17-002754 Galencare, Inc., D/B/A Northside Hospital vs. Florida Department Of Health Status: Closed Recommended Order on Wednesday, December 20, 2017.

Summary: Northside Hospital met its burden of establishing that its trauma center application meets all applicable criteria, thereby entitling it to provisional status as a Level II trauma center.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

GALENCARE, INC., d/b/a NORTHSIDE

HOSPITAL,

Petitioner,

vs.

FLORIDA DEPARTMENT OF HEALTH,

Case No. 17 - 2754

Respondent,

and

BAYFRONT HMA MEDICAL CENTER,

LLC, d/b/a BAYFRONT HEALTH -

ST. PETERSBURG; AND ST. JOSEPH'S

HOSPITAL, INC., d/b/a

ST. JOSEPH'S HOSPITAL,

Intervenors.

_______________________________/

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 D OAH Ñ ), on July 12 and 13 , 2017, in

Tallahassee , Florida.

APPEARANCES

For Galencare, Inc., d/b/a Northside Hospital:

Stephen A. Ecenia, Esquire

Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202

Post Office Box 551

Tallahassee, Florida 32302 - 0551

For Florida Department of Health :

Jay Patrick Reynolds, Esquire

Michael Jovane Wi lliams, Esquire

Prosecution Services Unit

Department of Health

4052 Bald Cypress Way , Bin A02

Tallahassee, Florida 32399

For Bayfront HMA Medical Center, LLC, d/b/a Bayfront

Healt h - St. Petersburg:

Timothy Bruce Elliott, Esquire

Smith & Associates

3301 Thomasville Road , Suite 201

Tallahassee, Florida 32308

For St. JosephÓs Hospital, Inc., d/b/a St. JosephÓs

Hospital:

Karen Ann Putnal, Esquire

Moyle Law Firm, P.A.

118 North Gadsden Street

Tallahassee, Florida 32301

R. Kathleen Brown - Blake, Esquire

1520 Kil learn Center Boulevard

Tallahassee, Florida 32309

STATEMENT OF THE ISSUE

The issue in this case is whether the application filed with

the Department of Health (ÐDepartmentÑ) on March 31, 2017 , by

Galencare Inc., d/b/a Northside Hospital (ÐNorthsideÑ) , to

operate as a provisional Level II trauma center met the

applicable criteria and standards under Part II, Chapter 395,

Florida Statutes (2017) , 1 / and Florida Administrative Code

Chapter 64J - 2.

PRELIMINARY STATEMENT

On May 1, 2017, the De partment notified Petitioner,

Northside, that its application to become a provisional Level II

trauma center was denied. Northside challenged the denial by

filing a petition pursuant to section 120.57(1), Florida

Statutes. The DepartmentÓs review determi ned that NorthsideÓs

a pplication failed to meet at least three of the Critical

Elements required by law for a trauma center. On May 15, 2017, a

Notice of Agency Referral was filed at DOAH , whereby the p etition

was assigned DOAH Case No. 17 - 2754. On May 1 8, 2017, Bayfront

HMA Medical Center, LLC, d/b/a Bayfront Health - St. Petersburg

(ÐBayfrontÑ) , filed a Petition to Intervene asserting that, as an

existing trauma center in the same Trauma Service Area ( Ð TSA Ñ ) ,

it had standing to intervene , including becaus e its substantial

interests would be impacted should Northside be approved. On

May 25, 2017, St. JosephÓs Hospital, Inc., d/b/a St. JosephÓs

Hospital (ÐSJHÑ) , filed a Petition to Intervene with Full - party

Status. In a June 9, 2017 , Order, BayfrontÓs inte rvention was

granted, but with some limitations on BayfrontÓs participation.

In the same Order, SJH was granted leave to intervene, but with

greater limitations than Bayfront. The final hearing in this

matter was held on July 12 and 13, 2017, in Tallahas see, Florida.

At the hearing, Northside presented the testimony of Peter

Kennedy, Doreen Gilligan, Angela Chisolm, and Dr. Erik Barquist.

The Department presented the testimony of Cynthia Dick (ÐChief

DickÑ), the DepartmentÓs assistant deputy secretary o f Health and

also the interim d irector for the Division of Emergency

Preparedness and Community Support, with oversight of several

divisions, bureaus and programs , including the DepartmentÓs

ÐTrauma Program.Ñ Intervenor, Bayfront, presented the testimony

of its corporate representative, Dr. Steven Epstein. Joint

Exhibits 1 through 10 were admitted into evidence. NorthsideÓs

Exhibits 1 through 6, 10 through 15, 20, 23 , and 26 were admitted

into evidence. In addition, the ALJ took official recognition of

NorthsideÓs Exhibits 7 and 8. The DepartmentÓs Exhibits 2 and 3

were admitted into evidence , and the ALJ took official

recognition of BayfrontÓs Exhibits 11 through 13. Intervenor,

SJH, monitored the hearing , but did not actively participate in

the heari ng and so did not offer any exhibits into evidence.

After an initial deadline of 30 days from the filing of the

transcript for filing proposed recommended orders was

established, the parties requested, and were granted , three

extensions of time to file th eir proposals. All parties have

timely submitted proposed findings of fact and conclusions of law

on or before October 2, 2017 , which have been duly considered in

the preparation of this Recommended Order.

FINDING S OF FACT

I. Parties

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

created pursuant to section 20.43, Florida Statutes. The

DepartmentÓs mandate is to Ðpromote, 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. Northside is a 288 - bed acute - care hospital located in

TSA 9, Pinellas County, Florida. Northside provides a wide range

of services, including inpatien t cardiovascular and neuroscience

services.

3. Northside has developed a trauma program and submitted

an application to operate as a provisional Level II trauma center

in March 2017. The DepartmentÓs preliminary determination to

deny NorthsideÓs applic ation on May 1, 2017 , is the subject of

this proceeding.

4. Bayfront is an acute - care hospital located in TSA 9,

Pinellas County, Florida. Bayfront has been designated by the

Department as a Level II trauma center.

II. NorthsideÓs Trauma Center Ap plication

A. Northside Submitted a Timely Letter of Intent

5. In the summer of 2016, Northside received a letter from

the Department notifying Northside of the opportunity to submit a

letter of intent to become a trauma center.

6. Northside ti mely submitted a letter of intent with the

Department in September 2016. This letter indicated that

Northside would seek approval from the Department to operate as a

Level II trauma center. Northside was well - situated for a trauma

center because of the r esources and services already in place at

the hospital. Moreover, Northside was prepared to open a trauma

program because it already had extensive experience treating

critically ill patients.

