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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
2
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
CON Action Numbers: 10148 and 10149
3
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
CON Action Numbers: 10148 and 10149
4
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.
CON Action Numbers: 10148 and 10149
5
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.
CON Action Numbers: 10148 and 10149
6
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/
CON Action Numbers: 10148 and 10149
7
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/
CON Action Numbers: 10148 and 10149
8
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.
CON Action Numbers: 10148 and 10149
9
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
CON Action Numbers: 10148 and 10149
10
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.
CON Action Numbers: 10148 and 10149
11
● 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.
CON Action Numbers: 10148 and 10149
12
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.
CON Action Numbers: 10148 and 10149
13
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.
CON Action Numbers: 10148 and 10149
14
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
measured by submission of an annual report by the hospital to
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
CON Action Numbers: 10148 and 10149
15
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.
CON Action Numbers: 10148 and 10149
16
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
measured by submission of an annual report by the hospital to
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.
CON Action Numbers: 10148 and 10149
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
CON Action Numbers: 10148 and 10149
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.
CON Action Numbers: 10148 and 10149
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.
CON Action Numbers: 10148 and 10149
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.
CON Action Numbers: 10148 and 10149
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
CON Action Numbers: 10148 and 10149
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.
CON Action Numbers: 10148 and 10149
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.
CON Action Numbers: 10148 and 10149
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.
CON Action Numbers: 10148 and 10149
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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.
South Broward Hospital District d/b/a Memorial
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
CON Action Numbers: 10148 and 10149
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(CON #10148) states its adult ICU has one reverse isolation
room that will be available for heart transplant patients, as
needed.
South Broward Hospital District d/b/a Memorial
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.
CON Action Numbers: 10148 and 10149
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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).
CON Action Numbers: 10148 and 10149
28
South Broward Hospital District d/b/a Memorial
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).
CON Action Numbers: 10148 and 10149
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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.
South Broward Hospital District d/b/a Memorial
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.
CON Action Numbers: 10148 and 10149
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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
CON Action Numbers: 10148 and 10149
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.
South Broward Hospital District d/b/a Memorial
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.
CON Action Numbers: 10148 and 10149
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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
CON Action Numbers: 10148 and 10149
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.
South Broward Hospital District d/b/a Memorial
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.
CON Action Numbers: 10148 and 10149
34
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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.
South Broward Hospital District d/b/a Memorial
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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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.
CON Action Numbers: 10148 and 10149
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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.
South Broward Hospital District d/b/a Memorial
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.
CON Action Numbers: 10148 and 10149
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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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(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.
South Broward Hospital District d/b/a Memorial
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”.
CON Action Numbers: 10148 and 10149
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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.
Cleveland Clinic Florida Health System Nonprofit Corporation, d/b/a Cleveland Clinic Hospital
(CON #10148) begins with an in-depth description of
discharge planning and that this process will start before the