STATE AGENCY ACTION REPORTahca.myflorida.com/MCHQ/CON_FA/Batching/pdf/10149.pdf · 2012. 8. 16. · CON Action Numbers: 10148 and 10149 2 Most of the letters support all three of

STATE AGENCY ACTION REPORT

ON APPLICATION FOR CERTIFICATE OF NEED

A. PROJECT IDENTIFICATION

1. Applicant/CON Action Number

Cleveland Clinic Florida Health System Nonprofit Corporation d/b/a Cleveland Clinic Hospital/CON #10148

3100 Weston Road

Weston, Florida 33331

Authorized Representative: Bernardo B. Fernandez, M.D.

(954) 689-5000

South Broward Hospital District d/b/a Memorial Regional Hospital/CON #10149

3501 Johnson Street

Hollywood, Florida 33021

Authorized Representative: Jon D. Bandes

(954) 265-3452

2. Service District/Subdistrict

Organ Transplantation 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.

Letters of Support Cleveland Clinic Florida Health System Nonprofit Corporation d/b/a

Cleveland Clinic Hospital (CON #10148): Seventy unduplicated letters

of support (some with multiple signatures) were included in the

application’s Volume I, Tab 5 and one was mailed directly to the Agency.

CON Action Numbers: 10148 and 10149

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Most of the letters support all three of the applicant’s proposals in this

batching cycle – CON application #10148 (adult heart transplantation),

CON application #10151 (adult kidney transplantation) and CON

application #10154 (adult liver transplantation). All letters were signed,

67 were dated between May 10 and June 18, 2012, three were not dated

and one was dated April 14, 2011. These letters are briefly described

below.

U.S. Representatives Debbie Wasserman Schultz, 20th Congressional

District of Florida, and Ileana Ros-Lehtinen, 18th Congressional District

of Florida, State Senators Nan H. Rich (34th District) and Larcenia J.

Bullard (39th District), and five City of Weston elected officials submitted

a letter that was signed by Mayor Eric M. Hersh and City Commissioners

Mercedes Henriksson, Angel M. Gomez, Toby Feuer and Jim Norton.

John R. Flint, City Manager/CEO also submitted a letter. These letters

indicate that:

● Many south Florida residents must leave the area to receive the

transplant and the project would enhance access to needed

transplant services.

● Cleveland Clinic Florida has a proven record of quality health care

delivery and south Florida educational institutions rely on Cleveland

Clinic Hospital to train medical professionals including physicians,

nurses and pharmacists.

Approval of the transplant programs would allow Cleveland Clinic to

provide a new level of care and these writers express confidence that

that “our community” will be “home to a renowned transplant center”.

Medhat Askar, MD, PhD, Director, Allogen Laboratories, stated that his

organization is a wholly owned subsidiary of Cleveland Clinic

Foundation, located in Cleveland, Ohio. Dr. Askar stated if the project is

approved, Allogen Laboratories will establish a histocompatibility lab on

Cleveland Clinic Hospital’s campus and will obtain a Florida license as a

tissue typing laboratory. Dr. Askar also stated he holds an active license

as a clinical laboratory director with the Florida Department of Health. A

copy of Dr. Askar’s clinical laboratory director license is included in CON

application #10148, Volume III, Tab 14.

Frank Dennis Irwin, MD, National Medical Director, Transplant,

OptumHealth (headquartered in Golden Valley, Minnesota) stated that if

any or all of the applicant’s transplantation proposals are approved, his

managed care company intends to enter into a contract with Cleveland


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Clinic Hospital to offer OptumHealth’s members an option for a

transplant center. This same commitment was stated in the support

letter by OptumHealth’s Sr. Vice President, Kevin O’Brien.

David Bjorkman, MD, MSPH, Dean and Professor, College of Medicine,

Florida Atlantic University stated there is only one existing adult heart

transplantation provider in the service area “yet our service area has

more population than anywhere else in the State of Florida”. John Rock,

MD, Founding Dean, Sr. Vice President for Medical Affairs, College of

Medicine, Florida International University stated Cleveland Clinic

Hospital has provided rotations and future internships and residencies to

his university’s medical students since 2009, providing “…exceptional

training for our students in an environment rich with high acuity

patients and clinical research”. J. David Armstrong, Jr., President,

Broward College and Eduardo J. Padron, President, Miami-Dade College

stated that project approval would “…enhance access to much needed

transplant services in and around south Florida”. The two presidents

also highly complimented Cleveland Clinic Hospital as a valuable partner

in helping their post-secondary schools provide students with high-

quality professional health care education and training.

Kutty Chandran, MD, President, Broward County Medical Association

stated Cleveland Clinic Hospital is highly regarded as a center of

excellence as well as a provider of medical education, training and

research. Jack Zeltzer, MD, President, Palm Beach County Medical

Society stated Cleveland Clinic Hospital is the highest ranked Broward

County hospital “by U.S. News & World Report (2011-2012) and is high

performing in many specialties”. John D. Couris, President and CEO,

Jupiter Medical Center, (Palm Beach County, Florida) stated that

“…Cleveland Clinic is world renowned for its transplant programming”.

Mr. Couris stated that patients at his facility in need of organ

transplantation “..must travel great distances to obtain such services”.

Also, Mr. Couris stated the nearest adult transplantation for Palm Beach

County residents is Jackson Health System (Miami-Dade County).

Mr. Couris concluded that, “due to the overwhelming nature of the

Jackson campus and its surrounding environment” there is a desire for

an alternative.

Andrew Boyle, MD, Medical Director of the heart failure, cardiac

transplantation, and mechanical circulatory support programs at Aurora

St. Luke’s Medical Center, Milwaukee, Wisconsin stated he has been

appointed Chairman of the Department of Cardiovascular Medicine and

will be the Medical Director of the Heart Transplant program at Cleveland


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Clinic Florida. Dr. Boyle stated he understands that there are very few

mechanical circulatory support devices implanted in patients at hospitals

in the State of Florida, particularly in south Florida. The care of these

patients is one of his areas of special interest.

Delos Cosgrove, MD, Chief Executive Officer and President, Cleveland

Clinic (Ohio), stated the projects would increase access to not only

transplant services, “…but also to other end-stage organ disease

treatments, as well as bring awareness to organ donation”. Nicholas

Smedira, MD, Program and Surgical Director, heart transplantation,

stated Cleveland Clinic performed 58 heart transplants in CY 2011.

John Fung, MD, PhD, Chairman, Digestive Disease Institute and

Director, Cleveland Clinic Transplant Director, stated “In 2011, we

completed 453 organ transplants of the heart, intestine, kidney, liver,

lung, pancreas or combinations of these organs”. Kandice Kottke-

Marchant, MD, PhD, Chair, Pathology and Laboratory Medicine Institute

and Chair, Department of Pathology, stated Cleveland Clinic “performs

over 21 million tests annually”.

Bernardo Fernandez, Jr., MD, Chief Executive Officer, Cleveland Clinic

(Florida) and practicing physician (vascular medicine), stated his facility

is home to nearly 200 physicians in 35 medical specialties and is the

“…largest non-university based teaching hospital”1 in Florida, training

more than 100 residents each year and offering 16 fellowship programs.

Randall Starling, MD, MPH, FACC, Interim Chairman of the Department

of Cardiovascular Medicine at Cleveland Clinic Florida and Program and

Medical Director of the Heart Transplant program in Cleveland indicates

that Cleveland Clinic delivers world-class cardiovascular care in Florida

through a seamless transfer of information and the benefit of shared

cutting edge technology. “Our Florida and Cleveland campuses are

integrated to synergize collaborations and outcomes”.

