STATE AGENCY ACTION REPORT
ON APPLICATION FOR CERTIFICATE OF NEED
A.
PROJECT IDENTIFICATION
1.
Applicant/CON Action Number
South Broward Hospital District
d/b/a Memorial Hospital West/CON #10108
3501 Johnson Street
Hollywood, Florida 33021
Authorized Representatives:
2.
Mr. Jon D. Bandes
(954) 265-3452
Service District/Subdistrict
Organ Transplant Service Area 4: District 10 (Broward County), District
11 (Miami-Dade and Monroe Counties); Collier County only (in District 8)
and Palm Beach County only (in District 9).
B.
PUBLIC HEARING
A public hearing was not held or requested. However, letters of support
were received as discussed below.
The applicant submitted 22 unduplicated letters of support (Attachment
D-Letters of Support) that were signed and dated between August 16 and
December 16, 2010. Most of the support letters were from elected
officials that represent the area at the local, state and federal level.
These include: Debbie Wasserman Schultz (20th District, Florida),
U.S. House of Representatives, Eleanor Sobel (District 31) and Nan Rich
(District 34), Florida Senate and Evan Jenne (District 100), Florida House
of Representatives. These four elected officials‟ letters emphasize that
Memorial Healthcare System is a tax assisted hospital district that
provides state-of-the-art, safe, quality medical services to patients
regardless of their ability to pay, that Memorial Hospital West is the
second largest Memorial Healthcare System hospital and that Memorial
West has a stellar oncology program that provides outpatient bone
CON Action Number: 10108
marrow transplant services. They also indicate that the applicant “had
to refer more than 165 patients to facilities far from patients‟ homes over
the last three years, which creates a tremendous hardship” for patients
and their families.
Sue Gunzburger, Mayor, Broward County, Peter Bober, Mayor, City of
Hollywood, Lori Moseley, Mayor, City of Miramar, Frank Otis, Mayor and
Jack McCluskey, Vice-Mayor, City of Pembroke Pines and Iris Siple, Carl
Shechter and Angelo Castillo, City Commissioners, City of Pembroke
Pines, signed letters which stated it is their understanding that a
“significant amount of patients from south Florida have to travel far to
other facilities to receive bone marrow transplants each year and that
number will no doubt continue to grow”. They also indicate the addition
of bone marrow transplantation services to the Memorial Cancer
Institute at Memorial Hospital West “will enhance access and address a
need in our community, making an emotionally and financially stressful
time less so for patients and families in our area”.
Aaron Elkin, M.D., F.A.C.O.G., President, Broward County Medical
Association, stated that on behalf of his 1,700 physician members, he
supported the project. Dr. Elkin indicated Memorial Hospital West
currently has an “outstanding oncology program” that provides project
related outpatient but not inpatient services. Similar to other support
letters, Dr. Elkin indicated he understood that “numerous” patients in
the community have to travel to other facilities not in the immediate area
to obtain needed care and that such travel adds to patient and family
difficulties in obtaining services and fragments and interrupts continuity
of medical care.
Claudio Anasetti, M.D., Department Chair – Blood & Marrow
Transplantation, H. Lee Moffitt Cancer Center indicated that he visited
the Leukemia Lymphoma and Bone Marrow Transplant Program at
Memorial Hospital West on August 30th, 2010. Dr. Anasetti provided a
detailed description of the physician, staff and resources that the
applicant already has in place. He stated there is a need in Florida to
provide blood or marrow transplants to an additional 500 patients with
leukemia, lymphoma or myeloma each year. Dr. Anasetti further stated
he understood the applicant‟s bone marrow transplant program
transplanted or “referred away” about 70 patients “last year alone”, and
that if approved and operational, the project should allow for “about 150
transplants per year”. Dr. Anasetti concluded that Floridians and
especially residents of south Florida need the program without traveling
“hundreds of miles or out of state” and that Memorial Hospital West has
“phenomenal infrastructure that is well suited” to support the project.
2
CON Action Number: 10108
Joanne Davis, CFRE, Executive Director, South Florida Chapter, The
Leukemia & Lymphoma Society, indicated that each year, her
organization provides direct support and services to over 2,000 blood
cancer patients and family members in the community. Ms. Davis also
stated the project would improve quality of life for patients and their
families.
Shelley Goren, President and CEO, Gilda‟s Club South Florida, stated
her organization has worked with “Memorial Hospital” on many
successful programs that have benefited people in the community
affected by cancer and that the project would be “a significant
commitment to medical excellence and oncology services” available to
area residents.
The remaining support letters were from area residents and family
members who described the challenges (such as patient isolation, family
stress and financial hardships) when bone marrow transplantation is
sought outside the local area. They indicate that improved access would
be realized if the project is approved.
C.
PROJECT SUMMARY
South Broward Hospital District d/b/a Memorial Hospital West seeks
approval to establish an adult inpatient autologous and allogeneic bone
marrow transplantation program at Memorial Hospital West‟s Memorial
Cancer Institute, to serve patients in Transplant Service Area 4. The
applicant states that the inpatient bone marrow transplant program will
be located on the third floor of a new 80-bed1 tower which will also
include the hospital‟s current inpatient oncology program. Memorial
Hospital West presently provides outpatient adult bone marrow
transplant services.
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
Hospital West‟s 304 licensed bed compliment includes 284 acute care
beds and 20 Level II neonatal intensive care unit (NICU) beds. Memorial
Hospital West is a Level I adult cardiovascular services center and a
primary stroke center. The applicant states the following seven reasons
justify the project:
1
The applicant has notification #NF1000012 for the 80-bed addition.
3
CON Action Number: 10108
•
Transplant Service Area 4 residents have inadequate access to bone
marrow transplant services (as evidenced by historically low
transplant rates among service area residents),
•
a high percentage of Service Area 4 residents who receive inpatient
transplants must travel long distances for their transplant (creating
significant financial, logistical and emotional hardship for patients
and their families) given the need for close patient surveillance posttransplant;
•
the demand for bone marrow transplant will steadily rise due to
increasingly safer transplant procedures, favorable survival rates,
expanded sources of donor cells, and an aging population susceptible
to diseases for which transplant is indicated;
•
Memorial Hospital West operates a robust oncology program that
treats many patients who are candidates for adult bone marrow
transplant (with the existing program having referred over 176
patients for inpatient bone marrow transplant to other centers over
the past four years (70 autologous and 106 allogeneic ) of which more
than 87 percent have been referred to the programs outside of Service
Area 4 or outside the State of Florida;
•
the projected number of adult inpatient bone marrow transplants in
the third year of operation of the proposed program well exceeds the
statutory minimum thresholds of 10 allogeneic and 10 autologous
transplants per year;
•
without the proposed new program at Memorial Hospital West,
approximately 40 percent of Service Area 4 residents receiving adult
inpatient bone marrow transplants will travel to transplant centers
outside Service Area 4 and will be subject to the financial, logistical
and emotional hardships attendant to being transplanted away from
home; and
•
project approval will enable Memorial Healthcare System and
Memorial Hospital West to expand its hematology and oncology
programs and the existing outpatient autologous bone marrow
transplant program in order to perform inpatient autologous and
allogeneic transplant.
The adult inpatient autologous and allogeneic transplant bone marrow
transplant program, if approved, is to complete its first year of operation
in December 2012.
4
CON Action Number: 10108
Project costs total $4,951,000. The project involves 16,670 gross square
feet (GSF) of new construction and 958 GSF of renovated space with a
construction cost of $3,265,000. Total project costs include building,
equipment and project development costs.
The applicant proposes to condition the project to the location at 703
North Flamingo Road, Pembroke Pines, Florida 33028, and “to treat two
charity care patients a year, regardless of their ability to pay”.
D.
REVIEW PROCEDURE
The evaluation process is structured by the certificate of need review
criteria found in Section 408.035, Florida Statutes. These criteria form
the basis for the goals of the review process. The goals represent
desirable outcomes to be attained by successful applicants who
demonstrate an overall compliance with the criteria. Analysis of an
applicant's capability to undertake the proposed project successfully is
conducted by assessing the responses provided in the application, and
independent information gathered by the reviewer.
Applications are analyzed to identify strengths and weaknesses in each
proposal. If more than one application is submitted for the same type of
project in the same district (subdistrict), applications are comparatively
reviewed to determine which applicant best meet the review criteria.
Section 59C-1.010(2) (b), Florida Administrative Code, allows no
application amendment information subsequent to the application being
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 and consultation from
the architect, Scott Waltz, who evaluated the architecturals and the
schematic drawings.
5
CON Action Number: 10108
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 bone marrow 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 bone marrow transplants that will be performed in the first years of
operation.
There are presently two operational and one CON approved adult bone
marrow transplant programs in Service Area 4. As noted at the
beginning of this review, Service Area 4 includes Districts 10 and 11 and
also Collier County only (in District 8) and Palm Beach County only (in
District 9). The operational programs are at Good Samaritan Medical
Center and Jackson Memorial Hospital. The University of Miami is
approved to begin adult inpatient bone marrow transplantation at the
University of Miami Hospital & Clinics (CON #10041).
Data reported to the Agency for the most recent reporting period, July 1,
2009 through June 30, 2010 show the following adult bone marrow
transplant utilization data:
Florida Adult Bone Marrow Transplantation Program Utilization
July 2009 – June 2010
Hospital
OTSA*
Shands at University of Florida
1
Mayo Clinic
1
H. Lee Moffitt Cancer Center
2
Florida Hospital-Orlando
3
Good Samaritan Medical Center 4
Jackson Memorial Hospital
4
District
3
4
6
7
9
11
TOTAL
Total Procedures
123
63
366
80
1
88
721
Source: Agency for Health Care Administration Utilization Data for Adult Organ Transplantation
Programs published October 10, 2010.
Note: *OTSA is Organ Transplant Service Area as defined in Rule 59C-1.044(2)(f) Florida
Administrative Code and is synonymous with „TSA‟ for this review.
