17-003265 Shands Jacksonville Medical Center, Inc., D/B/A Uf Health Jacksonville vs. Department Of Health Status: Closed Recommended Order on Wednesday, June 13, 2018.

Summary: Memorial met its burden--establishing that its trauma center application met applicable standards; Shands' argument that the Dep't acted pursuant to an unadopted rule is contrary to ?395.4025, Fla Stat. Memorial is entitled to provisional Level II status.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

SHANDS JACKSONVILLE MEDICAL

CENTER, INC., d/b/a UF HEALTH

JACKSONVILLE,

Petitioner,

vs. Case No. 17 - 3265

DEPARTMENT OF HEALTH,

Respondent,

and

MEMORIAL HEALTHCARE GROUP, INC.,

d/b/a MEMORIAL HOSPITAL

J ACKSONVILLE,

Intervenor.

_______________________________/

RECOMMENDED ORDER

A final hearing was held in this matter before Robert S.

Cohen, Administrative Law Judge ( Ð ALJ Ñ ) with the Division of

Administrative Hearings ( Ð DO AH Ñ ), on November 16, 17, and 20 ,

2017, in Tallahassee, Florida.

APPEARANCES

For Petitioner: Seann M. Frazier, Esquire

Marc Ito, Esquire

Parker, Hudson, Rainer & Dobbs, LLP

215 South Monroe Street , Suite 750

Tallahassee, Florida 32301

For Respondent: Michael Jovane Williams, Esquire

Prosecution Services Unit

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallaha ssee, Florida 32399

For Intervenor: Stephen A. Ecenia, Esquire

Gabriel F.V. Warren, Esquire

Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202

Post Office Box 551

Tallahassee, Florida 32302 - 0551

STATEMENT OF THE ISSUE S

Whether the application timely filed with the Department of

Health ( Ð Department Ñ ) by Memorial Healthcare Group, Inc. , d/b/a

Memorial Hospital Jacksonville ( Ð Memorial Ñ ) , met the applicable

standards for approval to operate as a provisional Level II

trauma center; and whether the Department Ó s approval of the

application was based upon an unadopted rule.

PRELIMINARY STATEMENT

On May 1, 2017 , the Department approved Memorial Ó s timely

submitted applicati on ( Ð Memorial Ó s Application Ñ ) for approval to

operate as a provisional Level II trauma center. After review,

the Department determined that Memorial Ó s Application met the

critical elements required by law for a trauma center, and

Memorial Ó s Application wa s approved.

On May 22, 2017, Shands Jacksonville Medical Center, Inc.,

d/b/a UF Health Jacksonville ( Ð Shands Ñ ) challenged the approval

of Memorial Ó s Application with the filing of a petition, pursuant

to section 120.57(1), Florida Statutes, seeking to rev erse the

Department Ó s decision.

The final hearing in this matter was held on November 16,

17, and 20 , 2017, in Tallahassee, Florida. At the hearing,

Shands presented the testimony of Cynthia Gerdik, assistant vice

president of n ursing t rauma at Shands; Ch ad McIntyre, m anager of

TraumaOne Flight Services; and Dean Co c chi, associate vice

president of finance at Shands . In lieu of live testimony, the

Department presented the depositions of Cindy Dick , assistant

deputy secretary for the D epartment; and Leah C olston, c hief of

the Bureau of Emergency Medical Oversight at the Department .

Memorial presented the testimony of El e anor Lynch, senior vice

president of operations at Memorial; Ernest Block, M . D . , trauma

surgeon at Memorial; Greg Miller, emergency medica l services

(Ð EMS Ñ) c oordinator at Memorial; Marca Bonta, M . D . , a department

c onsultant; and Nurse Marla Vanore, a department con sultant .

S h ands Ó Exhibits 1, 2, 4, 9, 12 through 14, 19, and 20 were

admitted into evidence . Memorial Ó s Exhibits 16 through 2 0, 22,

24 through 27, 29, 30, 32 through 35, 38, 40, 41, 43, and 47 were

admitted into evidence . Joint Exhibits 1 through 8 were admitted

into evidence. The four - volume Transcript of the final hearing

was filed with DOAH on December 15, 2017. After an i nitial

deadline of January 12, 2018, for the filing of the proposed

recommended orders was established, the parties requested, and

were granted, three extensions of time to file their proposals.

All parties timely submitted P roposed Recommended Orders on

February 14, 2018 , which have been duly considered in the

preparation of this Recommended Order.

References to statutes are to Florida Statutes (2017),

unless otherwise noted.

FINDING S OF FACT

1. The Department is an agency of the State of Florida

created pursuant to section 20.43, Florida Statutes. The

Department Ó s mandate is to Ð promote, protect and improve the

health of all people in the state , Ñ and it has a primary

responsibility for evaluating provisional trauma center

applications submitted by acute care hospitals. §§ 381.001 and

395.40(3), Fla. Stat.

2. Shands is an acute - care hospital l ocated in Trauma

Service Area ( Ð TSA Ñ ) 5, which lies in Baker, Nassau, Duval, Clay ,

and St. Johns counties. Shands has been designated by the

Department as a Level I trauma center.

3. Memorial is an acute - care hospital also located in

TSA 5 .

4. Memorial operates a provisional Level II trauma center.

The application that was submitted by Memorial and approved by

the Department on May 1, 2017 , is the subject of thi s proceeding.

5. Chapter 395, Part II (§§ 395.40 Î 395.51) , Florida

Statutes ( Ð Trauma Statute Ñ ) , sets forth the statutory framework

for the development of a statewide trauma system. The Department

is charged with the planning and establishment of the sta tewide

inclusive trauma system. See , § 395.40(3), Fla. Stat. The

Legislature recognized the benefits of trauma care provided

within an Ð inclusive trauma system, Ñ that is Ð designed to meet

the needs of all injured trauma victims. Ñ § 395.40(2), Fla.

Stat.

6. Section 395.401(2) directs the Department to Ð adopt, by

rule, standards for verification of trauma centers based on

national guidelines, including those established by the American

College of Surgeons . Ñ The Trauma Center Standards are published

in DH Pamphlet (DHP ) 150 - 9, which is incorporated by reference in

Florida Administrative Code Rule 64J - 2.011 (the Ð Trauma

Standards Ñ ).

7. Section 395.4025 (the Ð Application Statute Ñ ) describes

the application process for hospitals seeking to become

designated as a trauma center.

8. Section 395.4025(2)(c) requires the Department to

conduct a Ð provisional review Ñ of each trauma center application

to determine if Ð the hospital Ó s application is complete and that

the hospital has the critical elements required for a trauma

center. Ñ This Ð critical review Ñ shall be based on Ð trauma center

standards Ñ and shall include a review of whether the hospital

has: (1) equipment and physical facilities necessary to provide

trauma services; (2) personnel in sufficient numbers a nd with

proper qualifications to provide trauma services; and (3) an

effective quality assurance process. Id .

9. Notably, the provisional review described in section

395.4025(1)(c) looks only to the application to determine whether

an application Ð has [ m et ] the critical elements required for a

trauma center. Ñ Id .