Leslie Cortina, CPA, Executive Director, Life Alliance, Organ Recovery

Agency, University of Miami, Miami, Florida stated her organization

supports Cleveland Clinic’s projects and that “the collaborative effort

would yield improved care and seamless healthcare services to

patients”.2 George “Bud” Scholl, Executive Vice President, OneBlood,

Inc. (the blood supply/blood product provider in Broward County,

Florida) stated his organization would have applicable supplies available

1 Cleveland Clinic Hospital is not a statutory teaching hospital as defined in Section 408.07(45) Florida Statutes. 2 The Life Alliance Organ Recovery Agency is the non-profit organ procurement organization that serves six south Florida counties – Broward, Collier, Miami-Dade, Monroe, Palm Beach and St. Lucie.


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to enhance Cleveland Clinic Hospital’s internal blood bank. Bonnie

Anderson, President, LifeTrac Network headquartered in Minneapolis,

Minnesota) indicated her organization’s clients would benefit from project

approval. She stated LifeTrac is a national transplant network that for

over 20 years “has held a contractual relationship with Cleveland Clinic

to provide liver, heart and kidney transplant services to members of

LifeTrac’s clients”.3

Several Florida residents who received transplants at Cleveland Clinic’s

Main Campus praised Cleveland Clinic Ohio’s quality of care and stated

that the proposal would provide like services nearer to home.4 However,

one of the patients who had a heart transplant questioned the ability of

Cleveland Clinic Florida to implement the transplant programs stating

“CC Weston has a long way to go to developing their expertise with

transplant patients before creating a transplant program on their own”.

The majority of the applicant’s physician support letters were from

physicians on staff at Cleveland Clinic Florida and Cleveland Clinic

(Ohio). Recurring themes in many of these letters were that the project

would:

● Enhance access, reducing outmigration or patients traveling long

distances.

● Use Cleveland Clinic’s unique model of care to foster collaboration

and innovation in diagnosis and treatment and Cleveland Clinic Ohio

Campus’ expertise and success in “their long-established and very

successful organ transplant programs”.

● Be a “natural extension” of Cleveland Clinic Hospital’s commitment to

south Florida.

● Reflect that Cleveland Clinic Hospital is highly regarded as a world-

class center for excellence in health care services, including medical

education, training and research and south Florida educational

institutions rely on the applicant to train future medical professionals.

Florida International University and Florida Atlantic University rely on

the applicant to train medical students and the transplant projects

would be an outstanding addition to physician training. South Broward Hospital District d/b/a Memorial Regional Hospital

(CON #10149): Thirty-three unduplicated letters of support were

included in CON application #10149, Volume II, Attachment S and one

3 Per its website, LifeTrac Network payor clients include HMOs, TPAs, other major insurance companies, self-funded plans and employer health plans. 4 Cleveland Clinic Main Campus will be referred to as Cleveland Clinic Ohio Campus in our review.


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letter was received by the Agency directly. All letters of support were

signed, 33 were dated between May 3 and June 11, 2012, one was not

dated (though it had a fax date of July 5, 2005). The 34 support letters

were from 11 elected officials; 15 physicians, four area hospital senior

executive management staff and three residents. The support letters are

briefly summarized below.

Elected officials include:

Congresswoman Debbie Wasserman Schultz, Member of Congress,

20th Congressional District, Florida and

Congressman Ted Deutch, 19th Congressional District, Florida, United

States House of Representatives;

Elaine Schwartz (District 99), Evan Jenne (District 100) and Joe

Gibbons (District 105), State Representatives, The Florida House of

Representatives;

John Rodstrom, Jr., Broward County Commissioner/Mayor-District 7;

Debby Eisinger, Mayor, City of Cooper City;

Lori Moseley, Mayor, City of Miramar;

Peter Bober, Mayor, City of Hollywood;

Eric Jones, Jr., Mayor, City of West Park and

Frank Ortis, Mayor, City of Pembroke Pines.

In summary, recurring themes in these letters were:

● as a tax-assisted hospital group, the Memorial Healthcare System

provides medical care for patients regardless of their ability to pay;

● project approval would enhance access;

● the number of patients from south Florida who are wait listed to

receive a heart transplant each year continues to grow;

● currently patients in the area must travel to Miami or outside the

service area for this procedure; and

● Memorial Regional Hospital has already demonstrated excellent

comprehensive cardiovascular and pediatric heart transplantation

programs.

Physician support letters were received from: Cardiovascular Consultants

of South Florida5 (five physicians); Memorial Healthcare System (four);

The Cardiac Center-Joe DiMaggio Children’s Hospital/Memorial

5 Per their website at http://www.heartpartners.com/, this 35 member physician group has south Florida’s largest cardiology patient volume and its physicians are affiliated with eight Broward County hospitals, including Memorial Healthcare System facilities and Aventura Hospital & Medical Center in Miami-Dade County.

http://www.heartpartners.com/


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Healthcare System (three; Florida Institute for Cardiovascular Care

d/b/a Healthworx6 (two) and one from University of Miami, Miller School

of Medicine. Recurring themes in many of these letters were that:

● Memorial Regional Hospital already possesses the unique feature of

having a fully established and operational pediatric heart transplant

program, provides adult and pediatric cardiac surgery and has a

congenital heart program;

● per the American Heart Association, in a few years the number of

adults with congenital heart disease will exceed the number of

children with congenital heart disease; and

● adult cardiologists and adult heart transplant surgeons do not

typically manage adults with congenital heart disease, so the ideal

cardiac transplantation center must consist of pediatric and adult

specialists to handle this patient subset.

Memorial Regional Hospital’s Richard Perryman, MD, Medical Director,

Cardiac and Vascular Institute, stated he has at various times, been

Director of adult and pediatric heart transplant at the University of

Miami/Jackson and he understands the needs and requirements for

adult heart transplantation. Dr. Perryman stated that “the presence of

an active pediatric heart transplant program within the Memorial

Healthcare System brings considerable advantages to an adult cardiac

transplant program”. He provided a detailed description of the

experience of Memorial’s support services for pediatric heart transplant

and concluded these “are all ready for the transfer into the area of adult

heart transplantation”. Dr. Perryman indicated that based on Memorial’s

expertise and existing quality programs—pediatric heart transplantation,

a congenital heart program, a cardiac surgery program nationally

recognized for its quality and the largest interventional cardiology

program in Broward County, Memorial Regional Hospital is ready to

provide adult heart transplantation.

Juan Plate, MD, FACS, Division of Cardiac Surgery, stated that he was

previously on the heart failure team at Robert Wood Johnson University

Hospital in New Jersey and his role included insertion of assist devices,

organ procurement, heart transplantation and other advanced heart

failure procedures. Sean O’Donnell, MD, FACS, Medical Director of

6 Per their website at http://www.mitral.com/, this group consists of 12 cardiologists, nine primary care physicians and one geriatrician and is the largest cardiovascular based, multi-specialty medical practice of its kind, bringing together highly trained, experienced physicians and state-of-the-art diagnostic and treatment facilities throughout Dade and Broward Counties. Certain members of the group are on staff at the five Memorial Healthcare System hospitals, Aventura Medical Center and Westside Regional.

http://www.mitral.com/


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Vascular & Endovascular Surgery, stated the existing heart

transplantation program at Jackson Memorial Hospital, “…well exceeds

the minimum threshold required for an adult program..”.

Maryanne R. K. Chrisant, MD, Medical Director of the Pediatric Cardiac

Transplant, Heart Failure and Cardiomyopathy programs at The Cardiac

Center-Joe DiMaggio Children’s Hospital/ Memorial Healthcare System,

stated that she has “built or revitalized and directed heart transplant

programs at The Cleveland Clinic (in Cleveland, Ohio), Children’s

Hospital of Philadelphia and the University of Virginia (in

Charlottesville)”. She also provided a description of her involvement in

Memorial’s pediatric cardiac transplant program and indicated they have

transplanted six children since beginning operation in December 2010

and “all (are) doing well post-transplant”7. Dr. Chrisant indicated that

“as pediatric cardiologists we are seeing more adults with congenital

heart disease” and that it’s likely around 10 percent of these patients will

require cardiac transplantation. Dr. Chrisant concluded that the

program would allow Memorial to continue serving its aging pediatric

population as well as adults.

