14-001022RP Shands Teaching Hospital And Clinics, Inc., D/B/A Uf Health Shands Hospital vs. Department Of Health Status: Closed DOAH Final Order on Friday, June 20, 2014.

Summary: The Proposed Rule is not an invalid exercise of the agency's delegated legislative authority.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

SHANDS TEACHING HOSPITAL AND

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

SHANDS HOSPITAL,

Petitioner,

vs. Case No. 14 - 1022RP

DEPARTMENT OF HEALTH,

Respondent,

and

OSCEOLA REGIONAL HOSPITAL, INC.,

d/b/a OSCEOLA REGIONA L MEDICAL

CENTER,

Intervenor.

_______________________________/

THE PUBLIC HEALTH TRUST OF

MIAMI - DADE COUNTY,

Petitioner,

vs. Case No. 14 - 1027RP

DEPARTMENT OF HEALTH,

Respondent,

and

OSCEOLA REGIONAL HOSPITAL, INC.,

d/b/a OSCEOLA REGIONAL MEDICAL

CENTE R,

Intervenor.

_______________________________/

ST. JOSEPH'S HOSPITAL, INC.,

d/b/a ST. JOSEPH'S HOSPITAL,

Petitioner,

vs. Case No. 14 - 1028RP

DEPARTMENT OF HEALTH,

Respondent,

and

OSCEOLA REGIONAL HOSPITAL, INC.,

d/b/a OSCEOLA REGIONAL MEDICAL

CENTER ,

Intervenor.

_______________________________/

FLORIDA HEALTH SCIENCES CENTER,

INC., d/b/a TAMPA GENERAL

HOSPITAL,

Petitioner,

vs. Case No. 14 - 1034RP

DEPARTMENT OF HEALTH,

Respondent,

and

OSCEOLA REGIONAL HOSPITAL, INC.,

d/b/a OSCEOLA REGIONAL MEDICAL

C ENTER,

Intervenor.

_______________________________/

BAYFRONT HMA MEDICAL CENTER,

LLC, d/b/a BAYFRONT MEDICAL

CENTER,

Petitioner,

vs. Case No. 14 - 1035RP

DEPARTMENT OF HEALTH,

Respondent,

and

OSCEOLA REGIONAL HOSPITAL, INC.,

d/b/a OSCEOLA REGION AL MEDICAL

CENTER,

Intervenor.

_______________________________/

FINAL ORDER

Pursuant to notice, a formal hearing was held in this case

before R. Bruce McKibben , Administrative Law Judge of the

Division of Administrative Hearings, on April 28 - 30 and May 2,

5 - 7 and 22 , 2014 , in Tallahassee, Florida.

APPEARANCES

For Petitioner Shands Teaching Hospital and Clinics, Inc. ,

d/b/a UF Health Shands Hospital :

Seann M. Frazier, Esquire

Jonathan L. Rue, Esquire

Parker, Hudson, Rainer and Dobbs, LLP

215 South Monroe Street, Suite 750

Tallahassee, Florida 32301

For Petitioner The Public Health Trust of Miami - Dade

County:

Eugene Shy, Jr., Esquire

Christopher C. Kokoruda, Esquire

Office of Miami - Dade County, Florida

Jackson Memorial Hospital

1161 NW 12 th Avenue, Wes t Wing, Suite 109

Miami, Florida 33136 - 1005

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

JosephÓs Hospital:

Robert A. Weiss, Esquire

Karen Ann Putnal, Esquire

Moyle Law Firm

118 North Gadsden St reet

Tallahassee, Florida 32301

For Petitioner s, Florida Health Sciences Center, Inc. ,

d/b/a Tampa General Hospital (ÐTampa GeneralÑ) , and Bayfront HMA

Medical Center, LLC , d/b/a Bayfront Medical Center (ÐBayfrontÑ) :

Jeffr ey L. Frehn, Esquire

Christoper Lunny, Esquire

Radey, Thomas, Yon and Clark, P.A.

301 South Bronough Street, Suite 200

Tallahassee, Florida 32301

Fo r Respondent Department of Health :

Caryl Kilinski, Esquire

Chadwick R. Stevens, Esquire

Office of the General Counsel

Department of Health

2585 Merchants Row Boulevard

Tallahassee, Florida 32399 - 1073

For Intervenor Osceola Regional Hosp ital , Inc. , d/b/a

Osceola Regional Medial Center :

Stephen A. Ecenia, Esquire

J. Stephen Menton, Esquire

David Prescott, Esquire

Rutledge, Ecenia and Purnell, P.A.

119 South Monroe Street, Suite 202

Tallahassee, Florida 32302 - 0551

STATEMENT OF THE ISSUE

Whether the Proposed R ule 64J - 2.010 enlarges, modifies or

contravenes the specific provisions of law implemented, or is

arbitrary or capricious, and thus constitutes an invalid

exercise of delegated legislative authority.

PRELIMINARY STATEMENT

On March 6, 2014, Shands Teach ing Hospitals and Clinics ,

Inc. , d/b/a UF Health Shands Hospital ("Shands") filed its

Petition to Determin e Invalidity of Proposed R ule 64J - 2.010

originated by the Florida Department of Health (the ÐDepartmentÑ

or ÐDOHÑ) . The Shands petition was assigned DOAH Case No. 14 -

1022 RP .

On March 7, 201 4, The Public Health Trust of Miami - Dade

County (which governs the Jackson Health System and will be

referred to herein as ÐJackson Memorial Ñ), filed its Petition

for Determination of Invalidity of Proposed Rule. The Jackson

Memorial petition was assigned DOAH Case No. 14 - 1027 RP .

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

(ÐSt. JosephÑ) filed its Petition to Determine Invalidity of

Proposed Rule on Ma rch 7, 2014. St. JosephÓs petition was

assigned DOA H Case No. 14 - 1028 RP .

Also filed on Mar ch 7, 2014, was the Petition for

Determination of Invalidity of DOHÓs Proposed Trauma Center Need

Rule . That petition, filed by Florida Health Sciences Center,

Inc. , d/b/a Tampa General Hospital (ÐTampa GeneralÑ) was

assigned DOAH Case No. 14 - 1034 RP .

T he Petition for Determination of Invalidity of DOHÓs

Proposed Trauma Center Need Rule filed by Bayfron t HMA Medical

Center, LLC , d/b/a Bayfront Medical Center (ÐBayfrontÑ) was

filed on March 7, 2014, and assigned DOAH Case No. 14 - 1035 RP .

A Petition to Int ervene was filed by Osceola Regional

Hospital, Inc. , d/b/a Osceola Regional Medical Center

(ÐOsceolaÑ) on March 11, 2014, in each of the aforementioned

cases. Intervention was granted by Order of the undersigned

dated March 12, 2014. That Order also cons olidated all of the

cases noted above.

This matter was set for hearing on March 31 Î April 4, 10,

and 11, 2014 by agreement of all parties . On March 21, 2014 , a

motion hearing was held during which the parties asked to amend

the proposed final hearing d ates. Upon agreement of the

parties, the final hearing was rescheduled for April 10 - 11, 14,

17, 21 - 22, and 25. An amended Notice of Hearing was issued that

day . A status conference was held via telephone on March 31,

2014. At that time, the parties agr eed to amend the final

hearing schedule once again. On April 1, 2014, an Amended

Notice of Hearing was entered setting the final hearing for

April 28 - 30 and May 2, 5, and 6.

The final hearing was ultimately held on April 28 - 30 and

May 2 , 5 - 7, and 22 , 20 14 , in Tallahassee, Florida.

At final hearing, Shands called five witnesses:

Steve McCoy, Program Administrator for the DepartmentÓs Health

Analysis Bureau; Jennifer Tschetter, Esquire, general counsel

for the Department; Dr. David Ciesla, accepted as a n expert in

trauma systems design and performance; Dr. Fred Moore, accepted

as an expert in acute care surgery and trauma systems

development; and Dr. Joseph Tepas, accepted as an expert in

pediatric surgery, pediatric trauma surgery, and trauma systems

pl anning. ShandsÓ Exhibits 13, 22 - 25, 27, 31 - 35, 52 - 53 , and 64 -

65 were admitted into evidence.

Jackson Memorial called one witness: Dr. Nicholas Namias,

accepted as an expert in trauma surgery and trauma systems.

Jackson Memorial Ós Exhibits 30 - 32, 34 - 35, and 46 were admitted

into evidence.

St. Joseph called no witnesses . St. JosephÓs Exhibits 1

and 2 were admitted into evidence.

Tampa General and Bayfront, collectively, called one

witness : Mark Richardson, accepted as an expert in health care

planning. Tampa General and Bayfront Ós Joint Exhibits 2 - 5, 8 -

10, 12, 23, 35 - 38, 42 - 44, 46 - 47, 57 - 58, as well as pages 175 - 200

and Exhibits 8 - 10 and 12 - 15 of E xhibit 59 , were admitted into

evidence.

The Department called two witnesses: Steve McCoy and

Jennifer Tsche tter. DOHÓs Exhibits 1 - 10, 12 - 28, 30 - 31, and 34

were admitted into evidence.

Osceola called s ix witnesses: Gene Nelson, expert in

health planning, health policy, and trauma center feasibility

analysis; Dr. James Hurst, expert in trauma surgery, trauma

sy stems development, trauma surgery training and education , and

surgical critical care; Michael Heil, expert in trauma system

planning and development, trauma center planning and operation,

hospital administration , and pre - hospital transport; Dr. Eriq

Barqui st, expert in trauma surgery and trauma planning;

Anna Burrus; and Dr. Darwin Ang, expert in epidemiology, trauma

surgery and trauma planning. OsceolaÓs Exhibits 1 - 2, 15, 22 - 32,

38 - 40, 131, 146, 148, 152, 158, 184, 186 - 189, 258, 263, 265,

293, 295, 345, a nd 346 were admitted into evidence.

A transcript of the proceeding was ordered by the parties .

Proposed final orders were to be filed no later than ten days

after the filing of the hearing transcript at DOAH. The

transcript was filed on May 30, 2014. Each party timely filed a

Proposed Final O rder, all of which have been carefully

considered in the preparation of this Final Order.

All citations are to Florida Statutes (201 3 ), unless

otherwise indicated.

FINDINGS OF FACT

The Parties

1. Shands operates an 852 - bed hospital and Level I t rauma

c enter in Gainesville, Alachua County, Florida. Its business

address is 1600 S outhwest Arch er Road, Gainesville, Florida.

Shands treats about 2,500 trauma patients each year. Shands is

located within trauma service area (TSA) 4, which is comprised

of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton,

Lafayette, Levy, Putnam, Suwan n ee, and Union counties.