10. Section 395.4025(13) authorizes the Department to

Ð adopt, by rule, the procedures and processes by which it will

select trauma centers. Ñ Pursuant to this authorization, the

Department issu ed r ule 64J - 2.012, which provides detailed

regulations governing the application process.

11. Rule 64J - 2.012(1)(d) includes a detailed list of

elements that a provisional trauma center applicant must satisfy

(the Ð critical elements Ñ ) to receive provisiona l approval from

the Department.

12. The Trauma Standards contain other elements that were

not designated by the Department as Ð critical Ñ (the Ð n on - critical

e lements Ñ ). These standards pertain primarily to ensuring the

programmatic integrity of a trauma c enter. Provisional trauma

center applications must eventually establish compliance with

the non - critical elements, but the non - critical elements are not

examined by the Department until after a provisional trauma

center application is granted. See Fla. Admin. Code

R. 64J - 2.012(1)(h).

13. The process for obtaining designation as a provisional

trauma center begins on October 1 each year. By that date,

hospitals must submit to the Department a letter of intent to

file a provisional trauma center applicat ion. See

§ 395.4025(2)(a), Fla. Stat.; Fla. Admin. Code R. 64J -

2.012(1)(a). If a hospital timely submits a letter of intent,

the Department must provide the hospital with a provisional

trauma center application and instructions for sub mitting it to

the D epartment. § 395.4025(2)(b), Fla. Stat.

14. April 1 of the following year is the deadline for the

hospital to submit a provisional trauma center application. See

Fla. Admin. Code R. 64J - 2.012(1)(a). The Department conducts a

review of the application t o determine whether it is complete and

has established compliance with the critical elements. See Fla.

Admin. Code R. 64J - 2.012(1)(d). The Department does not conduct

a site visit until a provisional trauma center application is

approved and the trauma c enter is operational.

§ 3 95.4025(2)(d) and (5), Fla. Stat.

15. By April 15, the Department must provide the applicant

with written notice of any deficiencies in the critical elements

and gives the hospital the opportunity to submit additional

clarifying or correcting information. See Fla. Admin. Code

R. 64J - 2.012(1)(e). Applicants then have five working days to

address the identified deficiencies and submit additional

information. See Fla. Admin . Code R. 64J - 2.012(1)(f).

1 6 . On or before May 1, the De partment must send written

notification to each applicant hospital advising whether its

application was approved or denied. See Fla. Admin . Code

R. 64J - 2.012(1)(g)1. - 2.

1 7 . If a hospital is granted provisional approval, it is

required to begin operation as a provisional trauma center on

May 1 and becomes a full member of Florida Ó s integrated trauma

system on that day. § 395.4025(3), Fla. Stat.; Fla. Admin. Code

R. 64J - 2.012(1)(g)1. The Department also immediately notifies

EMS providers of the newly ope rational provisional trauma center.

Providers are required immediately to begin transporting Ð trauma

alert Ñ victims, as identified pursuant to field triage criteria,

to the newly designated provisional trauma center for trauma care

when it is the nearest trauma center to the location of the

incident. See Fla. Admin. Code R. 64J - 2.002(3)(g).

1 8 . In the summer of 2016, Memorial received a letter from

the Department notifying Memorial of the opportunity to submit a

letter of intent to become a trauma center .

19 . Memorial timely submitted a letter of intent to the

Department in September 2016. This letter indicated that

Memorial would seek approval from the Department to operate as a

Level II trauma center.

2 0 . After Memorial submitted its letter of intent , the

Department responded by sending Memorial a notice accepting its

letter of intent and providing information on the application

process. The notice directed Memorial to the Department Ó s trauma

center application and contained instructions for the comp letion

and subm ission of the application.

2 1 . Once Memorial received the Department Ó s notice

confirming acceptance of its letter of intent, it began making

significant investments of resources and capital to develop its

trauma program. It did so to ensu re that its application would

be compliant with the Trauma Standards.

2 2 . In order to implement its trauma program and meet the

required Trauma Standards, Memorial made investments in a

number of areas, including the r enovation of its emergency

department ( Ð ED Ñ ) to accommodate two dedicated trauma

resuscitation bays; the h iring and recruitment of new physicians

and staff; conducting s ignificant staff education ; and beginning

work towards the construction of a new helipa d.

2 3 . By May 1, 2017, Memorial had invested over $4 million

to develop its trauma program. This capital investment included

approximately $2.5 million in construction and equipment.

2 4 . Memorial also invested $1.7 million in recruiting

physicians and staff, as well as trauma - related train ing and

education. Memorial was well positioned to develop its trauma

program, since many of the needed surgical specialties were

already offered at the hospital. The hospital recruited

additional physicians to fill the more than 20 non - surgical

specialt ies required by the Trauma Standards. In addition to new

physicians, Memorial recruited many new specialized nurses needed

to serve trauma patients.

2 5 . Memorial ultimately provided over 6,000 hours of trauma

training before May 1, 2017, and continues to train new nurses.

The hospital ensured that over 200 nurses received training in

Trauma Nurse Core Competencies, which ensures that nursing staff

can provide high quality care for severely injured patients.

2 6 . Memorial made all of the above investments prior to

March 31, 2017, the date on which Memorial submitted its

application to the Department.

2 7 . Memorial Ó s A pplication was prepared by a core team,

headed by Eleanor Lynch, s enior v ice p resident of o perations at

Memorial. The key members of the tea m included Memorial Ó s trauma

medical director, trauma program director, as well as

representatives from the intensive care unit ( Ð ICU Ñ ) and

operating room . In order to ensure Memorial Ó s A pplication met

the Trauma Standards, the team preparing the applicat ion met at

least three times each week. Those meetings sometimes consisted

of 30 different individuals from a variety of disciplines,

including the trauma program director, trauma medical director,

registration, respiratory, ICU , and the ED . The process was

comprehensive and inclusive to ensure the hospital was fully

prepared to address each Trauma Standard in its application.

This team reviewed the application before it was submitted to the

Department to ensure that it complied with the Trauma Standards .

2 8 . Memorial also received assistance from K . C . Pidgeon,

v ice p resident of t rauma for HCA South Atlantic Division -- which

includes Memorial. Mr. Pidgeon, who has significant experience

in developing trauma programs in Florida, participated in each of

th e team meetings. He provided guidance into making sure the

hospital and its application met the Trauma Standards, including

updating policies and procedures, purchasing equipment,

recruiting staff, and development of nurse leaders .

29 . The final applicat ion submitted to the Department

consisted of 32 separate binders encompassing thousands of pages

of information.

30 . In order to be ready to operate by May 1, 2017,

Memorial set an internal deadline of February 27, 2017 , for the

hospital to meet each of t he Trauma Standards. Memorial met this

internal deadline and included a letter in its application from

Memorial Ó s CEO confirming this milestone.

31 . Memorial timely submitted its trauma center application

to the Department on March 31, 2017.

32 . In deve loping its trauma program and preparing its

application, Memorial ensured that it met all of the Trauma

Standards that are required for provisional approval.