Frank Scholl, MD, Chief of Pediatric Cardiac Surgery at Memorial

Regional Hospital, stated that in the current scenario, pediatric cardiac

patients that age into adulthood and need adult heart transplantation,

are, “…forced to seek treatment elsewhere..”. Dr. Scholl stated this is

detrimental to patients and their families, at least in part because it

removes them from the care team that“…knows them best”. Dr. Scholl

concluded that the project would mean more seamless, continuity of

care, from fetal life to advanced age and would be in the best long-term

interest of patients and families.

Calvin Glidewell, Jr. FACHE, Broward Health Broward General Medical

Center; Roger Kirk, President & CEO, Bethesda Healthcare System and

Bethesda Memorial Hospital; Jerry Fedele, President & CEO, Boca Raton

Regional Hospital and Mark Robitaille, President & CEO Martin Memorial

Health Systems submitted letters citing their positive relationship with

Memorial Regional Hospital and that project approval would reduce

travel time/distance for patients in need of the level of service consistent

with the project. Bethesda, Boca Raton and Martin’s CEOs indicate their

facilities refer patients who require services they do not provide to

Memorial.

7 The Pediatric Heart Transplant Program’s first procedure was 12/16/10 and three procedures were reported for CY 2011.


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George “Bud” Scholl, Chief Executive Officer, OneBlood, Inc. d/b/a

Community Blood Centers of Florida, Inc., stated his organization will

provide laboratory and blood product support for the proposed project,

consistent with the existing contract with the applicant. Marvin Keyser,

Southern Regional Director and Member, Board of Directors, Mended

Hearts, Inc.8, stated his support.

In summary, recurring major themes to support the project were:

● as a tax-assisted hospital group, the Memorial Healthcare System

provides medical care for patients regardless of their ability to pay;

● project approval would enhance access;

● the number of patients from south Florida who are wait listed to

receive a heart transplant each year continues to grow;

● currently patients in the area must travel to Miami or outside the

service area for this procedure;

● Memorial Regional Hospital already possess the unique feature of

having a fully established and operational pediatric heart transplant

program, provides adult and pediatric cardiac surgery and has a

congenital heart program;

● per the American Heart Association, in a few years the number of

adults with congenital heart disease will exceed the number of

children with congenital heart disease; and

● adult cardiologists and adult heart transplant surgeons do not

typically manage adults with congenital heart disease, so the ideal

cardiac transplantation center must consist of pediatric and adult

specialists to handle this patient subset.

Letters of Opposition

Carlos Migoya, President and CEO, Jackson Memorial Hospital, Jackson

Health System, Public Health Trust submitted a 51-page opposition

letter. Mr. Migoya stated his hospital has the capacity to perform more

cases than actual caseloads and has experienced a decline in adult liver,

lung, heart and kidney transplants over the past several years.

8 Per their website at http://mendedhearts.org/about-us, Mended Hearts is a national and community-based non-profit organization for heart disease patients and their families.

http://mendedhearts.org/about-us


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Mr. Migoya also indicated this decline is consistent with the rest of the

state and the nation. He further indicated outmigration rates of patients

from OTSA 4 are in the range of eight to 25 percent for the four counties

on the southeast coast of Florida. He indicated most outmigration from

OTSA 4 is attributable to patients from Collier County who often use

Tampa General Hospital’s transplant services and Palm Beach County

for patients in OTSA 4 that seek services at Florida Hospital-Orlando.

Mr. Migoya stated that Jackson Memorial Hospital is heavily dependent

on cases from the counties within OTSA 4 and approval of any new adult

organ transplantation programs would adversely affect Jackson’s

transplantation programs. Further, Mr. Migoya stated project approval

would adversely affect his hospital’s teaching and research functions and

role as the safety-net hospital for Miami-Dade County.

Specific to adult heart transplantation, Jackson Memorial Hospital

estimated an adult heart transplantation “trended use rate” of 0.37 (per

100,000 population [age 15+] in OTSA 4), by 2015, with a resulting

incremental case load of five adult heart transplants. Mr. Migoya

concluded that while approval of any transplantation program in the

current batching cycle would “..provide some residents of OTSA 4 with a

closer alternative to transplant services and perhaps some minimal

savings in terms of travel expenses and time”, that approval would be

“…a solution in search of a problem”.

Jackson Memorial Hospital contends that the reasons below support the

denial of this proposal as well as all adult transplantation proposals in

the current batching cycle.

● The number of existing adult organ transplant programs for liver,

lung, heart and kidney per 100,000 adult population 15+

approximates the ratio of the state.

● There is an adequate number of adult organ transplant programs in

OTSA 4 when evaluated on the basis of per capita rates.

● Despite population growth, adult organ transplant cases and use

rates have declined over the most recent three years for OTSA 4,

Florida and the nation. This decline was stated to be specific to

resident transplant cases as well as resident use rates in OTSA 4 for

the three-year period.


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● Twenty four OTSA 4 resident adult heart transplants were performed

during the 12 months ending September 2011. All but two of these

were performed at Jackson Memorial with exception of two Collier

County residents who were treated at Tampa General. Approval of a

new heart transplant provider would not change the outmigration of a

few patients.

● OTSA 4’s incremental adult heart transplant growth is projected to be

one based on the 2011 use rate and -5 based on the 2009-2011

trended use rate. Jackson concluded that based on the incremental

cases forecast for 2015 and the low outmigration, projected caseloads

would come from existing providers. As such, Jackson Memorial

would be adversely affected by the approval of a new program.

C. PROJECT SUMMARY

Cleveland Clinic Florida Health System Nonprofit Corporation,

d/b/a Cleveland Clinic Hospital (CON #10148) proposes to establish

an adult heart transplantation program at Cleveland Clinic Hospital, in

Weston, Broward County, Florida, District 10, OTSA 4.

Cleveland Clinic Hospital indicates it is the hospital entity and Cleveland

Clinic Florida is the multi-specialty physician group practice. The

applicant states Cleveland Clinic Florida is a “closed staffing model” and

is uncommon in south Florida. The closed staffing model is stated to

make it easier to coordinate care and implement evidence-based

treatments. It is also stated Cleveland Clinic Florida physicians are not

community physicians but are on payroll. Cleveland Clinic Hospital is a

not-for-profit general hospital, licensed for 155 acute care beds. The

hospital currently provides no transplantation programs. Cleveland

Clinic Hospital provides Level II adult cardiovascular services and is a

designated primary stroke center. The applicant indicates that the

project will predominantly serve the residents of OTSA 4 counties.

The adult heart transplant program, if approved, is to be operational by

January 1, 2013. Project costs total $764,615. The applicant’s narrative

on page one incorrectly stated it was $543,345. These costs include

equipment, project development and start-up costs. There is no

construction or renovation associated with the project.


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Schedule C includes the following conditions:

1. Mechanical Assist Device Program: The applicant has conditioned

approval of the application on the provision it will have an active

and certified mechanical assist device program where all modalities

of treatment will be considered before resorting to transplantation.

Three treatment plans will be considered for each and every patient

who qualifies after initial evaluation:

a. Implantation of a mechanical assist device as a destination

therapy,

b. Bridge to transplant where a mechanical assist device is

implanted with the ultimate goal to transplant,

c. Heart transplant with no mechanical assist device.

To accomplish this, all heart transplant surgeons on Cleveland Clinic

Florida staff will have assist device background. Compliance will be

measured by an annual report from the hospital certifying the

availability of the mechanical assist device program and that its heart

surgeons are qualified in this procedure.