2. St. JosephÓs is a regional tertiary hospital and has

served the Tampa area for 75 years and has appro ximately 800

licensed acute care beds. St. Joseph offers a broad array of

acute care services including tertiary health care, serves as a

comprehensive regional stroke center, and has been repeatedly

recognized as a Consumers Choice hospital. St. Joseph operates

a Level II t rauma c enter and a Level I pediatric trauma center .

St. Joseph is located in TSA 10, co nsisting of a single county,

Hillsborough.

3. Tampa General is a major tertiary hospital that is

designated by the state as a Level I trauma cen ter. Tampa

General also serves as a teaching hospital for the University of

South Florida, College of Medicine ("USF"). Tampa General is

located in Tampa, Hillsborough County, Florida , TSA 10.

4. Bayfront is a 480 - bed tertiary hospital located in

Pinell as County, Florida . In addition to serving as a teaching

hospital, Bayfront is designated as a Level II trauma center

pursuant to chapter 395, Part II, Florida Statutes. It is

located in TSA 9, comp osed of Pinellas and Pasco counties.

5. The Public Hea lth Trust of Miami - Dade County, is an

entity which governs and operates the Jackson Health System,

including the Ryder Trauma Center at Jackson Memorial Hospital.

It is in TSA 19, consisting of Dade and Monroe counties.

6. The Florida Department of Heal th is the state agency

authorized to verify and regulate trauma centers in the state of

Florida pursuant to chapter 395, Part II, Florida Statutes , and

Florida Administrative Code R ule 64J - 2.001 et seq . The Division

of Emergency Medical Operations, Office of Trauma, oversees the

Department's responsibilities with respect to the statewide

trauma system.

7. Osceola is a licensed acute care general hospital,

located at 700 West Oak Street, Kissimmee, Florida. Osceola

provides a wide array of high quality he alth services to the

residents and visi tors within its service area. It is located

in TSA 8, c onsisting of Lake, Orange, Osceola, Seminole, and

Sumter counties.

T he Florida Trauma System

8. For purposes of organizing a statewide network of

trauma servi ces, the Florida Legislat ure directed the Department

to undertake the implementation of a statewide inclusive trauma

system as funding is available. § 395.40(3), Fla. Stat.

9. The need for a trauma system is premised on the basic

principle that a trauma victim who is timely transported and

triaged to receive specialized trauma care will have a better

clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's

injuries are evaluated and assigned an Injury Severity Score

("ISS"). § 395.4001(5), Fla. Sta t. Patients with ISS scores of

nine or greater are considered trauma patients. § 395.402(1),

Fla. Stat.

10. Trauma experts speak in terms of "a Golden Hour," a

clinical rule of thumb that postulates no more than 60 minutes

should elapse from the occur rence of an injury to the beginning

of definitive treatment. There is, however, no current

consensus on what constitutes the "Golden Hour" for transport

times. A 1990 Department study recommended travel time of 25 - 35

minutes as the outside range for opti mal outcomes. A 1999

Department study favored a goal of 30 minutes transport time by

ground, and a 50 - mile radius by helicopter. By contrast, a 2005

study conducted for the Department used 85 minutes "total

evacuation time" as "acceptable."

11. A traum a center is a hospital that has a collection of

resources and personnel who are charged with taking care of

trauma patients. They are recognized by the community as a

resource for care of severely injured patients. The

International Classification Injury Severity Score (ÐICISSÑ)

methodology, considered with discharged patient data from the

Agency for Health Care Administration database, was used by DOH

to determine severely injured patients. An ICISS score is the

product of the survival risk ratios (i.e. , the probabilities of

survival) calculated for each traumatic injury a single patient

suffers.

12. Level I trauma centers are generally larger and busier

and treat more patients than Level II centers. Level I trauma

centers are required to engage in edu cation and research.

13. Trauma centers are required to have several types of

physician specialists at the ready at all times. For instance,

with respect to surgical services, a Level I trauma center must

have a minimum of five qualified trauma surgeons, assigned to

the trauma service, with at least two trauma surgeons available

to provide primary (in - hospital) and backup trauma coverage 24

hours a day at the trauma center when summoned.

14. Further, in addition to having at least one

neurosurgeon to p rovide in - hospital trauma coverage 24 hours a

day at the trauma center , a Level I provider must also have

surgeons available to arrive promptly at the trauma center in 11

other specialties, including (but not limited to) hand surgery,

oral/maxillofacial su rgery, cardiac surgery, orthopedic surgery,

otorhinolaryngologic surgery and plastic surgery. Level II

trauma centers must comply with similar physician specialist

standards. Little if any credible evidence was presented in the

present case to suggest th at the ability to hire qualifie d

clinical staff, technicians, specialty physicians and other

personnel would be severely impacted if the Proposed Rule is

implemented . Rather, the existing trauma centers lamented the

possibility of reduced case loads which could make it more

difficult to retain proficiency.

Invalidation of Former Rule 64J - 2.010

15. In 1992, the Department of Health and Rehabilitative

Services (HRS), the Department of Health's predecessor,

promulgated Florida Administrative Code Rule 64J - 2. 010, titled

"Apportionment of Trauma Centers within a Trauma Service Area,"

(hereinafter referred to as the Ð Former Rule Ñ ). The Department

of Health assumed administration of the Former Rule in 1996,

when the Legislature split HRS into two new agencies, the

Department of Health and the Department of Children and

Families.

16. The Former Rule regulated the number of trauma centers

that could be established in Florida. The Former Rule di vided

the state into TSAs as set forth in section 395.402(4), and for

each TSA, announced the number of trauma center "positions"

available.

17. In 2004, the Florida Legislature amended section

395.402 to require the Department to complete an assessment of

Florida's trauma system, and to provide a report to the Governor

a nd Legislature no later than February 1, 2005 (the 2005

Assessment). The scope of the assessment was defined in

paragraphs (2)(a) through (g) and subsection (3) of section

395.402.

18. One objective of the assessment was to consider

aligning trauma servi ce areas within the trauma region

boundaries as established in section 395.4015(1) . It required

the Department to establish trauma regions that cover all

geographic areas of the state and have boundaries that are

coterminous with the boundaries of the Regional Domestic

Security T ask F orces (ÐR DSTF Ñ) established under s ection

943.0312.

19. In a related 2004 amendment, the Legislature added a

provision that gave the Department the option to use something

other than the trauma service areas codified in s ecti on

395.402(4) upon completion of the 2005 Assessment. See

§ 395.402(2) , Fla. Stat. ("Trauma service areas as defined in

this section are to be utilized until the Department of Health

completes" the 2005 Assessment.) § 395.402(4) , Fla. Stat.

("Until the department completes the February 2005 assessment,

the assignment of counties shall remain as established in this

section.").

20. As part of the 2004 amendments to the trauma statute,

the Legislature also required the Department to conduct

"subsequent annual reviews" of Florida's trauma system. In

conducting such annual assessments, the Legislature required the

Department to consider a non - exhaustive list of criteria set

forth in section 395.402(3)(a) - (k). Further, the Legislature

required the Departmen t to annually thereafter review the

assignment of FloridaÓs 67 counties to trauma service areas.

21. The Department timely submitted its 2005 Assessment to

the Legislature on February 1, 2005.

22. With respect to its review of the trauma service

areas, the 2005 Assessment recommended against the continued use

of the 19 trauma service areas. The 2005 Assessment instead

suggested that i t may be feasible for the existing trauma

service areas t o be modified to fit the seven RDSTF regions to

facilitate regional planning.

23. Following receipt of the 2005 Assessment, the

Department took no action to amend the Former Rule and adopt the

recommendations of the 2005 Assessment. As a result, in

June 2011, several existing trauma centers challenged the

validity of the Former Rule pursuant to sections 120.56(1) and

(3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health ,

DOAH Case Nos. 11 - 2602RX, 11 - 2603RX, 11 - 2746RX, 11 - 2796RX ( Fla.

Div. Adm in . H ear ., Sept. 23, 2011).

24. On September 23, 2011, an administ rative law judge of

the Division of Administrative Hearings entered a final order

holding that the Former Rule was an invalid exercise of

delegated legislative authority. The administrative law judge

concluded that the Former Rule was invalid because it

contravened the laws it purportedly implemented, including

section 395.402. The judge found:

The authority granted by section 395.402 for

the use of the [nineteen] identified TSAs

existed only until February 2005. After

that time, the Department was requi red to

consider the findings of the 2005

Assessment, as well as the recommendations

made as part of the regional trauma system

plan. Thus, section 395.402 can no longer

service as a valid basis for the Rule.

25. However, as set forth below , the author ity to utilize

the 19 TSAs was not rescinded; rather, the mandated requirement

to use only the TSAs was rescinded.

26. T he Department was required to review the assignment

of FloridaÓs 67 counties to trauma service areas, taking into

consideration the fa ctors set forth in paragraphs (2)(b) - (g) and

subsection (3) of section 395.402. Having done so, it was

incumbent on the Department to amend its [Former] Rule to

allocate the number of trauma centers determined to be needed

within each designated area through systematic evaluation and

application of statutory criteria.

27. On November 30, 2012, the First District Court of

Appeal affirmed the administrative law judge's determination

that the Former Rule was an invalid exercise of delegated

legislative auth ority. See Dep't of Health v. Bayfront Med.

Ctr., Inc. , 134 So. 3d 1017 (Fla. 1st DCA 2012).

28. After noting that the Former Rule claimed to implement

sections 395.401, 395.4015, and 395.402, the appellate court

held that the Former Rule was invalid be cause it failed to

reflect the substantial amendments to those laws that were

enacted in 2004. The appellate court held:

Both the pre - and post - 2004 versions of the

statute require the Department to establish

trauma regions that "cover all geographic

area s of the state." However, the 2004

amendment requires that the trauma regions

both "cover all geographical areas of the

state and have boundaries that are

coterminous with the boundaries of the

regional domestic security task forces

established under s. 9 43.0312."

§ 395.4015(1), Fla. Stat. (2004).

Similarly, the rule fails to implement the

2004 amendments to section 395.402. The

version of the statute in effect at the time

the rule was promulgated set forth the

nineteen trauma service areas reflecte d in

the rule. [T] he 2004 version of the statute

required the Department to complete an

assessment of Florida's trauma system no

later than February 1, 2005. It further

provides that the original nineteen trauma

service areas shall remain in effect until

the completion of the 2005 Assessment.

Bayfront , 134 So. 3d at 1019Ċ20 (Emphasis added) .

29. It should be noted that the 20 0 4 version of the

statute does not specify at what point in time the 19 TSAs could

no longer be utilized , only that they would have to be used at

least until completion of the 200 5 Assessment .