6
CON Action Number: 10108
For the 12-month period ending June 30, 2010, one procedure was
performed at Good Samaritan Medical Center, while 88 were performed
at Jackson Memorial Hospital (the two operational providers of adult
inpatient bone marrow transplants in Service Area 4). Good Samaritan
historically has low volume.
Adult Bone Marrow Transplantation Facilities
Mileage Chart Including Applicant
Memorial
Hospital
West
Memorial Hospital West
UM Hospital & Clinics
Shands at UF
Mayo Clinic-Jacksonville
H. Lee Moffitt Cancer Center
Florida Hospital-Orlando
Good Samaritan MC
Jackson Memorial Hospital
Source: www.Mapquest.com
22
324
332
264
233
62
23
UM
Hospital
& Clinics
22
336
344
286
234
71
0.1
Shands
at UF
324
336
89
125
116
272
336
Mayo
Clinic
-Jax
332
344
89
209
138
284
344
H.Lee
Moffitt
Cancer
Center
264
286
125
209
87
204
285
Florida
Hospital
Orlando
233
234
116
138
87
172
237
Good
Samaritan
MC
62
71
272
284
204
172
71
The above chart shows that there is distance of 22 miles between the
applicant and CON approved University of Miami Hospital & Clinics, 23
miles between the applicant and Jackson Memorial Hospital and 62
miles between the applicant and Good Samaritan Medical Center. All
other operational adult bone marrow transplant programs are outside
Service Area 4, at a minimum of 233 miles one-way. Broward County
has the second largest population in Service Area 4.
The map below shows the applicant‟s location and the service area‟s
existing and CON approved adult inpatient bone marrow transplantation
programs.
7
Jackson
Memorial
Hospital
23
0.1
336
344
285
237
71
CON Action Number: 10108
Transplant Service Area 4
CON #10108 and Existing & CON Approved
Adult Inpatient Bone Marrow Transplant Programs
Source: MapPoint 2006
Below is a five-year chart to account for adult inpatient bone marrow
transplants over the time period.
8
CON Action Number: 10108
Adult Bone Marrow Transplantation Procedures
June 30, 2006 through June 30, 2010
Facility/Transplant Service Area (TSA)
2006
2007
2008
2009
2010
Shands at UF (TSA 1)
119
110
150
124
123
Mayo Clinic*-Jacksonville (TSA 1)
27
43
38
45
63
H. Lee Moffitt Cancer Center (TSA 2)
235
270
270
311
366
Florida Hospital-Orlando (TSA 3)
39
29
38
47
80
Good Samaritan Medical Center (TSA 4)
5
2
2
6
1
Jackson Memorial Hospital (TSA 4)
53
48
40
22
88
State Total
478
502
538
555
721
Source: Agency for Health Care Administration Organ Transplantation Program Utilization
published October 2006 – October 2010.
* Mayo Clinic transferred from St. Luke‟s Hospital effective 4/12/2008.
Total
626
216
1452
233
16
251
2,794
data
Historic data also show for the five years ending June 30, 2010, H. Lee
Moffitt Cancer Center maintained the highest volume of adult bone
marrow transplantations, followed by Shands at the University of Florida
Jackson Memorial Hospital, Florida Hospital-Orlando, Mayo ClinicJacksonville and Good Samaritan Medical Center, which is the only
provider that limits its services to autologous (the patient‟s own cells)
peripheral blood stem cell bone marrow transplant. National Marrow
Donor Program data indicates that 70 percent of patients do not have a
suitable donor in their family and must therefore seek an unrelated
donor.2 So, Good Samaritan‟s program is expected to remain relatively
small. During the five-year period adult inpatient bone marrow
transplantations trended upward each year, with H. Lee Moffitt Cancer
Center being the only provider that consistently provided more or the
same number of these procedures each year.
Rule 59C-1.044(9)(b), Florida Administrative Code, states that adult
allogeneic bone marrow transplantation programs shall be limited to
teaching and research hospitals. Memorial Hospital West is not a
teaching hospital. However, the applicant states that Memorial
Healthcare has academic affiliations and conducts research projects with
the following post-secondary schools: Nova Southeastern University,
Barry University, New York College of Podiatric Medicine, Ohio College of
Podiatric Medicine, and Temple University. Memorial Hospital West‟s
Memorial Cancer Institute has an active Clinical Research Department
that participates in cancer treatment clinical research trials, including
collaboration with Mayo Clinic‟s North Central Cancer Treatment Group
(NCCTG)3. The applicant states that the outpatient bone marrow
Source: http://www.marrow.org.
The NCCTG is a national clinical research group based at the Mayo Clinic in Rochester, Minnesota
that is sponsored by the National Cancer Institute, http://ncctg.mayo.edu/.
2
3
9
CON Action Number: 10108
transplant program at Memorial Hospital West has a well established
relationship with H. Lee Moffitt Cancer Center (Hillsborough County) and
the Fred Hutchinson Cancer Research Center, in Seattle, Washington4.
The chart below shows the improved life expectancy (one year survival) of
unrelated transplant recipients at United States‟ transplant centers.
According to the National Bone Marrow Program, a major reason for the
continued increase in unrelated donor transplantation is the steady
improvement in transplant outcomes, as shown below.
Improved Survival with Unrelated Transplantation
Report Year
2006
2007
2008
Period
2000-2004
2001-2005
2002-2006
One-Year Survival
48.8%
51.5%
54.0%
Source: National Marrow Donor Program at http://www.marrow.org.
The National Marrow Donation Program also indicates that recent
studies have demonstrated that unrelated donor transplant outcomes are
now comparable to related donor transplant outcomes in several patient
populations.
South Broward Hospital District proposes a 47-page need argument
(CON #10108, pages 18-64), with four figures and 20 tables. The
applicant‟s need justification is briefly discussed below.
The applicant reports that from 2007 through 2009, Service Area 4
adults (age 18 and older) experienced a consistently lower bone marrow
transplant rate (per 100,000 adult residents) than the rest of the service
areas in the state. The applicant attributes this lower transplant rate to
inadequate access to applicable services in the area, a situation the
project is designed to help address. Below is a table to account for the
applicant‟s assessment.
Adult Inpatient Blood and Marrow Transplants
Per 100,000 Population (Age 18 or Older) by TSA
2007-2009
Transplant Service
Area (TSA)
TSA 1
TSA 2
TSA 3
TSA 4
Total
Transplants per
100,000 Residents
2007
4.0
3.5
3.4
2.2
3.4
Transplants per
100,000 Residents
2008
4.1
3.9
4.3
2.4
3.8
Transplants per
100,000 Residents
2009
4.4
4.8
4.9
3.1
4.5
Source: CON application #10108, page #32, Table 4.
The Fred Hutchinson Cancer Research Center is affiliated with the National Cancer Institute and the
National Comprehensive Cancer Network, http://www.fhcrc.org.
4
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CON Action Number: 10108
Memorial Hospital West states that the consistently lower transplant
rates in Service Area 4 cannot be attributed to less population-based
demand for transplant services. The applicant indicates that between
2002 and 2006, Service Area 4 had the highest new cancer (all cancer
diagnoses) incidence rates (including the highest leukemia and highest
non-hodgkin lymphoma incidence rates) per 100,000 adult residents, of
any service area. For the 12-month periods ending June 30, 2006, 2007,
2008 and 2010, Service Area 4 providers reported the second fewest
procedures of the states‟ four service area and in 2009. This supports
the applicant‟s contention that the service area has limited access for
bone marrow transplant services.
The applicant notes that Service Area 4 residents have higher outmigration to other service areas than do other service area residents who
receive their transplants in their respective service area. During
calendar year 2009, 133 Service Area 4 adult residents (15 years of age
or older) were discharged with a blood and bone marrow transplant
procedure, 64 patients (48.12 percent) received the procedure at a
Service Area 4 provider and the remaining 69 patients (51.88 percent)
received the procedure at a non-Service Area 4 provider. H. Lee Moffitt
Cancer Center served 67 of the 133 patients. Below is a table to account
for these totals and percentages.
Transplant Service Area 4 Adult Residents (Age 15 or Older)
With a Blood or Bone Marrow Transplant Discharge (DRG 009)
Calendar Year 2009
Hospital
Good Samaritan Medical Center
H Lee Moffitt Cancer Center
Jackson Memorial Hospital
Mayo Clinic
Shands Hospital at UF
Total Procedures
Total Procedures
2
67
62
1
1
133
Percentage
1.50%
50.38%
46.62%
0.75%
0.75%
100.00%
Source: Florida Center for Health Information and Policy Analysis database run date of 01/05/11.
Agency records indicate that in calendar year 2009, 47 Broward County
adult residents (15 years of age or older) were discharged with a blood
and bone marrow transplant procedure, 16 patients (34.04 percent)
received the procedure at a Service Area 4 provider (Jackson Memorial
Hospital) and the remaining 31 patients (65.96 percent) received the
procedure at a non-Service Area 4 provider. H. Lee Moffitt Cancer Center
served 30 of the 47 Broward County residents. Below is a table to
account for these totals and percentages.
11
CON Action Number: 10108
Broward County Adult Residents (Age 15 or Older)
With a Blood or Bone Marrow Transplant Discharge (DRG 009)
Calendar Year 2009
Hospital
H Lee Moffitt Cancer Center
Jackson Memorial Hospital
Shands Hospital at UF
Total Procedures
Total Procedures
30
16
1
47
Percentage
63.83%
34.04%
2.13%
100.00%
Source: Florida Center for Health Information and Policy Analysis database run date of 01/05/11.
During calendar year 2009, 28 Palm Beach County adult residents were
discharged with a blood and bone marrow transplant procedure, nine
patients (32.14 percent) received the procedure at a Service Area 4
provider (Good Samaritan Medical Center or Jackson Memorial Hospital)
and the remaining 19 patients (67.86 percent) received the procedure at
a non-Service Area 4 provider. H. Lee Moffitt Cancer Center served 19 of
the 28 Palm Beach County residents. Below is a table to account for
these totals and percentages.