2. Whole Slide Imager: The applicant will install a whole slide imager

to have real time consults with main campus pathologists when

reading biopsies. This would commence with initiation of the

program. The applicant has budgeted $100,000 to purchase a

whole slide imager which is included in project costs on Schedule

19. The transplant center at the main campus is completely

digitized, which means that with the use of whole slide digital

imaging, a biopsy can be read anywhere in the world. Whole slide

digital imaging uses computerized technology to scan and convert

pathology specimen glass slides into digital images which are then

accessible for viewing using a computer monitor and viewing

software. The digital slides (images) are maintained in an

information management system that allows for archival and

intelligent retrieval. Computerized image analysis tools can be

used with digital slides to perform objective quantification

measures for special stains and tissue analysis. Digital pathology

is an image based information environment that supports the

management of information generated from digital slides for use in

education, diagnostics, publications and research. This will be

measured by an annual report from the applicant certifying the

availability of the whole slide imager.

9 Schedule 1 indicates the estimated cost of a whole slide imager is $103,315.


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3. Video Conferencing: The applicant will perform the transplant

with a live video conferencing feed to the Jagelman Conference

Center for training and education of its residents, fellows and other

medical students, subject to patient consent, once a year for the

first two years, increasing to quarterly by year three. This will be

measured by an annual report from the applicant certifying the

number of its transplants on live video conference feed.

4. Electronic Medical Record: Cleveland Clinic Hospital will maintain

its electronic medical record system and integrated software

systems which currently include EpicCare, eCleveland Clinic,

DrConect and MyChart. This will be measured by submission of

an annual report by the hospital certifying this system is

maintained. This will be measured by an annual report from the

applicant.

5. Hispanic Outreach to Enhance Organ Donation and

Transplantation Services: The applicant will enhance awareness

and educate the Hispanic community on the importance of organ

donation and benefits of transplantation. To accomplish this, the

applicant will:

a. Either host or attend a minimum of six community outreach

events per year where it will provide transplant education,

organ donation information from Life Alliance and other useful

informative material, in both Spanish and English. This will

begin immediately at the start-up of the program.

b. The applicant will provide public service announcements on

both Spanish and English radio stations in the south Florida

market that will educate listeners on the importance of organ

donation.

c. The applicant will meet regularly with Life Alliance and assist

Life Alliance in meeting with families of minorities.

These indicators will be measured by submitting an annual

report to AHCA certifying compliance.


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6. Establish a Donor Council: The applicant will establish a donor

council consisting of an ethicist, nurses and others. The goal of

the donor council will be to further enhance organ donation and

awareness initiatives aimed at patients, families and employees of

the hospital and to assure optimal communication and referral

practices with the organ procurement organization (OPO) as a

donor hospital. This is indicative of the hospital’s desire to be a

donor hospital as much as a transplant hospital. This will be

measured by submission of an annual report by the hospital to

AHCA certifying this training has taken place.

7. Shared Appointments: The applicant will develop a shared

appointment program for end-stage liver disease and make this

shared appointment program available to all end-stage liver

disease patients. Shared appointments are two or more patients

with similar or same diagnosis or evaluative plan or treatment plan

scheduled be seen by the same physician and other clinicians

together10. This alleviates anxiety, the feeling of aloneness and

provides a structure for support. Shared appointments will be

provided to all patients and scheduled accordingly. This will be


AHCA certifying the availability of the shared appointments and

identifying the number of patients who participate in shared

appointments.

8. Support Group for End Stage Heart Disease, Heart Transplant

Candidates & Recipients: The applicant will host regularly

scheduled support groups for patients who have either been

diagnosed with end stage heart failure, undergoing evaluation for

transplant candidacy, awaiting a heart transplant or have received

a heart transplant. This will be measured by submission of an

annual report by the hospital to AHCA certifying this support

group is in place and list where meetings are held.

10 Shared appointments involve “patients with common needs together with one or more health care

providers” and typically, “are about 90 minutes long, allowing participants to spend more time with the

health care team”. “During the shared visits, patients can also be seen in a private exam room for

individualized care, if needed”. Source: http://my.clevelandclinic.org/patients-visitors/prepare-

appointment/shared-medical-appointments.aspx.

http://my.clevelandclinic.org/patients-visitors/prepare-appointment/shared-medical-appointments.aspxhttp://my.clevelandclinic.org/patients-visitors/prepare-appointment/shared-medical-appointments.aspx


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9. Establish a Transplant Recipient International Organization (TRIO)

Chapter: TRIO is an independent not-for-profit international

organization committed to improving the quality of life of

transplant recipients, candidates, their families and donor family

members. The applicant will establish the first local chapter of

TRIO to service its members in the areas of donor awareness,

transplant education, support for patients and caregivers, and

patient advocacy. The applicant will make space on the Weston

campus if the group wants to use it. This TRIO chapter will be

established during the first year of the heart transplant program.

This condition will be measured by submission of an annual report

by the hospital to AHCA certifying the TRIO chapter has been

established and is active.

10. Staff Education:

a. Community Continuing Medical Education: The applicant will

offer two additional Grand Rounds with transplant topics,

annually, as part of its surgical series, open to all health care

professionals within the community.

b. Certified Transplant Coordinators and Transplant Nurses: 11

100 percent of Cleveland Clinic Hospital’s transplant

coordinators and transplant nursing staff will become certified

according to their areas of specialty within the first two years of

serving in that capacity. This will be measured by submitting

copies of applicable certifications to AHCA.

c. Nurse Orientation: All (not just transplant) new nurses at

Cleveland Clinic Hospital, as part of their orientation, will have

a one-day orientation to transplant. Topics to be covered will

include but are not limited to organ donation, overall

transplant evaluation and eligibility and organ specific

education. All existing nurses at Cleveland Clinic Hospital will

be provided an orientation to transplantation and the

transplant program within 12 months of initiating the

transplant programs at the hospital. These will be measured

by submission of an annual report by the hospital to AHCA

certifying that these orientations have taken place.

11 The reviewer notes Cleveland Clinic Hospital lists the first two staff education sub-conditions as both being condition #10.a.


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d. Brain Death Training: All Cleveland Clinic Florida staff and

residents will go through formal training for determination of

brain death. This training is necessary so that staff members

can accurately and efficiently determine death by neurological

criteria brain death. This is important for the finality of the

diagnosis, the need of family members to grieve and make final

arrangements, and to procure organs and tissues for

transplantation. This will be measured by submission of an

annual report by the hospital to AHCA certifying this training

has taken place.

e. General Surgery Residents will Rotate Through Transplant

Services: All general surgery residents at Cleveland Clinic

Hospital will rotate through the transplant service as part of

the general surgery residency curriculum. This will be


AHCA certifying this rotation is in place.

11. Financial Commitment:

a. Financial Coordinator Education and Development: The

applicant will commit to funding a membership for each of its

transplant financial coordinators in the Transplant Financial

Coordinators Association (“TFCA”). TFCA is a national, non-

profit organization with a mission to coordinate the

dissemination of useful information related to transplant

finance. The goal is to assure that accurate financial

information is provided to patients and their families in a

compassionate and tactful manner. Membership in TFCA will

provide the transplant financial coordinators with access to

continuing education and networking opportunities with their

peers from across the country. In addition to membership,

support will include attendance at the annual TFCA

conference. This will assure that the hospital’s transplant

financial coordinators are knowledgeable about transplant-

related financial issues and serve as effective advocates for

patients and their family members.


17

b. Insurance Coverage: The lack of insurance coverage for

transplant will not in itself be the reason to deny a transplant.