Rule Development

30. T he Department thereafter initiated rule development

workshops to commence construction of a new rule . The first

workshop concerning this rule was in Tallahassee, Florida , on

December 21, 2012. In January and Februar y 2013, w orkshops were

then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami,

as DOH continue d working on a new rule. Each of the sessions

involved input from interested persons both live and by

telephone . Written comments and oral presentations by these

persons were considered by the Department. After these first

six workshops, held in various regions of the State to make them

more accessible to more citizens, DOH then scheduled three more

workshops in March 2013 , to be held in areas where there were no

existing trauma centers, specifically Ft. Walton Beach, Naples,

and Sebring.

31. DOH also considered the recommendations of a report

issued by the American College of Surgeons (ÐACSÑ), the lead

professional group for trauma systems and trauma car e in the

United States. The ACS sent a consultation team to Tallahassee,

Florida , to conduct a three - day site visit and hold public

workshops in February 2013. The ACS ultimately issued a report

entitled ÐTrauma System Consultation Report: State of Flor ida,Ñ

in May 2013. The report included as one of its recommendations

the use of RDSTF regions as the TSA area s to be used in

determining need for additional trauma centers .

32. In November 2013, DOH released a draft proposed rule

and a draft of its firs t TSA A ssessment (the January TSA

Assessment) . The Department then conducted three additional

workshops in Pensacola, Orlando, and Miami. Again, DOH

solicited comments from interested persons and entered into a

dialogue as to what the proposed rule shoul d look like upon

publication.

33. On January 23, 2014, DOH conducted a Negotiated

Rulemaking Committee meeting at the DepartmentÓs headquarters in

Tallahassee, Florida. The committee consisted of seven persons:

Karen Putnal, Esq uire and Dr. Fred Moore - - representing existing

trauma centers; Steve Ecenia, Esq uire and Dr. Darwin Ang --

representing new trauma centers currently under challenge;

Dr. Patricia Byers -- representative of the EMS Advisory Council;

Jennifer Tschetter, Esq uire and Dr. Ernest Block -- re presenting

DOH. The public was invited to attend the session but w as not

afforded an opportunity to speak.

34. The Department considered all the input from each of

the workshops , the ACS Report, and the negotiated session, as

well as all the applicable items enumerated in s ection

395.402(3)(a) - (k) .

The Proposed Rule

35. On February 3, 2014, the Department published Notice

of Development of Proposed Rule 64J - 2.010 (the "Proposed Rule")

in Florida Administrative Register , Volume 40, Number 22.

36. The D epartment's Notice cited s ection 395.405, as

rulemaking authority for the Proposed Rule. The Notice also

cited sections 395.401, 395.4015, 395.402 , and 395.405 as the

laws intended to be implemented by the Proposed Rule.

37. The following day, February 4, 2014, the Department

published a Notice of Correction in Florida Administrative

Register, Volume 40 , No. 23, to correct the history notes of the

Proposed Rule. In the corrected Notice, the Department cited

section 395.402 as its rulemaking authority in addition to

section 395.405. The correction also removed reference to

sections 395.401, 395.4015, and 395.405 , as laws implemented by

the Proposed Rule. Following the Department's correction, the

Proposed Rule was intended only to implement section 395. 402.

3 8 . T he Proposed Rule established 19 TSAs and determined

the number of trauma centers to be allocated within each TSA,

based upon a scoring system established in the Proposed Rule.

3 9 . Under the scoring system, TSAs were awarded positive

or negative points based on data in an annual Trauma Service

Area Assessment relating to the following six criteria: (1)

population; (2) median transport times; (3) community support;

(4) severely injured patients not treated in trauma centers; (5)

Level 1 trauma ce nters; and (6) number of severely injured

patients (in each TSA) .

40 . M s. Tschetter added the last two criteria (Level I

Trauma Centers and Number of Severely Injured Patients) in

response to comments received at the negotiated rulemaking

session.

4 1 . Subsequent to a final public hearing held on

February 25, 2014, DOH revised its January TSA Assessment and

the earlier version of the Proposed Rule. The revised TSA

assessment (the ÐMarch TSA AssessmentÑ) reflected more

conservative calculations (as gl eaned from input and discussions

with stakeholders) and documents the statutory patient volumes

for the existing Level I and Level II trauma centers in each

TSA. The March TSA A ssessment further recalculated the Median

Transport times, including all trans ports from 0 - 10 minutes (as

opposed to only those transports greater than 10 minutes) and

only transports to trauma centers (as opposed to transports to

all hospitals).

4 2 . O n March 25, 2014, a Notice of Change was published in

the Florida Administrativ e Register. The Proposed Rule, as

published on that date, is as follows :

Notice of Change/Withdrawal

DEPARTMENT OF HEALTH

Division of Emergency Medical Operations

RULE NO.: RULE TITLE:

64J - 2.010 Apportionment of Trauma Centers within a Trauma

Service Are a (TSA)

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to

the proposed rule in accordance with subparagraph 120.54(3)(d)1.,

F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the

Florida Administrative Register .

64J - 2.010 Allocation of Trauma Centers A a mong the Trauma Service

Areas (TSAs).

(1) Level I and Level II trauma centers shall be allocated among the

trauma service areas (TSAs) based upon the following:

(a) The following criteria shall be used to determin e a total score

for each TSA. Points shall be determined based upon data in the

Trauma Service Area Assessment.

1. Population

a. A total population of less than 0 to 600,000 receives 2 points.

b. A total population of 600,001 to 1,200,000 receives 4 points .

c. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6

points.

d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000

receives 8 points.

e. A total population greater than 2,400,000 2,300,000 receives 10

points.

2. Median Trans port Times

a. Median transport time of less than 0 to 10 minutes receives 0

points.

b. Median transport time of 1 0 1 to 20 minutes receives 1 point.

c. Median transport time of 21 to 30 minutes receives 2 points.

d. Median transport time of 31 to 40 minut es receives 3 points.

e. Median transport time of greater than 41 minutes receives 4

points.

3. Community Support

a. Letters of support for an additional trauma center from 25 0 to 50

percent of the city and county commissions located within the TSA

receive 1 point. Letters of support must be received by the

Department on or before April 1 annually.

b. Letters of support for an additional trauma center from more than

50 percent of the city or county commissions located within the TSA

receive 2 points. Lette rs of support must be received by the

Department on or before April 1 annually.

4. Severely I injured Patients Discharged from Acute Care Hospitals

Not Treated In Trauma Centers

a. Discharge of 0 to 200 patients with an International

Classification Injury Severity Score (ÐICISSÑ) score of less than

0.85 (Ðseverely injured patientsÑ) from hospitals other than trauma

centers receives 0 points.

b. Discharge of 201 to 400 severely injured patients from hospitals

other than trauma centers receives 1 point.

c. Discharge of 401 to 600 severely injured patients from hospitals

other than trauma centers receives 2 points.

d. Discharge of 601 to 800 severely injured patients from hospitals

other than trauma centers receives 3 points.

e. Discharge of more than 800 seve rely injured patients from

hospitals other than trauma centers receives 4 points.

5. Level I Trauma Centers

a. The existence of a verified Level I trauma center receives one

negative point.

b. The existence of two verified Level I trauma centers receives t wo

negative points.

c. The existence of three verified Level I trauma centers receives

three negative points.

6. Number of Severely Injured Patients

a. If the annual number of severely injured patients exceeds the

statutory trauma center patient volumes identified in Section

395.402(1), F.S. , by more than 500 patients, the TSA receives 2

points.

b. If the annual number of severely injured patients exceeds the

statutory trauma center patient volumes identified in Section

395.402(1), F.S. , by 0 to 500 patient s, the TSA receives 1 point.

c. If the annual number of severely injured patients is less than

the statutory trauma center patient volumes identified in Section

395.402(1), F.S. , by 0 to 500 patients, the TSA receives one

negative point.

d. If the annual n umber of severely injured patients is less than

the statutory trauma center patient volumes identified in Section

395.402(1), F.S., by more than 500 patients, the TSA receives two

negative points.

(b) The following scoring system shall be used to allocate trauma

centers within the TSAs:

1. TSAs with a score of 5 points or less shall be allocated 1 trauma

center.

2. TSAs with a score of 6 to 10 points shall be allocated 2 trauma

cen ters.

3. TSAs with a score of 11 to 15 points shall be allocated 3 trauma

cen ters.

4. TSAs with a score of more than 15 points shall be allocated 4

trauma centers.

(2) An assessment and scoring shall be conducted by the Department

annually on or before August 30th, beginning August 30, 2015.

(3) The number of trauma centers allocat ed for each TSA based upon

the Amended Trauma Service Area Assessment, dated March 24, 2014

January 31, 2014 , which can be found at www.FLHealth.gov/ licensing -

and - regulation/trauma - system/_documents/trauma - area - service -

assessment.pdf , is as follows:

TSA Counties Trauma

Centers

1 Escambia, Okaloosa, Santa Rosa, Walton 1

2 Bay, Gulf, Holmes, Washington 1

3 Calhoun, Franklin, Gadsden, Jackson, 1

Jefferson, Leon,

Liberty, Madison, Taylor, Wakulla

4 Alachua, Bradford, Columbia, Dixie, 1

Gilchrist, Hamilt on, Lafayette, Levy,

Putnam, Suwannee, Union

5 Baker, Clay, Duval, Nassau, St. Johns 1 2

6 Citrus, Hernando, Marion 2

7 Flagler, Volusia 1

8 Lake, Orange, Osceola, Seminole, Sumter 3

9 Pasco, Pinellas 2 3

10 Hillsborough 1

11 Hardee, Highlands, Polk 1

12 Brevard, Indian River 1

13 DeSoto, Manatee, Sarasota 2

14 Martin, Okeechobee, St. Lucie 1

15 Charlotte, Glades, Hendry, Lee 1 2

16 Palm Beach 1

17 Collier 1

18 Broward 2

19 Dade, Monroe 3

Rulemaking Authority 395.402, 395.405 FS. Law Impleme nted 395.402 FS.

History Î New 12 - 10 - 92, Formerly 10D - 66.1075, Amended 6 - 9 - 05, 12 - 18 -

06,Formerly 64E - 2.022, Amended_________.

4 3 . DOH did not incorporate the March TSA Assessment by

reference in the rule. After exchanges of communications with

the Joint Ad ministrative Procedures Committee (ÐJAPCÑ), wherein

DOH sought guidance concerning this matter, there was no

directive by JAPC that such adoption by reference would be

required.

4 4 . DOH revised the population criterion in the Proposed

Rule to have even br eaks in intervals of 600,000 people. The

February proposed rule awarded 6 points in TSAs with a

population of 1,200,001 to 1,700,000 people (i.e., a 500,000

person interval), where all other measures were based upon a

600,000 person interval. This discre pancy is corrected in the

newly Proposed Rule.

