STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

SHANDS JACKSONVILLE MEDICAL CENTER, INC., d/b/a UF HEALTH JACKSONVILLE,

Petitioner,

vs.

DEPARTMENT OF HEALTH,

Respondent,

and

JFK MEDICAL CENTER LIMITED PARTNERSHIP, d/b/a JFK MEDICAL CENTER; THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, d/b/a JACKSON SOUTH COMMUNITY HOSPITAL; AND ORANGE PARK MEDICAL CENTER, INC., d/b/a ORANGE PARK MEDICAL CENTER,

Intervenors.

/

Case No. 16-5837RP

FLORIDA HEALTH SCIENCES CENTER, INC., d/b/a TAMPA GENERAL HOSPITAL,

Petitioner,

vs.

DEPARTMENT OF HEALTH,

Case No. 16-5838RP

Respondent,

and

JFK MEDICAL CENTER LIMITED PARTNERSHIP, d/b/a JFK MEDICAL CENTER; THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, d/b/a JACKSON SOUTH COMMUNITY HOSPITAL; AND ORANGE PARK MEDICAL CENTER, INC., d/b/a ORANGE PARK MEDICAL CENTER,

Intervenors.

/

LEE MEMORIAL HEALTH SYSTEM, d/b/a LEE MEMORIAL HOSPITAL,

vs.

Petitioner,

Case No. 16-5839RP

DEPARTMENT OF HEALTH,

Respondent,

and

JFK MEDICAL CENTER LIMITED PARTNERSHIP, d/b/a JFK MEDICAL CENTER; THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, d/b/a JACKSON SOUTH COMMUNITY HOSPITAL; AND ORANGE PARK MEDICAL CENTER, INC., d/b/a ORANGE PARK MEDICAL CENTER,

Intervenors.

/

BAYFRONT HMA MEDICAL CENTER, LLC, d/b/a BAYFRONT HEALTH - ST. PETERSBURG,

Petitioner,

vs.

DEPARTMENT OF HEALTH,

Case No. 16-5840RP

Respondent,

and

JFK MEDICAL CENTER LIMITED PARTNERSHIP, d/b/a JFK MEDICAL CENTER; THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, d/b/a JACKSON SOUTH COMMUNITY HOSPITAL; AND ORANGE PARK MEDICAL CENTER, INC., d/b/a ORANGE PARK MEDICAL CENTER,

Intervenors.

/

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

vs.

Petitioner,

Case No. 16-5841RP

DEPARTMENT OF HEALTH,

Respondent,

and

JFK MEDICAL CENTER LIMITED PARTNERSHIP, d/b/a JFK MEDICAL CENTER; THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, d/b/a JACKSON SOUTH COMMUNITY HOSPITAL; AND ORANGE PARK MEDICAL CENTER, INC., d/b/a ORANGE PARK MEDICAL CENTER,

Intervenors.

/

FINAL ORDER

Pursuant to notice, a final hearing was held in this case on January 10 through 13, 2017, in Tallahassee, Florida, before Garnett W. Chisenhall, a duly-designated Administrative Law Judge of the Division of Administrative Hearings (“DOAH”).

APPEARANCES

For Petitioners: Sean Frazier, Esquire

Marc Ito, Esquire

Parker, Hudson, Rainer & Dobbs, LLP

215 South Monroe Street, Suite 750 Tallahassee, Florida 32301

(Counsel for UF Health Jacksonville, Lee Health, and Tampa General Hospital)

Geoffrey D. Smith, Esquire Smith & Associates

3301 Thomasville Road, Suite 201

Tallahassee, Florida 32308 (Counsel for Bayfront Health - St. Petersburg)

Karen Putnal, Esquire Moyle Law Firm, P.A.

1. North Gadsden Street Tallahassee, Florida 32301 (Counsel for St. Joseph’s Hospital)

   
   

   For Respondent: Jay Patrick Reynolds, Esquire

   Michael Jovane Williams, Esquire Department of Health

   Prosecution Services Unit

   4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399

   
   

   For Intervenors: Stephen A. Ecenia, Esquire

   J. Stephen Menton, Esquire Gabriel F.V. Warren, Esquire Rutledge, Ecenia, & Purnell, P.A.

2. South Monroe Street, Suite 202 Tallahassee, Florida 32301 (Counsel for JFK Medical Center and Orange Park Medical Center)

Thomas F. Panza, Esquire Jennifer K. Graner, Esquire Panza, Maurer & Maynard, P.A.

2400 East Commercial Boulevard, Suite 905 Fort Lauderdale, Florida 33308

(Counsel for The Public Health Trust of Miami-Dade County)

STATEMENT OF THE ISSUE

Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative

authority as defined in section 120.52(8), Florida Statutes (2016).1/

PRELIMINARY STATEMENT

On October 6, 2016, Shands Jacksonville Medical Center, Inc., d/b/a UF Health Jacksonville (“Shands Jacksonville”); Florida Health Sciences Center, Inc., d/b/a Tampa General Hospital (“Tampa General”); Lee Memorial Health System, d/b/a Lee Memorial Hospital (“Lee Memorial”); Bayfront HMA Medical Center, LLC, d/b/a Bayfront Health – St. Petersburg (“Bayfront Health”); and St. Joseph’s Hospital, Inc., d/b/a St. Joseph’s Hospital (“St. Joseph’s Hospital”), filed petitions alleging that the Proposed Rules are an invalid exercise of delegated legislative authority. The aforementioned entities will be collectively referred to as “Petitioners.”

Petitioners alleged that the Proposed Rules are invalid because they: (a) exceed the Department of Health’s (“the Department”) rulemaking authority; (b) enlarge, modify, or contravene the specific provisions of law to be implemented;

(c) vest unbridled discretion in the Department; and (d) are arbitrary and capricious.