Each patient referred for a transplant will be immediately

assigned to a transplant financial coordinator. The financial

coordinator will work with patients and family members to

research insurance coverage; provide estimates of out-of-

pocket costs and, if necessary, help patients explore the use of

organizations such as the National Foundation for Transplants

for fund raising. The availability of insurance coverage and/or

personal financial resources can be a factor in the decision of

whether a patient is an appropriate candidate for transplant,

as it relates to the overall psycho-assessment and the ability to

comply with post-transplant clinical requirements.

This will be measured by submission of an annual report by the hospital

to AHCA certifying this has taken place.

South Broward Hospital District d/b/a Memorial Regional Hospital

(CON #10149) proposes to establish an adult heart transplantation

program at Memorial Regional Hospital, in Hollywood, Broward County,

Florida, District 10, OTSA 4. South Broward Hospital District, also

known as Memorial Health System, operates Memorial Regional Hospital,

Memorial Regional Hospital South, Memorial Hospital West, Memorial

Hospital Miramar and Memorial Hospital Pembroke, all Class 1 acute

care hospitals.

Memorial Regional Hospital is a 757-bed general hospital, licensed for

621 acute care, 22 Level II neonatal intensive care (NICU), 42 Level III

NICU, 45 adult psychiatric, 10 child/adolescent psychiatric, 11 adult

substance abuse and six comprehensive medical rehabilitation beds.

Memorial Regional offers pediatric cardiac catheterization, pediatric open

heart surgery and pediatric heart transplantation programs, as well as

Level II adult cardiovascular services and is a Comprehensive Stroke

Center. Memorial Regional Hospital is a Level I Trauma Center12. The

applicant indicates that the project will predominantly serve the

residents of OTSA 4 counties.

The adult heart transplant program, upon final approval, is to be

implemented within 15 months or less. Project costs total $253,600.

These costs include equipment, project development and start-up costs.

12 This is confirmed, per the Florida Department of Health, Office of Trauma website at http://www.doh.state.fl.us/DEMO/Trauma/center.htm.

http://www.doh.state.fl.us/DEMO/Trauma/center.htm


18

There is no reported construction or renovation associated with the

project.

In addition to the project location at 3501 Johnson Street, Hollywood,

Florida 33021, Schedule C includes the following conditions:

(1) Once certified for Medicare participation, the heart transplant

program will comply at all times with Medicare conditions of

participation, including the requirement of providing a minimum

average annual volume of 10 heart transplants per year and meeting

Medicare specified transplant patient survival standards.

(2) Memorial Health System will discontinue operation of the heart

transplant program if Medicare certification should lapse. Heart

transplant programs can continue to operate following the loss of

Medicare certification, and some do. Memorial Health System

pledges that it would not.

(3) The applicant will provide a combined 12 percent of its heart

transplant program discharges to Medicaid and charity patients in

each of years one and two of operation and 19 percent in year three

and thereafter.

Should a project be approved, the applicant’s conditions would be reported

in the annual condition compliance report as required by Rule 59C-1.013 (3)

Florida Administrative Code. Pursuant to Section 408.043 (4) Florida

Statutes, accreditation by any private organization may not be a

requirement for the issuance or maintenance of a certificate of need.

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.


19

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

Felton Bradley, who evaluated the financial data. There is no reported

construction or renovation associated with the project. 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.

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 heart 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 heart transplants that will be performed in the first years of

operation.

OTSA 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 heart transplant program – Jackson Memorial Hospital (Miami-

Dade County, District 11). During CY 2011, OTSA 1 had two adult heart

transplantation programs, OTSAs 2 and 4 one, and OTSA 3 had none.


20

As of February 17, 2012 publication deadline for this batching cycle,

Florida Hospital-Orlando had CON #10026 approved to establish the first

adult heart transplant program in OTSA 3. Florida Hospital-Orlando

reported its first procedure was performed on January 31, 2012.

Data reported to the Agency by the local health councils for calendar year

2011 show the following adult heart transplant utilization, by facility:

Florida Adult Heart Transplantation Program Utilization January 2011 – December 2011

Hospital Service Area District Total Procedures Shands at Univ. of Florida (UF) 1 3 21 Mayo Clinic 1 4 25 Tampa General Hospital 2 6 54 Jackson Memorial Hospital 4 11 27 TOTAL 127 Source: Florida Adult Organ Transplantation Program Utilization data published March 30, 2012.

As shown in the table above, Jackson Memorial Hospital provided the

second most procedures of the four facilities.

Below is a five-year chart to account for adult heart transplantations

performed from calendar year 2007 through 2011. As shown, in

calendar years 2007 through 2011, the cumulative totals, from most to

least procedures, were as follows: Tampa General Hospital; Shands

Hospital at the University of Florida: Jackson Memorial Hospital and

Mayo Clinic. Jackson Memorial Hospital averaged approximately 28

procedures each year.

Adult Heart Transplantation Procedures

CY 2007-2011 Facility/Organ Transplant Service Area (OTSA) 2007 2008 2009 2010 2011 TOTAL

Shands Hospital at UF (Service Area 1) 32 28 26 34 21 141

Mayo Clinic/St. Luke’s Hospital (Service Area 1)* 22 18 27 26 25 118

Tampa General Hospital (Service Area 2) 51 47 58 53 54 263

Jackson Memorial Hospital (Service Area 4) 22 30 31 28 27 138

State Total 127 123 142 141 127 660 Source: Florida Adult Organ Transplantation Program Utilization data for above indicated years.

Note: *Mayo Clinic licensed former St. Luke’s Hospital program effective 4/12/2008.

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.


21

Organ Procurement and Transplantation Network (OPTN)

Current Florida Wait List Registrants Based on OPTN Data as of June 29, 2012

Heart

Total 174

< 30 Days 21

30 to < 90 Days 21

90 Days to < 6 Months 26

6 Months to < 1 Year 32

1 Year to < 2 Years 44

2 Years to < 3 Years 16

3 Years to < 5 Years 9

5 or More Years 5 Source: http://optn.transplant.hrsa.gov/latestData/rptData.asp, with a July 12, 2012 run.

Donor/patient matches are also a factor in transplant services. The

chart below contains the most recent five-year volume of heart donations

by Florida residents.

Florida Heart Donors Recovered

January 1, 2006 - December 31, 2011 Based on OPTN Data as of June 29, 2012

2011 2010 2009 2008 2007 2006

All Donor Types 168 160 144 143 151 130

Deceased Donor 168 160 144 143 151 130

Living Donor 0 0 0 0 0 0 Source: http://optn.transplant.hrsa.gov/latestData/rptData.asp, with a July 12, 2012 run.

As shown above, there were 168 Florida heart donors in 2011. Florida

Center for Health Information and Policy Analysis data indicates there

were a total of 130 adult heart transplants and 123 adult heart implant

assist device procedures performed at Florida hospitals in CY 2011. The

total procedures (130 adult heart transplants) were fewer than the donor

recovery total of 168 (a difference of 38 more donors than adult heart

transplant procedures, in CY 2011).

Agency data indicates that 124 of 130 (or 95.38 percent) of the adult

patients [15 years of age or older (15+)] receiving heart transplants

performed in Florida in CY 2011 were Florida residents13. The remaining

six adult patients had an unknown residence. Service Area 4 residents

accounted for 30 of the 124 procedures, or 24.19 percent. Below is a

chart to account for these totals.

13 There were 127 total adult heart transplant procedures reported to the local health councils for CY 2011. Some variation in the patient data is to be expected.

http://optn.transplant.hrsa.gov/latestData/rptData.asphttp://optn.transplant.hrsa.gov/latestData/rptData.asphttp://optn.transplant.hrsa.gov/latestData/rptData.asp


22

Adult Heart Transplants at Florida Hospitals by Patient Residence Calendar Year 2011

Service Area Transplants Performed Percent of Total

1 29 22.31%

2 45 34.62%

3 20 15.38%

4 30 23.08%

Unknown 6 4.62%

Total 130 100.00% Source: Florida Center for Health Information and Policy Analysis CY 2011 database,

MS-DRGs 001 and 002 (excluding heart implant assist devices).