4 5 . DOH revised the community support criterion in the

Proposed Rule to no longer award a point to TSAs where 0 - 50% of

the city and county commissions send letters of support, because

this could have reflect ed the need for a trauma center (by

awarding points to the TSA) when no letters of support were

received. The Proposed Rule now awards a point to TSAs where

25 - 50% of the county commissi ons send letters of support. DOH

chose twenty - five percent as the mi nimum necessary community

support because the smallest number of city and county

commissions in all of the TSAs is four, which ensures everyone

has a voice.

4 6 . DOH revised the title of the fourth criterion from

Ðseverely injured patients not treated in t rauma centers Ñ to

Ðseverely injured patients discharged from acute care

hospitals ,Ñ which more accurately depicts the function of the

criterion.

4 7 . DOH revised the sixth criterion to include citations

to the statutory minimum volumes for Level I and Leve l II trauma

centers in response to a request by the staff attorney for the

Joint Administrative Procedures Committee.

4 8 . DOH also revised the rule to reference the March TSA

Assessment in place of the January TSA Assessment.

4 9 . Finally, DOH revised the Proposed RuleÓs allocation

table based on the revisions to the rule and assessment. The

Proposed Rule as amended allocates a total of 27 trauma centers

throughout FloridaÓs 19 TSAs. Each TSA is still allocat ed at

least one trauma center.

50 . The Propos ed Rule allocates only Level I and Level II

trauma centers, not pediatric trauma centers. The rulemaking

directive in section 395.402(4) is interpreted by DOH to be

limited to the allocation of Level I and Level II trauma

centers. In addition, the alloca tion of stand - alone pediatric

centers would not be feasible because pediatric trauma patients

make up such a small percentage of the population and all of the

Level I and II trauma centers have the ability to become

pediatric trauma centers. Currently, al l of the existing Level

I trauma centers provide pediatric care and there are only two

stand - alone pediatric centers in Florid a.

5 1 . The Proposed RuleÓs allocation of 27 trauma centers is

conservative. There are currently 27 verified trauma centers in

th e state, including two verified trauma centers under

administrative challenge .

5 2 . There are several elements of the Proposed Rule which

Petitioners have raised as evidence of the DepartmentÓs failure

to comply with its rulemaking authority. Petitioner s maintain

that DOH failed to consider all of the items enumerated in

section 395.402(3)(a) - (k) . Each of those criteria is addressed

below.

5 3 . (a) T he recommendations made as part of the regional

trauma system plans submitted by regional trauma agencie s --

There is only one regional trauma agency in Florida. DOH

reviewed the regional agencyÓs plan, but it was devoid of any

recommendations related to trauma center allocation within the

TSAs. The regional agency did not amend its plan or submit any

sepa rate recommendations throughout the year - long, public

rulemaking process.

5 4 . (b) S takeholder recommendations -- Petitioners complain

that DOH did not do enough to solicit input from everyone who

would be affected by the Proposed Rule. The Department,

ho wever, obtained stakeholder testimony from 171 individuals and

written comments from 166 stakeholders through the course of the

12 rule development workshops conducted around the state. The

workshops were held in several cities to allow for geographic

access by more residents. Over 400 people attended the

workshops. The January TSA A ssessment was also modified prior

to its publication as a result of the stakeholder discussions at

the workshops and the negotiated rulemaking session. The March

TS A A ssessm ent was further amended after its publication as a

result of testimony at the public hearing for the Proposed Rule .

5 5 . (c) T he geographical composition of an area to ensure

rapid access to trauma care by patients -- While Florida contains

no mountains, it s geography is unique to other states in that it

contains several inlets, bays, jetties, and swamplands. As

such, the DOH data unit examined the coastal areas versus non -

coastal areas. The unit also analyzed urban versus rural areas.

The unit also looke d at the communities surrounding Lake

Okeechobee. Ultimately, the analysis was not meaningful because

the effect geography has on access to trauma centers is captured

by FloridaÓs transport time records for emergency vehicles and

helicopters. Thus, by re viewing the Emergency Medical Services

Tracking and Reporting System (ÐEMSTARSÑ) database, DOH could

know the actual effects of FloridaÓs geography on access to

trauma centers.

5 6 . (d) H istorical patterns of patient referral and

transfer -- This item was considered, but the January TSA

Assessment does not address it because it was neither measurable

nor meaningful. The data was not measurable because of

limitations of data quality in the Trauma Registry. Even if the

data were measureable it would not hav e been meaningful because

it would have only illustrated the catchment areas -- i.e., the

geographic distribution of patients served by existing trauma

centers. As recommended by the ACS, DOHÓs primary focus is on

the trauma system as a whole, not individua l trauma centers.

Moreover, transfer and referral history is not meaningful to an

assessment designed to inform an allocation rule because, again,

DOH does not have the authority to define where new trauma

centers are developed within a TSA. S ee § 402.39 5(4)(b), Fla.

Stat. (charging DOH with allocating by rule the number of trauma

centers in each TSA, not trauma center location within a trauma

service area).

5 7 . (e) I nventories of available trauma care resources,

including professional medical staff -- Petitioners suggest that

DOH should have made a determination of existing professional

medical staff , but suggest no viable means of doing so. The

January TSA Assessment catalogues several trauma care resources

within TSAs, including financing, trauma center s, acute care

hospitals, and EMS response capabilities. The January TSA

Assessment does not catalogue available professional medical

staff. DOH is unaware of any database that compiles this

information. DOH sent a survey to the existing trauma centers

requesting information as to their resources and professional

staff, however it was not useful due to the limited responses

and potential for bias. The data unit also reviewed the DOH

Division of Medical Quality Assurance health professional

licensure data base (COMPASS), however , it was not helpful

because physician specialty reporting is voluntary. Similarly,

the data unit reviewed AH C AÓs inventory of licensed acute care

hospitals and the DOH annual physician workforce survey results,

but neither data sou rce provided trauma - specific information.

As such, the information was not complete and so was not

included in the January TSA A ssessment .

5 8 . (f) P opulation growth characteristics -- In response to

this criterion, the DOH data unit analyzed the potential for

growth in all of the TSAs, but the January TSA A ssessment did

not include this analysis because it was not meaningful given

DOHÓs requirement to conduct the assessment annually. The

January TSA Assessment does however document the population in

each TSA. DOH decided that in light of the continuing change of

population in Florida, the best it could do would be to make a

finding as to the population in each TSA and use it -- year by

year -- to look at the potential need for additional (or

presumably fewer) trauma centers in an area. Obviously the

population of an area is not directly commensurate with the

number of severely injured patients that might be found. Not

all areas have equal percentages of severely injured patients;

urban areas would have highe r percentages than rural areas, in

general. Areas through which a major interstate highway runs

would expect a higher percentage. There are a number of factors

that could potentially affect an areaÓs expectation of trauma

services. Inasmuch as they coul d not all possibly be included

in an analysis, DOH defaulted to a more general view, i.e., the

total population. The total population figure became the first

measurement in the Proposed Rule.

5 9 . (g) T ransportation capabilities ; and (h) M edically

appropriate ground and air travel times -- DOH considered these

two factors together and determined to cover them by way of a

determination of median transport time, which was to become the

second measurement in the Proposed Rule. The data unit gathered

transport capability data by reviewing the COMPASS licensure

database and archived paper applications to discern the number

of licensed emergency medical stations, helicopters, and

vehicles in each TSA. The data unit further calculated the

number of ground vehicle s per the population in each TSA and

every 100 square miles. The January TSA Assessment included

this information because it was meaningful and gathered from a

reliable database. DOH considered the testimony from a number

of trauma surgeons during the 12 workshops regarding transport

times and learned that the medically appropriate transport time

depends on the nature of injuries and individual patients, which

are not always discernable at the scene of an accident. Because

of this, the sooner a patient c an be transported to a trauma

center, the better it is for patient outcomes. In light of the

patient - specific realities of establishing a medically

appropriate transport time, the data team used EMSTARS to

calculate the median emergency transport times in each TSA for

the assessment . Granted the EMSTARS is a fairly new system

under development, and it reports all 911 calls voluntarily

reported (not just trauma patients), so it is not a completely

accurate measure. But it is a reasonable approach based up on

what is available. Also, the transport times do not reflect

whether pre - hospital resources are sufficient for the patient or

how far away the closest trauma center may be. It is not an

absolutely perfect measurement, but it is reasonable and based

on logic.

60 . (i) R ecommendations of the Regional Domestic Security

Task Force -- Like FloridaÓs lone regional trauma agency, the

RDSTF did not offer any input throughout the year - long, public

rulemaking process. However , DOH considered the testimony of

nume rous emergency management and law enforcement officials

during the rule development process. For example, Chief Loren

Mock, the Clay County fire chief and also a member of the

Domestic Security Oversight Council, testified at the

Jacksonville workshop. T here is no evidence DOH directly

contacted a RDSTF representative to solicit input.

6 1 . (j) T he actual number of trauma victims currently

being served by each trauma center -- The March TSA Assessment

included the annual trauma patient volume reported to th e Trauma

Registry by the existing trauma centers. When comparing the

average patient volume reported to trauma registry from 2010 -

2012 to the data unitÓs calculation of the average number of

severely injured patients treated in trauma centers during this

same time span, the volumes reported by the trauma centers were

approximately 333% greater. This large disparity prompted DOH

to follow the example of many other states and use population as

a proxy for the number of potential trauma patients in each TSA

in its Proposed Rule. DOH found that : greater population means

a greater need for health care; population is a good indicator

of need for medical services; population is a reasonable proxy

for patient volume; and, more people in a given area results in

m ore trauma cases in a given area .

6 2 . (k) O ther appropriate criteria : It was well

documented in literature presented to DOH during the rulemaking

process that there w ere a large percentage of severely injured

patients in Florida not being seen by trauma centers. The data

unit confirmed this by evaluating the AHCA administrative

database, which identifies the injuries suffered by patients as

well as the type of hospitals discharging those patients , i.e.,

comparing the total number of severely injured pati ents with the

number of severely injured patients discharged from acute care

hospitals in each TSA. This disparity was worrisome to DOH and

therefore included in the March TSA Assessment. As pointed out

by Petitioners, the DepartmentÓs figures include pa tients who

may have received treatment outside the TSA in which the injury

occurred. The figures may not have contained patients who

needed trauma care but could not access it for other reasons.

The Proposed Rule, however, makes as complete an evaluation of

the potential patient base for trauma centers as is possible.