St. Joseph’s Hospital additionally alleged in its Petition that the Proposed Rules are invalid because the Department failed to follow the applicable rulemaking procedures. Shands Jacksonville, Tampa General, Lee Memorial, and Bayfront Health

additionally alleged that the Proposed Rules would impose a regulatory cost that could be reduced through a less costly alternative. However, the aforementioned additional arguments were not raised during the final hearing or in Petitioners’ jointly-filed Proposed Final Order.

Shands Jacksonville additionally alleged in its Petition that the Department utilized unadopted rules in: (a) measuring community support for new trauma centers; and (b) allowing provisionally approved trauma centers to operate during challenges to the Department’s provisional approval. The foregoing arguments specifically pertain to the application of Orange Park Medical Center, Inc. (“Orange Park”), to operate a provisional trauma center in close proximity to Shands Jacksonville. Administrative Law Judge (“ALJ”) W. David Watkins considered Shands Jacksonville’s challenge to Orange Park’s application in Shands Jacksonville Med. Ctr., Inc. v. Dep’t of

Health and Orange Park Med. Ctr., Case No. 16-3369 (Fla. DOAH

Jan. 27, 2017), and ALJ Watkins concluded that the Department “acted illegally” in allowing Orange Park to operate as a provisional trauma center during the pendency of a challenge to its application. That conclusion along with other reasoning led ALJ Watkins to recommend that Orange Park’s application be denied.

The aforementioned arguments by Shands Jacksonville are additional attacks on Orange Park’s application. Given ALJ Watkins’ ruling and the fact that Shands Jacksonville’s arguments regarding the application of an unadopted rule were not set forth as grounds for relief in the “Conclusions of Law” section of Petitioners’ jointly-filed Proposed Final Order, the undersigned has elected not to address them herein.

On October 12, 2016, the Department moved to consolidate the aforementioned cases pursuant to Florida Administrative Code Rule 28-106.108.

On October 13, 2016, Orange Park and JFK Medical Center Limited Partnership, d/b/a JFK Medical Center (“JFK Medical Center”), filed Petitions to Intervene.

The Public Health Trust of Miami-Dade County, Florida, d/b/a Jackson South Community Hospital (“Jackson South”), filed a Petition to Intervene on October 14, 2016.

On October 14, 2016, the undersigned granted the Department’s Motion to Consolidate. The undersigned also scheduled the final hearing for November 9, 2017, and November 15 through 17, 2016.

Via Orders issued on October 18, 2016, the undersigned granted Orange Park, JFK Medical Center, and Jackson South’s Petitions to Intervene. Orange Park, JFK Medical Center, and

Jackson South will be collectively referred to as “the Intervenors.”

On October 19, 2016, Orange Park and JFK Medical Center filed Amended Petitions to Intervene that were granted via Orders issued on October 25, 2016.

On October 27, 2016, the Department filed a Motion for Protective Order seeking to prevent discovery of certain information pertaining to trauma centers. In support thereof, the Department asserted that section 395.402(12), Florida Statutes, rendered the information at issue confidential and non-discoverable. Via a “Motion to Compel Department of Health Production of Documents and Request for Expedited Hearing on Motion” (“the Motion to Compel”) filed on October 28, 2016,

St. Joseph’s Hospital argued that it was not seeking information that fell under the scope of section 395.402(12).

On October 28, 2016, Petitioners filed an opposed “Joint Motion for Continuance” asking that the final hearing begin on November 15, 2016, rather than November 9, 2016.

Via an “Order on Pending Requests for Relief” issued on October 31, 2016, the undersigned: (a) granted the Joint Motion for Continuance; (b) granted St. Joseph’s Motion to Compel; and

(c) denied the Department’s Motion for Protective Order.

On November 2, 2016, St. Joseph’s Hospital filed a “Motion to Compel Department of Health’s Responses to SJH

Interrogatories 12 through 22 and Request for Expedited Ruling.” The undersigned issued an “Order to Show Cause” requiring the Department to show cause by November 7, 2016, why the aforementioned Motion to Compel should not be granted.

On November 3, 2016, Petitioners filed a “Memorandum of Law Regarding Order of Presentation” (“the Memorandum of Law”). The Memorandum of Law noted that the Florida Legislature had amended section 120.56(2)(a) during the 2016 legislative session so that the aforementioned statute provides that:

The petitioner has the burden to prove by a preponderance of the evidence that the petitioner would be substantially affected by the proposed rule. The agency then has the burden to prove by a preponderance of the evidence that the proposed rule is not an invalid exercise of delegated legislative authority as to the objections raised.

§ 120.56(2)(a), Fla. Stat. Because section 120.56(2)(a) still directs that petitioners in rule challenge proceedings have the burden of going forward with evidence supporting their objections, Petitioners in the instant case requested that they be allowed to present their case in chief first.

On November 4, 2016, St. Joseph’s Hospital filed a motion asking that the final hearing be briefly continued. In support thereof, St. Joseph’s Hospital alleged that there had been issues with the Department’s document production and that there

was insufficient time to resolve those issues prior to expert witness depositions.

After holding a telephonic motion conference on November 8, 2016, the undersigned issued an Order on November 14, 2016, canceling the final hearing scheduled for November 15

through 17, 2016. On November 15, 2016, the undersigned issued an Order re-scheduling the final hearing for January 10 through 13, 2017.

With regard to St. Joseph’s Hospital’s Motion to Compel that had been filed on November 2, 2016, the undersigned issued an Order on November 17, 2016, requiring the Department to “provide full and specific answers” to the interrogatories in question by December 2, 2016.

On November 18, 2016, the undersigned addressed the question regarding the order of presentation. In the course of doing so, the undersigned observed that:

The final legislative staff analysis stated that the foregoing amendment to section

120.56 “clarifies the parties’ respective burdens of proof in challenges to proposed rules and unadopted rules.” (emphasis added).