Palm Beach County Adult Residents (Age 15 or Older)
With a Blood or Bone Marrow Transplant Discharge (DRG 009)
Calendar Year 2009
Hospital
H Lee Moffitt Cancer Center
Jackson Memorial Hospital
Good Samaritan Medical Center
Total Procedures
Total Procedures
19
7
2
28
Percentage
67.86%
25.00%
7.14%
100.00%
Source: Florida Center for Health Information and Policy Analysis database run date of 01/05/11.
Residents of Broward and Palm Beach counties who received blood and
bone marrow transplants (DRG 009), received those services primarily at
H. Lee Moffitt Cancer Center, a Service Area 2 provider. This supports
the applicant‟s limited access argument.
The applicant projects that in 2015, Service Area 4 will have 255 and the
state 1,004 adult blood and bone marrow transplants. The applicant‟s
Service Area 4 projection is based on an average annual increase of
16.43 procedures from 2009 to 2015, while Service Area 4 experienced
an annual average incremental increase of 6.20 procedures from July
2006 through June 2010. Therefore, an incremental increase of 16.43
procedures may be ambitious since it would average an additional 10.23
procedures each year. However, it is reasonable that the increase could
be realized considering a likely reduction in Broward County
outmigration and the addition of a new blood and bone marrow
transplant provider in Service Area 4 (CON #10041, University of Miami
Hospital & Clinics). The applicant‟s statewide estimate of 1,004
procedures by 2015 is an annual average incremental increase of 50.14
12
CON Action Number: 10108
procedures, while the state had an average incremental increase of 48.60
procedures from July 2006 through June 2010. Therefore, an
incremental increase of 50.15 procedures appears to be reasonable.
The applicant projects 18 transplants in 2012 (year one), 31 in 2013
(year two) and 45 in 2014 (year three). By 2014, the applicant estimates
45 procedures, with 24 for Broward County adults, 12 Miami-Dade
County adults and nine Palm Beach County adults. Based on the
applicant‟s estimates, by 2014, approximately 26.79 percent of Service
Area 4 adults that seek this procedure will receive it at Memorial Hospital
West, though the majority of procedures in the service area,
approximately 73.21 percent, will be performed at Miami-Dade County
facilities (Jackson Memorial Hospital and CON approved CON #10041 University of Miami Hospital & Clinics). Below is a table to account for
the applicant‟s assessment.
CY 2014 Adult Inpatient Blood and Bone Marrow Transplant
Projected TSA 4 Market Share and Volume
by Facility and Resident County
Facility
Percent
of
County
Total
31.17%
0.00%
13.19%
0.00%
18.75%
Facility
Percent
of
County
Total
23.38%
0.00%
35.16%
0.00%
20.83%
County / # Projected
Memorial
Jackson
U of M
Bone Marrow
Hospital
Memorial
Hospital
Transplants
West
Hospital
& Clinics
Broward - 77
24
18
16
Collier - 12
0
0
3
Miami-Dade - 91
12
32
32
Monroe - 2
0
2
0
Palm Beach - 48
9
10
10
Total TSA 4 Resident
Procedures In TSA 4
Facilities
45
26.79%
62
36.90%
61
Total TSA 4 Resident
Procedures in NonTSA 4 Facilities
Total Procedures (TSA
4 and Non-TSA 4
Facilities)
Source: CON application #10108, pages 57 - 60, Tables 18 and 19.
Note: Good Samaritan Medical Center is not projected to provide any procedures.
Facility
Percent
of
County
Total
20.78%
25.00%
35.16%
0.00%
20.83%
Total
Procedures
58
3
76
2
29
36.31%
168
62
230
The applicant contends that an estimate of 45 procedures by 2014 is
reasonable considering that Memorial Hospital West referred 47 adults
for blood and bone marrow transplants in 2008 and 71 adults for blood
and bone marrow transplants in 2009.
The majority of Broward and Palm Beach County residents who obtained
bone marrow transplants out-migrated to H. Lee Moffitt (Service Area 2)
in 2009 to receive the transplant, indicating limited access. Good
Samaritan Medical Center is and has historically been a low volume
provider. Increasingly safer and more successful blood and bone marrow
transplants likely accounts, at least in part, for the steady increase in
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CON Action Number: 10108
these procedures over the last several years and will likely continue to
contribute to more procedures into the future. Memorial Hospital West
is an outpatient provider of blood and bone marrow transplantation
services and this project is likely to enhance these services.
The applicant indicates that some reduction in the number of Broward
and Palm Beach residents who out-migrate to other service areas will
occur with the opening of the University of Miami Hospital & Clinics
(CON #10041) program. Memorial Healthcare indicates that during CY
2009, its program referred 71 bone marrow transplant patients to other
facilities. As previously shown, H. Lee Moffitt Cancer Center (a Service
Area 2 provider) serves the majority of Broward and Palm Beach
residents. Memorial West indicates that since 2006, it has referred 133
patients to H. Lee Moffitt and 13 to Fred Hutchinson Cancer Center in
Seattle, Washington. Memorial‟s program would likely result in a
significant reduction in the out-migration of these residents.
2.
Applications for the establishment of new adult allogeneic and adult
autologous bone marrow transplantation program shall not normally
be approved in a service planning area unless the following
additional criteria are met:
(a)
Adult Allogeneic Bone Marrow Transplantation Programs:
Adult allogeneic bone marrow transplantation programs shall
be limited to teaching and research hospitals. Applicants shall
meet the following requirements. (Rule 59C-1.044(9)(b) Florida
Administrative Code).
Memorial Hospital West is not a teaching hospital. However, the
applicant states that Memorial Healthcare has academic
affiliations and conducts research projects with the following postsecondary schools: Nova Southeastern University, Barry
University, New York College of Podiatric Medicine, Ohio College of
Podiatric Medicine and Temple University. Memorial Hospital
West‟s Memorial Cancer Institute has an active clinical research
department that participates in cancer treatment clinical research
trials, including collaboration with the Mayo Clinic‟s North Central
Cancer Treatment Group. Memorial Hospital West has a well
established relationship with the bone marrow transplant program
at H. Lee Moffitt Cancer Center (Hillsborough County) and the Fred
Hutchinson Cancer Research Center in Seattle, Washington.
14
CON Action Number: 10108
(b)
Applicants shall be able to project that at least 10 adult
allogeneic transplants will be performed each year. New
units shall be able to project the minimum volume for
the third year of operation.
The applicant estimates 18, 31 and 45 adult inpatient blood
and bone marrow transplants for the first three years of
operation, respectively (ending December 2012-2014).
(c)
A program director who is a board-certified hematologist
or oncologist with experience in the treatment and
management of adult acute oncological cases involving
high dose chemotherapy or high dose radiation therapy.
The program director must have formal training in bone
marrow transplantation.
The applicant states that Lyle Feinstein, M.D., the medical
director of the Memorial Hospital West Memorial Cancer
Institute Bone Marrow Transplant Program since 2007, will
be the program‟s director. Dr. Feinstein is stated to have
extensive experience in bone marrow transplantation and
cases involving high dose chemotherapy. Dr. Feinstein is
also stated to be the principal investigator and director of the
Memorial Healthcare System‟s Umbilical Cord Blood Project,
a program that allows expectant mothers to donate umbilical
cord blood to the public cord blood bank. He was a research
associate and principal investigator of clinical trials
evaluating nonmyeloablative allografting for both acute
lymphocytic leukemia and acute myeloid leukemia
conducted by the University of Washington and the Fred
Hutchinson Cancer Research Center. Dr. Feinstein is boardcertified in internal medicine and medical oncology, and is a
member in good standing with the American College of
Physicians – American Society of Internal Medicine, the
American Society of Clinical Oncology, the American Society
of Hematology and the American Society of Blood and
Marrow Transplant. Dr. Feinstein‟s two-page curriculum
vitae was included in the application‟s Volume 1, Attachment
E.
15
CON Action Number: 10108
Other prominent physicians associated with the project
include: Daren Grossman, MD, PhD, Associate Medical
Director, Memorial Cancer Institute and Director, Leukemia
and Lymphoma Program, Memorial Hospital West; Allen
Greenberg, MD, responsible for leukemia, lymphoma and
multiple myeloma patients at Memorial Cancer Institute and
an associate professor of hematology/oncology at the
University of Miami School of Medicine, a co-director of the
University of Miami Hemophilia Center and an affiliate
member of the University‟s Center for Blood Diseases; and
Neil Nagovski, MD, who also has responsibilities for the care
of leukemia, lymphoma and multiple myeloma patients at
Memorial Cancer Institute. These physicians‟ curriculum
vitas are also included in Volume 1, Attachment E.
(d)
Clinical nurses with experience in the care of critically
ill immuno-suppressed patients. Nursing staff shall be
dedicated full time to the program.
The applicant states that Memorial Hospital West/Memorial
Cancer Institute has a highly qualified nursing staff for the
treatment of critically ill immune-suppressed patients and
that many of the staff at the hematology/oncology unit will
be dedicated to the program. The adult bone marrow
program manager/coordinator will be Maria Lopez-Bover,
RN, BSN, OCN, who has been the Memorial Cancer Institute
Bone Marrow Transplant Manager/Coordinator since
September 2006. Ms. Lopez-Bover is an oncology nurse,
with other directly related nursing experience and
responsibility. The application‟s Volume 2, Attachment N
includes Ms. Lopez-Bover‟s resume.
(e)
An interdisciplinary transplantation team with expertise
in hematology, oncology, immunologic diseases,
neoplastic diseases, including hematopoietic and
lymphopoietic malignancies, and non-neoplastic
disorders. The team shall direct permanent follow-up
care of the bone marrow transplantation patients,
including the maintenance of immunosuppressive
therapy and treatment of complications.
