided to Medicaid, Medicaid HMO and charity care patients during both years one and two. Considering that the applicant provided adult liver transplants to 15 Medicaid/Medicaid HMO patients in 2009, this estimate appears to be reasonable. 2. Applications for the establishment of new adult liver transplantation program shall not normally be approved in a service planning area unless the following additional criteria are met: (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. Broward General Medical Center does not meet the definition of a teaching hospital as shown in Rule 59C-1.044(2)(g), Florida Administrative Code; however, it reports it does meet the definition of a research hospital as set forth in paragraph (2)(d) of the same rule. 5 Florida Center for Health Information and Policy Analysis database, DRGs 005 and 006 Liver Transplant for CY

12 Broward General Medical Center offers clinical trial options to its community by conducting cancer clinical research studies for adults and children as well as an established cardiac clinical trial program offering cardiovascular disease related trials. Broward General Medical Center is a Level One Trauma Center and in addition to providing comprehensive services to severely injured patients, Level One centers are required to maintain a trauma teaching and research capability. The applicant provides an extensive list of current clinical trials, trauma research and medical staff research (a clinical trial report roster with research studies totaling 108 projects), a variety of publications and abstracts by staff physicians and signed university research affiliation agreements between the Broward General Medical Center and both the Florida International University College of Medicine and the Nova Southeastern University College of Osteopathic Medicine 6. The applicant notes areas of research in adult cancer, child cancer, cardiovascular trials, along with pharmaceutical clinical research studies and also trauma. (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. Broward General Medical Center reports a department of gastroenterology, with Satya Singh, MD and Murali Shankar, MD staffing the department. For Agency review, the applicant provides CVs of these physicians 7. These two physicians CVs indicate they are board-certified gastroenterologists 8. The applicant reports that procedures performed include all surgical specialties, including liver transplant. Procedures include the full complement of diagnostic, therapeutic and interventions using flexible endoscopes, and minimally invasive techniques. The transplant clinic is reported to be in the west/wing - first floor. Hours of operation are typical daytime business hours. 6 CON Application #10087, Tab Ibid, Tab Board certification in gastroenterology, for both these physicians, is verified through the Florida Department of Health s Division of Medical Quality Assurance Practitioner Profile, at 12

13 2. Radiology services to provide complex biliary procedures, including transhepathic cholangiography, protal venography and arteriography. As a Level One Trauma Center, Broward General Medical Center reports it maintains a high level, state-of-the-art radiology service with 24/7 on-site coverage, managed by Jon Guben, MD, Chief of Radiology at Broward General. For Agency review, the applicant provides the hospital s radiology scope of service and a CV of this physician 9. Dr. Guben s CV indicates he is a Diplomate of the American Board of Radiology 10. The applicant reports radiology services with the capability 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. Broward General Medical Center s laboratory is stated to have been working with the shared services liver transplant program since its inception in 2004 and to be capable of implementing the proposed stand-alone program. This includes performing and promptly reporting results of liver function tests as well as required chemistry, hematology, and virology tests. 4. A patient convalescent unit for further monitoring of patient progress for approximately one month posthospital discharge following liver transplantation. Broward General Medical Center reports that, based on its experience, most liver transplant patients do not require convalescent unit care following hospital unit discharge. Per 9 CON Application #10087, Tab Board certifications in diagnostic radiology and also in vascular and interventional radiology, for this physician, is verified through the Florida Department of Health s Division of Medical Quality Assurance Practitioner Profile, at 13

14 Broward General, for the vast majority of patients, monitoring activity following hospital discharge is conducted on an outpatient basis in the clinic, treatment rooms, or physician offices. However, for those instances in which convalescent unit care is required, Broward General reports referral arrangements with skilled nursing and long-term care facilities with appropriate convalescent care capability for transfer of patients. Broward General in partnership with the Transplant House Foundation has developed plans, secured property, and is in process of finalizing financing so as to begin construction on the Broward Transplant House 11. The transplant house is to be a freestanding housing facility of 16 units, available to patients and family members before, during, and after the transplant surgery. (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. The applicant reports that largely as a result of the long-standing shared services liver transplant program between Broward General Medical Center and Jackson Memorial Hospital (Miami-Dade County), Broward General staff associated with the program are thoroughly trained and skilled in the care of patients with hepatic diseases and liver transplantation. Per the applicant, project approval would assure continuation of the existing level of training, skill and expertise among existing staff This project is referenced in a letter of support by County Commissioner Ilene Lieberman, Broward County Board of County Commissioners. 12 The Agency notes many physician letters of support were from Broward General Medical Center and University of Miami/Miller School of Medicine physicians that commit to continuing training and services under this program at Broward General Medical Center, if approved. 14