Service Area 4 residents generally do not migrate outside their home

service area for adult heart transplantation; this is verified for calendar

year 2011. Below is a chart to account for these procedures.

Service Area 4 Resident Facility Selection Adult Heart Transplantation Procedures

Calendar Year 2011 Facility/Organ Transplant Service Area Patient Total Patient Percent

Shands Hospital at UF (Service Area 1) 0 0.00%

Mayo Clinic (Service Area 1) 0 0.00%

Tampa General Hospital (Service Area 2) 4 13.33%

Jackson Memorial Hospital (Service Area 4) 26 86.67%

Service Area 4 Total 30 100.00%

Source: Florida Center for Health Information and Policy Analysis CY 2011 database, MS-DRGs 001 and 002

(excluding heart implant assist devices).

The above chart indicates that in calendar year 2011, 26 of the 30 (or

86.67 percent) of Service Area 4 residents/patients who had adult heart

transplants remained in Service Area 4 for the procedure (Jackson

Memorial Hospital). Jackson Memorial Hospital’s service to Service Area

4 residents consisted of procedures for 13 Miami-Dade County, six

Broward, six Palm Beach County and one Collier County resident.

Tampa General Hospital provided heart transplants to two Collier County

and two Miami-Dade County residents.

For the three-year period ending December 31, 2011, given somewhat

steady but relatively declining demand for adult heart transplantation at

OTSA 4’s sole adult heart transplantation provider, and relatively low

outmigration to a non-OTSA 4 facility to have this procedure, it is

reasonable to conclude that another program would likely reduce

demand at the existing OTSA 4 adult heart transplant provider.


23

It is also reasonable to expect that the implantation of heart assist

devices will lower heart transplant volume. A Florida hospital is not

required to have a heart transplantation program in order to provide

heart assist implants. The chart below shows the state’s heart

transplants and heart assist volume for the previous five years.

Heart Transplant & Heart Assist Implant Discharges

All Florida Hospitals CY 2007-2011

Year Heart

Transplants Heart Assist

Total Heart Transplant/Assist

Discharges

2007 128 89 217

2008 127 92 219

2009 141 167 318

2010 143 277 420

2011 130 369 499

Source: Florida Center for Health Information & Policy Analysis Hospital

Discharge data for the appropriate years.

Note: Heart Assist ICD-9 Codes include 37.6, 37.60, 37.62, 37.65, 37.66 & 37.68.

As shown above, heart assist implantation increased from 167

procedures in CY 2009 to 369 in CY 2011, or by 121 percent. Heart

transplant volume actually decreased by 7.8 percent from CY 2009 to

CY 2011.

The sole Service Area 4 provider of adult heart transplantation (Jackson

Memorial Hospital) has averaged 28.67 procedures over the three-year

period ending December 31, 2011. Each co-batched applicant’s second

year volume estimate exceeds the number of patients (four patients) from

Service Area 4 that received the service in a non-OTSA 4 facility in CY

2011. Both co-batched applicants’ volume estimates appear somewhat

ambitious. Both applicants’ projections meet the CMS minimum annual

volume requirement for 10 procedures, by year two.

Below is each applicant’s expected adult heart transplantation count

during its first years of operation.

Cleveland Clinic Florida Health System Nonprofit Corporation,

d/b/a Cleveland Clinic Hospital (CON #10148): Cleveland Clinic

Hospital expects to perform eight adult heart transplantations in year

one of operation (ending December 31, 2013), 12 procedures in year two

and 16 in year three.


24

South Broward Hospital District d/b/a Memorial Regional Hospital

(CON #10149): Memorial Regional Hospital expects to perform six adult

heart transplantations in year one of operation (ending October 31, 2014)

and 15 procedures in year two.

2. Applications for the establishment of new adult heart

transplantation program shall not normally be approved in a service planning area unless the following additional criteria are met: (a) Staffing Requirements: An applicant for a heart

transplantation program shall have the following program personnel and services. (Rule 59C-1.044(6)(a) Florida Administrative Code).

(1) A board-certified or board-eligible adult cardiologist; or

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

Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital

(CON #10148) states 18 board-certified cardiologists will

support the adult heart transplantation program. Among

these, cardiologists Dr. Andrew Boyle and Dr. Vivian Navas

are described in detail. Dr. Boyle is stated to have

experience in end stage heart failure, including mechanical

circulatory support and heart transplantation. He will be

the Chair of the Department of Cardiovascular Medicine and

the Medical Director, Heart Transplant Program. Dr. Navas

is stated to have experience in and will provide care to pre

and post-transplant patients and for left ventricle assist

device (LVAD) patients. Cleveland Clinic states Dr. Navas is

a cardiologist who is board-certified in heart failure and

cardiac transplant medicine. Further, the applicant states

this physician is, “…one of less than 300 similarly certified

specialists in the United States”. In this section of the

application, it is stated, “In addition to Drs. Brozzi, Boyle

and Navis…”14.

14 The reviewer notes a Dr. Bozzi is not discussed in this section; however, a CV is included (CON application #10148, Volume III, Tab 16) for a Cleveland Clinic Foundation, Cleveland, Ohio practitioner, Nicolas Brozzi, MD.


25

South Broward Hospital District d/b/a Memorial

Regional Hospital (CON #10149) states having a

comprehensive group of physicians on staff who are all

board-certified and actively practice at the hospital in the full

array of specialties and sub-specialties likely to be called

upon to support and complement the project. The applicant

states that Memorial Regional Hospital has 41 board-

certified adult cardiologists and 18 pediatric cardiologists

with active medical staff privileges at Memorial Healthcare

System hospitals and these physicians are board-certified in

cardiology, cardiovascular disease, and clinical cardiac

electrophysiology. Memorial Regional Hospital plans, upon

project approval, to recruit an adult transplant cardiologist,

who will serve as medical director of the program.

The applicant reports the following physicians already on

staff: Dr. Michael Cortelli, Chief of Adult Cardiac Surgery;

Dr. Juan Plate, Lead Transplant Surgeon; Dr. Lyle Feinstein,

Medical Director of the Bone Marrow Transplant Program

and Dr. Maryanne Chrisant, Director, Heart Transplant,

Heart Failure and Cardiomyopathy Programs. (2) An anesthesiologist experienced in both open heart

surgery and heart transplantation.


(CON #10148) states it has 17 board-certified

anesthesiologists and six anesthesiologists are currently

providing all the anesthesia needs of Cleveland Clinic

Hospital’s cardiac surgeries. These six physicians are stated

to have experience in heart surgery and heart

transplantation.


Regional Hospital (CON #10149) states a group of

transesophageal, echo certified adult cardiac

anesthesiologists are part of the adult cardiac surgical team.

Dr. Robert Brooker is the chief of the cardiac anesthesia

section and he and Dr. Jeremy Gold have adult heart

transplant patient experience. These two physicians are


26

stated to be cardiac anesthesia fellowship trained and board-

certified. The reviewer notes these physicians are board-

certified in anesthesiology and perioperative

echocardiography, per their CVs (CON application #10149,

Attachment P). (3) A one-bed isolation room in an age-appropriate intensive

care unit.


(CON #10148) states its adult ICU has one reverse isolation

room that will be available for heart transplant patients, as

needed.


Regional Hospital (CON #10149) states it has an eight-bed

heart surgery unit, which “consists of all large private rooms,

one of which is suitable for reverse isolation”.

(b) Need Determination: An application for a certificate of need to establish a new heart transplantation program shall not normally be approved in a service area unless: (Rule 59C-1.044(6)(b) Florida Administrative Code).