7. After Northside submitted its letter of intent, the

Depa rtment responded by sending Northside a notice accepting its

letter of intent and providing information on the application

process. The notice directed Northside to the DepartmentÓs

trauma center application and contained instructions for the

completion a nd submission of the application.

B. Northside Established a Full Trauma Program a fter the

Department Accepted its Letter of Intent

8. Once Northside received the DepartmentÓs 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 ensure that its forthcoming

application was compliant with the requirements set forth in

DOH Pamphlet (DHP) 150 - 9 (the ÐTrauma StandardsÑ or ÐDHPÑ) , which

is inco rporated by reference in r ule 64J - 2.011.

9. As part of the development of its trauma program,

Northside hired Doreen Gilligan in October 2016 to serve a s

d irector of Trauma Services. The hospital also worked with Angie

Chisolm to draw on resources from other approved trauma centers,

such as trauma - related policies and procedures and best practices

for trauma center operations.

10. NorthsideÓs expertise in advanced, life - saving care,

including cardiovascular and neuroscience programs and its

intensive care unit (ÐICUÑ) , made it a well - qualified candidate

to open a new trauma center.

11. Between October 1, 2016 , and April 1, 2017, Northside

invested over $4 million to develop its trauma program.

12. Northside invested $2.5 million in physical p lant

improvements and equipment. These improvements included:

• A helipad, which is properly licensed by

the Department of Transportation and FAA.

The helipad is operational and Northside is

already receiving patients from helicopters

on a daily basis in its capacity as an acute -

care hospital.

• Two state - of - the - art trauma resuscitation

bays in the emergency department (ÐEDÑ) that

are in immediate proximity to the helipad.

These new trauma bays can accommodate up to

four trauma patients at the same time.

• The expansion of the ICU to include 12 beds

that are specifically designated for trauma

patients.

• The expansion of one of the operating rooms

because trauma patients often require care

from multiple doctors simultaneously.

• The purchase of new equipment, including

new ICU monitors, operating room equipment,

and equipment to support physician

subspeci alists.

• The purchase of a blood track machine for

the emergency department. This machine

dramatically reduces the amount of time it

tak es for patients to receive blood

transfusions.

• The purchase of a platelet function testing

machine and a thromboelastography machine.

These machines help identify where a trauma

patient is bleeding. These machines also

play a critical role in quickl y stopping

bleeding Î one of the key functions that

every traum a center must perform.

• The purchase of a second computed

tomography (ÐCTÑ) machine dedicated solely to

the provision of radiology services needed by

trauma patients.

13. Northside inves ted approximately $1.7 million in

physician and staff employment and recruitment. This investment

has enabled Northside to do the following:

• Provide continuous, around - the - clock trauma

surgeon coverage, 7 days a week (beginning

February 16, 2017).

• Provide continuous, around - the - clock

anesthe siology coverage.

• Provide hospital coverage for the required

19 physician sub - specialty groups. These

physicians are able to arrive at the hospital

within 30 minutes or less.

• Hire more than 30 addition al full - time

nurses to meet the staffing requirements in

the Trauma Standards. These hires have

allowed Northside to provide a continuous,

in - house presence of operating room nurses

and technicians.

• Hire specialized administrative staff for

the traum a program, including Doreen Gilligan

(Director of Trauma Services), a trauma

registrar, and a performance improvement

coordinator dedicated solely to ensuring

NorthsideÓs trauma patients receive high

quality care. Once NorthsideÓs trauma

program becomes o perational, Northside plans

to hire a second trauma performance

improvement coordinator.

14. Between January and March 2017, Northside provided over

5,000 hours of trauma training to its staff, including the CEO

and CFO of the hospital. The major focu s of this training was

the Trauma Nursing Core Course (ÐTNCCÑ) for nursing staff, which

is the foundation of emergency nursing education and ensures that

the nursing staff can provide high - quality care for the most

severely injured patients. The hospital implemented nursing

education requirements which exceeded the Trauma Standards. Some

of this training included actual operational practice using

simulations and mock trauma drills.

15. Northside implemented over 200 new facility policies

related to tra uma during this period. Northside subsequently

trained its staff on these new programs.

16. Northside made all of these investments prior to

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

applic ation to the Department.

C. Northside Timely Assembled and Submitted Its Trauma

Center Application and Deficiency Response to the Department

17. NorthsideÓs application was prepared by a core team

whose mission was to ensure that the application fully complied

with the Trauma Standards. Th e key members of that team were

Peter Kennedy, chief operating officer ; Doreen Gilligan, d irector

of Trauma Services; Dr. Erik Barquist, interim trauma medical

director ; and Angie Chisolm , assistant vice president of Trauma

Services for HCA East and West F lorida Divisions. The final

application submitted to the Department encompassed over 10,000

pages of information. Because the application was too voluminous

for any one person to prepare alone, each of the team members

played an important role in ensurin g the application addressed

each Trauma Standard. Preparation of the application involved

thousands of staff hours and required close cooperation with the

physicians, staff, and community members.

18. Northside timely submitted its trauma center

applic ation (ÐNorthside ApplicationÑ) to the Department on

March 31, 2017 .

19. After receiving the Northside A pplication, the

Department arranged for it to be reviewed by two outside experts,

Dr. Lawrence Reed and Nurse Susan Cox. Both Dr. Reed and Nurse

Cox have reviewed trauma applications on behalf of the Department

in the past.

20. On April 14, 2017, the Department sent Northside a

letter notifying it of the deficiencies that Dr. Reed and

Nurse Cox had identified (the ÐDeficiency NoticeÑ). The

Departme nt provided a checklist ( Department of Health Initial

Provisional Review Checklist for Northside, Apr il 5, 2017 ,

hereafter referred to as the ÐInitial ChecklistÑ ) based on the

Trauma Standards with boxes marked ÐYesÑ or ÐNoÑ to indicate

whether the reviewe rs found evidence to demonstrate that each

particular Trauma Standard and subpart w as met. The checklist

also contained written comments from the reviewers for subparts

which were checked ÐNo. Ñ Of the more than 350 subparts that make

up the Trauma Standa rds, the reviewers only identified 35 about

which they had concerns or additional questions. Most of the

comments from the reviewers consisted of simple requests for

clarification. In some cases, the reviewers asked for

information that Northside had alr eady submitted with the initial

application on March 31, 2017.