The applicant restates the following practitioners as part of
the interdisciplinary transplantation team: Lyle Feinstin,
MD, Daren Grossman, MD, Allen Greenberg, MD, Neil
Nagovski, MD and Maria Lopez-Bover, RN, BSN, OCN. In
16
CON Action Number: 10108
addition, the applicant introduces the following
interdisciplinary transplantation team members: Linda
Fuller, RN, BSN, transplant nurse coordinator (having served
as the current bone marrow transplant nurse coordinator for
the existing outpatient autologous program for the past year)
and Annie Kuehnel, MSN, ARNP, AOCN and Maria
Thompson, MSN, ARNP as bone marrow transplant nurse
practitioners. The application‟s Volume 2, Attachment N
includes the resumes of Ms. Fuller, Ms. Kuehnel, Ms.
Thompson, and other related physicians and practitioners.
(f)
Inpatient transplantation units for post-transplant
hospitalization. Post-transplantation care must be
provided in a laminar air flow room; or in a private room
with positive pressure, reverse isolation procedures, and
terminal high efficiency particulate aerosol filtration on
air blowers. The designated transplant unit shall have a
minimum of two beds. This unit can be part of a facility
that also manages patients with leukemia or similar
disorders.
The project is to include a 24-bed adult bone marrow
transplant unit, with separate private toilet rooms, positive
pressure, reverse isolation procedures, HEPA filtration and
high efficiency particulate aerosol filtration on air blowers.
In the all private room 24-bed unit, 16 beds are dedicated to
inpatient private beds and eight are for patients who will be
receiving transplants (to be located across from the new
hospital expansion). One of the 16 beds is to be in a
negative pressure isolation room with a separate anteroom
containing a counter and scrub sink. All rooms will have full
height partitions, sealed to the structure above, to prevent
infections, as well as scrubbable floors, walls, ceilings, doors,
windows, and curtains, per the applicant. Additional scrub
sinks will be located outside the bone marrow patient rooms.
(g)
A radiation therapy division on-site which is capable of
sub-lethal x-irradiation, bone marrow ablation, and total
lymphoid irradiation. The division shall be under the
direction of a board certified radiation oncologist.
The applicant reports that the Memorial Cancer Institute at
Memorial Hospital West already has a highly specialized
team of board-certified radiation oncologists, oncologycertified nurses, registered radiation therapists, certified
17
CON Action Number: 10108
physicists and certified dosimeetrists. Srinath
Sundararaman, MD, certified by the American Board of
Radiology, is the medical director of the Memorial Center
Institutes‟ Radiation Oncology Program and has held this
post since 2004. The application‟s Volume 2, Attachment N
includes Dr. Sundararaman‟s curriculum vitae. Per the
applicant, the Memorial Cancer Institute offers the following
state-of-the-art treatments and technologies: CT-based
simulation, image-guided radiation therapy, intensitymodulated radiation therapy, external beam radiation,
brachytherapy, radiofrequency ablation, CyberKnife robotic
stereotatic radiosurgery and Yttriu-90 microspheres.
(h)
A laboratory equipped to handle studies including the
use of monoclonal antibodies, if this procedure is
employed by the hospital, or T-cell depletion, separation
of lymphocyte and hematological cell subpopulations
and their removal for prevention of graft versus host
disease. This requirement may be met through
contractual arrangements.
South Broward indicates that there are no plans to perform
graft engineering for stem cell transplant recipients as part
of the project. However, if needed, it would be provided
through contractual arrangements with an accredited and
qualified laboratory.
(i)
An on-site laboratory equipped for the evaluation and
cryopreservation of bone marrow.
Memorial Hospital West currently has an existing
contractual agreement with Community Blood Centers of
South Florida, which provides tissue typing. The
application‟s Volume 2, Attachment H includes this
agreement.
(j)
An ongoing research program that is integrated either
within the hospital or by written agreement with a bone
marrow transplantation center operated by a teaching
hospital. The program must include outcome
monitoring and long-term patient follow-up.
Memorial West‟s Memorial Cancer Institute is affiliated with
the North Central Cancer Treatment Group (NCCTG) and
participates in clinical trials and experimental therapies for
all major blood cancers currently available through the
18
CON Action Number: 10108
NCCTG. The existing outpatient bone marrow transplant
program at Memorial Hospital West has a well established
relationship with the bone marrow transplant program at H.
Lee Moffitt Cancer Center (Hillsborough County) and the
Fred Hutchinson Cancer Research Center, in Seattle,
Washington.
(k)
An established research-oriented oncology program.
Memorial West‟s Memorial Cancer Institute has an active
clinical research department, designed to increase
participation in cancer treatment clinical research trials.
Current clinical research programs are focusing primarily on
the following cancer challenges in the South Broward
community: breast, lung, colorectal, gastrointestinal and
leukemia/lymphoma5. The applicant reports 26 research
protocols currently available to patients or under
consideration by the applicant‟s institutional review board.
Every oncologist in the Memorial Healthcare System can
reportedly enroll patients into these research trial programs
(as appropriate) to participate in a cancer treatment clinical
trial. Stated active protocols as of December 2010 are as
follows: breast cancer, gastrointestinal malignancies,
genitourinary malignancies, hematologic malignancies, lung
cancer, brain cancer, sarcoma and melanoma.
(l)
A patient convalescent facility to provide a temporary
residence setting for transplant patients during the
prolonged convalescence.
Memorial West states that it has an established relationship
with a Residence Inn by Marriott, located in Miramar,
Florida. According to the applicant, this relationship was
established to service the existing outpatient autologous
bone marrow transplant program and there are negotiated
rates for patients. The applicant also indicates that
currently a social worker is available to work with patients
and their families to ensure “any other needs required” are
addressed and managed.
The CON reviewer confirmed that these were Broward County‟s leading cancer deaths during 2007 2009 per the Florida Department of Health, Office of Planning, Evaluation and Data Analysis,
Community Health Assessment Resource Tool Set website at
http://www.floridacharts.com/charts/chart.aspx.
5
19
CON Action Number: 10108
(m)
An outpatient unit for close supervision of discharged
patients.
Memorial Hospital West already operates an outpatient
autologous bone marrow transplant program and will
relocate it into the main hospital directly adjacent to the
project‟s new inpatient area, providing for a quality and safe
continuum of care.
2.
Agency Rule Criteria
Chapter 59C-1.044, Florida Administrative Code, contains criteria
and standards by which the department is to review the
establishment of organ transplantation programs under the
certificate of need program. Appropriate areas addressed by the rule
and the applicant's responses to these criteria are as follows:
a.
Coordination of Services. Chapter 59C-1.044(3), Florida
Administrative Code. Applicants for transplantation
programs, regardless of the type of transplantation program,
shall have:
1.
Staff and other resources necessary to care for the
patient's chronic illness prior to transplantation, during
transplantation, and in the post-operative period.
Services and facilities for inpatient and outpatient care
shall be available on a 24-hour basis.
The applicant reports having staff and other resources both
inpatient and outpatient, 24 hours a day, seven days a week,
in-house, as follows: pharmacy, respiratory, nursing,
infusion, radiation/oncology, laboratory and food services,
along with a cardiology center/non-invasive laboratory. The
following are services stated to be available after-hours and
on-call: clinical nutritionist, psychosocial and imaging
services. Key physicians and staff necessary to support the
program are reportedly already in place, with many of these
physicians already participating in the outpatient program,
making this project an extension of the existing one. The
applicant refers the reviewer to Schedule 6 for the new
positions it projects will be needed for the project.
20
CON Action Number: 10108
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.
This is not applicable to bone marrow transplantation
programs.
3.
An age-appropriate (adult or pediatric) intensive care
unit which includes facilities for prolonged reverse
isolation when required.
The applicant plans to initially use four intensive care unit
(ICU) beds at Memorial Hospital West‟s ICU unit to meet
project-applicable patient needs. The rooms will be
retrofitted with HEPA filtration and positive pressure to
accommodate prolonged reverse isolation patients, as
required.
4.
A clinical review committee for evaluation and decisionmaking regarding the suitability of a transplant
candidate.
The applicant indicates the bone marrow transplant clinical
review committee will meet once a week, to review new
patients for adult bone marrow transplantation
consideration. The applicant provides a comprehensive
outpatient bone marrow transplant protocol (Volume 1,
Attachment F), with detailed transplant inclusion and
transplant exclusion criteria. The clinical review committee
includes: the chairman (Lyle Feinstein, MD, Medical
Director), a three-physician bone marrow transplant
physician staff; a five-physician, one clinical psychologist
and one registered nurse supportive medical staff and a
seven practitioner (RNs, advanced registered nurse
practitioners, social worker and registered dietician)
supportive staff. The committee will determine a candidate
is either accepted for transplant, not suitable for transplant
or the decision will be tabled.
21
CON Action Number: 10108
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.
Memorial West states that it already has outpatient bone
marrow transplant services protocols. The applicant
provides a detailed discussion of the applicable protocols it
proposes to use which Memorial states were developed by H.
Lee Moffitt Cancer Center and the Fred Hutchinson Research
Center. The applicant includes several extensive protocols
from H. Lee Moffitt Cancer Center (Volume 2, Attachment G).
Memorial West indicates that its protocols follow the
guidelines developed by the National Marrow Donor Program
and the American Society for Blood and Marrow
Transplantation. curricula vitae
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.
The applicant describes acute and long-term management of
patients, including the management of commonly
encountered complications. Both acute and chronic graftversus-host disease is discussed, with effects on the patient
and likely time of onset. Less serious but still common
effects are also discussed, such as fatigue, memory and
concentration problems, infertility and other long-term
effects. The applicant‟s description of the applicable
therapeutic and evaluative procedures demonstrates that
Memorial West is prepared to manage complications.
7.
