17-003200 Southern Baptist Hospital Of Florida, Inc., D/B/A Wolfson Children&Apos;S Hospital vs. Department Of Health Status: Closed Recommended Order on Tuesday, November 14, 2017.

Summary: Petitioner's application for a pediatric trauma center meets the necessary requirements for provisional approval.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

SOUTHERN BAPTIST HOSPITAL OF

FLORIDA, INC., d/b/a WOLFSON

CHILDREN'S HOSPITAL,

Petitioner,

vs. Case No. 17 - 3200

DEPARTMENT OF HEALTH,

Respondent.

_______________________________/

RECOMMENDED ORDER

Pursuant to notice to all parties, a final hearing was

held in this case before the Honorable R. Bruce McKibben,

Administrative Law Judge, on September 19 and 29 , 2017, in

Tallahassee, Florida. The purpose of the final hearing was to

conduct a de novo review of the evidence.

APPEARANCES

For Petitioner : Jeffrey L. Frehn, Esquire

Radey Law Firm, P.A.

Suite 200

301 South Bronough Street

Tallahassee, Florida 32301

For Respondent : William D. Hall, Esquire

Jones Walker , LLP

Suite 130

215 South Monroe Street

Tallahassee, Florida 32301

STATEMENT OF THE ISSUE

The issue in this case is whether an applic ation filed by

Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a

Wolfson ChildrenÓs Hospital (ÐWolfsonÑ), to operate a pediatric

trauma center should be approved .

PRELIMINARY STATEMENT

Wolfson filed its application on March 31, 2017. It was

rev iewed by Respondent, Department of Health (ÐDOHÑ or the

ÐDepartmentÑ) to ascertain whether the application satisfied

certain critical elements. Finding that the application did not

satisfy those elements, even after the submission of additions

and correct ions, DOH denied the application. Wolfson timely

filed a request for formal administrative hearing to contest the

DepartmentÓs decision .

At the final hearing, Wolfson called three witnesses:

Michael Aubin, president of Wolfson, accepted as an expert in

the administration of a childrenÓs hospital, including

development and administration of pediatric trauma centers ;

Nicholas Dean Poulos, M.D., accepted as an expert in trauma

services and quality of care; and Pamela Pieper, senior

consultant, accepted as a n expert in trauma program management .

WolfsonÓs Exhibits 1 through 14 were admitted into evidence.

The Department called one witness: Cindy Dick , assistant deputy

secretary and interim director for emergency preparedness. The

DepartmentÓs Exhibits 1 a nd 2 were admitted, along with Joint

Exhibits 1 through 3.

A transc ript of the final hearing was ordered. By rule,

parties are allowed 10 days after filing of the transcript at

DOAH to submit proposed r ecommended orders ( Ð PROs Ñ ). The

T ranscript was filed on October 16 , 2017 ; PROs were due on or

before October 26 , 2016 . Each party timely filed its PRO and

each was considered in the preparation of this Recommended

Order.

FINDING S OF FACT

T he following findings of fact are derived from

the stipulation of t he parties , the admitted

exhibits, and the testimony at fina l hearing .

1 . DOH is the state agency responsible for, inter alia,

the review and approval (or denial) of applications to operate

trauma centers, including pediatric trauma centers . DOH denied

the trauma center application filed by Wolfson, not due to an

absence of need in the area, but due to WolfsonÓs failure to

comply with some requirements set forth in the application .

2 . Wolfson is a 216 - bed not - for - profit childrenÓs hospital

located in J acksonville, Duval County, Florida. It is part of

the Baptist Health organization and is one of three hospitals

operated under tha t entityÓs license. Wolfson is located on the

same campus as Baptist Medical Center Î Jacksonville. The two

hospitals share a pharmacy which is located in the childrenÓs

hospital and a laboratory located in the adult hospital , but no

other services or staff.

3. Interestingly, Wolfson was developed by the sons of

Morris Wolfson, a Jewish immigrant to the United States. One of

Mr. WolfsonÓs children had died at an early age due to lack of

access to health care services. Later in his life, after

acquiring a small fortune from his business, Mr. Wolfson asked

his five remaining sons to develop a childrenÓs hospital

accessible t o every child, regardless of race, creed, or

religious affiliation. By 1951 the sons had raised over half a

million dollars and were prepared to cons truct a hospital. T hey

approached the Baptists, who agreed to build the childrenÓs

hospital as part of th eir development of Baptist Hospital. In

1955, Mr. WolfsonÓs dream became a reality.

4 . Wolfson provides a wide range of services to children,

including but not limited to : two neonatal intensive care

units ; cardiac catheterization ; open heart surgery ; bone marrow

transplants ; and extracorporeal membrane oxygenation , a less

complex bypass procedure.