21. Northside timely responded to each deficiency

identified by the Department on April 21, 2017 (the ÐDeficiency

ResponseÑ), five business days after receipt of the Deficiency

Notice. The Deficiency Response was prepared by the same team

that prepared the initial application. Much like the initial

application, the teamÓs role was to ensure that each concern was

addressed and that the application demonstrated that the hospital

met the Traum a Standards. The Deficiency Response included

78 supporting exhibits consisting of hundreds of pages.

22. The Deficiency Response was divided in two sections:

(1) a narrative table; and (2) supporting exhibits to the

narrative table. In the narrative table, Northside addressed

each Trauma Standard subpart identified in the Initial Checklist

as an area not met or an area of concern. The table was

organized into three columns: the first reciting the subpart

language; the second copying the reviewer co ncern from the

Initial Checklist; and the third detailing NorthsideÓs narrative

response or explanation to each comment.

23. The Deficiency Response was also reviewed by Dr. Reed

and Nurse Cox. These reviewers determined that Northside

addressed and co rrected the vast majority of deficiencies

identified in the initial review. Only three Trauma Standard

subparts were identified as remaining areas of concern:

Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard

XVIII(G). Each of these issues was i dentified by Dr. Reed.

Neither Dr. Reed nor Nurse Cox recommended to the Department that

NorthsideÓs application be denied.

24. On May 1, 2017, the Department informed Northside that

its application was not in compliance with the applicable Trauma

Stand ards and would be denied (ÐDenial LetterÑ). The Denial

Letter did not identify which (if any) of the Standards that the

Department believed that Northside had not met. Instead, the

Denial Letter attached a checklist indicating concerns with only

three su bparts. The Department now takes the position that

NorthsideÓs application is deficient because it did not satisfy

Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard

XVIII(G), although the Department has not stated whether each one

of these Standar ds, standing alone, would have (in its view)

warranted denial of the application.

25. The Denial Letter did not afford Northside any

opportunity to address the potential issues identified with

respect to the three Standards. Instead, it informed Norths ide

that its only options were to seek an administrative hearing

challenging the DepartmentÓs denial or to submit a trauma center

application the following year. Northside therefore did not

submit any additional documentation to the Department.

D. NorthsideÓs Evidence Establishes That It Satisfied Each

of the Three Standards the Department Claimed Were Deficient

i. Standard V(B)(3)(a)(1)

26. Standard V addresses the facility requirements relating

to the emergency department. It includes requir ements for a

trauma resuscitation area, helipad, emergency physicians, support

staff, and trauma flow sheet, among other criteria. This

Standard also details the required qualifications for emergency

room physicians who may provide care to trauma patients .

Emergency room physicians must be board certified in emergency

medicine or meet stringent alternate criteria demonstrating their

qualifications.

27. There are two ways to meet the alternate criteria. The

first includes attestation from the trauma med ical director that

there is a critical need for the physician , completion of an

accredited residency training program , documentation that the

physician participated in the Advanced Trauma Life Support

(Ð ATLS Ñ) program , 48 hours of trauma - related continuing medical

education in the past three years , evidence that the physician

attends at least 50 percent of the trauma performance improvement

meetings , evidence of membership or attendance at regional or

national trauma meetings during the past three years , an d

attestation by the trauma medical director and emergency

department director that the physician compares favorably with

other physicians on the trauma call schedule. The second way for

a physician to meet the alternate criteria is by providing

evidence of board certification in a primary care specialty and

attestation by the emergency department director that the

physician has worked as a full - time emergency physician for three

of the last five years.

28. As part of its initial application, Northside p rovided

the Department with staffing schedules for March, April, and

May 2017 , which documented the physicians on staff in the

emergency room during those months and the shift times they would

cover. Northside also submitted substantial evidence regarding

the qualifications of each of these emergency room physicians.

One of these emergency room physicians was Dr. Abraham Wilks. At

the time it submitted its initial application, Northside believed

Dr. Wilks met both paths of the alternate criteria. In

pre paration for the initial application, Dr. Wilks, working with

Northside, went to extraordinary lengths to secure the seven

required components under the first alternate criteria path.

Northside also provided evidence that Dr. Wilks qualified under

the sec ond alternate criteria path since he was board eligible

for family medicine and had been working as an emergency

physician for the past five years. The staffing schedules

submitted with NorthsideÓs application on March 31, 2017 , showed

that Dr. Wilks was scheduled to be the sole physician provider

for short periods of time on a limited number of days.

29. During his review of the initial application, Dr. Reed

concluded that Dr. Wilks did not meet either of the alternative

criteria because he did not com plete an emergency medicine

residency and was no longer board - certified in family medicine.

Because Dr. Wilks did not meet these qualification requirements

in Standard V(B)(3) as an emergency department physician, he

could not be the sole physician provid er in the emergency

department.

30. After receiving the Deficiency Notice and Initial

Checklist, Northside immediately took steps to address Dr. ReedÓs

comments. NorthsideÓs leadership worked with the director of the

emergency department to ensure that Dr. Wilks would not be the

sole physician provider in the emergency room. After April 18,

2017, Dr. Wilks never served as the sole physician provider in

the emergency room. The emergency department physician staffing

schedule for April and May 2017 , was updated to reflect these

changes ( ÐUpdated Staffing ScheduleÑ ) . The other physicians

listed on the staffing schedule were appropriately qualified, and

the staffing schedule provided for appropriate physician

coverage.

31. In its Deficiency Response, No rthside noted these

operational changes regarding Dr. Wilks and specifically

addressed Dr. ReedÓs concerns. Northside informed the Department

that ÐDr. Wilks has been removed from the ED Trauma assignment

and will never be the single provider in the ED, e ffective

immediately.Ñ Dr. Reed agreed at his deposition that if

Dr. Wilks were removed from the staffing schedule, Northside

would be in compliance with Standard V(B)(3)(a)(1).

32. The Deficiency Response also referenced a related

exhibit , which Norths ide intended to be the amended staffing

schedule. However, due to a clerical error, NorthsideÓs

Deficiency Response included the old staffing schedule from the

initial application, which incorrectly showed Dr. Wilks as the

sole provider for limited period s. The old staffing schedule

contradicted the narrative explanation of NorthsideÓs operational

changes included in the Deficiency Response and was clearly

submitted in error. Dr. Reed himself noted this contradiction:

The response document also states t hat ÐDr. Wilks has been

removed from the ED Trauma assignment and will never be the

single provider in the ED, effective immediately. However, it

appears that Dr. Wilks is the only ED physician on site from

6a - 8a on May 4, May 7, May 20, and May 21. Ple ase clarify this

contradiction.Ñ

33. The Department did not follow Dr. ReedÓs

recommendation. It never contacted Northside to ask why the

staffing schedule listed Dr. Wilks as the sole provider for

limited periods of time when NorthsideÓs submission e xpressly

stated that Dr. Wilks would no longer be the sole provider. Had

the Department contacted Northside, it would have learned that

the ÐoldÑ staffing schedule had been submitted rather than the

current and correct staffing schedule, i.e., the one tha t did not

include Dr. Wilks as the sole provider.