33 . After receiving Memorial Ó s A pplication, the Department

arranged for it to be reviewed by two outside experts, Dr. Marco

Bonta and Nurse Marla Vanore. Both Dr. Bonta and Nurse Vanore

have reviewed numerous trauma applications on behalf of the

Department, and are very familiar with the Trauma Standards.

Following their review, Dr. Bonta and Nurse Vanore sent the

Department a checklist identifying alleged deficiencies in

Memorial Ó s A pplication. Both reviewers concluded that the

quality of the application on initial review was excellent, and

reflected a serious effort to meet the Trauma Standards be fore

beginning operations.

34 . On April 14, 2017, the Department sent Memorial a

letter notifying it of the deficiencies that Dr. Bonta and

Nurse Vanore had identified. The few deficiencies identified by

the Department were mainly clerical in nature or r equired simple

clarifications. For instance, one of the noted deficiencies

included updating the curriculum vitae of Memorial Ó s trauma

program director.

35 . Memorial timely responded to each deficiency identified

by the Department on April 22, 2017.

36 . Memorial Ó s deficiency response was also reviewed by

Dr. Bonta and Nurse Vanore. Following their review of Memorial Ó s

deficiency response, the expert reviewers concluded that Memorial

properly addressed each deficiency identified during the

Department Ó s i nitial review .

37 . On May 1, 2017, the Department informed Memorial that

its application was in compliance with the applicable Trauma

Standards and directed it to begin trauma operations on that same

day.

3 8 . As indicated by the parties Ó stipulation, Sha nds takes

issue with only a few of the hundreds of requirements that

comprise the Trauma Standards. The only aspects of Memorial Ó s

A pplication which Shands disputes are the standards related to

trauma surgeon call coverage (Standard s II.A.4 - 5, II.B.2, and

III.A) and the helipad (Standard V.A.5). Shands does not dispute

that the application meets the remaining Trauma Standards.

39 . Standard III of the Trauma Standards details the

surgical staffing requirements that each trauma center must meet.

Standard III.A specifically addresses the requirements for

general trauma surgeons. Standard III.A.1 requires that Ð [t]here

shall be a minimum of five qualified trauma surgeons, assigned to

the trauma service, with at least two trauma surgeons available

to provide primary and backup trauma coverage 24 hours a day at a

trauma center when summoned. Ñ Standard III.A.2 requires each

trauma surgeon to sign the General Surgeons Commitment Statement,

which confirms that each surgeon on primary and backup call will

comply with certain conditions, including arriving promptly when

summoned. Standard III.A.3 lists the minimum qualifications for

each trauma surgeon taking call, such as certifications and

hospital privileges.

40 . Memorial submitted substantial documentation wh ich

demonstrated its compliance with the requirements in Standard

III.A. Although the Trauma Standards only require five trauma

surgeons, Memorial secured nine trauma surgeons for its program.

For each of these surgeons, Memorial provided proof of hospit al

privileges, board certification, state licensure, Advanced Trauma

Life Support ( Ð ATLS Ñ ) certification, proof of participation in

past trauma cases, completion of continuing medical education

courses, attestation by the Chief of Neurosurgery, and the

com mitment statement, among other documentation. Memorial Ó s

documentation for this section totaled more than 500 pages.

4 1 . Memorial also submitted primary and backup call

schedules for February, March, April, and May 2017 , indicating

when each trauma surge on was scheduled to take trauma call.

4 2 . In addition, Memorial submitted a number of policies

and procedures , including Memorial Ó s credentialing criteria,

which is more stringent than what the Department requires . In

order to be credentialed at Memorial , a trauma surgeon must agree

to the following requirements for primary trauma call: b e

physically present in - house to meet all trauma patients in the

trauma resuscitation areas at the time of the trauma patient Ó s

arrival; p erform no elective surgery or p rocedures during the on -

call period that would render the trauma surgeon unavailable to

arrive promptly to a trauma alert patient; and r efrain from

taking general surgery emergency call at any other facility or

trauma call at any other facilities while on trauma call at the

primary facility. Similar requirements exist for trauma backup

call.

43 . Standard II of the Trauma Standards sets forth the

trauma call coverage requirements that each trauma center must

meet. Specifically, Standard s II.A.4 and II.A.5 require Ð [a]t

least one qualified trauma surgeon (as described in Standard

III.A) to be on primary trauma call at all times to provide

trauma service care Ñ and Ð [a]t least one qualified trauma surgeon

(as described in Standard III.A) to be on backup traum a call at

all times to provide trauma service care . Ñ Simply put, there

must be one trauma surgeon on primary call and one trauma surgeon

on backup call at all times.

4 4 . As part of its application, Memorial submitted detailed

information about each of th e nine trauma surgeons on its monthly

call schedules, including the call schedules themselves. The

call schedules detail each of the trauma surgeons scheduled to

take primary and backup trauma call for February through May

2017.

4 5 . Memorial secured and submitted commitment statements

(DH Form 2043E) from each of the trauma surgeons on its call

schedule. These signed commitment letters indicate that each

trauma surgeon agreed to commit to the call schedules submitted

to the Department and be available as indicated. These letters

also indicate that each surgeon pledged not to take trauma call

at any other facility while on trauma call at Memorial.

4 6 . Trauma Standard II also includes a requirement that the

hospital ensure any new trauma surgeons are appr opriately

qualified and sign the commitment statement. Specifically, Ð [a]s

surgeons change, the trauma medical director must ensure that the

new surgeons have the qualifications delineated in Standard

III.A.3 and that they sign the General Surgeons Commit ment

Statement. The trauma service shall keep a current and up - to -

date commitment statement on file in the hospital Ó s trauma center

application at all times for Department of Health review. Ñ In

response to this subpart, Memorial appropriately submitted t he

commitment statements for its initial nine trauma surgeons.

Because this was Memorial Ó s provisional application, none of the

new trauma surgeons who have subsequently joined its program

after May 1, 2017 , were included with this submission.

4 7 . After completing their initial review of Memorial Ó s

A pplication, the Department Ó s expert reviewers identified only

one issue to be addressed in the above sections. For one of the

trauma surgeons, Dr. Alton Parker, there was a question as to

whether he had met a ll the required continuing medical education

(ÐCMEÑ) requirements. As requested, Memorial submitted

additional documentation with its Deficiency Response confirming

that Dr. Parker had in fact completed the required CME courses.

With this concern resolve d, the expert reviewers ultimately

concluded that Memorial Ó s A pplication met every requirement.

4 8 . At hearing, Shands alleged that because some of the

trauma surgeons listed in Memorial Ó s A pplication do not live in

Jacksonville year round, the applicatio n did not meet the Trauma

Standards detailed above. However, there is no requirement in

the Trauma Standards that trauma surgeons must live full time in

the same community as the hospital at which they take trauma

call. Rather, the Trauma Standards requi re that trauma surgeons

on primary and backup trauma call in Level II trauma centers be

available within 30 minutes once summoned. In actuality, Shands Ó

criticisms appear to be a matter of preference or imagining the

ideal situation , rather than substanti ve questions about

compliance with the legal requirements for trauma surgeon call .