6 3 . Notwithstanding complaints about how the Department

addressed some of the criteria set forth in the statute, it is

clear that all criteria were considered and implemented into the

Proposed Rule to the extent feasible and possible. The most

credible testimony at final hearing supports the DepartmentÓs

process. Criticisms of the various elements within the Proposed

Rule expressed by Petitioners at final hearing seemed to be

based on the concept that the Proposed Rule may allow

competition to existing trauma centers rather than real

complaints about the elements themselves. All agree, for

example, that population, transportation times, number of

patients, and the existence of nearby traum a centers are

important factors that should be considered. Petitioners just

seemed to want those factors expressed in different (though

unspecified) terms.

6 4 . Petitioners did enunciate certain shortcomings they

felt made the Proposed Rule less than com plete. St. Joseph

lamented the absence of all the DepartmentÓs analysis and

background for each of the proposed measurements contained in

the Proposed Rule. Jackson Memorial pointed out that pediatric

trauma centers were not specifically included in the Proposed

Rule. Shands showed that odd or unusual results could arise

from implementation of the Proposed Rule. For example, the

March TSA Assessment showed a total of 216 severely injured

patients in TSA 6, comprised of Marion, Citrus, and Hernando

count ies. The Proposed Rule called for two trauma centers in

that TSA. Although the number of patients necessary to maintain

a trauma centerÓs proficiency was disputed by various experts in

the field, it is clear that 108 patients per center would be

extremel y low. However, the figure appearing in the March

Assessment is not absolute or necessarily completely definitive

of need. There are other factors concerning population and

patients that may affect that figure.

The Six Measurement Criteria in the Propos ed Rule

6 5 . Petitioners also took exception to the measurement

criteria in the Proposed Rule. Each of those six criterion is

discussed below .

Population

6 6 . The Proposed Rule awards from two to ten points to a

TSA, depending on the TSA total population . Two poi nts are

awarded for a population of less than 600,000 and ten points are

awarded for a popu1 ation greater than 2.4 million.

6 7 . T he Department used t otal p opulation as a "proxy" for

the actual number of trauma patients in the state rather than

u sing the actual number of trauma victims in the state. The

Proposed Rule does not define ÐpopulationÑ or ÐTotal

Population,Ñ nor are those terms defined in the trauma statute ,

but those words are subject to their normal definition .

6 8 . The Proposed Rule does not re - state the source of the

summary Total Population data ; it is already contained in the

TSA Assessment. Neither the Proposed Rule nor the March TSA

Assessment contains any data or analysis reflecting population

by age cohort, population density, or incidence of trauma injury

in relation to these factors, and the Department did not

specifically conduct any analysis of the significance of any

aspect of population data as it relates to the need for new

trauma centers, other than determining the tota l population

growth rate in the TSAs. Rather, DOH decided upon total

population as the most reliable measure available.

6 9 . Traumatic injury rates and the severity of traumatic

injury vary widely based on a number of factors, including

whether the area is urban or rural, the population age cohort,

and the infrastructure and physical characteristics or features

of the geographic area. Thus, the most reasonable way to

measure possible need was to look at the total population of an

area and extrapolate fro m that basis.

70 . The Department presented no specific data or analysis

to support the incremental cutoff points for the Total

Population scale contained in the Proposed Rule. Rather, the

Department took population as a whole because it was the most

readily available, annually updateable, and understandable

factor it could access .

7 1 . The use of population as a proxy is not without

problems, however. In TSA 19, for instance, the population has

increased by about thirty - eight percent in recent decades, but

the number of trauma victims has declined by approximately

twelve percent. As stated, the Proposed Rule as written is not

inerrant.

Median Transport Times

7 2 . The Proposed Rule awards from zero to four points to a

TSA, depending on the Median Trans port Time within a TSA .

7 3 . ÐMedian Transport TimeÑ is not defined in the Proposed

Rule, nor is the methodology for determining the summary ÐMedian

Transport TimeÑ statistics set forth in the TSA Assessment and

relied on in the Proposed Rule. Informatio n concerning

transport times is, however, contained within the TSA

Assessment .

7 4 . T he Median Transport Time used in the Proposed Rule

represents the average transport time for all 911 transports

voluntarily reported to the state EMSTARS database. EMST ARS is

a database that is under development and that collects

information voluntarily provided by emergency medical transport

providers throughout the state. Although not all EMS providers

current ly report to EMSTARS (most notably, Miami - Dade County EMS

does not participate), the database is useful for research and

quality improvement initiatives.

7 5 . T he Median Transport Time set forth in the March TSA

Assessment and used in the Proposed Rule includes transport time

for all patients, rega rdless of the n ature of the emergency,

whether the call involved trauma , other types of injury, or

illness , and regardless of whether the transport was conducted

with the regular flow of traffic or required Ðlights and siren.Ñ

7 6 . T he Median Transport Time used in the Proposed Rule

includes all EMS transports of up to two hours in duration. T he

Median Transport Time excludes transports of patients to trauma

center s operating pursuant to the initial stage of trauma center

licensure known as Ðprovisional approval.Ñ

7 7 . T he Department address ed Ðmedically appropriate air or

ground transport times,Ñ as required by section 395.402(3)(h),

by its generally accepted conclusion that "faster is better."

7 8 . Not all injured patients, however, benefit from

receiving care at a trauma center. Thus, while an existing

trauma center is an appropriate destination for all patients

with any level of injury who live in the area of a trauma

center, the trauma centerÓs value beyond its immediate area is

as a resource for the most severe ly injured patients whose

problems exceed the capabilities of their nearest hospital.

7 9 . The Department did not undertake any analysis to

balance its "faster is better" approach to trauma planning

against the reality that the resources necessary to prov ide high

quality trauma care are limited, as is the number of severely

injured patients.

80 . There is a general (but not universal) consensus among

trauma experts that access to a trauma center within 30 - 50

minutes is an appropriate benchmark for access to trauma care.

Other than "faster is better," the Department did not determine

a medically appropriate travel time for any type of trauma or

any geographic area, but recognizes the general consensus as

appropriate.

8 1 . The Proposed Rule awards from one to four points that

weigh in favor of approval of a new tra uma center within a TSA

if the Median Transport Time of patients transported in response

to any 911 c all is between 10 and 42 minutes, i.e., within but

faster than the generally accepted consensus.

Community Support

8 2 . The Proposed Rule awards from one to two points to

each TSA depending on the number of letters of support written

by elected city or county commissioners .

8 3 . T he Proposed Rule allows for consideration of

stakeholder recommendations by way of allowing letters of

support from local governments . ÐStakeholdersÑ in the state

trauma system include existing trauma centers, as well as all

acute care hospitals, and pre - and post - hospital care providers,

including emergency transport servi ces, air ambulances, and

emergency management planning agencies.

8 4 . The Department could find no better way to acknowledge

support from those stakeholders, and citizens in general, than

to have their elected representatives listen to their

constituents a nd then reflect those peopleÓs desires and

comments.

Severely Injured Patients Discharged from Acute Care Hospitals

8 5 . The Proposed Rule awards from zero to four points to a

T SA, depending on the number of severely injured patients

discharged from acu te care hospitals (non - trauma centers) .

8 6 . T he Proposed Rule addresses the number of severely

injured patients , i.e., those with an ICISS score of < 0.85="">

discharged from hospitals other than trauma centers. The

Proposed Rule does not specifically defin e Ðseverely injured

patient,Ñ but it is obvious from the context in which that term

is used.

8 7 . T he summary data in the TSA Assessment labeled "number

of severely injured patientsÑ within each TSA is intended to

reflect the number of severely injured p atients who ÐdidnÓt get

to trauma care.Ñ The Department's numbers may include patients

who received treatment at a trauma center outside of the TSA in

which the injury occurred. The Department did not conduct any

analysis of the "number of severely injur ed patients not treated

at a trauma center" to determine whether the patients not

treated at a trauma center received timely and appropriate care

at a non - trauma center hospital with the capability to treat the

patient's injuries. The number of Ðseverely injured patients

who did not get to trauma careÑ as reported by the Department is

unlikely to reflect the actual number of patients who required

care at a trauma center but did not have access, and suggests

that this number is far higher than it actually i s. The

Department, for example (and in response to discussion with

stakeholders), excluded from its analysis all patients with

isolated hip fractures as well as all patients who were released

from the hospital within 24 hours, which resulted in fewer

seve rely injured patients.

8 8 . Neither the Proposed Rule nor the TSA Assessment

considers demographics or outcomes for "severely injured

patients" treated at general acute care hospitals or outcome

data for these patients.

8 9 . The Proposed Rule does not inc lude any method for

projecting the actual demand for trauma services in the future ;

it is used to determine need at a single point in time (and will

be done so annually) . The Proposed Rule does not include any

criteria or method for evaluating whether the re are any capacity

problems at existing trauma centers, or other barriers that

impede access to trauma care.

90 . The Department intended this criterion to show a

highly conservative estimate of patients who definitely need

trauma care.

Level I Trauma C enters

9 1 . With respect to ÐLevel I Trauma Centers,Ñ the Proposed

Rule awards from negative one to negative three points to a TSA,

depending on whether the TSA already has one, two, or three

verified Level I trauma center(s) , respectively .

9 2 . The Propos ed Rule creates the opportunity for

establishment of both additional Level I and also additional

Level II trauma centers, pursuant to the allocation of need, but

the Proposed Rule does not assign or subtract points for the

existence of Level II trauma cent ers.

9 3 . This criterion reflects the recommendations of

stakeholders at the rule workshops. It was the consensus of

many stakeholders that Level I trauma centers should be

protected in order to safeguard the research and teaching

missions of those center s. The earlier proposal of a ÐhaloÑ

around existing centers, i.e., not approving a new trauma center

within a certain radius of existing centers, was not

incorporated into the Proposed Rule. This criterion, however,

offers some protection for existing ce nters.

Number of Severely Injured Patients

9 4 . The Proposed Rule awards negative two to two points

based on the "number of severely injured patients" in a TSA.

The criterion awards points based on the number of Severely

Injured Patients which exceed the target trauma center patient

volumes as provided in section 395.402(1). If the annual number

of Severely Injured Patients exceeds the statutory volumes by

more than 500 patients, the TSA will receive two points; if it

exceeds it by less than 500 the TSA r eceives one point; if the

number of Severely Injured Patients is less than the statutory

volumes by zero to 500 patients, the TSA receives one negative

point; if it is less than the volumes by more than 500 patients,

the TSA receives two negative points.

9 5 . T he Proposed Rule does not include any criterion

addressing the actual number of trauma victims currently being

served by each trauma center. Instead, Section 6 of the

Proposed Rule substitutes the "minimum statutory capacity" of

existing trauma cente rs for the actual capac ity of existing

trauma centers.