34. Thus, there can be no dispute that, as of April 18,

2017, ( 1 ) NorthsideÓs operative emergency department staffing

schedule was updated to reflect that Dr. Wilks would never be the

sole provider; and ( 2 ) at all times, NorthsideÓs emergency

department was fully staffed by properly qualified emergency

department physicians. Under these circumstances, the Department

erred in taking the position that Northside did not satisfy

Standard V(B)(3)(a)(1) simply because it mistakenly submitted an

outdated staffing schedule to the Department in conjunction with

its clear narrative explanation.

ii. Standard V(B)(3)(d)

35. The physician qualifications included in Standard V

also require that each physician mainta in a current ATLS provider

certification. The ATLS certification is required only of

emergency department physicians and trauma surgeons because these

are the physicians who treat trauma patients when they first

arrive at the trauma center. One of the em ergency department

physicians included in NorthsideÓs application is Dr. Joseph

Nelson. Dr. Nelson also serves as the emergency department Ós

pre - hospital trauma care expert for the Committee of Emergency

Preparedness and Readiness, meaning that he is the stateÓs expert

on issues relating to the emergency care provided on - site before

patients are brought to the hospital. NorthsideÓs application

included an extensive set of documents that established

Dr. NelsonÓs credentials, including the following: a com pilation

of Dr. NelsonÓs certifications, proof of his osteopathic board

certification, his Florida Department of Health medical license,

his physician profile with the American Medical Association,

proof of his continuing medical education hours, his lette r of

privileges at Northside, and his most recent ATLS certificate.

Dr. NelsonÓs ATLS certificate included a letter from ATLS that

recognized Dr. Nelson for high scores on his written and

practical tests and recommended that he apply to be an ATLS

course i nstructor, an honor that is accorded only to doctors who

attain the best performances at the training course.

36. At the time Northside submitted its initial

application, Dr. NelsonÓs ATLS certification had recently expired

and he was planning to take a course to renew his certification.

Dr. Nelson was aware of the expiration before the submission and

made a concerted effort to complete the course in advance by

registering for a course in February 2017. However, the course

Dr. Nelson was originally sched uled to take in February 2017 was

cancelled due to a snowstorm. Because ATLS courses are in high

demand and often full, Dr. Nelson was not able to immediately

reschedule for a course in his region. After working with

Northside and Angie Chisolm, he regis tered for another course to

be held in Tallahassee on April 23, 2017. Northside included

proof of his course registration with its initial application.

37. In the Deficiency Notice and Initial Checklist provided

by the Department, Dr. Reed noted that D r. NelsonÓs ATLS

certificate had expired and acknowledged that he was scheduled to

take his ATLS course on April 23, 2017. Dr. Reed asked the

hospital to Ðprovide evidence of successful completion of the

ATLS course he is scheduled to take on 4/23/2017.Ñ Dr. Reed did

not ask the hospital to submit any further documentation before

t he certificate arrived.

38. On multiple occasions, Northside sought clarification

from the Department regarding how it should establish that

Dr. Nelson was in compliance with Standard V(B)(3)(d). Before

Northside submitted its initial application to the Department, it

informed the Department that Dr. Nelson was registered for and

planned to take the ATLS course on April 23, 2017 , and asked for

guidance regarding how it should establish that Dr. Nelson was in

compliance with Standard V(B)(3)(d). The Department advised

Northside to provide proof of registration with its initial

application, and Northside did just that. Northside returned to

the Department for guidance after re ceiving the Deficiency Notice

and reminded the Department that Dr. Nelson planned to complete

the ATLS course on April 23 , 2017 . Once again, the Department

directed Northside to submit documentation of course registration

and to later submit Dr. NelsonÓs updated ATLS cert ificate when

available.

39. In its Deficiency Response, Northside reiterated that

Dr. Nelson was registered for and scheduled to complete the ATLS

certification course on April 23 , 2017 , just two days later.

Based on the DepartmentÓs g uidance, Northside also included

Dr. NelsonÓs ATLS course registration, which demonstrated that he

was scheduled to take the course in Tallahassee on April 23,

2017, as well as email communication from the course host

confirming that Dr. Nelson paid for an d secured a seat at that

course. Northside further indicated that it would provide

evidence to the Department of Dr. NelsonÓs ATLS recertification

following successful completion of the course. Northside also

informed the Department that if Dr. Nelson di d not attend and

pass the course on April 23, 2017, he would be removed from the

call schedule effective May 1, 2017.

40. Dr. Nelson successfully completed the course on

April 23, 2017 , and thus satisfied his ATLS requirement that day.

Northside immediat ely confirmed with the ATLS coordinator that

Dr. Nelson had passed the course and concluded that he was in

compliance with Standard V(B)(3)(d).

41. Dr. ReedÓs review of NorthsideÓs Deficiency Response

stated: ÐUpon receipt of a copy of Dr. NelsonÓs upda ted ATLS

certification, compliance with this standard will have been met.Ñ

Northside subsequently received Dr. NelsonÓs updated ATLS

certification. It did not arrive at Northside until after May 1 ,

2017, due to normal delays in processing by the American College

of Surgeons. At hearing, Northside presented Dr. NelsonÓs

updated ATLS certification reflecting his successful completion

on April 23, 2017.

42. In sum, Dr. Nelson was ATLS - certified as of April 23,

2017, which is before the DepartmentÓs May 1, 2017 , deadline.

Northside also provided a litany of information to the Department

with its initial application and Deficiency Response detailing

Dr. NelsonÓs efforts to secure his ATLS certification. Northside

therefore satisfied Standard V(B)(3)(d).

ii i. Standard XVIII(G)

43. Standard XVIII addresses quality management, which is

one of the core requirements of a trauma program. Since the time

that Northside began building its trauma program, it has

prioritized quality management. Northside began de veloping its

trauma quality management program in early December 2016. As

part of this effort, Northside developed a trauma quality

management plan, which is essential for any quality management

program. Following the beginning of limited trauma - related

operations on February 16, 2017, Northside held its first peer

review meeting on February 22, 2017 , to discuss patient treatment

issues. Dr. Barquist attended these meetings and minutes were

kept. Northside also began to hold nursing and ancillary staff

meetings, known as trauma quality management (ÐTQMÑ) meetings,

during this time. The directors of each department at the

hospital attended these meetings, as well as the chief operating

officer and chief financial officer . The objective of these

meetings was to operationalize the more than 200 trauma - specific

policies and procedures put in place during the trauma program

development. Any issues identified in these meetings were

addressed immediately with the whole trauma staff to ensure

program - wide comp liance.