49 . Memorial has not had any gap in trauma call coverage or

similar issues since it began operations on May 1, 2017 ; every

shift has been covered and each trauma surgeon av ailable as

required. Memorial Ó s trauma surgeons are committed members of

the trauma team, including active participants in the quality

improvement process , regardless of where their permanent

residence may be .

5 0 . As part of its mission to ensure high - qu ality care,

Memorial requires its trauma surgeons on primary trauma call to

be physically present at the hospital during the entire shift ,

which is beyond what the Trauma Standards require for Level II

trauma centers. Memorial established this requirement in part to

ensure that there would be no issues with response time for

trauma surgeons. Any trauma surgeons on backup call that do not

have permanent residences within 30 minutes response time of the

hospital, typically stay at a hotel close to the hospi tal in

order to comply with the Trauma Standards and Memorial Ó s own

requirements. For any trauma surgeons who do not live full time

in the Jacksonville area, Memorial requires that they report well

in advance of beginning the call coverage to ensure there are no

issues, e.g., a trauma surgeon beginning call at 9 :00 a . m . Monday

morning must report to the hospital by 9 :00 p . m . the night

before.

5 1 . Memorial Ó s trauma surgeons have positive working

relationships with other team members, like the ED physicians ,

and have collaborated well with local EMS. Memorial has worked

to build a full - time trauma surgeon roster, with the hope that

recruited physicians will ultimately decide to make the

Jacksonville area their home. Memorial currently has three

trauma surg eons, including the trauma medical director,

Dr. Michael Samotowka, who live full time in Jacksonville and

plans to continue recruiting until all six current spots are

filled by full - time residents .

5 2 . Both Dr. Bonta and Nurse Vanore determined that

Memo rial Ó s trauma call coverage met the applicable Trauma

Standards, including Standards II.A.4 - 5, II.B.2, and III.A. Both

expert reviewers confirmed at hearing that the Trauma Standards

only require trauma surgeons on primary and backup call to be

readily av ailable -- they do not dictate where surgeons must reside

full time. Nurse Vanore also testified that many trauma centers

across the country utilize physicians who do not live in the

immediate vicinity of the hospital. These physicians either stay

at the h ospital or make arrangements to stay nearby when on call.

This reflects a common trend in trauma centers nationwide, which

often use the rotation of trauma surgeon (both on - and off - call )

shifts to enhance patient care. Most trauma centers do not use

tra uma surgeons to provide longitudinal care (one surgeon with

the patient throughout the care process) . I nstead , there is a

comprehensive patient handoff to the next trauma surgeon. There

was no indication in Memorial Ó s A pplication that its trauma

surgeons would not fulfill their call obligations.

5 3 . The general trauma surgeon call schedules submitted by

Memorial adequately demonstrated that Memorial would be able to

fulfill its trauma call coverage requirements. Since beginning

trauma operations, Memori al has not had any gaps in coverage or

other issues related to trauma call. Therefore, Memorial

satisfied Standards II.A.4 - 5, II.B.2, and III.A.

54 . The helipad became a central issue at hearing.

Standard V addresses the facility requirements relating t o the

ED , including the helipad. Standard V.A.5 requires that e ach

hospital must have a Ð helicopter - landing site in close proximity

to the resuscitation area. Ñ Ð Close proximity Ñ is defined to mean

that Ð the interval of time between the landing of the hel icopter

and the transfer of the patient into the resuscitation area will

be such that no harmful effect on the patient Ó s outcome results. Ñ

In addition to this requirement, the helipad must be properly

licensed by state and federal authorities, and have ap propriate

policies and procedures for helipad operations.

55 . Memorial has used the helipad in its current location

since 1993. Before it began operations as a trauma center,

Memorial effectively used its helipad to transport trauma

patients out of its E D to Shands and other trauma centers without

incident for the entirety of that time period.

56 . The helipad is located approximately 1900 feet from

Memorial Ó s ED. To meet this Trauma Standard, Memorial hired

Liberty Ambulance Service, a private ambulance service, to staff

the helipad 24/7, so that at all times there is an advanced life

support ambulance with two paramedics ready to transport patients

from the helipad to the ED. In addition, the ambulance driver

has received emergency vehicle operations c ourse training.

Memorial also provided training to the ambulance crew members to

ensure they were proficient in helicopter safety. This training

included in - depth interaction with air crew of TraumaOne, which

is one of the region Ó s air transport provider s.

57 . Memorial hires deputies from the Jacksonville Sheriff Ó s

Office to be present at all times for helicopter arrivals. These

deputies can be used to block any pedestrian or vehicle access to

the transport route or otherwise provide transport assistanc e,

although this has not been needed .

58 . Memorial conducted numerous time studies , almost daily

since February 27, 2017 , to ensure it could quickly move patients

from the helipad to the ED without delaying treatment. The time

trials entailed actually lo ading a stretcher onto an ambulance at

the helipad, driving the ambulance to the ED, and unloading the

stretcher at the ED. These time trials, which were conducted

beginning in December 2016 and continue today, showed an average

transport time of two to t hree minutes. Each time trial was

attended by Memorial Ó s EMS Coordinator, Greg Miller, and signed

off by each ambulance crew that participated. These time trials

helped familiar ize the ambulance crew with the short route from

the helipad to the ED, as we ll as to identify an alternate route

that can be used if needed. Admittedly, the trials were

performed using hospital personnel posing as patients , rather

than actual trauma patients, but the methodology, while

presenting a best case scenario, was nonethe less reasonable.

59 . In addition to the time trials, actual air transports

of non - trauma patients confirm the close proximity of the

helipad. It only took five minutes to transport a recent non -

trauma patient from the helipad to the ED, as documented by the

LifeFlight air crew which transported the patient.

60 . Since beginning trauma operations, there have not been

any issues with trauma patients arriving by helipad. At the time

of hearing, Memorial ha d only had one trauma patient delivered by

helicopte r since May 1, 2017. Memorial has only had 24 total

non - trauma patients delivered by helipad in 2017. In fact, very

few patients are transported by air in TSA 5 , generally.

61 . As part of ongoing renovations, Memorial is currently

constructing a new hel ipad, which will be situated one floor

directly above the ED . The new helipad is scheduled to be

completed in July 2018.

6 2 . Shands alleged at hearing that Memorial Ó s helipad was

not optimally located and voiced general concerns about its

potential impac t on patient care. While 1900 feet from the ED

cannot be considered the Ð optimal location Ñ for the helipad, the

claims of adverse impact on patient care were not supported by

evidence produced at hearing . None of Shands Ó witnesses

suggested that the pati ent transport times reflected in

Memorial Ó s A pplication would adversely impact patient care , or

that any adverse incidents had occurred on Memorial Ó s helipad .

Actually , none of Shands Ó witnesses had even reviewed any of the

time trials or actual patient t ransport information included in

Memorial Ó s A pplication. The time it takes to transport patients

from Memorial Ó s helipad to the ED is not substantially different

from other trauma centers in the region. Shands Ó own witnesses

confirmed that Shands Ó helipa d sits atop a six - story parking

garage across the street from its ED, which requires patients to

be transported down an elevator and wheeled on a stretcher across

a road while security blocks traffic access. Despite their

criticisms, none of Shands Ó witne sses knew how long it took to

transport patients from Shands Ó helipad to the ED. Moreover,

with the construction of its new helipad atop the ED, any

concerns about the current transport times will be eliminated.