9 6 . The Department could not find Ða meaningfulÑ way to

measure actual capacity of existing trauma centers . The most

accurate way to measure capacity was a contentious topic at rule

workshops, and t he Department spent a good deal of time working

with stakeholders on how to measure capacity in such a way that

it could be included as a factor in the Proposed Rule. One

suggestion as to how to measure trauma center capacity is by how

often existing trau ma centers actually divert trauma patients to

other facilities. However, trauma centers rarely admit that

they are not able to take any more patients, and this is not a

realistic method to evaluate capacity.

9 7 . The capacity of an existing trauma center may be

measured by various means, including the number of beds at the

trauma center, the number of ICU beds, the number of trauma

bays, number of operating rooms, as well as the frequency of and

reasons for diversion. The trauma centerÓs clinical staff,

including medical and surgical specialists, and supporting

clinical personnel, are also indicator s of capacity. The

Department already routinely collects data reflecting trauma

center capacity as part of the quarterly and annual reports that

all existing t rauma centers are required to submit, and by way

of on - site licensure surveys. None of those means, however,

provided DOH with sufficiently reliable information and data.

9 8 . The Proposed Rule comports with the DOH Mission to

protect, promote, and improv e the health of all Floridians

through integrated state, county, and community efforts. While

by no means perfect, the Proposed Rule is based upon logic and

reason derived from an extensive analysis of all relevant

factors.

History of the Rule

9 9 . The ra tionale for DOHÓs inclusion of those particular

six criteria in the Proposed Rule can be better understood by

considering some more history of the trauma rule.

100 . As stated earlier herein, in 2004 the Legislature

made substantial revisions to the trauma statute and ordered the

Department to complete an assessment of FloridaÓs trauma system.

The scope of this assessment was defined in paragraphs (2)(a)

through (g) and subsection (3) of section 395.402 . An

appropriation of $300,000 was authorized for the Department to

contract with a state university to perform the actions required

under the amended statute. Ch. 2004 - 259, § 10, Laws of Florida.

10 1 . One proposal of the 2005 Assessment was to

"[c]onsider aligning trauma service areas within [sic] the

tra uma region boundaries as established in" s ection 395.4015(1).

§ 395.402(2)(a), Fla. Stat. In a related 2004 amendment, the

Legislature ended the statutory mandate to use the service areas

created in 1990.

10 2 . The obvious conclusion from the above sta tutory

change is that the section 395.402(4) service areas could be

replaced by the service areas DOH established or adopted once it

had the results of the 2005 Assessment. Unlike the prior

statute, there is no mandate for specific new service areas,

only the option not to use the prior service areas.

10 3 . The 2005 Assessment included five "Recommendations" :

1. Trauma centers should be placed in

Tallahassee and in Bay County, which do not

currently have a trauma center . . . .

2. It is reasonable to s et, as a system

goal, that 65 percent of trauma center

patients will be treated at a trauma

center. . . .

3. Designation of additional trauma centers

should be based on the need as determined by

trauma region. Deployment of additional

trauma cente r s sh ould take place based, not

only on the number of patients served per

t raum a center, but according to the concept

of Ðtrauma center capacityÑ which should be

determined by the staffing levels of medical

specialists and other healthcare

professionals. . . .

4. The data support the feasibility of

transforming the Florida Trauma Services

Areas so that these would coincide with the

Domestic Security Task Force Regions. . . .

5. It is reasonable to fund trauma centers

with public funds, based on the

unrecoverable financial burden incurred by

trauma centers.

10 4 . The only legislative response to the 2005 Assessment

was an increase in funding to trauma centers. The Legislature

did not repeal the statute establishing the current 19 TSAs.

Likewise, the Depart ment has not amended the Rule to implement

the recommendations contained in the 2005 Assessment until the

present Proposed Rule .

10 5 . The Department, instead, reviewed existing statutes,

interpreted section 395.4015 to mandate the establishment of a

traum a system plan (which plan would include trauma regions that

have boundaries coterminous with those of the regional domestic

security task force boundaries). The development of the trauma

system plan is distinct from the determination of need for new

traum a systems addressed by the Proposed Rule.

CONCLUSIONS OF LAW

10 6 . The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this cause

pursuant to section 120.56, Florida Statutes.

10 7 . Section 395.402, is the st atutory authority for the

Proposed Rule and the law implemented. It states, in its

entirety:

395.402 Trauma service areas; number and

location of trauma centers . Ï

(1) The Legislature recognizes the need for

a statewide, cohesive, uniform, and

integrated trauma system. Within the trauma

service areas, Level I and Level II trauma

centers shall each be capable of annually

treating a minimum of 1,000 and 500

patients, respectively, with an injury

severity score (ISS) of 9 or greater. Level

II trauma centers in counties with a

population of more than 500,000 shall have

the capacity to care for 1,000 patients per

year.

(2) Trauma service areas as defined in this

section are to be utilized until the

Department of Health completes an assessment

of the trauma system and reports its finding

to the Governor, the President of the

Senate, the Speaker of the House of

Representativ es, and the substantive

legislative committees. The report shall be

submitted by February 1, 2005. The

department shall review the existing trauma

system and determine whether it is effective

in providing trauma care uniformly

throughout the state. The assessment shall:

(a) Consider aligning trauma service areas

within the trauma region boundaries as

established in July 2004.

(b) Review the number and level of trauma

centers needed for each trauma service area

to provide a s t atewide integrated trauma

system.

(c) Establi sh criteria for determining the

number and level of trauma centers needed to

serve the population in a defined trauma

service area or region.

(d) Consider including criteria within

trauma center approval standards based upon

the number of trauma victims served within a

service area.

(e) Review the Regional Domestic Security

Task Force structure and determine whether

integrating the trauma system planning with

interagency regional emergency and disaster

planning efforts is feasible and identify

any dupli cation of efforts between the two

entities.

(f) Make recommendations regarding a

continued revenue source which shall include

a local participation requirement.

(g) Make recommendations regarding a

formula for the distribution of funds

identified for t rauma centers which shall

address incentives for new centers where

needed and the need to maintain effective

trauma care in areas served by existing

centers, with consideration for the volume

of trauma patients served, and the amount of

charity care provid ed.

(3) In conducting such assessment and

subsequent annual reviews, the department

shall consider:

(a) The recommendations made as part of the

regional trauma system plans submitted by

regional trauma agencies.

(b) Stakeholder recommendations.

(c) The geo graphical composition of an area

to ensure rapid access to trauma care by

patients.

(d) Historical patterns of patient referral

and transfer in an area.

(e) Inventories of available trauma care

resources, including professional medical

staff.

(f) Population growth characteristics.

(g) Transportation capabilities, including

ground and air transport.

(h) Medically appropriate ground and air

travel times.

(i) Recommendations of the Regional

Domestic Security Task Force.

(j) The actual number of t rauma victims

currently being served by each trauma

center.

(k) Other appropriate criteria.

(4) Annually thereafter, the department

shall review the assignment of the 67

counties to trauma service areas, in

addition to the requirements of paragraphs

(2 )(b) - (g) and subsection (3). County

assignments are made for the purpose of

developing a system of trauma centers.

Revisions made by the department shall take

into consideration the recommendations made

as part of the regional trauma system plans

approved by the department and the

recommendations made as part of the state

trauma system plan. In cases where a trauma

service area is located within the

boundaries of more than one trauma region,

the trauma service areaÓs needs, response

capability, and system requirements shall be

considered by each trauma region served by

that trauma service area in its regional

system plan. Until the department completes

the February 2005 assessment, the assignment

of counties shall remain as established in

this section.

( a) The following trauma service areas are

hereby established:

1. Trauma service area 1 shall consist of

Escambia, Okaloosa, Santa Rosa, and Walton

Counties.

2. Trauma service area 2 shall consist of

Bay, Gulf, Holmes, and Washington Counties.

3. Traum a service area 3 shall consist of

Calhoun, Franklin, Gadsden, Jackson,

Jefferson, Leon, Liberty, Madison, Taylor,

and Wakulla Counties.

4. Trauma service area 4 shall consist of

Alachua, Bradford, Columbia, Dixie,

Gilchrist, Hamilton, Lafayette, Levy,

Pu tnam, Suwannee, and Union Counties.

5. Trauma service area 5 shall consist of

Baker, Clay, Duval, Nassau, and St. Johns

Counties.

6. Trauma service area 6 shall consist of

Citrus, Hernando, and Marion Counties.

7. Trauma service area 7 shall consist of

Flagler and Volusia Counties.

8. Trauma service area 8 shall consist of

Lake, Orange, Osceola, Seminole, and Sumter

Counties.

9. Trauma service area 9 shall consist of

Pasco and Pinellas Counties.

10. Trauma service area 10 shall consist of

Hillsb orough County.

11. Trauma service area 11 shall consist of

Hardee, Highlands, and Polk Counties.

12. Trauma service area 12 shall consist of

Brevard and Indian River Counties.

13. Trauma service area 13 shall consist of

DeSoto, Manatee, and Sarasota C ounties.

14. Trauma service area 14 shall consist of

Martin, Okeechobee, and St. Lucie Counties.

15. Trauma service area 15 shall consist of

Charlotte, Glades, Hendry, and Lee Counties.

16. Trauma service area 16 shall consist of

Palm Beach County.

17. Trauma service area 17 shall consist of

Collier County.

18. Trauma service area 18 shall consist of

Broward County.

19. Trauma service area 19 shall consist of

Miami - Dade and Monroe Counties.

(b) Each trauma service area should have at

least one Level I or Level II trauma center.

The department shall allocate, by rule, the

number of trauma centers needed for each

trauma service area.

(c) There shall be no more than a total of

44 trauma centers in the state.

History. Ï ss. 5, 15, ch. 90 - 284; ss. 37, 98,

ch. 92 - 289; s. 195, ch. 99 - 397; s. 26, ch.

2000 - 242; s. 6, ch. 2004 - 259; s. 100, ch.

2008 - 4.

Note. Ï Former s. 395.033.

10 8 . Section 120.56(1)(a), provides that any person

substantially affected by Ða proposed rule may seek an

administrative determination of the invalidity of the rule on

the ground that the rule is an invalid exercise of delegated

legislative authority.Ñ

Standing

10 9 . As stipulated by the parties, all Petitioners and

Intervenor have standing under s ection 120.56(1), to participate

in this administrative hearing as persons substantially affected

by the Proposed Rule.

Burden of Proof

1 10 . Petitioners seek a determination that the Proposed

Rule constitutes an invalid exercise of delegated legislative

authority and is arbitrary and ca pricious, in violation of

section 120.52(8) . Under section 120.56(2)(a), the petitioner

has a burden of going forward and only thereafter is the agency

required to demonstrate by a preponderance of evidence that the

proposed rule is not an invalid exercis e of legislative

authority. Petitioners met their burden in this proceeding.