(1) Each existing heart transplantation provider in the

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

Both CON application #10148 and CON application

#10149 indicate, and the reviewer confirms that Jackson

Memorial Hospital performed more than the required

minimum number of heart transplants in the most recent

calendar year preceding the current application deadline and

that no other adult heart transplantation program has been

approved for the same service planning area.


27

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


(CON #10148) plans to perform 12 heart transplants in year

two (ending December 31, 2013). Per Cleveland Clinic

Hospital, for the 12-month period ending June 30, 2011,

statewide, 159 hearts were procured, 127 hearts were

transplanted and 32 hearts made up the resultant surplus.

For the same 12-month period, the applicant indicates in

OTSA 4, 41 hearts were procured, 27 hearts were

transplanted and 14 hearts were surplus. Cleveland Clinic

Hospital concludes that 32 hearts likely left the state for

transplantation elsewhere, while there were still waitlisted

candidates in Florida and in OTSA 4. Below is a table to

account for OTSA 4 and statewide hearts procured and

procedures performed.

Hearts Procured and Transplanted Service Area 4 and State of Florida 12-Month Ending June 30, 2011

Service Area 4 State of Florida

Hearts Procured by OPOs 41 159

Hearts Transplanted* 27 127

Net Surplus (Shortage) of Donor Hearts 14 32 Source: CON application #10148, page #85.

NOTES: * The reviewer confirms the totals on this row are consistent with those found in

the Agency publication, “Florida Adult Organ Transplantation Program Utilization Data,

July 2010 –June 2011”, issued September 30, 2011.

The reviewer has previously shown (see part E.1.a) that for

CY 2011, there were 38 more Florida heart donors than

adult heart transplants statewide. Per Cleveland Clinic

Hospital, the excess 14 donor organs procured in OTSA 4 is

sufficient to accommodate the proposal. In addition,

Cleveland Clinic Hospital has conditioned to enhance organ

donation (see part C, Project Summary, CON application

#10148, Schedule C-Condition #5).


28


Regional Hospital (CON #10149) plans to perform 15 adult

heart transplants in year two (ending October 30, 2015).

The applicant states that 132 hearts were procured in CY

2011 and during the 12-month period ending September 30,

2011, 126 were transplanted. During CY 2011, the

applicant indicates 35 hearts were procured in OTSA 4 and

34 OTSA 4 residents’ hearts were transplanted. Jackson

Memorial performed 32 heart transplants in CY 2011.

Memorial Regional Hospital calculates likely future adult

heart transplant demand based on calculations factoring in

adult transplants performed, transplants per million adult

population and the adult population, statewide and in OTSA

4. This is maintaining a constant annual percent change in

transplant rates of 7.0 percent (stated by Memorial Regional

Hospital to be consistent with the statewide transplant rate

from 2009-2011). Below is a table to account for the

applicant’s estimates.

Projected Number of Adult (Age 15+) Heart Transplants Provided to Residents of OTSA 4, 12 Months Ending September 30, 2011-2015

2011 2012 2013 2014 2015

Adult Population 4,811,200 4,836,800 4,889,800 4,944,100 4,993,000

Annual % Change in Transplant Rates 7% 7% 7% 7%

Transplants per Million 7.1 7.6 8.1 8.7 9.3

Transplants Performed 34 37 40 43 46

Source: CON application #10149, page #47, Table 12.

Based on Memorial Regional Hospital’s calculations, there is

sufficient demand to warrant the project.

Memorial Regional Hospital emphasizes the relevance of

congenital heart disease; that many pediatric congenital

heart disease patients progress on to needing adult heart

transplantation, with additional emphasis on the overall

robust set of cardiovascular services already offered at

Memorial Regional Hospital (including the adult congenital

heart program).


29

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


(CON #10148) reports performing 988 cardiac

catheterizations and 192 open heart surgeries in CY 2011.

Cleveland Clinic Hospital indicates project approval would

complement its cardiovascular services already provided,

ensuring availability and accessibility of what the applicant

considers a full continuum of cardiac care for the region.


Regional Hospital (CON #10149) reports performing 2,616

cardiac catheterizations and 350 open heart surgeries in

CY 2011.

Memorial Regional Hospital offers “Other Considerations” in

this section to support the project. They are briefly

described below:

● Geographic access will be enhanced for OTSA-4 residents

outside of Miami-Dade County;

● Experience and outcomes of Memorial Regional Hospital’s

established, mature cardiac program relative to the

Cleveland Clinic and the University of Miami Hospital;

and

● Jackson Memorial Hospital should not be negatively

impacted by project approval. Memorial Regional

Hospital projects rise in demand based on the state’s

seven percent growth in heart transplants between 2009

and 2011, coupled with OTSA 4’s projected adult

population will result in 46 procedures for CY 2015.

Memorial Regional provides the following chart to support its

contention that its cardiac case volume far exceeds Cleveland

Clinic and the University of Miami Hospital.


30

Number of Adult Open Heart Surgeries & Cardiac Procedures

Broward Regional, Cleveland Clinic & University of Miami Hospital Calendar Year 2011

Cleveland

Clinic Hospital

University of Miami Hospital

Memorial Regional Hospital

Memorial

Hospital West

Memorial Healthcare

System

Open Heart Surgeries 192 314 350 --- 350

Coronary Angioplasties 370 529 1,035 593 1,628

Cardiac Catheterizations 198 2,448 2,616 1,533 4,149 Source: CON application #10149, page 49, based on CY 2011 Hospital Utilization Reports from Broward

Regional Health Planning Council, Inc. and Health Council of South Florida, Inc.

The applicant notes that Memorial physicians performed nearly twice as

many open heart surgeries as Cleveland Clinic physicians during

CY 2011 and nearly three times as many coronary angioplasties. When

activity at Memorial Hospital West is included (593 angioplasties and

1,533 cardiac catheterizations, it is evident that Memorial Healthcare

System provides far more tertiary cardiovascular services to residents of

OTSA 4 than Cleveland Clinic. The applicant’s discussion included the

University of Miami which had an application but did not file omissions,

so the reviewer did not include UM in the narrative.

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.


(CON #10148) asserts it has sufficient staff and other

resources to care for the heart transplant patient’s chronic

illness prior to transplantation, during transplantation and


31

throughout the post-operative period. Services and facilities

for inpatient and outpatient care will be available on a 24-

hour basis.

The applicant again stresses its closed staff model, stating

this is unique and enhances continuity of care with higher

quality clinical outcomes, enabling the hospital to have high

acuity patients. These closed staff critical care physicians

are stated to actively monitor and manage transplant

patients on a 24-hour, seven day a week basis, in the

hospital’s intensive care unit (ICU), with both surgical and

medical beds. Critical care nurses are stated to be available

and will receive special training on the immunosuppression

of transplant patients. It is also stated the ICU has one

reverse isolation room that will be available for heart

transplant patients, though Cleveland Clinic Hospital states

prolonged reverse isolation is a rare necessity. Other

extensive post-operative and outpatient staff and services are

discussed. The applicant also reports a Palm Beach County

outpatient center, in the city of West Palm Beach, and an

outpatient center set to open within three to four months, in

the city of Palm Beach Gardens.

The applicant reports that all Cleveland Clinic physicians are

board-certified.

Cleveland Clinic Hospital indicates existing facility expansion

plans and activities are meeting area demand. Future

expansion (estimated to be from 2015 and beyond) is stated

to approximate 700,000 square feet in total, 400,000 square

feet being the hospital/inpatient component. Expansion

projects are expected to be licensed and available for patient

use by the end of 2015.