Because the Florida Legislature merely intended to clarify, rather than change, the parties’ respective burdens of proof in proposed rule challenge proceedings, the answer to the parties’ dispute about the order of presentation can be gleaned from existing precedent on proposed rule challenge proceedings.

The undersigned then cited St. Johns River Water Mgmt.

Dist. v. Consolidated Tomoka Land Co., 717 So. 2d 72, 76-77 (Fla. 1st DCA 1998), which held that “[a] party

challenging a proposed rule has the burden of establishing a factual basis for the objections to the rule, and then the agency has the ultimate burden of persuasion to show that the proposed rule is a valid exercise of delegated legislative authority.” Accordingly, the undersigned ordered that “Petitioners shall present their case first and attempt to establish a factual basis for their objections to the proposed rules at issue. The Department of Health and Intervenors shall then present their case and attempt to demonstrate that the proposed rules at issue are not invalid as to the objections raised. The evidentiary portion of this proceeding will then be concluded.”

On December 30, 2016, JFK Medical Center and Orange Park filed a Motion in Limine asking that Petitioners be precluded from: (a) raising issues that were previously litigated in a previous challenge2/ to the current version of rule 64J-2.010; and (b) arguing that the Department lacks the statutory authority to allocate the minimum number of trauma centers in each Trauma Service Area.

The undersigned deferred ruling on the Motion in Limine, and the Motion in Limine is now denied. While the undersigned

has the distinct impression that Petitioners are not fully supportive of the current version of rule 64J-2.010, Petitioners’ challenge was properly directed toward the Proposed Rules. Furthermore, to whatever extent that Petitioners’ presentation during the final hearing touched on their previously raised objections to the current version of rule 64J- 2.010, the undersigned finds that the information was useful background information and that the Department and Intervenors were not prejudiced.

On January 5, 2017, Petitioners filed a “Joint Motion for Summary Final Order” arguing that there were no disputed issues of material fact and that the Proposed Rules were invalid as a matter of law. The Joint Motion for Summary Final Order was denied during a telephonic pre-hearing conference on January 9,

2017.

The final hearing was held as scheduled on January 10

through 13, 2017. Joint Exhibits 1 through 5 were accepted into

evidence. Petitioners’ Exhibits 1 through 4, 6, 8, 18 through

26, 31, 35, 36, 37, 40 through 47, 50, 55, 66, and 67 were

accepted into evidence. Petitioners’ Exhibits 10, 11, 49, and

53 were accepted into evidence subject to hearsay objections.

Petitioners’ Exhibits 51, 52, 54, and 56 through 58 were accepted into evidence subject to objections as to their weight and credibility. Orange Park and JFK Medical Center’s

Exhibits 2 through 4, 6, 7, 11, 16, and 42 were accepted into evidence. Orange Park and JFK Medical Center’s

Exhibits 12 through 15 were accepted into evidence subject to hearsay objections.

Petitioners presented the testimony of Dr. David Ciesla, who was accepted as an expert in trauma medicine and surgical care; Leah Colston, the Department’s Chief of the Bureau of Emergency Medical Oversight; Cynthia Gerdik, R.N., PhD., who was accepted as an expert in nursing, trauma care, and trauma center administration; Dr. Steven Epstein, who was accepted as an expert in trauma surgery; Mark Richardson, who was accepted as an expert in healthcare facility and services planning; and

Dr. Mark Vaaler, who was accepted as an expert in trauma center and acute care medical staff administration.

The Department called Cindy Dick, its interim Division Director for the Division of Emergency Preparedness and Community Support.

Orange Park and JFK Medical Center called Dr. Mark McKinney, who was accepted as an expert in surgical care and trauma care; and Michael Heil, who was accepted as an expert in trauma center and system planning and development.

Toward the conclusion of the final hearing, Petitioners asked the undersigned to accept the deposition of Armand Balsano, a health planning expert. After Jackson South’s

counsel objected, the undersigned instructed Petitioners to file a motion regarding their request.

On January 20, 2017, Petitioners filed a “Motion to Receive Deposition Transcript into Evidence” (“the Motion to Receive Deposition”), and the Motion to Receive Deposition is granted.

However, the issue regarding the operation of provisional trauma centers was addressed by ALJ Watkins in his Shands Jacksonville

Med. Ctr., Case No. 16-3369 (Fla. DOAH Jan. 27, 2017). As a

result, Mr. Balsano’s opinion is cumulative.

The seven-volume transcript was filed on January 30, 2017, and the parties’ proposed final orders were due to be filed on February 9, 2017.

On February 9, 2017, Petitioners filed an “Unopposed Motion for One-Day Extension of Time for the Parties to File Proposed Final Orders” (“the Extension Motion”). In support thereof, Petitioners asserted that “[t]he parties have conferred and agree that an additional day will allow for a more complete review of the record and better proposed orders.”

On February 10, 2017, the undersigned granted the Extension Motion, and the parties timely filed their proposed final orders.

On February 16, 2017, Jackson South filed a Motion to Strike particular portions of Petitioners’ Proposed Final Order. In support thereof, Jackson South took issue with the fact that

Petitioners’ Proposed Final Order incorporated portions of Mr. Balsano’s deposition without it being admitted into evidence. As a result, Jackson South requested that the undersigned disregard the portions of Mr. Balsano’s deposition that were incorporated into Petitioners’ Proposed Final Order.

The Motion to Strike is denied. The undersigned considered Mr. Balsano’s deposition statements but did not find them helpful.

The undersigned considered all of the Proposed Final Orders in the preparation of this Final Order.

On March 8, 2017, St. Joseph’s Hospital filed a Notice of Supplemental Authority directing the undersigned’s attention to ALJ Watkins’ Recommended Order in Shands Jacksonville Med. Ctr. Jackson South responded by filing a “Motion to Strike St.