63 . Both Dr. Bonta and Nurse Vanore determ ined that

Memorial Ó s helipad met the applicable Trauma Standard, namely

Standard V.A.5. Based on the time studies provided by Memorial

which showed the average transport time from the helipad to the

ED was only two to three minutes, the expert reviewers d etermined

that the helipad was in Ð close proximity Ñ to the resuscitation

area. Based on their experience, the expert reviewers concluded

that two to three minutes was typical of other trauma centers,

including hospitals with rooftop helipads. This durati on of

transport time is actually quite good and would not adversely

affect patient care.

64 . Memorial Ó s helipad is in close proximity to the trauma

resuscitation area, as the Department properly concluded based on

the information provided in Memorial Ó s A pplication. The two - to -

three minute transport time for trauma patients is well within

the acceptable range and demonstrates that Memorial met Standard

V.A.5.

6 5 . Memorial elicited testimony from a longtime expert in

health care planning, Gene Nelson of Health Strategies, Inc.

Mr. Nelson spoke at length in an effort to establish need for an

additional trauma center in TSA 5 through a feasibility study

employing well recognized health planning concepts. He focused

primarily on access to trauma care for patients needing the

comprehensive specialized care offered by trauma centers.

6 6 . Mr. Nelson noted that many trauma patients were being

treated in general acute care hospitals without trauma centers

which fell short of the care provided in centers like Shands and

the proposed Memorial trauma center. He concluded that a

substantial need exists for another trauma center in TSA 5 and

that M emorial would fulfill that need.

6 7 . Shands objected to this discussion of need by

Mr. Nelson on behalf of Memorial, and argues that the letter of

intent and application filed by Memorial should not have been

accepted in the first place , since there was not a documented

need for another trauma center in TSA 5. As will be discussed in

the Conclusions of Law below, the n eed for an additional trauma

center is not a determination to be made at the time of a

hospital Ó s filing for authority to begin operating a provisional

trauma center.

68 . Shands testified that Memorial Ó s operation of a trauma

center in TSA 5 has already r esulted in injury to its operations

and profitability. This injury will only continue in the future

as M emorial gains a stronger foothold in the TSA.

69 . The negative impacts include fewer trauma patients at

Shands resulting in a longer period for trauma nurses to acquire

and maintain the specialized skills necessary for operating in a

trauma center versus a general acute care hospital.

70 . The opening of M emorial Ó s provis ional trauma center has

caused the number of severely injured trauma patients at Sh ands

to decrease. Shands predicts an annual loss of 324 trauma cases

due to Memorial Ó s opening, translating to a $2.25 to $2.7 million

annual loss of revenues. If outpatient cases are included in

th is analysis, Shands projects an annual loss in revenues of

$12,422 per case over the 324 lost cases, resulting in an annual

total loss of approximately $4 million.

7 1 . Memorial argues that sufficient trauma volume exists in

TSA 5 for both facilities to operate their trauma centers.

Memorial projects that it will treat 1,556 trauma patients per

year, well above the American College of Surgeons Ó ( Ð ACS Ñ )

recommendation of at least 1,200 patients per year as a minimum

volume level.

7 2 . Mr. Nelson estimates that , annually, only between 300

and 500 trauma patient s will be treated at Memorial that

otherwise would have been treated at Shands. The rest likely

would have received treatment at an acute care hospital, not a

trauma center.

7 3 . Mr. Nelson believes that Memorial Ó s trauma program has

had, at most, a minim al impact on Shands. An analysis produced

by Shands demonstrates that Shands Ó own projections estimate a

loss of only 154 trauma patient admissions, well below the

numbers projected by Memorial.

7 4 . Even with Memorial Ó s trauma program being fully

opera tional, Shands will continue to receive in excess of 2,000

trauma patients admitted annually. That volume is well above the

ACS Ó s recommended minimum patient volume of 1,200 for Level I

trauma centers. Shands Ó own data shows that it will continue to

see over 4,600 total trauma patients annually, including

inpatient and outpatient cases.

7 5 . Estimates prepared by Shands Ó a ssociate v ice p resident

of f inance , Dean Cocchi , demonstrate that even with a potential

impact from Memorial, Shands will still hav e a contribution

margin of well over $30 million. Mr. Cocchi also testified that

Shands Ó projected financial impact from Memorial operations will

not endanger the continued operation of its trauma program.

While the presence of M emorial in the TSA 5 mark et will have a

small negative financial impact on Shands, it is not projected to

be substantial ly adverse.

7 6 . The quality of care provided at Shands has not been

impacted by the opening of Memorial Ó s trauma center. Shands

remains a high - quality provider of trauma care.

CONCLUSIONS OF LAW

77 . The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this cause of

action pursuant to sections 120.569, 120.57(1), and 395.4025(7).

7 8 . As the specifically named approve d applicant, whose

substantial interests are being determined in this proceeding,

Memorial has standing to intervene in this case. Memorial bears

the burden of proof to establish that its application met all of

the substantive elements that are required i n order to receive

provisional approval. See Woodholly Assocs. v. Dep Ó t of Nat.

Res. , 451 So. 2d 1002, 1004 (Fla. 1st DCA 1984). Shands bears

the burden of proof regarding any factual issues relating to its

claim that the Department acted pursuant to an unadopted rule.

See Envtlust v. State, Dep Ó t of Envtl. Prot. , 714 So. 2d 493,

497 (Fla. 1st DCA 1998) ( Ð A party who asserts a disputed claim

before an administrative agency generally has the burden of going

forward with the evidence as well as the ult imate burden of

establishing the basis for the claim. Ñ ) (citing Young v. Dep Ó t of

Cmty. Aff . , 625 So. 2d 831 (Fla. 1993); Balino v. Dep Ó t of HRS ,

348 So. 2d 349 (Fla. 1st DCA 1977)).

79 . As this hearing is conducted pursuant to section

120.57, the standar d of review is de novo . See § 120.57(1)(k),

Fla. Stat. ( Ð All proceedings conducted under this subsection

shall be de novo. Ñ ). The purpose of this de novo review is to

formulate final agency action with respect to Memorial Ó s

A pplication. See, e .g. , J.D. v. Fla. Dep Ó t of Child . & Fam s . ,

114 So. 3d 1127, 1132 ( Fla. 1st DCA 2013) ( Ð [T]he Legislature

intended a Ò typical Ó chapter 120.57 proceeding in which the

purpose is to Ò formulate final agency action, not to review

action taken earlier and preliminarily. Ó Ñ (internal citation

omitted)).

80 . In this de novo hearing, the ALJ must recommend whether

the Department Ó s final agency action with respect to Memorial Ó s

A pplication should be to approve or deny the application. The

answer to that question depends on whether Memorial Ó s trauma

program met the applicable standards. See § 395.4025(3), Fla.

Stat.; Fla. Admin. Code R. 64J - 2.012(1)(g); Galencare, Inc. v.