Equipment for cooling, flushing, and transporting
organs. If cadaveric transplants are performed,
equipment for organ preservation through mechanical
perfusion is necessary. This requirement may be met
through an agreement with an organ procurement
agency.
This is not applicable to bone marrow transplantation
programs.
22
CON Action Number: 10108
8.
An on-site tissue-typing laboratory or a contractual
arrangement with an outside laboratory within the
State of Florida, which meets the requirements of the
American Society of Histocompatibility.
Memorial Hospital West currently has an existing
contractual agreement with Community Blood Centers of
South Florida for the provision of tissue typing. The
application‟s Volume 2, Attachment H includes this
agreement. The applicant indicates that Memorial Hospital
West‟s Department of Pathology will contract for tissuetyping with a licensed and fully-qualified laboratory.
9.
Pathology services with the capability of studying and
promptly reporting the patient's response to the organ
transplantation surgery, and analyzing appropriate
biopsy material.
The applicant indicates it already has board-certified
pathologists and clinical laboratory scientists on staff to
meet pathology and laboratory support needs. Services
include the capability of studying and promptly reporting a
patient‟s response to bone marrow transplantation and the
analysis of appropriate biopsy material. The applicant states
that David Marshall, MD, is the Laboratory Medical Director
and Marian Cavagnaro is the Administrative Director of
Laboratory Services. Volume 2, Attachment I includes
curriculum vitae for all pertinent staff. The applicant also
indicates that Pathology Consultants of South Broward, LLP,
provides clinical and anatomical pathology services for the
Memorial Healthcare System and that Memorial Healthcare
System‟s laboratories are licensed by the State of Florida,
CLIA and the Joint Commission.
10.
Blood banking facilities.
The applicant indicates that Memorial Hospital West has in
place blood bank facilities and services necessary to support
the project. South Broward Hospital District has a
contractual agreement with Community Blood Centers of
South Florida for the provision of blood and blood
component supply. The application‟s Volume 2, Attachment
H includes this agreement.
23
CON Action Number: 10108
The transfusion services laboratory, within Memorial
Hospital West, is part of the hospital‟s total laboratory
services complex. As stated previously, David Marshall, MD,
Laboratory Medical Director, oversees the laboratory and
Rita Reik, MD, is responsible for all transfusion services, and
medical and technical policies and procedures, at Memorial
Healthcare System. Volume 2, Attachment I includes Dr.
Reik‟s curriculum vitae and the curricula vitae of other
laboratory, pathology and blood bank staff. A written scope
of service for laboratory and transfusion services is provided
in Volume 2, Attachment J.
11.
A program for the education and training of staff
regarding the special care of transplantation patients.
As stated previously, Lyle Feinstein, MD is the medical
director at Memorial Hospital West‟s Memorial Cancer
Institute Bone Marrow Transplant Program and Maria LopezBover, RN, BSN, OCN is the clinical program manager/
coordinator. Upon project approval, the applicant plans for
these two practitioners to develop an educational series to
meet the needs of applicable project inpatients. The
applicant already has an extensive bone marrow transplant
manual (Volume 2, Attachment K) for its existing outpatient
autologous transplant program and a comprehensive quality
management plan (Volume 2, Attachment L) for autologous
transplant patients. The existing manual and quality
management plan are to be revised to address the full array
of education and training needs that will be absorbed into
the project. This is to be accomplished in coordination with
the bone marrow transplant program team.
12.
Education programs for patients, their families and the
patient's primary care physician regarding after-care for
transplantation patients.
The applicant provides a 112-page Bone Marrow
Transplantation Overview for Patients and Their Caregivers
in the application‟s Volume 2, Attachment M. This overview
was last updated in September 2007 and covers a wide
range of topics, some of which include the following: multiple
transplant processes, planning and preparing for transplant,
treatment, guidelines for daily care, managing symptoms at
home, nutritional and food safety guidelines and last, exiting
the program.
24
CON Action Number: 10108
b.
Staffing Requirements. Applicants for transplantation
programs, regardless of the type of transplantation program,
shall meet the following staffing requirements. Chapter 59C1.044(4), Florida Administrative Code.
1.
A staff of physicians with expertise in caring for patients
with end-stage disease requiring transplantation. The
staff shall have medical specialties or sub-specialties
appropriate for the type of transplantation program to be
established. The program shall employ a transplant
physician, and a transplant surgeon, if applicable, as
defined by the United Network for Organ Sharing (UNOS)
June 1994. A physician with one-year experience in the
management of infectious diseases in the transplant
patient shall be a member of the transplant team.
Lyle Feinstein, M.D., is the medical director of the Memorial
Hospital West Memorial Cancer Institute bone marrow
transplant program and will serve in this function for the
project. He has extensive experience in bone marrow
transplantation and cases involving high dose
chemotherapy. Dr. Feinstein is the principal investigator
and director of the Memorial Healthcare System Umbilical
Cord Blood Project, a program that allows expectant mothers
to donate umbilical cord blood to the public cord blood bank.
He is board-certified in internal medicine and medical
oncology, and is a member in good standing with the
American College of Physicians – American Society of
Internal Medicine, the American Society of Clinical Oncology,
the American Society of Hematology and the American
Society of Blood and Marrow Transplant. Dr. Feinstein‟s
two-page curriculum vitae was included in the application‟s
Volume 1, Attachment E.
Other prominent physicians associated with the project
include: Daren Grossman, MD, PhD, Associate Medical
Director, Memorial Cancer Institute and Director, Leukemia
and Lymphoma Program, Memorial Hospital West; Allen
Greenberg, MD, who is also an associate professor of
hematology/oncology at the University of Miami School of
Medicine, a co-director of the University of Miami Hemophilia
Center and an affiliate member of the University‟s Center for
Blood Diseases and Dr. Neil Nagovski. These physicians‟
curricula vitae are included in Volume 1, Attachment E.
25
CON Action Number: 10108
2.
A program director who shall have a minimum one year
formal training and one year of experience at a
transplantation program for the same type of organ
transplantation program proposed.
The applicant advises the bone marrow transplant program
director will be Lyle Feinstein, MD. Dr. Feinstein‟s two-page
curriculum vitae was included in the application‟s Volume 1,
Attachment E.
3.
A staff with experience in the special needs of children if
pediatric transplantations are performed.
This criterion is not applicable.
4.
A staff of nurses, and nurse practitioners with
experience in the care of chronically ill patients and
their families.
The applicant reports that Memorial Hospital West/Memorial
Cancer Institute has a highly qualified nursing staff for the
treatment of critically ill immune-suppressed patients and
that many of the staff at the hematology/oncology unit will
be dedicated to the program. Maria Lopez-Bover, RN, BSN,
OCN has been the Memorial Cancer Institute bone marrow
transplant manager/coordinator since September 2006.
Ms. Lopez-Bover is an oncology nurse, with other directly
related nursing experience and responsibility. The
application‟s Volume 2, Attachment N includes Ms. LopezBover‟s resume.
5.
Contractual agreements with consultants who have
expertise in blood banking and are capable of meeting
the unique needs of transplant patients on a long-term
basis.
Memorial Hospital West currently has an existing
contractual agreement with Community Blood Centers of
South Florida, for the provision of tissue typing. The
application‟s Volume 2, Attachment H includes this.
26
CON Action Number: 10108
6.
Nutritionists with expertise in the nutritional needs of
transplant patients.
The applicant has clinical dietitians with experience and
expertise in the nutritional needs of bone marrow transplant
patients and this expertise is stated to relate specifically to
optimization of the nutritional status of pre and posttransplant patients, feeding issues, food and drug interaction
of immunosuppressant patients, including issues with
electrolyte imbalance, fluid balance and healing promotion.
Heather English, registered dietician (RD) and Barbara
Gillette, RD, LD, are stated to have extensive expertise in the
management of oncology patients, including bone marrow
transplant. Ms. Stacy Roberts, RD, LD/N is the outpatient
oncology dietician at Memorial Hospital West. The
application‟s Volume 2, Attachment O includes these three
practitioners‟ resumes.
7.
Respiratory therapists with expertise in the needs of
transplant patients.
Memorial Hospital West employs 60 respiratory therapists,
all of whom have experience and training in caring for
patients with respiratory related conditions. Paul Pevoroff,
RRT, RN, Department Manager, respiratory therapy/
cardiopulmonary/EEG services at Memorial Hospital West,
is stated to have over 14 years of respiratory care experience
with Memorial Healthcare System. The application‟s Volume
2, Attachment O includes Mr. Pevoroff‟s resume.
8.
Social workers, psychologists, psychiatrists, and other
individuals skilled in performing comprehensive
psychological assessments, counseling patients, and
families of patients, providing assistance with financial
arrangements, and making arrangements for use of
community resources.
The applicant states that Sameet Kumar, PhD, will be the
psychologist for the proposed project and that Linda Sapp,
MSW, will be the social worker. Dr. Kumar is stated to have
worked in psycho-oncology for more than 10 years and has
experience working with patients and caregivers undergoing
bone marrow transplantation in all phases of the process.
27
CON Action Number: 10108
Ms. Sapp is stated to have worked in the field of oncology for
over 10 years and has additional experience in the field of
palliative care and behavior health. Ms. Sapp‟s duties will
include various assessments, collaboration with the
inpatient oncology social worker, arranging community
resources and financial issues. The application‟s Volume 2,
Attachment O includes Dr. Kumar‟s and Ms. Sapp‟s
resumes.
3.
Statutory Review Criteria
a.
Is need for the project evidenced by the availability, quality of care,
accessibility and extent of utilization of existing health care
facilities and health services in the applicant's service area?
ss. 408.035(1)(a) and (b), Florida Statutes.
As stated previously, there are presently two operational and one CON
approved adult bone marrow transplant programs in Transplant Service
Area 4. Service Area 4 includes Districts 10 and 11 and also Collier
County only (in District 8) and Palm Beach County only (in District 9).
