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THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, D/B/A JACKSON SOUTH COMMUNITY HOSPITAL vs DEPARTMENT OF HEALTH, 15-003171 (2015)

Court: Division of Administrative Hearings, Florida Number: 15-003171 Visitors: 16
Petitioner: THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, D/B/A JACKSON SOUTH COMMUNITY HOSPITAL
Respondent: DEPARTMENT OF HEALTH
Judges: DARREN A. SCHWARTZ
Agency: Department of Health
Locations: Tallahassee, Florida
Filed: Jun. 02, 2015
Status: Closed
Recommended Order on Monday, February 29, 2016.

Latest Update: Jul. 07, 2016
Summary: The issue for determination is whether Petitioner is in substantial compliance with the requirements in section 395.4025, Florida Statutes, and, therefore, has the critical elements required for a trauma center, so that Respondent must find Petitioner's Level II Trauma Center Application acceptable for approval, which would make Petitioner eligible to operate as a provisional trauma center.Petitioner is in substantial compliance with the requirements in section 395.4025 and, therefore, has the c
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STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS


THE PUBLIC HEALTH TRUST OF MIAMI-DADE COUNTY, FLORIDA, d/b/a JACKSON SOUTH COMMUNITY HOSPITAL,


Petitioner,


vs.


DEPARTMENT OF HEALTH,

Case No. 15-3171


Respondent,


and


KENDALL HEALTHCARE GROUP, LTD., d/b/a KENDALL REGIONAL MEDICAL CENTER,


Intervenor.

/


RECOMMENDED ORDER


This case came before Administrative Law Judge John G. Van Laningham for final hearing on October 8, 9, and 12 through 15, 2015, in Tallahassee, Florida.

APPEARANCES


For Petitioners: Thomas F. Panza, Esquire

Paul C. Buckley, Esquire Elizabeth L. Pedersen, Esquire Panza, Maurer & Maynard, P.A. 3600 North Federal Highway

Fort Lauderdale, Florida 33308


For Respondent: Jay Patrick Reynolds, Esquire

Department of Health Prosecution Services Unit

4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399


For Intervenor: Stephen A. Ecenia, Esquire

J. Stephen Menton, Esquire Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202 Tallahassee, Florida 32301


STATEMENT OF THE ISSUE


The issue for determination is whether Petitioner is in substantial compliance with the requirements in section 395.4025, Florida Statutes, and, therefore, has the critical

elements required for a trauma center, so that Respondent must find Petitioner's Level II Trauma Center Application acceptable for approval, which would make Petitioner eligible to operate as a provisional trauma center.

PRELIMINARY STATEMENT


Respondent Department of Health is the state agency responsible for licensing trauma centers. Petitioner Public Health Trust of Miami-Dade County, Florida, d/b/a Jackson South Community Hospital, applied during the 2014-16 application cycle for verification as a Level II trauma center. Respondent conducted the statutorily required "provisional review" of Petitioner's application and, by letter dated April 30, 2015, notified Petitioner that Respondent had determined, based upon Petitioner's application and the materials submitted with it, that


Petitioner did not have the critical elements required for a trauma center. For that reason, Respondent proposed to deny Petitioner's application.

On May 18, 2015, Petitioner filed a Petition for Formal Administrative Hearing to Contest the Decision to Deny Jackson South Community Hospital's Application to Operate a Provisional Level II Trauma Center, whose title describes its purpose. By letter dated June 2, 2015, Respondent referred the matter to the Division of Administrative Hearings ("DOAH"), where the undersigned received the file on June 17, 2015.

On August 7, 2015, Kendall Healthcare Group, Ltd., d/b/a Kendall Regional Medical Center, filed a Petition to Intervene, which was granted, with restrictive conditions, on August 27, 2015.

The final hearing was held on October 8, 9, and 12 through 15, 2015, as scheduled, with both parties present.