15 (d) Need Determination. 1. The application includes documentation that a minimum of five liver transplants will be performed within two 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 commonlyaccepted 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 one year without the transplantation. Per the applicant, this is thoroughly discussed under the Need section. (See Section 3.a. below). 2. The application includes documentation that the new liver transplantation program improves patient access. Per the applicant, this is thoroughly discussed under the Need section. (See Section 3.a. below). The Agency includes the mileage chart below to account for the driving distances between current adult liver transplant providers. Driving Distances to Liver Transplantation Centers Broward General Medical Center Jackson Memorial Hospital Florida Hospital Tampa General Hospital Shands at University of Florida Mayo Clinic Broward General Medical Center Jackson Memorial Hospital Florida Hospital Tampa General Hospital Shands at University of Florida Mayo Clinic Source: 15

16 The table above illustrates that after the relatively near 26.5 miles from the applicant to Jackson Memorial Hospital (Miami-Dade County), the next nearest provider of this service is 217 miles and all other providers are a further driving distance. Agency data has also previously shown that Service Area 4 adult liver transplant recipients, in 2009, generally did not migrate outside of their home Service Area for this service. In fact, 99 of 107 (or percent) of Service Area 4 s liver transplant patients remained in Service Area 4 for transplant services (78 at Jackson Memorial Hospital and 21 at Broward General Medical Center). 2. Agency Rule Criteria Chapter 59C-1.044, Florida Administrative Code, contains criteria and standards the Agency uses 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. Per the applicant, Broward General Medical Center has the staff and resources necessary to care for a liver transplant patient's chronic illness prior to transplantation, surgical needs during transplantation, and medical care in the postoperative period. These services, including inpatient and outpatient care, are reported to be available on a 24-hour basis, and are designed to provide individualized physical, emotional, spiritual and psychosocial care. Broward General has been operational in this capacity since 2004, through its shared services agreement for a liver transplant program with Jackson Memorial Hospital (Miami-Dade County). The applicant reports five transplant surgeons and two transplant physicians (hepatologists), as well as other support and direct care staff (a medical director, a program administrator, transplant coordinator, transplant advanced 16

17 registered nurse practitioner, transplant social services worker and transplant department administrative assistant. The applicant also explains in-hospital, patient discharge and post-discharge procedures are in place for applicable patients. 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. The applicant does not anticipate live donors in the foreseeable future. A signed agreement with Life Alliance Organ Recovery Agency is included for Agency review (CON Application #10087, Tab 7) 13. According to the applicant, performance of the actual transplant surgery most often occurs on very short notice due to the nature of the organ acquisition process. As a result, all the planning, staffing, procedures and protocols are oriented to respond quickly, efficiently and effectively 24 hours a day, 365 days a year. Recruitment, staffing, and staff training will further reflect this imperative and enhance Broward General Medical Center s capability. Broward General has a 24-hour call system maintained for assessment, management and retrieval of all referred donors, cadaver donors or organs shared by other transplant or organ procurement agencies. 3. An age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required. Broward General Medical Center states that it has a 24-bed adult surgical intensive care unit adjacent to the operating suite where liver transplant surgeries are conducted and the unit is equipped with prolonged reverse isolation, if required. 13 Leslie Cortina, CPA, Executive Director of Life Alliance Organ Recovery Agency provided a letter of support. 17

18 4. A clinical review committee for evaluation and decisionmaking regarding the suitability of a transplant candidate. The applicant reports an interdisciplinary team at Broward General Medical Center for the liver transplantation program, under the leadership of Andreas Tzakis, MD, PhD, FACS. The applicant provides liver transplant evaluation materials, listing guidelines, inclusion criteria, a selection committee worksheet and other related materials (CON Application #10087, Tab 8). 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. The applicant has written protocols for selection and management of liver transplant patients currently in place to guide care provided in the existing program and attests that these written protocols will continue to be used for the proposed program. The applicant includes the Broward General's Transplant Unit Policy and Procedure Manual (CON Application #10087, Tab 9). 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. Broward General has detailed therapeutic and evaluative procedures for both acute and long-term management of each transplant program patient, including management of commonly encountered complications. These are based upon proven guidelines currently in use by Broward General s program director, as set forth in Broward General's Transplant Unit Policy and Procedure Manual. 18