44. To demonstrate compliance with this Standard, Northside

submitted nearly 400 pages of documents with its initial

application. These included NorthsideÓs Trauma Performance

Improvement and Patient Safety Plan, policies and procedures, and

pe er review minutes.

45. As part of its application, Northside submitted the

minutes of its peer review meetings at which quality management

issues were discussed. Even though Northside was not receiving

trauma alert patients from local emergency medical services

(something it could not do prior to becoming a provisionally

approved trauma center), it routinely conducted quality

management activities with regard to patients in the hospital

with trauma injuries. With this patient population, Northside

empl oyed its trauma improvement processes to identify areas in

which there was room for improvement in care, and to determine

how education, training , and equipment could be enhanced to

improve care for similar patients in the future.

46. In his review of S tandard XVIII(F), Dr. Reed affirmed

that Northside held quality management meetings at which the

following issues were discussed:

• The subject matter discussed, including an

analysis of all issues related to each case

referred by the trauma service medi cal

director to the trauma program manager, cases

involving morbidity or mortality determining

whether they were disease related or provider

related and the preventability, and cases

with other quality of care concerns.

• A summary of cases with variatio ns not

referred to the committee.

• A description of committee discussion of

cases not requiring action, with an

explanation or each decision.

• Any action taken to resolve problems or

improve patient care and outcomes.

• Evidence that the committee evaluated the

effectiveness of any action taken to resolve

programs or improve patient care and

outcomes.

47. Northside also submitted documents addressing Standard

XVIII(G). This subpart addresses a quarterly report prepared by

the trauma quality mana gement committee which must be submitted

to the Department by approved trauma centers 15 days after the

end of each quarter. If approved as a provisional trauma center,

Northside would have submitted its first quality report to the

Department on August 15 , 2017. The report, which is only

submitted by provisionally approved and verified trauma centers,

must include information related to patient case reviews, select

clinical indicators, and patient complications. The report is

only made available by the D epartment to approved trauma centers;

it is not provided to applicants. The report form is not

referenced in any Department rule, the Trauma Standards, or the

DepartmentÓs website. However, to establish that Northside was

prepared to provide the required report once it received

provisional approval, Northside obtained a copy of the template

from an affiliated operating trauma center and included that

template in its application.

48. Because it was not an approved trauma center, Northside

ultimately sub mitted a detailed template of the quality report to

be submitted following approval as required. The detailed

template included blank fields with the quality indicators

selected by the Department and the hospital, benchmarking data

points, patient complic ations, and case review information. The

fields in the report regarding patient complications and case

review information can be taken directly from the peer review

minutes, which Northside submitted with its initial application

and were located directly in front of its detailed template.

49. In his review of NorthsideÓs initial application,

Dr. Reed concluded that Northside provided much of the required

evidence , demonstrating Ðan active and effective trauma quality

improvement programÑ and met the va st majority of subparts in

this Standard. However, regarding Standard XVIII(G), Dr. Reed

identified deficiencies on the basis that Ð[a] template of a

report was submitted, but there were no cases recorded.Ñ

Dr. Reed confirmed that he reviewed the peer re view minutes

Northside submitted with its application.

50. In response to Dr. ReedÓs comment, Northside submitted

updated templates with additional information. The quality

indicator and benchmarking templates were populated with data

from its trauma re gistry regarding the patients with traumatic

injuries that the hospital had treated since February 16, 2017.

In addition to these documents , which specifically addressed

Standard XVIII(G), Northside also submitted more peer review

minutes from subsequent meetings since the initial application,

which were included directly in front of Exhibit 75.

51. Dr. Reed ultimately concluded that Northside had not

demonstrated compliance with Standard XVIII(G)(1) - (3). That

conclusion, however, is unsupportable by th e evidence at hearing .

Dr. Reed acknowledged that NorthsideÓs Deficiency Response

provided the Ðquarterly data regarding the state required

indicators and the additional institution - specific indicators.Ñ

The only reason he believed that NorthsideÓs appli cation remained

deficient was that it did not Ðaddress the individual case

quality review issues required in Standard XVIII.G.1 - 3.Ñ This

conclusion is undermined by Dr. ReedÓs recognition - Î as reflected

in his review of Standard XVIII(F) - Î that Northside wa s conducting

case quality reviews. In his deposition, Dr. Reed agree d that

NorthsideÓs Deficiency Response Ðdid include information

regarding the number of cases and indicators and that sort of

thing.Ñ Indeed, Dr. ReedÓs true concern appears to have been

that NorthsideÓs Ðnumbers,Ñ i.e., the number of patient cases

reviewed by Northside, were Ðstill kind of thin.Ñ But Dr. Reed

himself recognized that prior to the time that a trauma center

application is provisionally approved and the trauma program

begin s treating trauma alert patients, a trauma program is

unlikely to have a large number of patient cases to review.

52. The DepartmentÓs view that Northside did not satisfy

Standard XVIII(G) is not supported by the evidence. The section

of the quality repo rt addressing individual case reviews is

simply a summary of the information contained in the hospitalÓs

peer review minutes - Î and Northside conducted the required peer

review meetings. Northside demonstrated at hearing that it was

capable of preparing a t able summarizing its peer review cases

and the corrective action taken for each case. All the

information contained in the completed table was taken verbatim

from the peer review minutes that Northside submitted with its

initial application and Deficiency Response. If approved,

Northside was prepared to submit the quarterly report as required

on August 15 , 2017 . Thus, at worst, Northside did not copy and

paste information from one place to another. To the extent

possible, Northside complied with this St andard.