1 1 1. An invalid exercise of delegated legislative

authority means action that goes beyond the powers, functions,

and dutie s delegated by the Legislature. A proposed or existing

rule is an invalid exercise of delegated legislative authority

if :

(a ) The agency has materially failed to

follow the applicable rulemaking procedures

or requirement set forth in this chapter;

(b) The agency has exceeded its grant of

rulemaking authority, citation to which is

required by s. 120.54(3)(a)1.;

(c) The rule enlarges, modifies, or

contravenes the specific provisions of law

implemented, citation to which is required

by s. 120.54(3 )(a)1.;

(d) The rule is vague, fails to establish

adequate standards for agency decisions, or

vests unbridled discretion in the agency;

(e) The rule is arbitrary or capricious. A

rule is arbitrary if it is not supported by

logic or the necessary facts ; a rule is

capricious if it is adopted without thought

or reason or is irrational;

(f) A grant of rulemaking authority is

necessary but not sufficient to allow an

agency to adopt a rule; a specific law to be

implemented is also required. An agency may

adopt only rules that implement or interpret

the specific powers and duties granted by

the enabling statute. No agency shall have

authority to adopt a rule only because it is

reasonably related to the purpose of the

enabling legislation and is not arbitr ary

and capricious or is within the agencyÓs

class of powers and duties, nor shall an

agency have the authority to implement

statutory provisions setting forth general

legislative intent or policy. Statutory

language granting rulemaking authority or

gener ally describing the powers and

functions of an agency shall be construed to

extend no further than implementing or

interpreting the specific powers and duties

conferred by the enabling statute.

§ 120.52(8), Fla. Stat.

Standard of Review

11 2 . A propose d rule may be challenged pursuant to s ection

120.56, only on the ground that it is an invalid exercise of

delegated legislative authority. An Administrative Law Judge is

without authority to declare a proposed rule invalid on any

other ground. To do so w ould be an impermissible extension of

the judgeÓs authority beyond the boundaries established by the

legislature.

11 3 . ÐAn arbitrary decision is one not supported by facts

or logic, or despotic.Ñ Bd . of Tr s. of Int . Impust Fund v.

Levy , 656 So. 2d 13 59, 1362 (Fla. 1st DCA 1995) ( quoting Agrico

Chem. Co. v. DepÓt of Envtl. Reg. , 365 So. 2d 759, 763 (Fla. 1st

DCA 1978)). ÐA capricious action is one which is taken without

thought or reason or irrationally. Ñ Id. A determination is not

arbitrary or capr icious if it is justifiable Ðunder any analysis

that a reasonable person would use to reach a decision of

similar importance.Ñ Dravo Basic Materials Co., Inc. v. State

of Fla., Dep Ó t of Trans p . , 602 So . 2d 632 (Fla. 2nd DCA 1992).

11 4 . An administrative agencyÓs interpretation of the

statute it is charged with implementing is entitled to great

deference. See Level 3 Comm cÓns , LLC v. Jacobs , 841 So. 2d 447,

450 (Fla. 2003); PW Ventures, Inc. v. Nichols , 533 So. 2d 281,

283 (Fla. 1988); Fl a . Hosp . (Adventi st Health) v. Agency for

Health Care Admin . , 823 So. 2d 844, 847 (Fla. 1st DCA 2002).

The deference to agency interpretation of a statute it is

charged with enforcing applies even if other interpretations or

alternative rules exist. Atlantic Shores Resor t v. 507 S. St.

Corp. , 937 So. 2d 1239, 1245 (Fla. 3d DCA 2006); Miles v. FAMU ,

813 So. 2d 242, 245 (Fla. 1st DCA 2002); B d. of Tr s. , 656 So. 2d

at 1363. Similarly, Ð[a]gencies are accorded wide deference in

the exercise of lawful rulemaking authority whi ch is clearly

conferred or fairly implied and consistent with the agency's

general statutory duties. Charity v. FS U , 680 So. 2d 463, 466

(Fla. 1st DCA 1996).

11 5 . The challenger's burden to demonstrate an invalid

exercise of delegated legislative author ity Ðis a stringent one

indeed.Ñ Agrico , 365 So. 2d at 763.

11 6 . The Department drafted the proposed rule pursuant to

section 395.402(4) . It developed a scoring system to assess

need based upon six criteria and allocated between one and three

trauma centers per TSA. The Proposed Rule allocated a maximum

total of 27 positions for trauma centers , precisely the number

currently existing or approved and fewer than the 44 allowed by

statute .

11 7 . Petitioners claim that the Proposed Rule is invalid

because i t does not incorporate all of the criteria set forth in

section 395.402(3) . These criteria, however, are part of a

separate and distinct statutory requirement that the Department

conduct an annual assessment as to whe ther the existing trauma

system is effective in providing trauma care throughout the

state. The statutory requirement for rulemaking ( s ection

395.402(b) - (c)) does not specify the criteria the Department was

required to use in allocating trauma centers.

11 8 . Nonetheless, d uring the rulemaking process, the

Department did consider each of the criteria listed in s ection

395.402(3) . If particular criteria were not reflected in the

Proposed Rule it was because , after careful consideration, the

data could not be confidently used .

11 9 . The Proposed Rule was issued after a rule development

process over the course of more than one year. The Department

afforded every impacted constituency the opportunity to express

their views and conducted an extensive review of literature and

data related to trauma care. During this process, t he

Department carefully considered the views of Stakeholders,

including Petitioners (or their representative s ) and, where

appropriate, modified the Proposed Rule to t ake into account

their input.

1 20 . The Legislature did not s pecify the criteria that the

Department was required to use in allocating TSAs but instead

delegated the Department a mandate to allocate Ðby ruleÑ the

number of trauma centers in each TSA. The Legislature

recognized that the Department, as a specialized administrative

body with expertise in public health, was in the best position

to make that determination. The allocation of trauma centers is

a complex process and there is no universally accepted

methodology. As the ACS has explained:

The optimal balanc e between these choices

and trade - offs will not yield a single

universal solution, but will depend upon

uniquely local factors, including geography,

resource availability, and regional social

elements. In the end, the decision is

inherently political rath er than purely

scientific. For that reason, it is a

decision that few regions have been able to

execute successfully.

Bayfront Exhibit 12.

12 1 . The DepartmentÓs Proposed Rule was the product of

thoughtful consideration by the DepartmentÓs experts durin g an

extensive rulemaking development process. Under these

circumstances, the DepartmentÓs determinations are accorded

deference. See, e.g. , Island Harbor Beach Club, Ltd. v. DepÓt

of Nat . Res . , 495 So. 2d 209, 223 (Fla. 1st DCA 1986) (ÐThe

complexity of the scientific and technical issues in this case

and the consequent deference necessarily given to [the

Department of Natural ResourceÓs] expertise vividly illustrate

the limited role an appellate court can play in resolving

disputes arising out of an adm inistrative agencyÓs exercise of

delegated discretion in respect to technical matters . . . .Ñ);

Rizov v. State, Bd. of Prof . Eng Órs , 979 So. 2d 979, 980 - 81

(Fla. 3d DCA 2008) (ÐAgencies generally have more expertise in a

specific area they are charged wit h overseeing. Thus, in

deferring to an agency's interpretation, courts benefit from the

agency's technical and/or practical experience in its field.Ñ);

see also Avatar Dev . Corp. v. State , 723 So. 2d 199, 207 (Fla.

1998) (ÐUnder the complexities of our mo dern system of

government, the Legislature has recognized that [the Department

of Environmental Protection], as a specialized administrative

body, is in the best position to establish appropriate standards

and conditions . . . .Ñ)

12 2 . The rulemaking proc ess also refutes any claim that

the Proposed Rule was arbitrary or capricious. There was ample

testimony as to the facts and logic supporting each of the

criteria in the Proposed Rule -- negating any claim of

arbitrariness. The fact that the Department dev eloped the

Proposed Rule after a year of careful analysis as to the factors

that should be used to assess trauma center need negates any

claim that the Proposed Rule is ÐcapriciousÑ because it was one

allegedly Ðtaken without thoug ht or reason or irrationa lly.Ñ

123. The DepartmentÓs determination that the TSAs should

not be abolished and that their borders should not be realigned

should be accorded deference because there was no statutory

mandate to abolish or realign the TSAs. It is difficult to

reconcil e the continued existence of s ection 395.402 after the

recommendations in the 2005 Assessment, unless the Legislature

meant for DOH to have an option to use the 19 TSAs un til they

found a more effective and manageable way to allocate trauma

centers within the State. In this case, DOH adequately

described its analysis resulting in the decision to continue

(for the present) to use the 19 TSAs in lieu of the RDSTF

regions or any other system.

124. The Legislature has mandated that the Department

address two separate functions: trauma planning (for example,

in response to mass - casualty events) and the alloc ation of

trauma centers to TSAs.

125. Section 395.4015, is focused exclusively on trauma

planning -- not trauma center allocation -- as indicated by its

title : ÐState regional trauma planning; trauma regions.Ñ As

part of the LegislatureÓs 2004 amendments to the Trauma Statu t e,

the Legislature mandated that Ðthe department shall establish

trauma regions that cover all geographical areas of the state

and have b oundaries that are coterminous with the boundaries of

the regional domestic security task forces,Ñ which Ðmay serve as

the basis for the development of department - approved local or

regional trauma plans.Ñ § 395.4015(1) , Fla. Stat . While this

section mandated that the Department establish trauma regions

that were coterminous with the RDSTFs, it said nothing about

TSAs, the allocation of trauma centers, or the provision of

trauma care.

126. Section 395.402 , the section implemented by the

Proposed Rule, exp licitly recognizes the continued existence of

TSAs. Subsection (2)(a) states that in conducting its annual

assessment, the Department was required to Ð[c]onsider aligning

trauma service areas within the trauma region boundaries as

established in July 2004 .Ñ The meaning of the term ÐconsiderÑ

as a matter of plain English is permissive, not mandatory. See ,

e.g. , Merriam - Webster dictionary (defining ÐconsiderÑ as Ðto

think about (something or someone) carefully especially in order

to make a choice or decisi onÑ). In other words, the Department

was supposed to consider whether the boundaries of the TSAs

should be redrawn to fit neatly within the trauma regions; this

provision did not contemplate abolishing TSAs altogether.

Subsection ( 4 ) similarly required t he Department to conduct an

annual review [of] the assignment of the 67 counties to trauma

service areas and stated that Ð[i]n cases where a trauma service

area is located within the boundaries of more than one trauma

region, the trauma service areaÓs need s, response capability,

and system requirements shall be considered by each trauma

region served by that trauma service area in its regional system

plan.Ñ This subsection contemplated the ongoing existence for

TSAs -- creating the need for annual reviews -- a nd a clear

distinction between TSAs on the one hand and trauma regions or

RDSTFs on the other, including the fact that they are different

entities and could have overlapping geographical boundaries. It

is noteworthy that the above - cited provisions were al so added as

a result of the 2004 statutory a mendments. Unlike the

amendments to section 395.4015, which included a mandate to

establish trauma regions that were coterminous with the RDS TF s,

the Legislature did not include any similar mandates with

respect to TSAs.