19 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. Broward General currently has an agreement with Life Alliance Organ Recovery Agency for recovery of organs for transplantation North Broward Hospital District hospitals and for distribution according to UNOS policies. A copy of the existing agreement and a letter of support from the organization s executive director are included for Agency review (CON Application #10087, Tab 7). The applicant also reports that as a Level I trauma center, Broward General is an active contributor hospital in the Life Alliance network for procurement of cadaveric transplant grafts. 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. The liver transplantation program at Broward General Medical Center has tissue typing laboratory services through contractual agreement with the University of Miami/Miller School of Medicine Histocompatibility Laboratory. The written signed agreement is provided for Agency review (CON Application #10087, Tab 10). It is indicated the arrangement will continue in the future. Documentation is provided to confirm the laboratory is fully accredited by the American Society for Histocompatibility and Immunogenics. HumanLeukocyte Antigen (HLA) typing, or tissue typing, will be performed at the University of Miami. The full battery of HLA tests is available. 9. Pathology services with the capability of studying and promptly reporting the patient's response to the organ transplantation surgery. Board-certified pathologists and the full resources of Broward General's pathology and laboratory services are available to provide all required pathology and laboratory support. Services available include the capability of studying and promptly reporting the patient's response to 19

20 the liver transplantation surgery and analyzing appropriate liver biopsy material. The laboratory at Broward General has full accreditation by the College of American Pathologists and the American Association of Blood Banks meets Joint Commission standards and operates in compliance with state and federal regulations. Comprehensive proficiency and quality assurance programs monitor performance. 10. Blood banking facilities. Broward General has appropriate blood banking facilities and services in place to support the existing shared transplant service at Broward General and this will continue to apply to the proposed transplant service. The applicant includes a written and signed agreement between the applicant and Community Blood Centers of South Florida, Inc. (CON #10087, Tab 10) A program for the education and training of staff regarding the special care of transplantation patients. Per the applicant, due to the nature of this proposed program, as an uninterrupted continuation of service through an independent program in the place of the existing shared services program (with Jackson Memorial Hospital, Miami-Dade County), virtually all of the critical care staff associated with the program is currently in place and fully trained. Consequently, there will be no extraordinary requirements to identify appropriate staff members and schedule and conduct pre-startup training activities in order to implement the program. Nonetheless, Broward General has in place a large, vigorous, and effective internal staff training and development department, which will incorporate the requirements of the proposed liver transplantation program into its existing training and education activities. A sample training material is included for Agency review, Introduction & Management of the Adult Liver Transplant Patient (CON Application #10087, Tab 19). This training booklet is reported to be a four-hour orientation tool. 14 Bruce Lenes, MD, Medical Director of Community Blood Centers of South Florida, Inc. provided a letter of support. 20

21 12. Education programs for patients, their families and the patient's primary care physician regarding after-care for transplantation patients. b. Staffing Requirements. Per the applicant, patients and families receive education on what to expect in the full array of liver transplantation at Broward General. This is incorporated through the shared services agreement between Broward General and Jackson Memorial Hospital (Miami-Dade County). A sample of transplantation packets/booklets are included for Agency review (CON Application #10087, Tab 20), provided in both English and Spanish. Some of these materials are issued by the U.S. Department of Health and Human Services, Health Resources and Services Administration. Some are more specific to step-by-step activities at Broward General regarding the local transplantation program. 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 A physician with one year experience in the management of infectious diseases in the transplant patient shall be a member of the transplant team. The adult liver transplantation program is currently in operation at Broward General as a shared services program with Jackson Memorial Hospital (Miami-Dade County). Broward General has a comprehensive slate of physicians on staff and has the full array of specialties and sub-specialties necessary to operate, support and complement the adult liver transplantation program. These physicians will all continue to function in their current roles and the University of Miami physicians continued participation in the stand-alone liver transplantation program will be through a new contractual agreement between North Broward Hospital District and the University of Miami. Other physicians are either employees of the applicant, or have privileges and provide services directly at Broward General. Transplant physicians include 21