53. The DepartmentÓs review of an earlier trauma center

application confirms that the Department should not have

determined that Northside did not satisfy Standard XVIII(G). In

April 2016, the Department approved an application to operate as

a p rovisional Level II trauma center submitted by Jackson South

Community Hospital. As part of its approval, the Department --

based on a review by Dr. Reed -- determined that Jackson South met

each of the requirements in Standard XVIII(G). However, Jackson

Sou th only submitted hospital policies , promising to prepare and

submit the required quality report if approved. Jackson South

did not submit any quality report or even a template of such a

report. Despite submitting far less evidence demonstrating

complian ce, Dr. Reed did not note any deficiencies for this

Standard with regard to Jackson SouthÓs application . T he

Department ultimately approved the application. Dr. Reed

confirmed that NorthsideÓs quality management program was

significantly more developed t han the one for Jackson South

Community Hospital that Dr. Reed himself had recommended be

approv ed only two years earlier. At hearing, Chief Dick could

not explain the inconsistency.

54. In sum, the Department erred in concluding that

Northside had not satisfied Standard XVIII(G) because Northside

had an active and effective quality management program that

involved thorough case reviews and Northside demonstrated that it

was capable of submitting the required forms once its program was

approved and its fully operational.

E. Contemporaneous Emails Demonstrate T hat the Department

Denied NorthsideÓs Application for Reasons Having Nothing to D o

with the Merits of NorthsideÓs Program

55. The DepartmentÓs decision to deny NorthsideÓs

application was not made in a vacuum. On April 28, 2017 - Î only

two days before the Department sent Northside the Denial Letter - Î

a circuit judge in Leon County entered an order (ÐInjunction

OrderÑ) temporarily enjoining Northside from operating as a

trauma center and enjo ining the Department from permitting

Northside to operate as a provisional trauma center. This

injunction was based exclusively on issues of administrative law

and did not in any manner address the merits of NorthsideÓs

application. In fact, the Departme nt strongly opposed the

injunction.

56. The injunction did not prevent the Department from

approving NorthsideÓs application. The DepartmentÓs internal

correspondence demonstrates that the injunction led the

Department to deny NorthsideÓs application, presumably because it

was concerned about the ramifications of provisionally approving

NorthsideÓs application while the injunction was pending and

Northside could not begin trauma center operations. On April 28,

2017, just hours before the I njunction O rd er was issued, Kate

Kocevar, head of the DepartmentÓs Trauma Section, emailed

Dr. ReedÓs final conclusions to Chief Dick and informed her that

in her opinion ÐNorthside Hospital appears to have passed the

reviewers [ sic ] survey and will be granted Provisio nal status.Ñ

Chief Dick confirmed at hearing that her initial impression based

on Ms. KocevarÓs email was that Northside passed the survey.

Later that day, Chief Dick received the injunction order and

immediately emailed other Department personnel , Ð[l]o oks like the

letter to Northside will not be going out on Monday as originally

written.Ñ Three days later, on May 1, 2017, the Department sent

Northside the Denial Letter, notifying the hospital that its

application had not met the Trauma Standards and wo uld be denied.

57. Given the looming injunction order, the DepartmentÓs

internal correspondence, and the fact that the three alleged

deficiencies are minor, at the very most, the DepartmentÓs

decision to deny the application was apparently motivated by an

administrative decision that it should not approve an application

while the injunction was in place - Î not by any genuine concerns

regarding the merits of NorthsideÓs program.

F. Northside Has Expended , and Continues to Expend ,

Millions of Dollars to Maintain an Operational Trauma Program

58. Northside has continued to maintain its trauma service

capability, including retaining physicians and staff, while

proceeding with its challenge of the DepartmentÓs preliminary

denial. As part of its readine ss efforts, NorthsideÓs quality

management program remains in place, meaning that Northside is

still holding peer review and quality i mprovement meetings.

Maintaining a continued state of readiness to initiate operations

as a provisional Level II trauma c enter will cost Northside

approximately $13 million this year.

CONCLUSIONS OF LAW

59 . 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 395.40 25(7).

60. Northside has standing to participate in this

administrative hearing as a party substantially affected by the

DepartmentÓs denial of the Northside Application, pursuant to

section 395.4025(7) and r ule 64J - 2.1012(2).

61. Bayfront petitioned to intervene as a party whose

substantial interests would be affected by the hearing pursuant

to sections 120.569, 120.57(1), and 395.4025(7) , and Florida

Administrative Code C hapters 28 - 106 and 64J - 2 .

62 . SJH petitioned to intervene with full - party status

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

chapters 28 - 106 and 64J - 2 .

63 . On June 9, 2017 , the ALJ granted BayfrontÓs petition to

intervene with limitations regarding interjection of issues, and

granted SJHÓs petition with significant restrictions. See Order

Denying BayfrontÓs Motion to Consolidate, Granting BayfrontÓs

Motion for Leave to Intervene with Restrictions, and Granting

St. JosephÓs Petition to Intervene with Limited Status (June 9,

2017).

64 . Northside seeks a determinatio n that the Department

erred when it denied NorthsideÓs provisional Level II trauma

center application.

65 . The standard of review in this proceeding is de novo .

See § 120.57(1)(k), Fla. Stat. The purpose of this de novo

review is to formulate final agenc y action with respect to the

Northside Application. See , e.g. , J.D. v. Fla . DepÓt of Child . &

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

legislature intended a ÒtypicalÓ chapter 120.57 proceeding in

which the purpose is to Ò formulate final a gency action , not to

review action taken earlier and preliminarily.ÓÑ) (emphasis

added).

66 . Under this standard of review, the ALJ stands in the

shoes of the Department. The ALJ evaluates whether the

DepartmentÓs final agency action should be to accept or reject

the Northside Application.

67 . In conducting this de novo review, the ALJ makes his or

her own determination as to whether the Northside Application, as

submitted to the Department, met applicable standards.

6 8 . The ALJ, however, must follow the Trauma s tatute s and

the DepartmentÓs trauma regulations. The ALJ must also defer to

the DepartmentÓs reasonable interpretation of those authorities.

See , e.g. , State Contracting & Eng Ó g Corp. v. DepÓt of Transp. ,

709 So. 2d 607, 610 (Fla. 1st DCA 199 8) (Ðthis policy of

deference to an agency's expertise in interpreting its rules

applies not only to the courts but also to administrative law

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

23 (Fla. 1st DCA 1985) (batching cycle rules gov erning CON

applications are binding on an ALJ). Ð[A]n agencyÓs

interpretation need not be the sole interpretation or even the

most desirable one; it need only be within the range of

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

Hous. Fin. Corp. , Case No. 00 - 4408RU, FO at 44 (Fla. DOAH Feb. 7,

2001).