Joseph’s Hospital, Inc.’s Notice of Supplemental Authority” (“the Motion to Strike”) on March 9, 2017. In support thereof, Jackson South set forth several reasons why the Notice of Supplemental Authority should be stricken.

The Motion to Strike is denied. The undersigned was aware of the ruling in DOAH Case No. 16-3369 when it was released on January 27, 2017, and had thoroughly reviewed the Recommended Order prior to the filing of the Notice of Supplemental Authority.

FINDINGS OF FACT

Background on Trauma Centers

1. A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ”

   § 395.4001(14), Fla. Stat.

   
   

2. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad.

3. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education.

4. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients.

   
   

5. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45.

6. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above.

7. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II

   
   

   trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat.

   (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/

8. In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital.

   The Parties

   
   

9. The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the

   intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national

   guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”);

   § 395.402(2), Fla. Stat. (mandating that “[t]he department shall

   
   

   review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”).

10. Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he

    department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”).

11. Those rules (see, e.g., rule 64J-2.010) determine how

    
    

    many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida.

    See § 395.402(4), Fla. Stat.

    
    

12. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties.

13. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County.

14. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties.

15. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties.

    
    

16. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County.

17. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County.

18. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below.

    The Statutory Scheme Governing Trauma Centers

    
    

19. As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma

    
    

    centers needed to ensure reasonable access to high-quality trauma services.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”).

20. The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.”

    § 395.402(4)(b), Fla. Stat.

    
    

21. However, there is a state-wide, statutory cap of

    
    

    44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”).

22. Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he

    department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the

    
    

    local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.”).

23. By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”).

24. “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat.

25. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year.

26. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat.

    
    

27. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has:

    1. the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat.

28. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat.

29. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified.

30. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat.

31. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The

    
    

    out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat.

32. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat.

33. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat.

    (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a

    need for such a trauma center.”). (emphasis added).

    
    

34. The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat.

35. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it

    
    

    must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id.

36. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id.

37. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least

    180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat.

38. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants.

    Assessment of Need for Trauma Centers under the Current Rules

    
    

39. The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed

    for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department to “[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system.”); § 395.402(3), Fla. Stat. (mandating that the Department must consider the following

    
    

    during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; medically appropriate ground and air travel times; recommendations of the Regional Domestic Security Task Force; the actual number of trauma victims currently being served by each trauma center; and other appropriate criteria).

40. As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”).

41. The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”).

    
    

42. With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs.

43. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J-

    2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA.

44. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population;

    1. median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals;

    (e) Level I trauma centers; and (f) number of severely injured patients.

45. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services.

46. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or

    8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1.

    
    

47. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points.

    
    

    In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2.

48. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that:

    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 centers.

       
       

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

       
       

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

       
       

49. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers.

    
    

    The Department Changes Its Interpretation of “Need”

    
    

50. In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5.

51. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent.

52. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular

    TSA.

    
    

53. In 2015, Orange Park submitted another letter of

    
    

    intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed.

54. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA.

55. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s

    
    

    application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange

    Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order

    
    

    Jan. 27, 2017).

    
    

56. Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a

    particular TSA.

    
    

    Assessment of Need under the Proposed Rules

    
    

57. During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted.

58. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida.

    
    

59. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA.

60. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department):

    [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than

    10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula.

    
    

61. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016.

    
    

62. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers

    needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA.

63. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs.

64. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect

    existing verified trauma centers seeking renewal of

    
    

    their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added).

65. The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in

    paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s

    TSA.” As a result, there would no longer be TSA-specific caps

    
    

    in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers.

66. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7):

    The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA.

    
    

67. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows:

    A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial.

    
    

68. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA

    rather than the maximum number of trauma centers allowed in that

    
    

    TSA, the Department could conceivably approve every applicant

    
    

    in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded.

69. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan.

70. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of

    44 would be met or exceeded and another TSA lacked the statutory minimum of one:

    Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but

    
    

    there is still not one in Collier County, how does it work at that point as a potential new applicant comes in?

    
    

    A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are

    43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe.

    
    

    Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then?

    
    

    A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well.

    
    

71. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule:

    Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications

    
    

    that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical?

    
    

    ALJ: We are still talking about the [Current Rules]?

    
    

    Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you.

    A: I understand what you are saying.

    
    

    Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number?

    
    

    A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do.

    
    

    Q: Correct. There’s no criteria or standards?

    
    

    A: No, those procedures are not outlined in the rule, no.

    
    

    Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring?

    
    

    A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need,

    
    

    we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum.

    
    

    Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County?

    
    

    A: No.

    
    

    Q: There’s nothing in [the Proposed Rules] that says that?

    
    

    A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances.

    
    

    * * *

    
    

    Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards?

    
    

    A: And have the endorsement of the regional trauma agency, yes.

    
    

    The Potential Utility Associated with Adopting the Proposed Rules

    
    

72. All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida.

73. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers.

74. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients.

75. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013.

76. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life:

    I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t

    
    

    have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number.

    
    

77. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.”

78. Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure.

79. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/

80. Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients.

81. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain

    
    

    high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients.

82. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients:

    If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma.

    
    

    We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas.

    The idea of the general surgeon is going away.

    
    

    The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this.

    
    

    The – what I call the voyeur, you bring in a general surgeon to do some trauma because we

    
    

    don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem.

    If the doctor doesn’t know how to treat the patient, then the patient suffers.

    
    

    And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise.

    
    

    * * *

    
    

    We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise.

    
    

    And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock.

    There’s this whole sequence of events that takes place.

    
    

    Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/

    
    

83. In addition, an increase in trauma centers would

    
    

    make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site.

    Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers.

    
    

84. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff:

    But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time.

    
    

85. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care.

86. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered.

87. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the

    
    

    Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA.

88. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably.

89. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point:

    Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences?

    
    

    A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s

    
    

    adding new programs where there’s already a pretty good network of care provided.

    
    

    * * *

    
    

    My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas.

    
    

    This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care.

    
    

90. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas.

91. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/

92. The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes

    
    

    perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.

    CONCLUSIONS OF LAW

    
    

93. DOAH has jurisdiction over the subject matter and the parties to this proceeding. §§ 120.56 and 120.57(1), Fla. Stat.

94. Section 120.56(1)(a) provides that “any person substantially affected by . . . a 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.”

95. All parties in the instant case agreed in the Pre- hearing Stipulation that the Petitioners would be substantially affected by the Proposed Rules and that the Intervenors have standing to participate in this proceeding.

96. With regard to the burden of proof, the undersigned noted above in the Preliminary Statement that Petitioners had to establish a factual basis for their objections to the Proposed Rules. If Petitioners are successful in satisfying their burden, then the Department and Intervenors have the ultimate burden of persuasion to demonstrate that the Proposed Rules are a valid exercise of delegated legislative authority.

    
    

97. Petitioners argue that the Proposed Rules should be deemed invalid because they allegedly: (a) exceed their grant of rulemaking authority; (b) enlarge, modify, or contravene the laws to be implemented; (c) vest unbridled discretion in the Department; and (d) are arbitrary and capricious.

98. Each of Petitioners’ arguments will be addressed below.

    Did the Department Exceed Its Grant of Rulemaking Authority?

    
    

99. Section 120.52(8)(b) provides that a rule is an invalid exercise of delegated legislative authority if the agency has exceeded its grant of rulemaking authority. Moreover, the “flush left” paragraph of section 120.52(8) explains that,

    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 arbitrary and capricious or is within the agency’s 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 generally 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.

    
    

100. The extensively cited cases of S.W. Florida Water

     
     

     Management District v. Save the Manatee Club, Inc., 773 So. 2d

     
     

     594 (Fla. 1st DCA 2000); and Board of Trustees of the Internal Improvement Trust Fund v. Day Cruise Ass’n, Inc., 794 So. 2d

     696 (Fla. 1st DCA 2001), recognize that the flush left paragraph of section 120.52(8) was intended to restrict and narrow the scope of agency rulemaking. As established in Day Cruise,

     794 So. 2d at 700:

     
     

     It is now clear, agencies have rulemaking authority only where the Legislature has enacted a specific statute, and authorized the agency to implement, and then only if the (proposed) rule implements or interprets specific powers or duties, as opposed to improvising in an area that can be said to fall only generally within some class or powers or duties the Legislature has conferred on the agency.

     
     

101. Nonetheless, “[i]t follows that the authority for an administrative rule is not a matter of degree. The question is whether the statute contains a specific grant of legislative authority for the rule, not whether the grant of authority is specific enough.” Save the Manatee Club., 773 So. 2d at 600.

     See United Faculty of Fla. v. Fla. St. Bd. of Educ., 157 So. 3d 514, 517-18 (Fla. 1st DCA 2015)(stating that “it is not necessary under Save the Manatee Club and its progeny for the

     
     

     statutes to delineate every aspect of tenure that the Board is authorized to address by rule; instead, all that is necessary is for the statutes to specifically authorize the Board to adopt rules for college faculty contracts and tenure, which the statutes clearly do.”).

102. With regard to the instant case, Proposed Rule 64J-

     
     

     2.010 allocates the minimum number of trauma centers to each TSA and cites sections 395.402 and 395.405 as its rulemaking authority.

103. Proposed Rule 64J-2.012 sets forth the process for approving trauma centers, and Proposed Rule 64J-2.013 governs requests to extend the application period. Both Proposed Rules cite section 395.405 as their rulemaking authority.

104. Proposed Rule 64J-2.016 governs site visits and approval and cites sections 395.4025 and 395.405 as its rulemaking authority.

105. Section 395.402(4)(b) provides in pertinent part that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”

106. Section 395.4025(13) provides that the Department “may adopt, by rule, procedures and process by which it will select trauma centers.”

     
     

107. Section 395.405 provides that “[t]he department shall adopt and enforce all rules necessary to administer ss. 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.404, and 395.4045.”

108. Given the language of the statutes cited above, the Department clearly has the authority to adopt the rules governing the placement of trauma centers. However, that does not address whether the Department can adopt rules governing the minimum number of trauma centers needed in each TSA.

     Are the Proposed Rules Arbitrary and Capricious?

     
     

109. “An arbitrary decision is one not supported by facts or logic, or despotic.” Bd. of Trs. of Int. Imp. Trust Fund v. Levy, 656 So. 2d 1359, 1362 (Fla. 1st DCA 1995)(quoting Agrico

     Chem. Co. v. Dep’t of Envtl. Reg., 365 So. 2d 759, 763 (Fla. 1st DCA 1978)). “A capricious action is one which is taken without thought or reason or irrationally.” Id. A determination is not arbitrary or capricious if it is justifiable “under any analysis that a reasonable person would use to reach a decision of similar importance.” Dravo Basic Materials Co., Inc. v. Dep’t of Transp., 602 So. 2d 632 (Fla. 2d DCA 1992).

110. As noted above, the disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current

     
     

     Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.

111. There are substantial benefits associated with reducing transport times and treating more severely injured patients in trauma centers.

112. Nevertheless, Petitioners presented compelling evidence indicating that the increased access to care could lead to decreased quality of care. For instance, given the specialized nature of the professionals that must continuously staff a trauma center, it is likely that all trauma centers in Florida would have more difficulty acquiring the necessary personnel if several new trauma centers were to open in rapid succession.