22 Eugene Schiff, MD, University of Miami/Miller School of Medicine, Chief, Division of Hepatology and Director for the Center of Liver Diseases at University of Miami/Miller School of Medicine. Five transplant surgeons are included (CON Application #10087, Tab 4). David Droller, MD, FACP, is reported as the Broward General infectious disease specialist and internist currently serving the liver transplantation program at Broward General. Yared Aklilu, MD is another physician in the Broward General s Department of Infectious Disease 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. Per the applicant, Andreas Tzakis, MD, PhD, FACS, serves as surgical director of liver transplantation at Broward General Medical Center 16, having held that position since its inception as a shared services agreement with Jackson Memorial Hospital in A staff of nurses and nurse practitioners with experience in the care of chronically ill patients and their families. Broward General indicates that it has been providing liver transplants via the shared program since 2004 and has developed extensive capability to provide care to these patients. The applicant notes that it has four advanced registered nurse practitioners on staff. The role of the transplant ARNP is provided in the applicant s discussion of services provided in response to item E. 2 a. 4. 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. Broward General has appropriate blood banking facilities and services in place to support the portion of the existing shared transplant service that takes place within the facility, and this will continue to apply to the proposed transplant service. The 15 These two physician s CVs indicate they are both board-certified in infectious disease for over a year each. This board certification is verified through the Florida Department of Health s Division of Medical Quality Assurance Practitioner Profile, at 16 Board certification in surgery for Dr. Tzakis is verified through the Florida Department of Health s Division of Medical Quality Assurance Practitioner Profile, at 22

23 applicant includes a written and signed agreement between the applicant and Community Blood Centers of South Florida, Inc. (CON #10087, Tab 10) Nutritionists with expertise in the nutritional needs of transplant patients. The applicant reports a variety of clinical dieticians and specialists with expertise in the nutritional needs of hospitalized acute and chronic care patients, including liver transplant patients. 6. Respiratory therapists with expertise in the needs of transplant patients. The applicant reports policies and procedures, along with pulmonary staff trained in and experienced in the respiratory therapy needs and service delivery to applicable liver transplantation patients. Gary Richmond, MD, a board-certified pulmonologist 18 of the Broward General respiratory care department has been providing respiratory support and therapy to the shared services liver transplantation program at Broward General since its inception in 2004, and is fully prepared to continue to do so. 7. 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. Per the applicant, Broward General has an appropriate support cast in place relative to this area. All patients are interviewed by a social worker during the pre-transplant phase, and continue to be followed by a social worker in-house, as well as during the posttransplant phase. Social workers are available as needed either on-site or after hours by pager. It is also reported while there is a program psychologist there is also availability of staff psychiatrists, as needed, especially for patients with a history of substance or alcohol abuse. 17 Bruce Lenes, MD, Medical Director of Community Blood Centers of South Florida, Inc. provided a letter of support. 18 Board certification in pulmonary disease for Dr. Richmond is verified through the Florida Department of Health s Division of Medical Quality Assurance Practitioner Profile, at 23

24 3. Statutory Review Criteria a. Is need for the project evidenced by the availability, quality of care, accessibility and extent of utilization of existing health care facilities and health services in the applicant's service area? ss (1)(a) and (b), Florida Statutes. The applicant proposes six primary reasons that need justifies project approval. These six reasons are as follows: The number of liver transplants performed at Broward General Medical Center has consistently exceeded the Agency's minimum requirement by a substantial margin. Over the past three years the number of liver transplants at Broward General has averaged 32.7 per year 19. The Scientific Registry of Transplant Recipients (SRTR) data document that during the past two years an average of adults received liver transplants at one of the two program locations in Service Area 4. Approximately 87 percent of these patients had a probability of death exceeding 25 percent during the next three months absent a transplant 20. A disproportionate share of the liver transplants performed at Broward General have been provided to low income residents of Collier and Palm Beach Counties as well as to those residing in Broward County, affording low-income residents in Service Area 4 access to this life saving technology 21. Prior to the initiation of liver transplantation services at Broward General in 2004, residents of Broward, Collier and Palm Beach Counties lacked adequate access to liver transplant services, as compared to residents of other areas of the state and the state as a 19 CON utilization data indicates Broward General averaged 33.3 adult liver transplantation procedures during CY CY CON utilization data shows the Jackson Memorial & Broward General shared program reported 188 liver transplants in 2008 and 153 in 2009, averaging procedures. 21 State Center data confirms that percent of Broward General s CY 2009 liver transplants were Medicaid patients and percent of the service area residents who had liver transplants were Medicaid recipients. Broward General provided percent of its program s patient days to Medicaid. Medicaid patients accounted for percent of the total service area resident patient days in CY