6 9 . The ALJ owes heightened deference to the DepartmentÓs

interpretation of the standards the applicants must satisfy in

order for the Department to grant provisional trauma center

status. S uch 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 DepartmentÓs unique technical and medical

expertise. See, e. g. , Rizov v. State, Bd. of Prof Ól EngÓrs , 979

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

more expertise in a specific area they are charged with

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

courts benefit from the agen cy's technical and/or practical

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

DepÓt of Health , Case No. 14 - 1022RP, FO at 121 (Fla. DOAH

June 20, 2014) (deferring to the DepartmentÓs determinations with

respect to the proposed trauma center allocation rule because it

Ðwas the product of thoughtful consideration by the DepartmentÓs

expertsÑ).

70 . In a hearing held pursuant to section 120.57(1) ,

Northside bears the ultimate burden of persuasion, by a

preponderance of the evidence, of entitlem ent to operate as a

provisional trauma center. See, e.g. , Fla. DepÓt of Trans p . v.

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

ÐfundamentalÑ that an applicant Ðcarries the ultimate burden of

persuasion of entitlement through all proceedings , of whatever

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

agencyÑ).

71 . In order to prevail, Northside must establish that the

Northside Application 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.

72 . The Department, consistent with its mission to

Ðpromote, protect and improve the health of all people in the

stateÑ and to ensure the provision of optimal trauma care must be

able to conclude from the face of the application that

NorthsideÓs 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 provisiona l 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.

73 . In this de novo hearing, Northside can attempt to meet

its burden by making arguments as to why the evidence that it

provided to the Department, properly understood, requires

approval of the Northside Application.

7 4 . Bayfront and the Department argue that Northside

impermissibly seeks to expand the scope of the ALJÓs review to

include: (1) evidence which was not submitted to the Department

within the prescribed time period; and (2) explanations of

evidence allegedly submitted in error. These categories of

evidence cannot be relied upon , they say, to establish that the

Northside Application met applicable standards within the

prescribed time period.

7 5 . Northside , they argue, cannot rely on evidence which

was not submitted to the Department within the prescribed time

period. In their eyes, the Ðprescribed time periodÑ is either

April 21 (B ayfront) or April 22 (the Department) 2017, the date

of the DepartmentÓs finding that the application was deficient.

They submit that t he DepartmentÓs decision about whether to grant

or reject an application must be based solely on the applicantÓs

submis sion to the Department. See Fla. Admin. Code

R. 64J - 2.012(e) - (f) (Ð[E]ach hospital whose application the

department finds to be unacceptable or deficient . . . will be

notified in writing of deficiencies. . . . Failure to provide

the requested informati on, or failure to successfully address the

deficiencies identified by the department, shall result in the

denial of the hospitalÓs application.Ñ ). They conclude that t he

DepartmentÓs rules and practice neither call for, nor authorize,

the Department to co nsider evidence submitted by a trauma center

applicant after the applicable deadlines.

7 6 . However, since the principal requirement of approval as

a provisional trauma center is that the applicant demonstrates it

meets the criteria for approval by May 1 o f the year in which it

applies, the ALJ should be entitled to consider any evidence of

compliance that existed, in this case, on May 1, 2017. To hold

otherwise transforms this case from a de novo proceeding to an

appellate or quasi - appellate proceeding wh ere the ALJ is

restricted to reviewing and deferring to the DepartmentÓs

evaluation of the decision of whether to approve the application

at a point in time fixed at the DepartmentÓs discretion, here

April 22, 2017.

7 7 . The Department has not offered a reasonable explanation

for its position that this ALJ should ignore evidence that

Northside was compliant on May 1 , 2017 , merely because the

evidence was not reflected on the application or response to

deficiencies submitted to the Department. The ALJÓs r eview

should not be constrained to a paper review of the application

completed by Northside , as well as its response to deficiencies

found by the Department. While the undersigned does not concur

with Judge Van LaninghamÓs O rder in the Jackson South case that

the compliance period should be extended to the date of the

hearing and that any amendments, updates , or supplements to the

application may be provided even at hearing , that issue need not

be addressed here. Northside was compliant with the three

def iciencies that remained on April 21 or 22, 2017, by May 1,

2017. In this case, the deficiencies were relatively minor, and

Northside addressed each fully to the satisfaction of this ALJ.

7 8 . The issue with Dr. Wilks not being properly certified

to be t he sole physician provider in the emergency room was

remedied by Northside amending its staffing schedules to have

Dr. Wilks Ðremoved from the ED trauma assignment and [he] will

never be the single provider in the ED, effective immediately [as

of April 18, 2017]. Ñ Dr. R eed testified that this action put

Northside in compliance with Standard V(B)(3)(a)1. The issue of

the purported amended staffing schedule removing Dr. Wilks from

being the sole physician provider in the emergency department is

a non - issue. NorthsideÓs key individuals involved with

establishing the trauma center testified, under oath, that the

old staffing schedule was inadvertently provided a second time to

the Department rather than the updated one. The credible

evidence at hearing was t hat Dr. Wilks had been removed from the

staffing schedule by April 18, 2017, well before the May 1 , 2017,

deadline. This clerical error is absolved as de minimus and

should not be a reason for denying NorthsideÓs application , in

light of the proven fact t hat Dr. Wilks had been removed .

Additionally, when the Department saw that Dr. Wilks remained on

the schedule, it had the opportunity to question the applicant as

to its intention and the discrepancy between the narrative in the

application and the schedu le submitted in error , yet chose not to

do so. The testimony was unequivocal that Northside would have

corrected the schedule had it been pointed out by the Department.

79 . Similarly, Northside demonstrated that it met Standard

V(B)(3)(d) which requires that each physician in the trauma

center maintain a current ATLS provider certification. The

explanation given for Dr. NelsonÓs failure to have a certificate

issued by May 1, 2017, even though he had completed the

recertification course, is acceptable. T he fact that credible

proof was given to the Department that Dr. Nelson had

successfully completed the course before that date is sufficient.

No evidence was presented to refute the claim that he had

successfully completed the course. In fact, the testim ony

offered was along the lines of, Ðfor something as important as a

provisional approval of a trauma center, we would have made sure

Dr. Nelson did not wait until the last minute to take the

certification course.Ñ This does not amount to proof he had not

completed the course; only that, in the eyes of a Department

witness, the more prudent course of action would have been to

take the course on an earlier date. The explanation of the

course he intended to attend in February being canceled due to a

snowsto rm and the fact that he successfully completed the course

in April 2017, are sufficient to show compliance with this

standard.