5 . There is an emergency department at Wolfson. It

receives approximately 60,000 patients per year. Wolfson also

operates three satellite emergency depa rtments and has three

mobile ICU s (known as Ð Kids Kare Ñ mobile units).

6 . WolfsonÓs service area is quite large, comprised of a

triangle identified by the vertices of Savannah, Georgia Î

Dothan, Alabama Î and Daytona Beach, Florida. About ninety

percent of WolfsonÓs patients come from within that area.

7 . There is not currently a pediatric trauma center in

Jacksonville , which is located in Trauma Service Area (ÐTSAÑ) 5 .

There are five counties in TSA 5: Duval , Baker, Clay, Nassau,

and St. Johns . The closest pediatric trauma center to

Jacksonville is located in Gainesville , Alachua County, Florida,

some 60 miles away. There is a Level II trauma center located

at UF Health Jacksonville, but it is not specifically for

pediatrics. There are differences in the provision of care to

pediatric patients versus adult trauma patients, including

specialized equipment, age - appropriate drugs, and modified

procedures.

8 . Pediatric trauma patients from TSA 5 must be

transported to UF Health Jacksonville or Shands in Gainesville.

Some of those patients are designated a s Ðtrauma alert

patients.Ñ Th o se are individuals identified by emergency

medical services as requiring immediate, high - level treatment by

skilled professionals. Not all trauma patients are trauma a lert

patients.

9 . Once a pediatric trauma patient has been stabilized at

UF Health Jacksonville or Shands , the patient can be transferred

to Wolfson for further treatment. Wolfson then undertakes the

care needed by the patient. UF Health Jacksonville tr ansfers

about 2 0 to 30 pediatric trauma patients per month to Wolfson.

Not all of th ose patients have previously been deemed trauma

alert patients , but Wolfson has extensive experience treating

patients with significant needs .

10 . It is WolfsonÓs des ire to operate its own pediatric

trauma center, thereby obviating the need for a trauma patient

to first go to UF Health Jacksonville or Shands before being

transferred . There are times when a delay in transfer can have

negative consequences for the patie nt. The number of such

occurrences was not quantified by Wolfson, but Wolfson considers

it a significant problem.

11 . There is, by rule, a very precise process for a

hospital to obtain verification as a trauma center. There are

three stages to the proce ss : provisional review, in - depth

review, and site visit. Hospitals are given only one

opportunity each year to apply for verification. In order to

apply, a hospital must file a letter of intent (ÐLOIÑ) between

September 1 and October 1. On or before Oc tober 15, the

Department sends an application package to each hospital which

had timely submitted an LOI. After receiving the application

package, a hospital has until April 1 of the following year to

complete and submit the application. DOH must complet e its

provisional review of the application and notify the applicant,

by April 15, of any deficiencies which should be addressed. The

hospital then has five business days to submit clarifying or

corrective information. In accordance with this process,

Wo lfson timely filed its application to operate a pediatric

trauma center.

12 . By rule, the application must contain responses and

support relating to nineteen Ðcritical elementsÑ related to

trauma care. The Department then reviews the application to

mak e sure that all minimum standards for approval have been met.

An applicant is not required to necessarily satisfy each el ement

or subpart of a standard in order for it to be approved by the

Department. However, failure to comply with a critical element

o verall can result in denial of the application. The initial

review of an application by the Department is extremely

important because, if provisionally approved, the applicant can

immediately commence operating as a trauma center.

13 . In the present case , WolfsonÓs application was

reviewed by two persons under con tract with the Department:

Dr. Robert Reed and Susan Cox, RN. The Department deems each of

those persons to be an expert in the field of trauma care based

on their background and training. The provisional review by

the reviewers was for the purpose of determining whether the

application was complete and whether the hospital satisfied the

critical elements required for a trauma center. After

completion of their initial review, the reviewers sen t a letter

to Wolfson identifying certain deficiencies they had found in

the application.

14. The re were a number of deficiencies identified by

Dr. Reed and Nurse Cox in WolfsonÓs application . However, the

most important of those (and the ones at issue in this

proceeding) were as follows: Standard II.B . 1 . b relates to

trauma - related continuing medical education (ÐCMEÑ) requirements

for emergency physicians ; Standard XVII relates to required

multidisciplinary conferences which must be held throughout the

year; and Standard XVI I I addresses Quality Management a/k/a

Quality Improvement (ÐQIÑ) , also referred to as Performance

Improvement .

15 . Wolfson was given an opportunity to address each of

the stated deficiencies and did, in fact, submit some additional

information. Despite the additional information, WolfsonÓs

application was still deemed insufficient and was denied.