113. Also, the preponderance of the evidence demonstrates that decreased volume at a trauma center can make it difficult for its personnel to maintain their proficiency. This is a legitimate concern for existing trauma centers, Florida residents, and visitors to Florida.

114. The evidence as a whole is convincing that the expected increase in trauma centers caused by the Proposed Rules would not impact patient volumes at every existing trauma center in Florida.

115. Instead, it is most probable that the new trauma centers would be predominantly limited to TSAs encompassing

     
     

     large metropolitan areas that already have adequate access to trauma care.

116. Therefore, to the extent that the Proposed Rules would cause patient volume at existing trauma centers to decrease, the evidence is persuasive that the impact would be limited to a subset of the 19 TSAs where quality of care could suffer if patient volume is divided among too many trauma centers.

117. In sum, there are advantages and disadvantages associated with adopting the Proposed Rules. It would be extremely difficult to formulate a set of trauma center rules that satisfy all of the relevant stakeholders while perfectly balancing “access to care” with maintaining high quality of care. Despite the evidence suggesting that quality of care could suffer under the methodology that would be established by the Proposed Rules, the undersigned cannot conclude that the Proposed Rules’ emphasis on increasing access to trauma care is illogical, despotic, unreasonable, or irrational.

     See generally Bayonet Point Hospital, Inc. v. Dep’t of HRS,

     
     

     490 So. 2d 1318, 1320 (Fla. 1st DCA 1986)(noting that “[t]he agency rulemaking function involves the exercise of discretion and this court will not substitute its judgment for that of the agency on an issue of discretion, unless the statutes mandate the adoption of the requested rule.”).

     
     

     Do the Proposed Rules Vest Unbridled Discretion in the Department?

     
     

118. Under section 120.52(8)(d) a rule is an invalid exercise of delegated legislative authority if it “is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency.”

119. With regard to what would fall under the scope of section 120.52(8)(d), the First District Court of Appeal has stated that “[a]n administrative rule which creates discretion not articulated in the statute it implements must specify the basis on which the discretion is to be exercised.” Cortes v.

     Bd. of Appeals, 655 So. 2d 132, 138 (Fla. 1st DCA 1995).

     
     

120. However, “Florida courts have previously recognized that executive agencies may exercise some discretion without breaching their authority.” Fla. East Coast Indus. v. Dep’t of Cmty. Aff., 677 So. 2d 357, 361 (Fla. 1st DCA 1996). “The

     exercise of some authority, discretion, or judgment may be incident or necessary to the performance of administrative or ministerial duties . . .” Id. (quoting Fla. State Bd. of Architecture v. Wasserman, 377 So. 2d 653, 656 (Fla. 1979)).

121. For instance, a situation may be so complex that it would be impossible to create a rule that could address every possible contingency. See generally Ameraquatic, Inc. v. Dep’t

     of Nat. Res., 651 So. 2d 114, 119 (Fla. 1st DCA 1995)(noting

     
     

     “[t]he record contains competent substantial evidence to support the hearing officer’s conclusion that the assignment of specific weight to each criterion, as suggested by appellants, would be impractical.”).

122. As noted above, the Proposed Rules establish a tiebreaker system to determine which provisional trauma centers would be selected if the sum of the number of provisional trauma centers eligible for selection and the number of existing trauma centers exceeds the statutory cap in section 395.402(4)(c).

123. During her testimony, Chief Dick explained that if a particular TSA did not have at least one trauma center as required by section 395.402(4)(b) and the Department received applications to operate trauma centers in one or more other TSAs, then the Department would not grant those applications.

124. Given that section 395.402 imposes a statewide cap of

     
     

     44 trauma centers while simultaneously requiring that each TSA have at least one trauma center, Chief Dick’s testimony on this point amounts to a reasonable interpretation of the statute rather than an unbridled exercise of agency discretion.

125. If the analysis could stop at this point, the undersigned would conclude without reservation that the Proposed Rules do not vest unbridled discretion in the Department.

126. However, Chief Dick’s testimony also addressed a hypothetical situation in which one or more TSAs did not have

     
     

     the minimum number of trauma centers determined by the Proposed Rules and the Department had a number of meritorious provisional trauma centers in other TSAs that would lead to the statutory cap of 44 being exceeded. See Finding of Fact ¶70.

127. Under the Proposed Rules, the Department takes the position that it would exercise discretion and not verify a trauma center for one TSA if rule 64J-2.010 indicated that another TSA did not have the minimum number of trauma centers called for by rule 64J-2.010 and the verification at issue would lead to the statutory cap of 44 being reached.

128. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or the Proposed Rules.

129. The Proposed Rules thus create an issue that did not exist prior to 2015. Under the Current Rules, the Department would not have even accepted a letter of intent if rule 64J- 2.010’s calculation of need indicated a trauma center was not needed in a particular TSA. There was no room for the Department to apply any discretion.

130. The Proposed Rules create a second minimum in addition to section 395.402(4)(b)’s mandate that every TSA must have one trauma center.

131. Chief Dick’s testimony indicates that the Department would exercise discretion and withhold approval from a

     
     

     provisional trauma center if another TSA lacked the statutory minimum and if that TSA lacked the minimum required under the Proposed Rules. However, there is nothing in the Proposed Rules

     memorializing that practice. The Department’s action in this situation would thus be within its unbridled discretion.

132. In sum, the Proposed Rules are invalid because they confer discretion on the Department that is not articulated in the statutes the Proposed Rules would implement. See generally

     Fla. PSC v. Fla. Waterworks Ass’n, 731 So. 2d 836, 843 (Fla. 1st DCA 1999)(noting that “[u]nlike the proposed rule in Cortes, the

     rule the PSC has proposed here articulates criteria that would channel the exercise of statutory authority formerly constrained only by what the record in an individual ratemaking case contained.”).

     Do the Proposed Rules Modify or Contravene the Laws Being Implemented?