127. As set forth above, the Department extensively

considered whether the boundaries of TSAs should be realigned

within the RDSTFs and reasonably concluded that the interests of

FloridaÓs public health was best served by maintaining the

status quo until such time as an appropriate regional trauma

planning structure was developed or the Department was given

clear authority to allocate trauma centers within RDSTFs.

128. Due to the size of the trauma planning regions, which

mirror the RDSTF bounda ries, regional trauma agencies are

necessary to aid in trauma center allocation and ensure trauma

centers are appropriately located throughout the regions. At

this time, there is only one regional trauma planning agency in

Florida.

129. In Citizens of Fl orida v. Mayo , 357 So. 2d 731, 733

(Fla. 1970), the Florida Supreme Court held that no court can

require an agency to adopt a specific rule, noting that Ðthe

agency rulemaking function involves the exercise of agency

discretion and this Court will not su bstitute its judgment for

that of the agency on an issue of discretion.Ñ The CourtÓs

analysis recognized that it is the statutory language which

controls the adoption of a rule, not the CourtÓs opinion as to

what a rule should include. In Bayonet Point H ospital, Inc. v.

Department of Health & Rehab ilitative Services , 490 So. 2d 1318,

1320 (Fla. 1st DCA 1986), the First District adopted the

analysis in Mayo , supra , and confirmed that a court has no

authority to compel agency adoption of a rule which repres ents a

policy choice in the area of the agencyÓs statutory concern.

Id. ( citing FEA/United v. PERC , 346 So. 2d 551 (Fla. 1st DCA

1977)). Prior decisions related to the 1992 Rule ( Bayfront Med .

C tr , Inc. et al. v. Dep Ó t of Health , Case Nos. 11 - 2602 RX , et al.

(Fla. D OAH , Sept. 23, 2013 ) ; and Dep Ó t of Health v. Bayfront

Med . Ctr . , Inc. , 134 So. 3d 1017 (Fla. 1 st DCA 2012)) , could not

dictate the results of the DepartmentÓs consideration over the

course of the rule development process for this Proposed Rule

a bout whether the TSAs should be aligned with the trauma

regions/RDSTFs, or mandate that the TSAs be abolished.

130. Contrary to the claim made by Petitioners, the

Proposed Rule is valid even though the Proposed Rule, on its

face, does not define the sourc es of data that would be used to

measure population, median transport time or hospital discharge

data.

131. In February 2014, the JAPC sent the Department a

letter stating that the Trauma Service Area Assessment, which

identifies the source data for crite ria used in the Proposed

Rule, was not specifically incorporated by reference into the

text of the Proposed Rule. The Department responded that the

assessment was prepared pursuant to a different statutory

requirement and that it did not have the force of law. The JAPC

has not objected to the Proposed Rule. The March TSA Assessment

does not constitute a rule as defined by section 120.52(16). It

is an informational reference only and therefore is not required

to be incorporated by reference. See ÐLookin g Glass Law:

Legislation by Reference in the States,Ñ F. Scott Boyd,

Louisiana L. Rev., Vol. 68, Number 4, Summer 2008.

132. Rules are valid even if they afford discretion to the

administrative agency in carrying them out. In Florida East

Coast Industri es , Inc. v. State Department of Community Affairs ,

677 So. 2d 357 (Fla. 1st DCA 1996), petitioners claimed that

proposed rules related to urban sprawl vested the agency with

unbridled discretion. The court agreed with the ALJÓs finding

that the rule in qu estion did not vest the agency with unbridled

discretion, relying upon testimony that determining what

constituted urban sprawl was so complex that it made a more

specific rule impossible. Id. at 361. The court concluded that

Ðexecutive agencies may exer cise some discretion witho ut

breaching their authority.Ñ Id.

133. Similarly , in Southwest Fl orida Water M anagement

District v. Charlotte County , 774 So. 2d 903, 911 (Fla. 2d DCA

2001), the court upheld the ALJÓs finding that a rule that used

subjective terminology like Ðadverse impactÑ did not improperly

vest the agency with Ðunbridled discretion.Ñ It agreed with the

ALJÓs conclusion that Ð[i]t is appropriate and acceptable for

the rules to allow for the exercise of professional judgment.Ñ

Id. It stat ed that if determining what constitutes an adverse

impact to the environment requires professional judgment, then

determining what measures could be taken to prevent or lessen

the adverse impact also allow for the use of professional

judgment. Id.

134. The Proposed Rule affords the Department far less

discretion than the rules in the cases described above. It is

certainly well within the DepartmentÓs professional judgment to

identify appropriate sources of data to measure population,

median transport ti me and hospital discharge data. This is

particularly true since these criteria reflect data gathered by

the Department or other government entities. Further, the

Department is working to improve and expand data sources

available, and the absence of defin ed data sources gives the

Department flexibility to use improved data sources in the

future.

135. The reasonableness of the DepartmentÓs use of

criteria without specific definitions as a means for allocating

points is confirmed by other rules with similar characteristics.

See, e.g. , Fla. Admin. Code R. 5F - 14.003(6)(b)1 . (awarding

points if a Ð[p]roject results in significant bioenergy

production from Florida grown biomass resourcesÑ -- without

definitions for measurement of Ðbioenergy productionÑ or

Ðbiomas s resourcesÑ); Fla. Admin. Code R. 14 - 79.006(8)(a) 2.

(awarding points for bidding/estimates based on the criteria of :

Ð[d]emonstrates an understanding of all requisite steps in the

preparation of Department bidsÑ and Ðdemonstrates competence in

estimating project cost accuratelyÑ -- without defining either

criteria); Fla. Admin. Code R. 1T - 1.038(4) (awarding points for

Ðartistic excellence , Ñ Ðtradition and authenticity , Ñ and

Ðcommunity impact and engagementÑ -- without defining those

terms).

136. The crux of P etitionersÓ objection is that the

Proposed Rule is invalid because it will result in increased

competition, which will allegedly cause harm to PetitionersÓ

trauma centers. As discussed above, the Legislature delegated

to the Department the responsibility to allocate trauma centers -

- which meant the Department was required to balance a myriad of

interests including those of PetitionersÓ trauma centers, the

Intervenor, newly established trauma centers that have not yet

received final approval, EMS providers, elected representatives

and patient advocates. It would be impossible to develop a rule

that could simultaneously satisfy all of these interests --

although, as discussed above, the Department incorporated the

PetitionersÓ concerns into the Proposed Rule as the Department

believed appropriate. The DepartmentÓs determination of the

appropriate balance of conflicting interests is owed deference --

even if the result was a Proposed Rule with which Petitioners do

not agree.

137. In Board of Trustees , petitioner challenged the

decision of the Trustees (an administrative agency) to deny his

application to extend his existing 500 - foot dock to 600 feet,

based upon a rule that mandated that the maximum dock length as

500 feet. 656 So. 2d at 1361. The ALJ found that the decision

was not capricious because it reflected Ðthe thoughtful

balancing of varying factors , Ñ but found that the rule was

arbitrary because there was no evidence that the 500 foot limit

protected environmental interests. Id. at 1362. The appellate

court agreed with the ALJÓs finding with respect to

capriciousness but reversed with respect to arbitrariness. Id.

at 1363. The court found that in promulgating a predecessor

rule, the Trustees Ðattempted to balance competing interests

such as environmen tal, aesthetic, recreational, and private

commercial.Ñ Id. It concluded by stating: ÐThe issue before

the hearing officer . . . was not whether Trustees made the best

choice . . . or whether their choice is one that the appellee

finds desirable for his particular location. The issue is

whether the Trustees made a choice based upon facts, logic and

reason. It is clear they did.Ñ Id. at 1364. Here too, the

Department developed the allocation rule based upon facts, logic

and reason. The fact that the P roposed Rule may cause

Petitioners economic harm is not a basis to invalidate it.

ORDER

Based on the foregoing Findings of Fact and Conclusions of

Law, it is ORDERED that r ule 64J - 2.010 does not constitute an

invalid exercise of delegated legislative aut hority.

DONE AND ORDERED this 20th day of June , 2014 , in

Tallahassee, Leon County, Florida.

S

R. BRUCE MCKIBBEN

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tall ahassee, 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 June , 2014 .

COPIES FURNISHED:

Seann M. Frazier, Esquire

Parker, Hudson, Rainer a nd Dobbs, LLP

215 South Monroe Street , Suite 750

Tallahassee, Florida 32301

Chadwick R. Stevens, Esquire

Department of Health

4052 Bald Cypress Way , Bin A02

Tallahassee, Florida 32399

Christopher Charles Kokoruda, Esquire

Miami - Dade County Attorney's O ffice

JMH, West Wing, Suite 109

1611 Northwest 12th Avenue

Miami, Florida 33136

Karen Ann Putnal, Esquire

Moyle Law Firm, P.A.

118 North Gadsden Street

Tallahassee, Florida 32301

Jeffrey L. Frehn, Esquire

Radey, Thomas, Yon and Clark , P.A.

301 South Br onough Street , Suite 200

Tallahassee, Florida 32301

W. Robert Vezina, III, Esquire

Vezina, Lawrence and Piscitelli, P.A.

413 East Park Avenue

Tallahassee, Florida 32301

Jonathan L. Rue, Esquire

Parker, Hudson, Rainer and Dobbs, LLP

285 Peachtree Center Avenue , Suite 1500

Atlanta, Georgia 30303

J. Stephen Menton, Esquire

Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202

Tallahassee, Florida 32301

John H. Armstrong, M.D., F.A.C.S.

State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399 - 1701

Jennifer A. Tschetter, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Jamie Briggs, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahas see, Florida 32399 - 1701

Ken Plante, Coordinator

Joint Administrative Procedures Committee

Room 680, Pepper Building

111 West Madison Street

Tallahassee, Florida 32399 - 1400

Liz Cloud, Program Administrator

Administrative Code

Department of State

R. A. Gray Building, Suite 101

Tallahassee, Florida 32399

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is

entitled to judicial review pursuant to section 120.68, Florida

Statutes. Review proceedings are gov erned by the Florida Rules

of Appellate Procedure. Such proceedings are commenced by

filing the original notice of administrative appeal with the

agency clerk of the Division of Administrative Hearings within

30 days of rendition of the order to be review ed, and a copy of

the notice, accompanied by any filing fees prescribed by law,

with the clerk of the District Court of Appeal in the appellate

district where the agency maintains its headquarters or where a

party resides or as otherwise provided by law.