80 . Finally, Northside proved that it has been committed to

quality management, one of the core requirements of a trauma

pro gram, since it began the process of initiating a trauma center

program. Chief DickÓs testimony showed that t he Department

determined that Jackson South, in a similar circumstance to this,

had satisfied Standard XVIII(G) , while Northside purportedly did

no t, notwithstanding that Northside had a far more developed

quality management program and submitted more detailed

information regarding the periodic reports that it would begin

filing once it received provisional approval. The purported

requirement that q uality reports, or a mock - up of such reports,

be given prior to the initiation of service as a provisional

trauma center, makes little sense. Dr. Reed confirmed that

NorthsideÓs quality assurance program was more advanced than

Jackson SouthÓs at this stag e of review and the Department should

consistently apply this standard to applicants for provisional

status. No credible evidence was provided by the Department or

Bayfront that Northside would not, as it testified, provide the

first of the required quart erly quality assurance reports by

August 15, 2017, after the initiation of the service on May 1,

2017.

81 . The Trauma s tatute s and the DepartmentÓs r ules require

that a provisional trauma center application must establish full

compliance with each and eve ry one of the Critical Elements. The

Trauma s tatutes state that an applicant must Ðmeet all

requirementsÑ mandated for the Ðcritical review.Ñ The

DepartmentÓs regulations similarly require ÐcomplianceÑ without

qualification, Ðwith the revised standards Ñ for provisional

status. They also explicitly state that Ðcompleted applications

for p rovisional trauma center status that do not demonstrate full

compliance with these standards shall be denied .Ñ (emphasis

added) . Fla. Admin. Code R. 64J - 2.011(1).

82 . NorthsideÓs application and the reaso na ble explanations

given at hearing, d emonstrate d full compliance with the

DepartmentÓs r ules requiring Northside to demonstrate that it had

met the C ritical E lements required for operation as a trauma

center as of May 1, 2017. Full compliance with the C ritical

E lements is required for provisional approval.

83 . The DepartmentÓs position that Petitioner cannot excuse

compliance with one or more of the Critical Elements on the basis

of a Ðsubstantial complianceÑ theory is a reasonable

interpretation of the Trauma s tatutes and the DepartmentÓs rules.

The DepartmentÓs position is rooted in its unique technical and

medical expertise regarding the standards that a trauma center

must satisfy in order to provide appropriate c are to all trauma

patients. The ALJ , therefore , owes deference to the DepartmentÓs

position that a provisional trauma center application can be

approved only if it establishes compliance with all of the

Critical Elements.

8 4 . For the reasons detailed abo ve, Northside established

compliance with all of the Critical Elements as defined by the

DepartmentÓs statute and rules . To summarize, Northside proved

that Dr. Nelson had received his re - certification as an ATLS

provider prior to the May 1 , 2017, deadlin e ; Dr. Wilks had b een

removed from the emergency department trauma assignment and would

no longer be the single provider in the emergency department

prior to the May 1 , 2017, deadline; and Northside proved that it

has been dedicated to and has been providi ng quality management

since it initiated the building of its trauma program. This case

came down to two ÐflawsÑ in the Northside A pplication, both of

which were explained away by credible evidence at hearing. The

ÐoldÑ schedule that was inadvertently put into the application

was purely a clerical error, not a failure to meet the standard.

The ÐrequirementÑ that quality management meetings were already

being held ( see supra ¶ 46 - 47), was clearly established by the

evidence. A template for quality assuran ce reports , although not

specifically required, was provided in the application. Since

Northside was not yet a provisional trauma center at the time of

the application and its responses to deficiencies, it could not

have submitted actual quality assurance reports. Req uiring a

hospital, prior to receiving provisional status as a trauma

center , to submit actual quality assurance reports is a fiction

not within the DepartmentÓs purview as the trauma application

reviewing agency. Dr. Reed, the DepartmentÓs o wn expert

reviewer, as noted previously, noted that Northside provided much

of the evidence demonstrating Ðan active and effective trauma

quality assurance program ,Ñ finding only that not actual cases

were recorded in the template provided. Northside adeq uately

demonstrated full compliance with this standard as of the May 1 ,

2017, deadline for an applicant that had not yet been granted

provisional status.

8 5 . Finally, should the D epartment prevail in this matter,

Northside would, once again, have to under go the entire review

process, submitting the same application, including the three

areas which were deemed deficient by the Department, but which

were fully explained as having been met by the May 1 , 2017,

deadline . This would result in additional expendi tures , in the

millions of dollars, by Northside and a significant delay to the

opening of its trauma program which it proved it is ready and

able to provide to the residents of TSA 9. Such a harsh result

does not represent prudent health care planning or allocation of

resources when the applicant , Northside, demonstrated that it had

fully complied with all of the C ritical Elements that entitle it

to be provisionally approved as a Level II trauma center. For

all the reasons set forth above, t he D epartment should

provisionally approve NorthsideÓs application to operate a trauma

center.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Department enter a f inal o rder

finding that Northside met its b urden of establishing that its

trauma center application met the applicable standards, and

awarding provisional Level II status to the applicant.

DONE AND ENTERED this 20th day of December , 2017 , 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 20th day of December , 2017 .

ENDNOTE

1/ References to statutes are to Florida Statutes (2017), unless

otherwise noted.

COPIES FURNISHED:

Stephen A. Ecenia, Esquire

Rutledge Ecenia, P.A.

119 South Monroe St reet, Suite 202

Post Office Box 551

Tallahassee, Florida 32302 - 0551

(eServed)

Michael Jovane Williams, Esquire

Prosecution Services Unit

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399

(eServed)

R. Kathleen Brown - Blake, E squire

1520 Killearn Center Boulevard

Tallahassee, Florida 32309

Timothy Bruce Elliott, Esquire

Smith & Associates

3301 Thomasville Road , Suite 201

Tallahassee, Florida 32308

(eServed)

Karen Ann Putnal, Esquire

Moyle Law Firm, P.A.

118 North Gadsden Str eet

Tallahassee, Florida 32301

(eServed)

Gabriel F.V. Warren, Esquire

J. Stephen Menton, Esquire

Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202

Post Office Box 551

Tallahassee, Florida 32302 - 0551

(eServed)

Geoffrey D. Smith, Esquire

Corinne T . Porcher, Esquire

Smith & Associates

3301 Thomasville Road, Suite 201

Tallahassee, Florida 32308

(eServed)

Jon C. Moyle, Esquire

Moyle Law Firm, P.A.

118 North Gadsden Street

Tallahassee, Florida 32301

(eServed)

Shannon Revels, Agency Clerk

Departmen t of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1703

(eServed)

Nichole C. Geary, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

(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)

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions 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.