     
     

133. Section 120.52(8)(c) provides that a rule is an unlawful exercise of delegated legislative authority if the rule at issue enlarges, modifies, or contravenes the specific provisions of law implemented.

134. In general, an agency is entitled to deference when interpreting one of its own statutes. However, that deference is far from absolute. Southpointe Pharmacy v. Dep’t of HRS,

     596 So. 2d 106, 110 (Fla. 1st DCA 1992)(noting that “[a]lthough

     
     

     we would generally defer to such an opinion, as we are required to give great weight to an agency’s interpretation of its own rule, that deference is not absolute.”).

135. For instance, an agency’s interpretation is owed no deference if the interpretation implicates no expertise on the agency’s part. See generally Big Bend Hospice, Inc. v. Ag. for Health Care Admin, 904 So. 2d 610, 611 (Fla. 1st DCA 2005)

     (explaining that “a review of an order of an administrative agency begins with the usual recognition of deference to an agency’s interpretation of a statute it is charged to administer.”); Doyle v. Dep’t of Bus. Reg., 794 So. 2d 686, 690 (Fla. 1st DCA 2001)(stating “a court need not defer to an agency’s construction or application of a statute if special agency expertise is not required.”); West Flagler Ass’n. v.

     Dep’t of Bus. & Prof’l Reg., 139 So. 3d 419, 421 (Fla. 1st DCA 2014)(noting “the well established proposition that an administrative construction of a statute given by those charged with its enforcement and interpretation is entitled to great weight, and the courts will not depart from such a construction unless it is clearly erroneous or unreasonable.”).

136. The Proposed Rules cite sections 395.1031, 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, and 395.405 as the laws being implemented.

     
     

137. The dispute in the instant case focuses on the meaning of the term “need” in chapter 395, Part II, and the laws implemented by the Proposed Rules refer to “need” multiple times. While the Department initially interpreted the term “need” as establishing a ceiling on the number of trauma centers that can be in a particular TSA, it now interprets that term as establishing a floor or a minimum number of trauma centers that

     can be in a particular TSA. In contrast, Petitioners argue that the term “need” should continue to refer to the maximum number of trauma centers that can be in a particular TSA.

138. The term “need” is used in multiple sections of chapter 395, part II. For instance, section 395.402(2)(b) requires the Department to “[r]eview the number and level of trauma centers needed for each trauma service area to provide a

     statewide integrated trauma system.” (emphasis added).

     
     

139. Section 395.402(2)(c) requires the Department to “[e]stablish criteria for determining the number and level of trauma centers needed to serve the population in a defined trauma service area or region.” (emphasis added).

140. Section 395.402(4)(b) provides that “[e]ach trauma service area should have at least one Leve I or Level II trauma center. The department shall allocate, by rule, the number of trauma centers needed for each trauma service area.” (emphasis

     added).

     
     

141. Also, section 395.4025(1) provides that “the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality

     trauma services.” (emphasis added).

     
     

142. If the undersigned were to limit the analysis of how to interpret “need” to sections 395.402(2)(b), 395.402(2)(c), 395.402(4)(b), 395.4025(1), and 395.4025(1), it would be difficult to conclude that the Department is clearly erroneous by interpreting “need” as referring to the minimum number of trauma centers that can be in a particular TSA.

143. However, section 395.4025(5) provides that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma center service area that has a need for such a trauma

     center.” (emphasis added).

     
     

144. Under the Proposed Rules, there would always be a need for a trauma center in every TSA because the table in rule 64J-2.010 would set forth the minimum number of trauma centers needed in each of the TSAs rather than the maximum. As a result, the Proposed Rules would render a critical and substantial portion of section 395.4025(5) superfluous.

     See Recovery Racing, LLC v. Dep’t of High. Saf. & Motor Veh.,

     
     

     192 So. 3d 665, 669 (Fla. 4th DCA 2016)(noting that “[w]hen interpreting statutes, we are required to give effect to every

     
     

     word, phrase, sentence, and part of the statute if possible, and words in a statute should not be construed as mere surplusage.”).

145. Also, section 395.402(4)(b) already establishes a floor or a minimum number of trauma centers that can be in a particular TSA. The Proposed Rules would implicitly supercede section 395.402(4)(b) when Proposed Rule 64J-2.010 determines a particular TSA’s “need” to be greater than 1.

146. Therefore, the Department’s revised interpretation

     
     

     of chapter 395 directly contravenes at least two of the laws the Proposed Rules purport to implement. Moreland v. APD, 19 So. 3d 1009, 1012 (Fla. 1st DCA 2009)(holding that “[b]y requiring all former FSL Waiver recipients [to] be placed into Tier 4 based solely on the fact that they formerly received services through the FSL Waiver, Proposed Rule 65G-4.0025 contravenes section 393.0661(3) which requires the Agency to assign each client to a tier based on an individual assessment.”)7/

147. While agencies are to be afforded deference when interpreting the statutes they administer, the statutory interpretation at issue in the instant case does not involve any agency expertise. This issue can be resolved by resorting to the plain language of the statutes cited herein, and the Department’s new interpretation of chapter 395 clearly contravenes that plain language. See generally State v. Jett,

     
     

     626 So. 2d 691, 693 (Fla. 1993) (stating “[w]e agree with the majority below that this language is unambiguous. It is a settled rule of statutory construction that unambiguous language is not subject to judicial construction, however wise it may seem to alter the plain language. While the dissent’s view below has much to commend it, we find that the decision whether or not to engraft that view into the Florida Statutes is for the legislature. We trust that if the legislature did not intend the result mandated by the statute’s plain language, the legislature itself will amend the statute at the next opportunity.”).