Regional Hospital (CON #10149) indicates its cardiac and

vascular institute has the existing capacity to care for

patients with acute and chronic heart failure due to

congenital heart disease, ischemic cardiomyopathy, dilated

and other forms of cardiomyopathy, or end-stage valvular

heart disease prior to heart transplant, during the heart

transplant process and in the early and late post-transplant

period. Memorial Regional Hospital indicates services and

personnel required for this care are available 24 hours a day.


32

The applicant states evidence for this by stating 350 adult

open heart surgeries and 3,651 diagnostic and interventional

catheterizations, in CY 2011.

Memorial Regional Hospital states it has on-site short term

and nearby extended stay accommodations to and from the

hospital for patient families.

MRH believes project approval would provide for seamless,

high quality, comprehensive care for the sickest patients and

eliminate unnecessary risk. The applicant provides a

voluminous existing operational “MRH Pediatric Heart

Transplant Protocols, Policies, Procedures and Manuals”

publication (CON application #10149, Volume II, Attachment

H).

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.


(CON #10148) states and the reviewer confirms, the

applicable organ procurement organization (OPO), Life

Alliance, provides a letter of support (CON application

#10148, Volume I, Tab 5). Cleveland Clinic Hospital states

Life Alliance has intent to contract with Cleveland Clinic

hospital for procurement of applicable organs. It is further

stated the applicant and Life Alliance will develop a system

whereby 24-hour calls will be maintained for assessment,

management and retrieval of all referred donors, cadaver

donors and organs shared by other transplant programs or

organ procurement agencies.

The applicant states it has a current agreement with Life

Alliance whereby the hospital seeks assistance from Life

Alliance to meet its obligations to promote donation of


33

transplantable deceased donor organs and tissues. This

agreement executed in October 2009, is included in CON

application #10148, Volume III, Tab 13.

Cleveland Clinic Hospital conditions to establish a donor

council, with a goal to further enhance organ donation and

awareness initiatives aimed at patients, families and

employees of the hospital and to assure optimal

communication and referral practices with the OPO as a

donor hospital.


Regional Hospital (CON #10149) includes a June 2009,

memorandum of understanding between South Broward

Hospital District and Life Alliance Organ Recovery Agency in

CON application #10149, Volume II, Attachment G. Heart

procurement will be in accord with organ allocation policies

and procedures established by the United Network for Organ

Sharing (UNOS). Memorial Regional Hospital advises it has

a fully trained staff with expertise in cardiac organ

transplantation and organ recovery. The applicant states it

will have a cardiac transplant team, complete with a

transplant donor coordinator and a lead transplant

coordinator. Applicable data gathering and consultation will

occur within UNOS guidelines. Memorial Regional provided

12 organ donors to Life Alliance in calendar years 2011 and

2010 and 14 in calendar years 2009 and 2008.

Memorial Regional Hospital states its cardiac and vascular

institute has a well-established 24/7 and 365 day per year

call schedule, operational for the past several years and that

the call schedule covers the following services: pediatric

cardiac surgeon; pediatric CV OR team; perfusion; cardiac

anesthesia, cardiologist and sonographer. The applicant

advises the call schedule will be expanded to include the on

call transplant coordinator/donor coordinator, transplant

surgeon and transplant cardiologist. It is also stated that

there is in place a 24/7 ECMO (heart-lung bypass) call

schedule if a patient needs support at that level either pre-

operative or post-transplant.


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The applicant indicates its existing pediatric heart

transplantation protocols/policies/procedures/manuals will

be developed for adult heart transplantation. These manuals

are included in CON application #10149, Volume I,

Attachment H.

3. An age-appropriate intensive care unit which includes

facilities for prolonged reverse isolation when required.


(CON #10148) indicates adult heart transplant recipients,

post-surgery, will be treated on the surgical area of the

14-bed adult ICU. This ICU has one reverse isolation room

that can accommodate any need as it arises, per the

applicant.


Regional Hospital (CON #10149) indicates it has a

dedicated eight-bed heart surgery ICU with large private

rooms. It is stated one of these rooms is suitable for reverse

isolation with the appropriate air flow system and that the

unit has the capability of converting any of the seven

remaining rooms to function as an isolation room.

4. A clinical review committee for evaluation and decision- making regarding the suitability of a transplant candidate.


(CON #10148), on the basis of what the applicant considers

their thorough evaluation, previous medical records, and

psychosocial information, a decision will be made by the

advanced heart failure treatment committee (AHFTC)

regarding the advisability of cardiac transplantation for

patients with severe functional impairment with no medical

or surgical therapeutic options. Meetings of this committee

are planned to be held weekly, once program volumes

increase. The committee is to be comprised of transplant

surgeons, cardiologists, transplant coordinators, social

workers, psychiatrists, bioethicists and anesthesiologists.


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Cleveland Clinic Hospital indicates there are 15 specific risk

factors that require careful consideration by the AHFTC. Per

the applicant, the selection committee makes a decision to

transplant or not transplant. If the decision is to transplant,

Cleveland Clinic Hospital states the patient is listed with

UNOS and prioritized, based on guidelines.

An outcome of the selection committee other than transplant

could be to surgically implant mechanical circular support,

usually a left ventricle assist device (LVAD). Another option

is a total artificial heart (TAH). The LVAD and TAH are

considered a bridge to transplant, though about half of LVAD

patients are never intended to experience a transplant, per

the applicant.


Regional Hospital (CON #10149) states that it will establish

a transplant selection committee which will meet weekly, or

as needed. The MRH cardiac and vascular institute

transplant selection committee (committee) is the clinical

review committee for transplant selection and is to be

organized under the Surgical Program Director, Juan Plate,

MD and a heart transplant cardiologist as medical director

(the latter to be recruited upon project approval).

Memorial Regional Hospital indicates its existing pediatric

heart transplantation protocols/policies/procedures/

manuals will be developed for adult heart transplantation.

Once a candidate is approved, he/she will be placed on the

waiting list and registered with the local organ procurement

organization. Depending on the results of the committee’s

review and decision, a candidate may be accepted, rejected

or tabled. The transplant coordinator will document these

decisions and families will be appropriately notified. The

applicant indicates emergency evaluations may be conducted

bedside in the case of severely ill patients.


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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.


(CON #10148) states it will adopt similar protocols for its

adult heart transplant program as Cleveland Clinic Ohio

Campus has in place. Cleveland Clinic Hospital further

states that the Cleveland Clinic Ohio Campus adheres to its

“Heart Transplantation Manual for Adults” (included in CON

application #10148, Volume II, Tab 6). The applicant states

the manual addresses more than just the pre-hospital,

inpatient and post discharge phases of the heart transplant

program. Other major headings under written protocols

include: management of patients on waiting lists; organ

procurement; transplantation and post-transplant in

hospital and discharge and follow-up care.

Per Cleveland Clinic Hospital, hearts are always offered

within a 500-mile radius first, then if there are no matches

or acceptances the organ goes go the next 500-mile radius.

Per the applicant, the decision to use an organ ultimately

depends on the transplant surgeon’s evaluation of the organ

during the procurement procedure and the potential

recipient’s medical status.


Regional Hospital (CON #10149) states it will develop a set

of protocols modeled after similar protocols developed and

successfully utilized by its existing pediatric heart

transplantation program and those of other existing

nationally renowned adult heart transplant facilities. The

applicant provides a detailed description of the credentials of

the three adult cardiac surgeons who will be performing

adult heart transplants. Memorial Regional Hospital

indicates the protocols will be developed “based on the

experience and outstanding outcomes from large adult heart

transplant programs that Drs. Plate, Cortelli, Perryman and

Scholl have played significant roles in”.


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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.


(CON #10148) begins with an in-depth description of

discharge planning and that this process will start before the

Documents

STATE AGENCY ACTION REPORTahca.myflorida.com/MCHQ/CON_FA/Batching/pdf/10149.pdf · 2012. 8. 16. · CON Action Numbers: 10148 and 10149 2 Most of the letters support all three of