Dep Ó t of Health , Case No. 17 - 2754 (Fla. DOAH Dec. 20, 2017).

8 1 . Under this standard of review, the ALJ stands in the

shoes of the Department. The ALJ evaluates whether the

Department Ó s final agency action should be to accept or reject

the Memorial A pplication.

8 2 . In conducting this de novo review, the ALJ makes a

determination as to whether the Memorial Application, as

submitted to the Department, met applicable standards.

8 3 . The ALJ, however, must follow the t rauma statutes and

the Department Ó s trauma regulations. The ALJ must also defer to

the Department Ó s reasonable interpretation of those authorit ies.

See, e.g. , State Contr acting & Eng Ó g Corp. v. Dep Ó t of Transp. ,

709 So. 2d 607, 610 (Fla. 1st DCA 1998) ( Ð this policy of

deference to an agency Ó s expertise in interpreting its rules

applies not only to the courts but also to administrative law

judges . Ñ ); Univ. Med. Ctr., Inc. v. Dep Ó t of HRS , 483 So. 2d 712

(Fla. 1st DCA 1985) (batching cycle rules governing CON

applications are binding on an ALJ). Ð [A]n agency Ó s

interpretation need not be the sole interpretation or even the

most desirable one; it ne ed only be within the range of

permissible interpretations. Ñ Lakesmart Assocs., Ltd. v. Fla.

Hous. Fin. Corp. , Case No. 00 - 42 87 RU, RO at 44 (Fla. DOAH Feb. 7,

2001).

8 4 . The ALJ owes heightened deference to the Department Ó s

interpretation of the standar ds the applicants must satisfy in

order for the Department to grant provisional trauma center

status. Such heightened deference is owed because determining

whether a provisional trauma center applicant demonstrates

readiness to provide high - quality trauma care on May 1, 2017, is

an area within the Department Ó s unique technical and medical

expertise. See, e.g. , Rizov v. State, Bd. of Prof Ó l Eng Ó rs , 979

So. 2d 979, 980 - 81 (Fla. 3d DCA 2008) ( Ð Agencies generally have

more expertise in a specific area they ar e charged with

overseeing. Thus, in deferring to an agency Ó s interpretation,

courts benefit from the agency Ó s technical and/or practical

experience in its field. Ñ ); Shands Teaching Hosp. & Clinics v.

Dep Ó t of Health , Case No. 14 - 1022RP, FO at 121 (Fla. DO AH

June 20, 2014) (deferring to the Department Ó s determinations with

respect to the proposed trauma center allocation rule because it

Ð was the product of thoughtful consideration by the Department Ó s

experts Ñ ).

8 5 . In a hearing held pursuant to section 120 .57(1),

Memorial bears the ultimate burden of persuasion, by a

preponderance of the evidence, of entitlement to operate as a

provisional trauma center. See, e.g. , Fla. Dep Ó t of Transp. v.

J.W.C. Co. , 396 So. 2d 778, 787 (Fla. 1st DCA 1981) (it is

Ð fundame ntal Ñ that an applicant Ð carries the ultimate burden of

persuasion of entitlement through all proceedings, of whatever

nature, until such time as final action has been taken by the

agency Ñ ).

8 6 . In order to prevail, Memorial must establish that its

Applic ation established compliance with the applicable standards

within the prescribed time period, namely by May 1, 2017, the

date established for the initiation of an approved provisional

trauma program.

8 7 . The Department, consistent with its mission to

Ð pro mote, protect and improve the health of all people in the

state Ñ and to ensure the provision of optimal trauma care must be

able to conclude from the face of the application that Memorial Ó s

proposed trauma center is compliant with those standards. See

§§ 381.001, 395.40, and 395.4025(2)(c), Fla. Stat. The

Department cannot approve a provisional trauma center application

based on pledges to comply with certain standards, as doing so

would not be consistent with its mission to protect people in

Florida.

8 8 . The Legislature charged the Department with overseeing

the State Ó s Ð inclusive trauma system Ñ that is Ð designed to meet

the needs of all injured trauma victims who require care in an

acute - care setting and into which every health care provider or

facility with resources to care for the injured trauma victim is

incorporated. Ñ § 395.40(2), Fla. Stat.

89 . In section 395.4025, the Legislature established a

detailed schedule governing the Department Ó s review of trauma

applications, which is supplemented by ad ditional deadlines in

the Department Ó s regulations:

( a) The Department Ð shall Ñ annually notify Ð each acute care

general hospital Ñ that Ð the Department is accepting letters of

intent Ñ to establish trauma centers. § 395.4025(2)(a), Fla.

Stat.

(b) October 1: Letters of intent are due.

§ 395.4025(2)(a), Fla. Stat.

(c) October 15: The Ð department shall send to all

hospitals that submitted a letter of intent an application

package. Ñ § 395.4025(2)(b), Fla. Stat.

(d) April 1: Deadline for hospitals to su bmit trauma

center applications to the Department. Upon receipt, the

Department Ð shall conduct a provisional review of each

application for the purpose of determining that the hospital Ó s

application is complete and that the hospital has the critical

eleme nts required for a trauma center. Ñ § 395.4025(2)(c), Fla.

Stat.

(e) April 15: The Department must notify a trauma center

applicant of any deficiencies in its application. Fla. Admin.

Code R. 64J - 2.012(1)(e).

(f) Five working days from April 15: By this date, an

applicant must submit whatever information is necessary to

address the deficiencies identified by the Department. Fla.

Admin. Code R. 64J - 2.012(1)(f).

(g) April 30: After this date, Ð any hospital that

submitted an application found accept able by the department based

on provisional review shall be eligible to operate as a

provisional trauma center. Ñ § 395.4025(3), Fla. Stat. The

Department Ó s rules further specify that a provisionally approved

trauma center must begin operations on May 1. Fla. Admin. Code

R. 64J - 2.012(1)(g) - (h).

(h) May 1 through October 1: The Department conducts an

Ð in - depth Ñ review of the application of each provisionally

approved trauma center. § 395.4025(4), Fla. Stat.

(i) October 1 through June 1: The Departme nt will send

out - of - state reviewers to perform an assessment of each

provisionally approved trauma center. § 395.4025(5), Fla. Stat.

(j) July 1: The Department will issue final verification

to provisional trauma center applicants that have met all

appl icable criteria. § 395.4025(6), Fla. Stat.

90 . Memorial established that its trauma center application

met all the applicable Trauma Standards that are required for

provisional approval , including those that remained at issue for

Shands in this hearing . Memorial Ó s A pplication was carefully

reviewed by the out - of - state trauma experts hired by the

Department. The Department and its experts properly concluded

that Memorial Ó s A pplication met each required Trauma Standard.

91 . Shands agrees, pursuant to the Joint Prehearing

Stipulation, that of the required 350 s tandards that a

provisional trauma center applicant must satisfy, Memorial has

satisfied all but a handful -- those relating to trauma call

coverage (Standards II.A.4 - 5, II.B.2, and III.A) and the heli pad

(Standard V.A.5). The evidence presented by Memorial at the

hearing, however, demonstrates that Memorial satisfied all three

of these standards and the Department properly approved

Memorial Ó s A pplication.