148. The interpretation of chapter 395 clearly implicates a substantial policy question, and there is precedent indicating that agencies should be afforded deference in such situations. See generally Utilities of Fla. v. Public Serv. Comm’n, 420 So. 2d 331, 333 (Fla. 1st DCA 1982)(explaining that “[t]he factual issue with which the PSC was concerned, i.e., the fair and proper rate of return on equity capital for a utility of the type and size of appellant, was not one susceptible to ordinary methods of proof; instead it was essentially a matter of opinion which necessarily had to be infused by policy considerations for which the PSC has special responsibility.”).

149. While the undersigned cannot conclude that the Department’s new interpretation of chapter 395 is arbitrary and

capricious, the outcome of the instant case must turn on the Legislature’s use of plain and unambiguous language that clearly establishes that the Department is to calculate the maximum (rather than the minimum) number of trauma centers needed in the

19 TSAs. See generally Dep’t of HRS. v. Fla. Psychiatric Soc.,

382 So. 2d 1280, 1285 (Fla. 1st DCA 1980)(stating “[w]e are not concerned, nor was the hearing officer, with the lack of merit in the proposed rules, nor whether operation of the proposed facilities would be beneficial to the public. These are questions for the legislature, not the courts. We are concerned only with statutory authority or its absence. Our comparison of the rules and the statutes indicates that the rules do not merely implement, they effectively abrogate the statutes, to a marked extent. Administrative regulations must be consistent with the statutes under which they are promulgated, and they may not amend, add to, or repeal the statute.”); Cleveland Clinic v.

Ag. for Health Care Admin, 679 So. 2d 1237, 1242 (Fla. 1st DCA

1996)(noting that “[t]o the extent that the results sought by an agency cannot be accomplished by changes in the administrative rules, interested parties must seek a remedy in the legislature.”).

ORDER

Based on the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that:

1. Proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes;

2. Jurisdiction is reserved for the undersigned to consider motions for fees and costs pursuant to section 120.595(2), Florida Statutes. Any such motions shall be filed within 10 days from issuance of this Final Order. The Department of Health shall then have 10 days to file a response thereto.

DONE AND ORDERED this 28th day of March, 2017, in Tallahassee, Leon County, Florida.

S

G. W. CHISENHALL Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 2017.

ENDNOTES

1/ Unless stated otherwise, all statutory references will be to the 2016 version of the Florida Statutes.

2/ The previous rule challenge was Shands Teaching Hospital and Clinics, Inc., d/b/a UF Health Shands Hospital, the Public Health Trust of Miami-Dade County, St. Joseph’s Hospital, Inc., d/b/a St. Joseph’s Hospital, and Florida Health Sciences Center., Inc., d/b/a Tampa General Hospital v. Dep’t of Health and Osceola Regional Hospital, Inc., d/b/a Osceola Regional Medical Center, Case Nos. 14-1022RP, 14-1027RP, 14-1028RP, & 14-1034RP (Fla.

DOAH, June 20, 2014).

3/ Section 395.4001(6)(a), Florida Statutes, defines a “Level I trauma center” as a trauma center that “[h]as formal research and education programs for the enhancement of trauma care; is verified by the department to be in substantial compliance with Level I trauma center and pediatric trauma center standards; and has been approved by the department to operate as a Level I trauma center.” Section 395.4001(7)(a) defines a “Level II trauma center” as a trauma center that “[i]s verified by the Department to be in substantial compliance with Level II trauma center standards and has been approved by the department to operate as a Level II trauma center or is designated pursuant to s. 395.4025(14).”

4/ A closely related argument concerns “mass casualty events.” A “mass casualty event” occurs when a health care facility receives a large number of severely injured patients simultaneously. The presence of multiple trauma centers in a particular TSA could prove to be beneficial if a mass casualty event were to occur. In all likelihood, more severely injured victims would be treated by trauma specialists, the treatment would be rendered faster, and there would be less need to transport severely injured victims to one or more trauma centers not in close proximity to where the mass casualty event occurred.

5/ Petitioners presented a recent study from the Annals of Surgery entitled “Impact of Volume Change over Time on Trauma Mortality in the United States.” That study found that trauma centers that increased their volume over a three-year period had a 73 percent chance of improving their mortality rate. In contrast, the study also found that trauma centers experiencing decreases in volume had a twofold chance of having increased mortality rates.

6/ In ruling that the current version of rule 64J-2.010 was a

valid exercise of delegated legislative authority, ALJ Bruce McKibben observed that “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 Petitioners’ 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 Petitioners’ concerns into the Proposed Rule as the Department believed appropriate. The Department’s 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.” Shands Teaching Hosp. and Clinic et al. v. Dep’t of Health and Osceola Reg’l Hosp., Case Nos. 14-1022RP, 14-1027RP, 14-1028RP, & 14-1034RP (Fla. DOAH June 20, 2014).

7/ In dicta, ALJ Watkins found in Shands Jacksonville Medical Center that “[t]he Department is required by law to allocate, by rule, the maximum number of trauma centers allowable in each TSA.” (emphasis added). Similarly, ALJ John G. Van Laningham found in The Public Health Trust of Miami-Dade County, Florida d/b/a Jackson South Community Hospital v. Department of Health and Kendall Healthcare Group, Ltd., d/b/a Kendall Regional Medical Center that “[t]he Department is charged with deciding where these 44 facilities should be located; it must allocate, by rule, the maximum number of trauma centers allowable in each trauma service area.” (emphasis added). ALJ Van Laningham’s finding was also dicta.

COPIES FURNISHED:

Seann M. Frazier, Esquire

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Jonathan L. Rue, Esquire Parker, Hudson, Rainer

and Dobbs, LLC Suite 3600

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Robert A. Weiss, Esquire Moyle Law Firm, P.A.

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Celeste Philip, M.D., M.P.H. Interim State Surgeon General Department of Health

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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 governed 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 reviewed, 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.

Docket for Case No: 16-005840RP

Orders for Case No: 16-005840RP