The operational programs in Service Area 4 are at Good Samaritan
Medical Center and Jackson Memorial Hospital. The CON approved
program is at The University of Miami/University of Miami Hospital &
Clinics (CON #10041).
Data reported to the Agency for the most recent reporting period,
July 1, 2009 through June 30, 2010 show the following adult bone
marrow transplant utilization data:
Florida Adult Bone Marrow Transplantation Program Utilization
July 2009 – June 2010
Hospital
TSA
Shands at University of Florida
1
Mayo Clinic
1
H. Lee Moffitt Cancer Center
2
Florida Hospital-Orlando
3
Good Samaritan Medical Center 4
Jackson Memorial Hospital
4
District
3
4
6
7
9
11
TOTAL
Total Procedures
123
63
366
80
1
88
721
Source: Agency for Health Care Administration Utilization Data for Adult Organ Transplantation
Programs published October 10, 2010.
For the 12-month period ending June 30, 2010, only one procedure was
performed at Good Samaritan Medical Center, while 88 were performed
at Jackson Memorial Hospital (the two sole operational providers of
authorized bone marrow transplants in Service Area 4).
28
CON Action Number: 10108
As previously stated, adult inpatient bone marrow transplant patients,
particularly in the counties of Broward and Palm Beach, in calendar year
2009, have tended to migrate to H. Lee Moffitt Cancer Center (Service
Area 2), for needed services.
Agency records indicate that in calendar year 2009, of the 133 Service
Area 4 residents (15 years of age or older) that were discharged with a
blood and bone marrow transplant procedure, 64 patients (48.12
percent) received the procedure at a Service Area 4 provider and the
remaining 69 patients (51.88 percent) received the procedure at a nonService Area 4 provider. H. Lee Moffitt Cancer Center served 67 of the
133 patients. Below is a table to account for these totals and
percentages.
Transplant Service Area 4 Adult Residents (Age 15 or Older)
With a Blood or Bone Marrow Transplant Discharge (DRG 009)
Calendar Year 2009
Hospital
Good Samaritan Medical Center
H Lee Moffitt Cancer Center
Jackson Memorial Hospital
Mayo Clinic
Shands Hospital at UF
Total Procedures
Total Procedures
2
67
62
1
1
133
Percentage
1.50%
50.38%
46.62%
0.75%
0.75%
100.0%
Source: Florida Center for Health Information and Policy Analysis database run date of 01/05/11.
The applicant projects 18 bone marrow transplants in 2012 (year one),
31 in 2013 (year two) and 45 in 2014 (year three). Based on the
applicant‟s projections for CY 2014, approximately 26.79 percent of
Service Area 4 adults that seek this procedure will receive it at Memorial
Hospital West, though the majority of procedures in the service area,
approximately 73.21 percent, will be performed at Miami-Dade County
facilities (Jackson Memorial Hospital and CON approved CON #10041 University of Miami Hospital & Clinics). Below is a table to account for
the applicant‟s assessment.
29
CON Action Number: 10108
CY 2014 Adult Inpatient Blood and Bone Marrow Transplant
Projected TSA 4 Market Share and Volume
by Facility and Resident County
Facility
Percent
of
County
Total
31.17%
0.00%
13.19%
0.00%
18.75%
Facility
Percent
of
County
Total
23.38%
0.00%
35.16%
0.00%
20.83%
County / # Projected
Memorial
Jackson
U of M
Bone Marrow
Hospital
Memorial
Hospital
Transplants
West
Hospital
& Clinics
Broward - 77
24
18
16
Collier - 12
0
0
3
Miami-Dade - 91
12
32
32
Monroe - 2
0
2
0
Palm Beach - 48
9
10
10
Total TSA 4 Resident
Procedures In TSA 4
Facilities
45
26.79%
62
36.90%
61
Total TSA 4 Resident
Procedures in NonTSA 4 Facilities
Total Procedures (TSA
4 and Non-TSA 4
Facilities)
Source: CON application #10108, pages 57 - 60, Tables 18 and 19.
Note: Good Samaritan Medical Center is not projected to provide any procedures.
b.
Facility
Percent
of
County
Total
20.78%
25.00%
35.16%
0.00%
20.83%
Total
Procedures
58
3
76
2
29
36.31%
168
62
230
Does the applicant have a history of providing quality of care? Has
the applicant demonstrated the ability to provide quality care?
ss. 408.035(1)(c), Florida Statutes.
Memorial Hospital West‟s Joint Commission accreditation and Agency
licensure for its clinical laboratory are included in the application‟s
Volume 1, Attachment C.
The applicant provides the following list of awards specific to Memorial
Hospital West.
● Excellence in Patient Care “Special Category” Award – Outpatient
Services, Studer Group®, 2010.
● 100 Top Hospitals®: National Benchmarks, Thomson Reuters, 20092008.
● Hospital Donor Group Award, Florida Association of Blood Banks,
2009-2008.
● Best in Value, Data Advantage Hospital Value Index, 2008.
● FMQAI Performance Improvement Award, Medicare Quality
Improvement Org. for Florida, 2008.
● Premier Award for Quality, Premier, Inc., 2006-2005.
● America‟s Best Hospitals for Digestive Disorders, U.S. News & World
Report, 2003.
● Best Run Hospital, Florida Medical Business, 2000.
● 100 Top Hospitals, HCIA & The Health Network, 1999.
● South Florida‟s Top Hospitals, Miami Metro, 1998.
30
CON Action Number: 10108
● Best of the Best: Readers‟ Choice, Florida‟s Top Hospitals for Quality
of Care, Organizational Culture, Communication, Professional
Development and Retention Efforts, Advance for Nurses, 2009-2007.
● Hall of Fame: Best of the Best Places to Give Birth, South Florida
Parenting, 2010-2007.
● Best Places to Give Birth in Broward County, South Florida Parenting,
2006, 2004-2000 and 1998.
The applicant also discusses programs provided by the Memorial
Hospital West Memorial Cancer Institute. Some of these include: cancer
support services (for patients and families as they relate to discharge
planning, community resource referrals, pain management, home health
care, hospice care and bereavement services), cancer recovery
scholarship program (a wellness program whereby qualified patients are
offered a free, two-month membership available through memorial fitness
and rehabilitation centers), and community cancer support groups. The
applicant states that Memorial Hospital West‟s outpatient autologous
bone marrow transplant program has a 100 percent bone marrow
transplant patient survival rate since its inception in CY 2006.
The applicant indicates that the South Broward Hospital District is the
fifth largest non-profit public health care system in the country. South
Broward Hospital District has five hospitals with a total of 1,798 beds
and is the area‟s safety-net provider. The applicant indicates that it
particularly strives to reach the medical needs of the poor, underinsured
and uninsured. The application‟s Volume 1, Attachment B contained the
Memorial Healthcare System 2010 Annual Report that includes the
district‟s “Seven Pillars of Excellence” which define its principles and
philosophies.
Agency complaint data indicates that South Broward Hospital District
had 21 substantiated complaints for the three-year period ending
January 7, 2011. Memorial Hospital West had five, while two of the
applicant‟s facilities, Memorial Hospital Pembroke and Memorial Hospital
South did not have substantiated complaints. The applicant‟s complaint
history is itemized below.
31
CON Action Number: 10108
South Broward Hospital District
d/b/a Memorial Hospital West (CON application #10108)
Substantiated Complaints
January 7, 2008 through January 7, 2011
Complaint Category
Administration/Personnel
Emergency Access
EMTALA
Failure to Report Incident
Lack of Supervision
Medicine Problem/Error/Formulary
Nursing Service
Patient Abuse/Neglect
Patient Rights
Plan of Care
Pressure Sores
Quality of Care/Treatment
Memorial
Regional
Hospital
Memorial
Hospital
West
Memorial
Hospital
Miramar
Total = 13
0
3
1
0
1
1
2
1
2
1
0
1
Total = 5
1
0
0
0
0
1
1
0
0
1
1
0
Total = 3
0
0
0
1
0
0
1
0
0
1
0
0
Source: Agency for Health Care Administration Complaint Review Records.
The applicant demonstrates the ability to provide quality care.
c.
What resources, including health manpower, management
personnel, and funds for capital and operating expenditures, are
available for project accomplishment and operation?
ss.408.035(1)(d) Florida Statutes
The financial impact of the project will include the project cost of
$4,951,000 and year two incremental operating costs of $1,949,000.
The audited financial statements of the applicant, for the periods ending
April 30, 2010 and 2009 were analyzed for the purpose of evaluating the
applicant‟s ability to provide the capital and operational funding
necessary to implement the project. Although the applicant only
provided its 2010 audit, we were able to analyze the 2009 audit that is
filed with the Agency for the FHURS report.
Short-Term Position:
The applicant‟s current ratio of 1.0 is well below average and indicates
current assets are slightly greater than current liabilities, an adequate
position. The ratio of cash flows to current liabilities of 3.1 is well above
average and indicates operating cash flow is over three times current
liabilities, a strong position. The working capital (current assets less
current liabilities) of $1.5 million is a measure of excess liquidity that
could be used to fund capital projects. It should be noted that the
applicant shows zero cash as part of a centralized cash management
system with South Broward Hospital District. As of April 30, 2010, the
32
CON Action Number: 10108
applicant had a net from the South Broward Hospital District of $335.1
million, in other words, a positive net cash balance. Overall, the
applicant has an adequate short-term position. (See table below).
Long-Term Position:
The ratio of long-term debt to net assets of 0.0 indicates that the
applicant has minimal long-term debt relative to equity and therefore
should have no difficulty obtaining additional debt financing if needed, a
strong position. The ratio of cash flow to assets of 90.9 percent is well
above average and a strong position. In fiscal year end 2010, the
applicant had $64.6 million in operating revenue in excess of expenses
which resulted in a margin of 17.2 percent. Overall, the applicant has a
strong long-term position. (See table below).