16 . The Department now concedes that the CME standard was

satisfied in WolfsonÓs application. The same is true for the

standard relati ng to multidisciplinary conferences.

17 . The QI standard (Standard XVIII) , however, remains in

dispute. DOH contends that the information submitted by Wolfson

in its initial application and deficiency response falls short

of proving compliance with this critical element . The QI

standard requires a system of procedures and protocols that will

promote performance improvement while maintaining patient

safety. The goal is to establish processes to ensure a hospital

is continually improving the quality of ca re provided. The

subparts of the QI standard require detailed demonstrations of

various processes, including:

A.2 Î A clearly defined performance

improvement program for the trauma

population;

B.1 Î Review of all trauma patient records

from five specifie d categories;

B.2 Î Monitoring of six indicators relevant

to the respective facility (which are in

addition to four state - mandated indicators) ;

B.3 Î Review of cases relevant to the six

indicators by the trauma medical director

(ÐTMDÑ) and trauma progra m director (ÐTPDÑ),

to decide whether the cases should be

referred to the quality management committee

(ÐQMCÑ).

B.5 Î Evaluation by QMC of the effectiveness

of action taken to ensure problem

resolution;

G Î Preparation and submittal of a qua rterly

repor t showing which cases have been

selected for corrective action; and

H Î Maintenance of an in - hosp i tal trauma

registry with information on patients being

treated.

18 . The gist of WolfsonÓs QI program is set forth on a

flow chart contained in the applica tion. That chart is

entitled, ÐTrauma PI Process: Levels of Review.Ñ Though not

explained at final hearing, the ÐPIÑ in the chart is presumably

ÐPerformance Improvement.Ñ The flow chart indicates there to be

a primary (daily) review, a secondary (weekl y) review, and a

tertiary (monthly) review involving certain designated persons.

In each of the ÐboxesÑ for the respective reviews, there is a

stated purpose for the review. For the primary review, the

purpose is stated as: Identification of opportuniti es for

Improvement/Validation. The secondary reviewÓs purpose is:

Adverse Event/Audit Filter Review. And the purpose of the

tertiary review is: Peer Review/Accountability Determination,

Loop Closure Plan, Trended Data Review.

19 . Phases of care iden tified in the flo w chart are: Pre -

hosp ital, Resuscitation, Inpatient Care Review, and Readmission

Review. There is a list of ÐactionsÑ in the flow chart:

Education ; Counseling ; Trend Report ; Guidance/Policy/Protocol

Development ; and Hospital PI Project. From that list, there is

an arrow pointing back toward the primary review box.

20 . There is no narrative in the flow chart to explain how

the various boxes interconnect or how the information therein

ties to the requirements as outlined in the applica tion form .

Wolfson asserts that all relevant information is contained in

the flow chart, whether in narrative form or not. There is also

additional information in the application, attached as a ÐScope

of ServicesÑ addendum, which further elucidates what is found in

the flow chart. The Department deems the flow chart and scope

of services information insufficient for determining whether the

proposal satisfies the critical elements.

21 . Wolfson says t he flow chart is a Ðclearly defined

performance improve ment program.Ñ It is, in fact, only an

outline of a clearly defined program. The testimony provided at

final hearing by WolfsonÓs TPM explained how that outline would

work to improve performance. With that explanation, the flow

chart/scope of service in formation minimally satisfies this

critical element of the application.

22 . Wolfson maintains that the information provided

supports the requirement for review of all records from five

specified categories, i.e., all trauma alert cases, critical or

ICU ad missions, operating room admissions for traumatic injury,

critical trauma transfers, and in - hospital deaths. Upon review

of the flow chart there is insufficient evidence concerning

those five areas. However, the scope of information addendum at

least min imally refers to those areas as part of the review

process .

23 . The flow chart/scope of service information address es

the four state - required indicators. The other six indicators

required in the application are listed as Ðto be determined by

the [Quality Management] committee.Ñ Wolfson points out that in

the minutes from a QMC meeting in February (which was included

in the application), nine additional indicators are listed. So,

although not easily found, the application does provide

sufficient response to the required element.

24 . The application is also supposed to identify cases

relevant to the six selected indicators in order to determine

whether any of those cases should be referred to the QMC. The

determination to refer cases is followed up by an evaluation of

the effectiveness of actions taken by the committee. The flow

chart can be interpreted to address this requirement, but it is

fairly nebulous. The scope of services information provides

some additional support, but only in general terms.