92 . Memorial met Standards II.A.4 - 5, II.B.2, and III.A.

These Trauma Standards relate to general trauma surgeon call

coverage. They require an applicant to have at least five trauma

surgeons assigned to its trauma program, with one trauma surgeon

on primary call and one trauma surgeon on backup cal l at all

times. These surgeons must be appropriately qualified and must

submit commitment statements to report promptly when summoned by

the hospital. Memorial clearly demonstrated that each of its

nine trauma surgeons met these requirements. Despite Sh ands Ó

claims that it is optimal that trauma surgeons reside full time

near the hospital , which might be preferable in a perfect world,

there is no such residency requirement in the Trauma Standards.

The evidence presented by Memorial demonstrated that its trauma

surgeons would be available and, at the time of hearing, had been

available for each of their trauma call coverage commitments.

Memorial ensured that there would be no coverage problems by

requiring that each trauma surgeon on primary call be stat ioned

at the hospital during the entirety of their coverage shift .

This is above and beyond what the Trauma Standards require of

Level II trauma centers. Further, the evidence clearly showed

that , since beginning trauma operations, Memorial has had no

is sues with trauma call coverage, nor could Shands identify any

such issues. Therefore, Memorial satisfied Standards II.A.4 - 5,

II.B.2, and III.A.

93 . Similarly, Memorial proved that it met Standard V.A.5 .

This Trauma Standard requires that an applicant Ó s helipad be

located in Ð close proximity to the resuscitation area . Ñ Ð Close

proximity Ñ is defined to mean that the time it takes to transport

the patient from the helipad to the resuscitation area will not

adversely impact the patient Ó s outcome. Importantl y, the Trauma

Standard does not mandate an exact location for an applicant Ó s

helipad. Memorial demonstrated through dozens of realistic time

trials that the transport time from its helipad to the ED is only

two - to - three minutes. The Department Ó s expert r eviewers

reasonably concluded that this length of transport time would not

adversely affect patient care and is actually consistent with

other trauma centers in the country, including those with rooftop

helipads. Moreover, to make the helipad in even clos er proximity

to the ED, Memorial testified it was already in the process of

building a new helipad atop the ED. While not completed at the

time of hearing, this is further evidence of M emorial Ó s

commitment to making access to the ED for trauma patients ev en

better. Memorial satisfied Standard V.A.5.

94 . Despite the fact that Memorial satisfied the Trauma

Standards, which would entitle it to provisional approval of its

L evel II trauma center, Shands argues that the Department

violated i ts own rules and re lied on unad o p ted and invalid rules

in its approval of Memorial Ó s A pplication. Particularly, Shands

argues that the Department Ó s rules prohibit the acceptance and

review of trauma applications where there is no allocated need in

a TSA, as is the case in T SA 5.

95 . The gist of Shands Ó argument rests on an interpretation

of section 395.4025 , which requires the need allocation found in

r ule 64J - 2.010 to be considered at the provisional application

stage; and a corresponding interpretation of r ule 64J - 2.012 ,

which makes the receipt of a hospital Ó s letter of intent

conditional on an allocation of need in that hospital Ó s TSA.

96 . Section 395.4025(2) makes clear that need is not a

consideration at the provisional stage. In Dep artmen t of Health

v. Bayfront HMA M ed ical Center , 236 So. 3d 466 , 473 (Fla. 1st DCA

2018) , the court confirmed this interpretation by holding that

Ð [t] he provisions of subsection (2) do not confer discretion on

the Department and require it to invite and accept a LOI and to

accept, provisio nally review, and provisionally grant an

application without regard to need . Ñ Ð Notably, Ñ states the

c ourt, Ñ section 395.4025(2)(d)1. authorizes the Department to

grant an extension of time to an applicant if the number of

applicants in the TSA is equal to or less than the service area

allocation, not if the number of applicants is equal to or less

than the number of open slots, which further evinces that the

Legislature considers need irrelevant at the provisional review

stage of the application process. Section 395.4025(3) provides

that after April 30, any hospital whose application has been

provisionally approved shall be eligible to operate as a

provisional trauma center. Section 395.4025(4) governs the in -

depth review of applications. Ñ Id .

9 7 . In de scribing the steps that lead up to granting

provisional approval, the statute repeatedly uses the term

Ð shall Ñ to mandate - Î without exception - Î the Department Ó s actions

in the provisional review process. These statutory provisions,

however, say nothing abou t the consideration of an available

Ð slot Ñ during the stages that lead to provisional approval.

Rather , the statute mentions Ð need Ñ only in connection with final

verification. Applying the principle of expressio unius est

exclusio alterius , the discussio n of need only in connection with

final verification is decisive evidence that the Legislature did

not authorize the Department to consider slot allocation in

connection with the steps that lead to provisional approval.

See, e.g . , Moonlit Waters Apartment s, Inc. v. Cauley , 666 So. 2d

898, 900 (Fla. 1996).

98 . The Department and Memorial agree that section 395.4025

does not permit the Department to consider need in its

determination of whether to provisionally approve a trauma center

application. Since th e Department is responsible for

administering section 395.4025, the undersigned must defer to the

Department Ó s interpretation of it , so long as it is not clearly

erroneous. See State Contr acting & Eng Ó g Corp. v. Dep Ó t of

Trans p . , 709 So. 2d. 607, 610 (Fla . 1st DCA 1998) ( Ð We have long

recognized that the administrative construction of a statute by

an agency or body responsible for the statute Ó s administration is

entitled to great weight and should not be overturned unless

clearly erroneous. . . . [T]his p olicy of deference to an

agency Ó s expertise in interpreting its rules applies not only to

the courts but also to administrative law judges. Ñ ) (internal

citation omitted). Far from being erroneous, the Department Ó s

interpretation of s ection 395.4025 is the only interpretation

that is consistent with the statute Ó s plain meaning, as validated

by the First DCA in Bayfront .

99 . Shands also claims that r ule 64J - 2.012(1)(a) requires

the Department to take the existence of a Ð slot Ñ into account

when deciding whet her to provisionally approve Memorial Ó s

A pplication. The First DCA explained in Bayfront that this rule

does not mandate the Department to consider need during its

provisional review and is consistent with the statutory

directives of the Trauma Statute. Bayfront , supra at 474.

10 0 . Rule 64J - 2.012(1)(a) states , that Ð [t] he letter of

intent is non - binding, but preserves the hospital Ó s right to

complete its application by the required due date if an available

position, as provided in Rule 64J - 2.010, F.A.C., exists in the

hospital Ó s TSA. Ñ

10 1 . Shands assumes that this provision requires the

Department to consider whether there is a Ð slot Ñ available at the

provisional review stage, but that is not the case. As noted in

Bayfront , this provision is not a prere quisite which prohibits a

hospital from submitting an application only if there is an open

Ð slot. Ñ Bayfront , supra , at 474 . Instead, the rule simply

preserves the hospital Ó s right to complete an application by

filing a non - binding letter of intent. Id . There is no

requirement or reference in r ule 64J - 2.012(1)(a) regarding the

consideration of need at the provisional review.