Capital Requirements:
Schedule 2 indicates the applicant has $460.4 million in capital projects,
including $4.9 million for the project subject to this review.
Available Capital:
The applicant indicates that funding for this project will be provided by
cash on hand from the South Broward Hospital District. According to
the applicant, the South Broward Hospital District showed $938.3
million in cash, cash equivalents and investments, including those
earmarked for capital improvements in its April 30, 2010 audited
financial statements. The applicant did not provide the 2010 audit of the
South Broward Hospital District; the applicant did provide the 2009 and
2008 audit of the South Broward Hospital District. The 2009 and 2008
audits show significant levels of working capital. Baring a significant
change in the financial position of the South Broward Hospital District
since the 2009 audit, it appears that the funding for the project and the
entire capital budget would be available as needed.
Staffing:
Currently, the applicant does not provide any inpatient transplant
services and approval would result in a new product line. However, the
applicant‟s existing hospital has staff with expertise and experience
regarding adult bone marrow transplantation and related skill and knowhow, through its current adult outpatient autologous bone marrow
transplantation program. According to Schedule 6A, the applicant
33
CON Action Number: 10108
dedicates 4.2 FTEs added for this project for year one (ending December
2012) and 6.2 FTEs added for this project for year two (ending December
2013). For each year, a 2.0 FTE increase occurs for other ancillary
services and for year one, 2.2 FTEs are added for registered nurses (RNs)
and for year two, 4.2 FTEs are added for RNs. All other FTEs are already
in-house, per Schedule 6A.
Conclusion:
The applicant appears to have the financial resources necessary to fund
this project and all capital projects listed on Schedule 2.
CON application #10108 - Memorial Hospital West
4/30/2010
Current Assets
4/30/2009
$34,774,000
$40,991,000
$0
$0
Due from Memorial Healthcare System
$335,125,000
$256,400,000
Total Assets
$523,786,000
$451,057,000
Current Liabilities
$33,251,000
$27,044,000
Total Liabilities
$47,535,000
$39,387,000
Net Assets
$476,251,000
$411,670,000
Total Revenues
$375,038,000
$342,948,000
Cash and Current Investment
Interest Expense
Excess of Revenues Over Expenses
Cash Flow from Operations
Working Capital
$0
$6,761,000
$64,581,000
$50,365,000
$103,281,000
$70,306,000
$1,523,000
$13,947,000
FINANCIAL RATIOS
4/30/2010
4/30/2009
Current Ratio (CA/CL)
1.0
1.5
Cash Flow to Current Liabilities (CFO/CL)
3.1
2.6
Long-Term Debt to Net Assets (TL-CL/NA)
0.0
0.0
Times Interest Earned (NPO+Int/Int)
0.0
8.4
Net Assets to Total Assets (TE/TA)
90.9%
91.3%
Total Margin (ER/TR)
17.2%
14.7%
Return on Assets (ER/TA)
12.3%
11.2%
Operating Cash Flow to Assets (CFO/TA)
19.7%
15.6%
34
CON Action Number: 10108
d.
What is the immediate and long-term financial feasibility of the
proposal? ss. 408.035(1)(f), Florida Statutes.
A comparison of the applicant‟s estimates to the control group values
provides for an objective evaluation of financial feasibility, (the likelihood
that the services can be provided under the parameters and conditions
contained in Schedules 7 and 8), and efficiency, (the degree of economies
achievable through the management skills of the applicant). In general,
projections that approximate the median are the most desirable, and
balance the opposing forces of feasibility and efficiency. In other words,
as estimates approach the highest in the group, it is more likely that the
project is feasible, because fewer economies must be realized to achieve
the desired outcome. Conversely, as estimates approach the lowest in
the group, it is less likely that the project is feasible, because a much
higher level of economies must be realized to achieve the desired
outcome. These relationships hold true for a constant intensity of service
through the relevant range of outcomes. As these relationships go
beyond the relevant range of outcomes, revenues and expenses may
either go beyond what the market will tolerate or may decrease to levels
where activities are no longer sustainable.
Comparative data were derived from hospitals in peer groups that
reported data in 2009; the applicant was compared to the hospitals in
Peer Group 4 (Medium Urban Hospital Group). Peer Group 4 has a total
of 28 facilities including the applicant. Per diem rates are projected to
increase by an average of 2.5 percent per year. Inflation adjustments
were based on the new CMS Market Basket, 3rd Quarter, 2010.
Projected net revenue per adjusted patient day (NRAPD) of $2,056 in year
one and $2,054 in year two is between the control group median and
highest values of $1,832 and $3,214 in year one and $1,881 and $3,300
in year two. With net revenues between the median and highest values
in the control group, the facility is expected to consume health care
resources in proportion to the services provided. (See table below). The
applicant‟s NRAPD in 2009 was reported as $2,002. The difference in
the NRAPD reported in 2009 and the year two projected NRAPD of
$2,056 results in an average compound annual increase of
approximately 0.56 percent. This level of increase is well below the
inflation percentage outlined in the CMS Market Basket, 3rd Quarter,
2010, index. Understating revenues is a conservative assumption and
therefore reasonable.
35
CON Action Number: 10108
Projected cost per adjusted patient day (CAPD) of $1,832 in year one and
$1,863 in year two is between the control group median and highest
values of $1,772 and $2,861 in year one, and $1,820 and $2,938 in year
two. With CAPD between median and the highest in the peer group,
costs are considered feasible. (See table below). The applicant‟s CAPD in
year 2009 was reported as $1,752. The difference in the CAPD reported
in 2009 and the year two projected CAPD of $1,863 results in an average
compound annual increase of approximately 1.4 percent. This level of
increase is well below the inflation percentage outlined in the CMS
Market Basket, 3rd Quarter, 2010, index. CAPD appear to be
understated. Although CAPD appear understated, the rate of increase is
faster than that projected for NRAPD. This is also a conservative
assumption and therefore reasonable.
The year two operating profit for the hospital of $38.3 million computes
to an operating margin per adjusted patient day of $190 (9.3 percent)
which is between the peer group‟s median and highest value of $29 and
$360 respectively. The applicant reported an operating margin per
patient day of $250 in 2009.
Conclusion:
This project appears to be financially feasible as part of the overall
hospital operations.
36
CON Action Number: 10108
South Broward Hospital District
CON application #10180
2009 DATA Peer Group 4
ROUTINE SERVICES
INPATIENT AMBULATORY
INPATIENT SURGERY
INPATIENT ANCILLARY SERVICES
OUTPATIENT SERVICES
TOTAL PATIENT SERVICES REV.
OTHER OPERATING REVENUE
TOTAL REVENUE
DEDUCTIONS FROM REVENUE
NET REVENUES
EXPENSES
ROUTINE
ANCILLARY
AMBULATORY
TOTAL PATIENT CARE COST
ADMIN. AND OVERHEAD
PROPERTY
TOTAL OVERHEAD EXPENSE
OTHER OPERATING EXPENSE
TOTAL EXPENSES
OPERATING INCOME
PATIENT DAYS
ADJUSTED PATIENT DAYS
TOTAL BED DAYS AVAILABLE
ADJ. FACTOR
TOTAL NUMBER OF BEDS
PERCENT OCCUPANCY
PAYER TYPE
SELF PAY
MEDICAID
MEDICAID HMO
MEDICARE
MEDICARE HMO
INSURANCE
HMO/PPO
OTHER
TOTAL
Dec-13
YEAR 2
ACTIVITY
0
0
0
1,464,609,000
1,313,910,000
2,778,519,000
7,488,000
2,786,007,000
YEAR 2
ACTIVITY
PER DAY
0
0
0
7,286
6,536
13,822
37
13,859
2,373,171,000
412,836,000
11,806
2,054
0
3,300
0
1,881
0
1,323
188,453,000
103,585,000
0
292,038,000
58,406,000
21,184,000
79,590,000
2,918,000
374,546,000
937
515
0
1,453
291
105
396
15
1,863
485
868
0
0
0
0
1,519
0
2,938
335
607
0
0
0
0
787
0
1,820
197
431
0
#REF!
0
0
571
0
1,292
38,290,000
190
9.3%
360
29
-800
105,677
201,021
140,160
0.5257
384
75.40%
PATIENT DAYS
0
9,939
0
21,848
0
0
58,276
15,614
105,677
37
VALUES ADJUSTED
FOR INFLATION
Highest
Median
Lowest
3,666
1,049
406
523
209
53
0
0
0
7,836
4,428
2,501
5,315
3,026
2,009
14,334
10,027
5,327
90
16
4
14,342
10,046
5,335
VALUES NOT ADJUSTED
FOR INFLATION
Highest
Median
Lowest
85.0%
59.0%
26.9%
% TOTAL
0.0%
9.4%
0.0%
20.7%
0.0%
0.0%
55.1%
14.8%
100%
37.5%
9.0%
2.8%
64.1%
44.5%
10.6%
53.6%
37.9%
25.6%
CON Action Number: 10108
e.
Will the proposed project foster competition to promote quality and
cost-effectiveness? ss. 408.035(1)(g), Florida Statutes.
Competition to promote quality and cost-effectiveness is driven primarily
by the best combination of high quality and fair price. Competition
forces health care facilities to increase quality and reduce charges/cost
in order to remain viable in the market.
Cost-effectiveness (as a result of competition) for transplant programs is
limited on two fronts. First, from the payment perspective, the impact of
competition on the price of services is limited to the payer type. Most
consumers do not pay directly for hospital services rather they are
covered by a third-party payer. The impact of price competition would be
limited to third-party payers that negotiate price for services, namely
managed care organizations. Therefore, price competition is limited to
the share of patient days that are under managed care plans. From the
facility‟s perspective, incentive for cost-effectiveness is driven by the
reimbursement rate. Currently, the fixed price payers‟ (the majority
payer) reimbursement does not cover the cost of providing the service.