25 . The required quarterly reports are supposed to show

which cases have been selected for corrective action by the

committee. Wolfson asserts that it cannot submit any such

reports until it is operating as a pediatric trauma center ,

i.e., until it ac tually has patient cases to report . That

position is plausible. The Department did not provide any

evidence as to how other applicants satisfied this requirement,

so WolfsonÓs position cannot be measured against other

providers. 1/

26 . The same is true a s to the requirement for an in -

hospital registry of information concerning patients who are

being treated. Wolfson has purchased the software needed to

commence its registry once patients are being admitted, but it

cannot do so at this time , again because it has no such

patients .

27 . All things considered, WolfsonÓs application wa s not

a superlative response to the qu estion of its abilities, but

it at least minimally met the requirements for approval of a

provisional license. Considering, de novo, all o f the evidence

concerning WolfsonÓs proposed trauma center operations, the

application is complete.

28 . Wolfson provided extensive testimony and evidence as

to the need for a pediatric trauma center in the service area

and its willingness and ability to meet that need. There is no

doubt that, if approved, the pediatric trauma center would be

beneficial to the area. However, need was not an issue in the

proceeding.

CONCLUSIONS OF LAW

29 . The Division of Administrative Hearings has

jurisdiction over th e parties to and the subject matter of this

proceeding. §§ 120. 569, 120. 5 7 (1) , and 395.4025(7) , Fla. Stat.

Unless specifically stated otherwise herein, all references to

Florida Statutes are to the 2017 version.

30 . Wolfson, as the party asserting the a ffirmative of the

issue, has the burden of proving whether it substantially

complied with all of the critical elements of the application,

and that its application should be approved. Fla. Dep Ó t of

Trans p . v. J.W.C. Co. , 396, So. 2d 778, 787 (Fla. 1st DCA 198 1 ).

Findings of fact are to be based on the preponderance of

evidence standard. § 120.57(1)(j), Fla. Stat.

31 . Pu rsuant to section 120.57(1)(k), this is a de novo

proceeding. As such, the hearing is for the purpose of

formulating agency action rath er than reviewing what the agency

has already decided. Boca Raton Artificial Kidney Ctr., Inc. v.

Dep Ó t of HRS , 475 So. 2d 260, 262 (Fla. 1st DCA 1985).

32 . This case addresses whether WolfsonÓs application to

operate a provisional pediatric trauma cente r should be

approved, i.e., whether Wolfson has met the critical elements

required for a trauma center. Wolfson must therefore s how that

its application is in substantial compliance with the

requirements of section 395.4025 . Substantial compliance is

imp ortant because, if the application is deemed so, Wolfson may

immediately engage in treatment of trauma patients.

33 . Neither the trauma rules nor the statutes define

Ðsubstantial complianceÑ in the context of trauma center

applications. The plain meanin g of the words is that WolfsonÓs

responses to the application questions amply covered the

information requested. As shown above, while the responses were

in some cases minimal and elusive, Wolfson was substantially in

compliance with all elements.

RECO MMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that Respondent, Department of Health,

enter a Final Order approving the pediatric trauma center

application filed by Petitioner, Southern Baptist Hospital of

Flor ida, Inc. d/b/a Wolfson ChildrenÓs Hospital.

DONE AND ENTERED this 14 th day of November, 2017 , in

Tallahassee, Leon County, Florida.

S

R. BRUCE MCKIBBEN

Administrative Law Judge

Division of Administrative Hearings

The DeS oto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 14 th day of November , 2017 .

ENDNOTE

1/ In fact, the Agency provided no direct evidence concerning

how the hired consultants review ed WolfsonÓs application, how

much time they spent, how in - depth their review was, or whether

they even reviewed the e ntire application. Rather, Ms. Dick

formulated her positio n on the application solely upon what she

had been provided by the consultants. While her testimony was

given due consideration based on her current position and past

experience, it was insufficient to rebut WolfsonÓs statements

concerning the application content.

COPIES FURNISHED:

Jeffrey L. Frehn, Esquire

Radey Law Firm, P.A.

Suite 200

301 South Bronough Street

Tallahassee, Florida 32301

(eServed)

Jay Patrick Reynolds, Esquire

6938 Cortona Hills Way

Tallahassee, Florida 32312

(eServed)

Daniel Ryan Russell, Esquire

Jones Walker, LLP

Suite 130

215 South Monroe Street

Tallahassee, Florida 32301

(eServed)

William D. Hall, Esquire

Jones Walker LLP

Suite 130

215 South Monroe Street

Tallahassee, Florida 32301

(eServed)

Shannon Revels, Agency Clerk

D ep artment of H ealth

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1703

(eServed)

Celeste M. Philip, M.D., M.P.H.

State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399 - 1701

(eServed)

Nichole C. Ge ary, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

(eServed)

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recomme nded Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.