10 2 . Shands also assumes that there is currently only one

Ð slot Ñ in TSA 5. Rule 64J - 2.010, which was promulgated by the

Departmen t in 2014, provided that there was one Ð slot Ñ in TSA 5.

This argument is based on a misunderstanding of r ule 64J - 2.010.

T his rule has two parts: (1) a list of the Ð scoring Ñ criteria

that the Department is to use in determining how many trauma

centers sh ould be permitted in each TSA; and (2) an allocation

table that shows how many trauma center Ð slots Ñ are in fact

allocated to each TSA (results that are reached by applying some

of the data set forth in the Department Ó s review of the TSA

Assessment to scor ing criteria). Rule 64J - 2.010 provides that

the Department was to conduct a new assessment by August 30,

2015 , and to revise the allocation table based on the results of

the new assessment. Fla. Admin. Code R. 64J - 2.010(2). Had the

Department followed t he plain language of the rule, it would have

conducted a new assessment; conducted an analysis of the data

from the new assessment; and promulgated a new rule that would

have included a new allocation table. The Department conducted a

2015 TSA Assessment, reviewed the data, and proposed new

allocations, which included increased allocations in TSA 5.

Based on this 2015 assessment, the Department proposed two rules

reflecting the allocation of at least one additional Ð slot Ñ to

TSA 5. Id . However, these pr oposed rules were not adopted, nor

was the 2015 TSA Assessment incorporated into the current rule.

Id . As the Department did not revise the allocation table by the

August 30, 2015 , deadline to reflect its updated assessment of

the allocation of slots in the TSAs, the allocation table

prepared in 2014 is no longer valid. Accordingly , there is no

longer just one Ð slot Ñ in TSA 5.

10 3 . With the expiration of the 2014 rule, c urrently, the

only limitation on trauma centers is the statewide statutory cap

of 4 4 trauma centers. That cap does not preclude Memorial Ó s

trauma center being approved because there are fewer than 44

trauma centers statewide.

10 4 . Even if Shands Ó interpretation of r ule 64J - 2.012(1)(a)

w ere correct, which the Bayfront c ourt has determin ed it is not,

the Department would still have been required to provisionally

approve Memorial Ó s A pplication. Shands Ó interpretation of this

rule would have put it in direct conflict with section 395.4025

of the Trauma Statute. Ð It is axiomatic that an ad ministrative

rule cannot enlarge, modify or contravene the provisions of a

statute. Ñ Willette v. Air Prods. , 700 So. 2d 397, 401 (Fla. 1st

DCA 1997) (citation omitted). Since the Department was

statutorily required to provisionally approve Memorial Ó s

A pp lication if it met the Trauma Standards, the Department Ó s rule

could not validly provide to the contrary. See id .

10 5 . Since section 395.4025(2) , as affirmed by the Bayfront

c ourt, makes clear that need is not a consideration at the

provisional stage, no need for a rule re iterating the statutory

language is required, or even permitted:

[A]n agency interpretation of a statute which

simply reiterates the legislature Ó s statutory

mandate and does not place upon the statute

an interpretation that is not readil y

apparent from its literal reading, nor in and

of itself purport to create certain rights,

or require compliance, or to otherwise have

the direct and consistent effect of the law,

is not an unpromulgated rule, and actions

based upon such an interpretation are

permissible without requiring an agency to go

through rulemaking.

St. Francis Hosp . , Inc. v. Dep Ó t of HRS , 553 So. 2d 1351, 1354

( F la. 1st DCA 1989). When an agency simply follows the plain

statutory text without issuing a rule that simply regurgita tes

that statutory text, the agency is not deemed to be acting

pursuant to an unadopted rule. See, e. g. , State Bd. o f Admin. v .

Huberty , 46 So. 3d 1144, 1147 (Fla. 1st DCA 2010) .

10 6 . The Department is not permitted to depart from its

statutory mandate , by way of an unadopted rule or otherwise . Ð In

cases of conflict, a statute takes precedence over an

administrative rule. Ñ One Beacon Ins. v. Ag . for Health Care

Admin , 958 So. 2d. 1127 , 1129 (Fla. 1st DCA 2007).

10 7 . Since the question of need for Memor ial Ó s provisional

trauma center cannot be an issue at the provisional stage of

review and approval, no further discussion of the Ð need Ñ for the

center is necessary, despite the detailed testimony given by

Mr. Nelson at hearing. That discussion may ripen a t some point

down the road, but not today. Since the First DCA has clearly

spoken on the need issue as it related to provisional approval of

trauma centers, the undersigned must, and will, abide by the

decision in Bayfront , th us end ing th at discussion her e.

1 08 . Based upon the foregoing Findings of Fact and

Conclusions of Law, it is , therefore, concluded that: Memorial

met its burden of establishing that its trauma center application

met the applicable standards ; and that Shands Ó argument that the

Depart ment acted pursuant to an unadopted rule when it

provisionally approved Memorial Ó s trauma center application even

though there allegedly was no available Ð slot Ñ in TSA 5 is

contrary to section 395.4025 as interpreted by the First DCA in

the Bayfront case .

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Department of Health enter a

final order finding that Memorial met its burden of establishing

that its trauma center application met the applicable standards ;

awarding provisional Level II status to Memorial ; and dismissing

Shands Ó petition .

DONE AND ENTERED this 1 3 th day of June , 2018 , in

Tallahassee, Leon County, Florida.

S

ROBERT S. COHEN

Administrative Law Judge

Division of Administrative Hearings

The DeSoto 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 1 3 th day of June , 2018 .

COPIES FURNISHED:

Stephen A. Ecenia, Esquire

Gabriel F.V. Warren, Esquire

Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202

Post Office Box 551

Tallahassee, Florida 32302 - 0551

(eServed)

Seann M. Frazier, Esquire

Marc Ito, Esquire

Pa rker, Hudson, Rainer & Dobbs, LLP

215 South Monroe Street , Suite 750

Tallahassee, Florida 32301

(eServed)

Daniel Ryan Russell, Esquire

Jones Walker, LLP

215 South Monroe Street , Suite 130

Tallahassee, Florida 32302

(eServed)

Michael Jovane Williams, Esquire

Prosecution Services Unit

Department of Health

4052 Bald Cypress Way , Bin A - 02

Tallahassee, Florida 32399

(eServed)

Martin B. Goldberg, Esquire

Lash & Goldberg , LLP

100 Southeast Seco nd Street , Suite 1200

Miami, Florida 33131

(eServed)

Jeffrey L. Frehn, Esquire

Radey Law Firm, P.A.

301 South Bronough Street , Suite 200

Tallahassee, Florida 32301

(eServed)

J. Stephen Menton, Esquire

Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202

Post Office Box 551

Tallahassee, Florida 32302 - 0551

(eS erved)

Nichole Chere Geary, General Counsel

Department of Health

4052 Bald Cypress Way , Bin A - 02

Tallahassee, Florida 32399 - 1701

(eServed)

Shannon Revels, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1703

(eServed)

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

State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A - 00

Tallahassee, Florida 32399 - 1701

(eServed)

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written excep tions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.