The difference is material and ensures that only large facilities with
sufficient resources and economies of scale are able to absorb the losses
generated by a transplant program over the long-term. Therefore, from
the facility‟s perspective, although cost-effectiveness may be impacted by
this project, it is more likely to be driven by the facility‟s need to reduce
the gap between cost of service and the reimbursement rates rather than
by competition.
There aren‟t any other inpatient adult allogeneic and autologous bone
marrow transplant programs in Broward County, District 10. The
closest existing operational provider is Jackson Memorial Hospital, which
is 23 miles away. Because of the proximity of these two facilities, any
consideration in choosing a provider-based on location and/or ease of
physical access is mitigated. Transplant programs need to maintain a
minimum level of procedures to remain proficient and ensure quality of
outcomes. Therefore, these programs would need to attract a minimum
number of patients. With the limits on price-based competition and the
removal of location as a consideration, these two programs would likely
have to focus on promoting increased quality to differentiate themselves
from one another in order to attract patients.
Conclusion:
Although price-based competition for the transplant program is limited,
the potential for provider-based competition exists in this case due to a
combination of the current regulatory environment and this project‟s
close proximity to an existing provider.
38
CON Action Number: 10108
f.
Are the proposed costs and methods of construction reasonable?
Do they comply with statutory and rule requirements?
ss. 408.035(1)(h), Florida Statues and Ch. 59A-3 or 59A-4, Florida
Administrative Code.
The proposed service would include renovations to the hospital‟s existing
blood lab and a new bone marrow transplant unit. The unit would be
located on the third floor of a four-story 74,379 square hospital
expansion. The expansion is currently under construction and will add
80 new beds to the facility. The unit will occupy 24 of the beds on the
3rd floor with a 16-bed oncology unit occupying the remainder of the
beds on the floor.
All patient rooms in the unit exceed minimum size requirements. It
appears that all toilet/shower rooms have been design to meet
accessibility requirements. The narrative indicates that the HVAC
system for the unit will be separate from the rest of the hospital and will
provide the required 12 air changes per hour. All patient rooms will be
positively pressurized with the exception of one room that will be used as
an isolation patient room. The isolation patient room will be accessed
through an anteroom that will maintain positive pressure in relation to
both the isolation room and the adjacent corridor.
The schematic plans provide a current list of applicable codes including
the National Fire Protection Association (NFPA) Life Safety Code and the
Florida Building Code. A complete listing of applicable codes and dates
of the codes will be required for future submissions.
The cost projections for construction are consistent with similar projects.
The schedule for construction from the time of building permit to final
inspection is reasonable.
The design provides all of the functional spaces required for the patients
and staff for the new program. The design as presented does not indicate
any major impediments that would prevent the design and construction
of a code compliant facility.
The architectural review of the application shall not be construed as an
in-depth effort to determine complete compliance with all applicable
codes and standards. The final responsibility for facility compliance
ultimately rests with the owner.
39
CON Action Number: 10108
g.
Does the applicant have a history of and propose the provision of
health services to Medicaid patients and the medically indigent?
Does the applicant propose to provide health services to Medicaid
patients and the medically indigent? ss. 408.035(1)(i), Florida
Statutes.
The applicant reports that Memorial Hospital West is a designated
Medicaid and Disproportionate Share Provider. Below is a chart showing
the applicant‟s participation in the low income pool program payment
distributions for the state fiscal year 2009-2010. These facilities also are
participating in the program during FY 2010 -2011.
Low Income Pool Participating Hospitals
Memorial Healthcare System Hospitals
State Fiscal Year 2009-2010
Memorial Healthcare System Hospitals
Memorial Hospital Miramar
Memorial Hospital Pembroke
Memorial Hospital West
Memorial Regional Hospital
Total
Payment Distribution
$
386,594
$ 5,828,462
$14,217,242
$60,221,408
$80,653,706
Source: Medicaid Cost Reimbursement Planning and Analysis as of 10/14/10.
Memorial Healthcare has a history of serving the Medicaid population
and the medically indigent. The applicant proposes to condition CON
approval to provide inpatient adult bone marrow transplantation
treatment to two charity care patients a year regardless of ability to pay.
Memorial Hospital West‟s provision of Medicaid and charity care is
presented below.
Memorial Hospital West & District 10
Medicaid and Charity Care
FY 2009
Applicant and District 10
Memorial Hospital West
Memorial Healthcare System
District 10 Average
Medicaid &
Medicaid HMO
Percentage
14.5%
20.2%
19.4%
Charity
Percentage of
Charges
4.4%
7.4%
6.1%
Combined
Medicaid &
Charity Care
18.9%
27.6%
25.5%
Schedule 7A for the project indicates that there will be no Medicaid and
does not show the projected charity care. The applicant projects
Medicaid at 9.4 percent, Medicaid HMO at 0.0 percent and “self-pay and
other” at 14.8 percent of Memorial Hospital West‟s total hospital annual
patient days during the first two years of operation (years 2012 and
2013). Schedule 7A for the total facility also shows a Medicaid deduction
from revenue based on contractual adjustments, charity care and bad
debt in year one of $227,771 and $258,777 in year two.
40
CON Action Number: 10108
F.
SUMMARY
South Broward Hospital District d/b/a Memorial Hospital West
(CON #10108) proposes to establish an adult inpatient autologous and
allogeneic bone marrow transplantation program at 304-bed Memorial
Hospital West, in Pembroke Pines (Broward County), Florida, Organ
Transplant Service Area 4. Memorial Hospital West has an existing adult
outpatient autologous bone marrow transplantation program.
Project costs total $4,951,000. The project involves 16,670 GSF of new
construction and 958 GSF of renovated space (17,628 GSF total). Total
construction costs are estimated at $3,265,000.
The applicant proposes to condition the project to the location at 703
North Flamingo Road, Pembroke Pines, Florida 33028, and “to treat two
charity care patients a year, regardless of their ability to pay”.
Need
There is no fixed need pool publication for adult bone marrow
transplantation programs. It is the applicant's responsibility to
demonstrate the need for the project.
There are presently two operational and one CON approved adult bone
marrow transplantation programs in Service Area 4 (Good Samaritan
Medical Center [Palm Beach County] and Jackson Memorial Hospital
[Miami-Dade County]). The University of Miami Hospital & Clinics
(CON #10041) is the approved program.
The applicant projects 18, 31 and 45 adult inpatient bone marrow
transplants for the first three years (CY 2012-2014) of operation. The
applicant contends that the following support need for the project:
Service Area 4 residents have inadequate access as evidenced by the
historically low service area resident transplant rates.
A high percentage of Service Area 4 residents must travel long
distances for their transplant.
Demand for bone marrow transplant will increase due to safer
transplant procedures, favorable survival rates, expanded sources for
donor cells, and an aging population.
Memorial West‟s outpatient program has referred 176 patients to
other providers over the past four years and 87 percent of these were
to programs outside of Service Area 4 and outside the State of Florida.
41
CON Action Number: 10108
The project will likely improve access in Service Area 4. During CY 2009,
most Broward and Palm Beach residents seeking adult bone marrow
transplant patients received these procedures at H. Lee Moffitt Cancer
Center (a Service Area 2 provider).
Quality of Care
The applicant demonstrated it met the rule requirements per Chapter
59C-1.044, Florida Administrative Code, with regard to the provision of
quality of care for transplant programs and also demonstrated quality of
care measures and appropriate policies and protocols to accommodate
the proposed project.
Agency complaint data indicates that the applicant had 21 substantiated
complaints for the three-year period ending January 7, 2011. Memorial
Hospital West had five of these.
The applicant is a quality care provider.
Cost/Financial Analysis
The applicant has an adequate short-term and a strong long-term
position and overall appears to have the financial resources necessary to
fund the project and all capital projects.
This project appears to be financially feasible. Although price-based
competition for the transplant program is limited, the potential for
provider-based competition exists in this case due to a combination of
the current regulatory environment and this project‟s close proximity to
an existing adult bone marrow transplantation provider.
Medicaid/Charity Care Commitment
The applicant conditions project approval to treat two charity care
patients a year regardless of ability to pay. Schedule 7A for the project
indicates that there will be no Medicaid and does not show the projected
charity care.
42
CON Action Number: 10108
The applicant projects Medicaid at 9.4 percent, Medicaid HMO at 0.0
percent and “self-pay and other” at 14.8 percent of Memorial Hospital
West‟s total hospital annual patient days during the first two years of
operation (years 2012 and 2013). Schedule 7A for the total facility shows
a Medicaid deduction from revenue based on contractual adjustments,
charity care and bad debt in year one of $227,771 and $258,777 in year
two.
The applicant is a safety net provider and participates in the states‟ low
income pool program.
Architectural Analysis
The project calls for renovation of the hospital‟s existing blood lab and a
new bone marrow transplant unit, located on the third floor of the
hospital‟s expansion project.
The bone marrow transplant unit patient rooms meet the positive
pressure and isolation requirements, accessibility requirements and
other applicable building code and related code requirements.
The cost projections for construction are consistent with similar projects
and the time line from building permit to final inspection is reasonable.
G.
RECOMMENDATION
Approve CON #10108 to establish an adult inpatient autologous and
allogeneic bone marrow transplantation program in Organ Transplant
Service Area 4. The total project cost is $4,951,000. The project involves
16,670 GSF of new construction, 958 GSF of renovated space and
construction costs of $3,265,000.
CONDITIONS:
(1)
(2)
The project will be located at 703 North Flamingo Road, Pembroke
Pines, Florida 33028.
The applicant shall treat two charity care patients a year,
regardless of their ability to pay.
43
CON Action Number: 10108
AUTHORIZATION FOR AGENCY ACTION
Authorized representatives of the Agency for Health Care Administration
adopted the recommendation contained herein and released the State Agency
Action Report.
DATE:
James B. McLemore
Health Services and Facilities Consultant Supervisor
Certificate of Need
Jeffery N. Gregg
Chief, Bureau of Health Facility Regulation
44