Joint Exhibits 1 through 12 were moved into evidence by agreement. Petitioner called as witnesses Nicholas Namias, MD; Enrique Ginzburg, MD; Kimberly Clark; Olga Quintana, RN; Ana Russo, RN; Camille Baptiste-Smith, MD; and Marlys Yu, MSN, each of whom works in the Jackson Health Systems network of hospitals. Petitioner also presented Dr. Stephen Smith as an expert on the subject of trauma center accreditation.

Petitioner's Exhibits 8, 10, 12, 14, 16, 18, 23, 26, 27, 39, 40,


42, 43, 55 through 57, 61, 68, 69, 81, 95 through 102, and 108 through 110, were received in evidence.

Respondent's witnesses were Susan Bulecza, DNP, Trauma System Administrator; and outside consultants Dr. Lawrence Reed and Marla Vanore, RN, who all testified at hearing.

Petitioner was granted leave to take the post-hearing deposition of Michael Leffler, an employee of Respondent who had written a document that was belatedly produced at hearing to the surprise of Petitioner. On December 1, 2015, the undersigned entered an Order Supplementing the Record, which received into the record, as Petitioner's impeachment evidence, the Leffler deposition. On December 8, 2015, the Affidavit of Leah Colston, Chief of Petitioner's Emergency Medical Oversight Bureau, was admitted as Respondent's Exhibit 1.

The final hearing transcript was filed on November 2, 2015. The deadline for filing proposed recommended orders, originally November 23, 2015, was extended to December 21, 2015. Each party timely filed a Proposed Recommended Order.

Unless otherwise indicated, citations to the official statute law of the state of Florida refer to Florida Statutes 2015.

FINDINGS OF FACT1/


  1. Respondent Department of Health (the "Department") is the agency responsible for licensing and regulating trauma


    centers in the state of Florida. 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 pediatric trauma center[.]" § 395.4001(14), Fla. Stat.

  2. Petitioner Public Health Trust of Miami-Dade County, Florida, d/b/a Jackson South Community Hospital ("JSCH"), is an acute care hospital located in south Miami-Dade County. JSCH is one of several health care facilities in the Jackson Health System network, which includes Jackson Memorial Hospital with its Ryder Trauma Center ("Ryder").

  3. Intervenor Kendall Healthcare Group, Ltd., d/b/a Kendall Regional Medical Center ("Kendall"), is an acute care hospital that operates a verified Level II trauma center in Miami-Dade County.

  4. This case arises from the Department's intended decision, after a provisional review, to deem JSCH's Level II Trauma Center Application (the "Application") unacceptable, which has kept JSCH from becoming eligible to operate as a provisional trauma center. If reduced to a final order, the Department's preliminary agency action would deny JSCH's Application to become a verified Level II trauma center.


  5. Part II of chapter 395, Florida Statutes, comprises the sections of the code providing for the establishment of a statewide trauma system "designed to meet the needs of all injured trauma victims who require care in an acute-care setting and into which every health care provider or facility with resources to care for the injured trauma victim is incorporated." § 395.40(2), Fla. Stat. The Department is the agency having primary responsibility for administering the trauma system.

  6. The state's 67 counties have been assigned to trauma service areas for purposes of managing the trauma system. JSCH is located in trauma service area 19 ("TSA 19"), which consists of Miami-Dade and Monroe Counties. § 395.402(4)(a)19., Fla. Stat.

  7. The legislature has capped, at 44, the total number of trauma centers that may operate in the state. § 395.402(4)(c), Fla. Stat. The 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. § 395.402(4)(b), Fla. Stat. In TSA 19, the Department has determined, there can be no more than three. Fla. Admin. Code R. 64J-2.010(3). At all times relevant to this case, two verified trauma centers (Kendall and Ryder) have


    occupied positions in TSA 19, leaving just one "slot" vacant—— the slot which JSCH hopes to fill.

  8. Section 395.4025 outlines the 21-month process a hospital must follow to obtain verification as a trauma center, and the Department, by rule, has established additional procedures governing the selection of trauma centers. See Fla. Admin. Code R. 64J-2.012. This lengthy, multistage process is punctuated by three decision-points at which the Department must take agency action on the hospital's application.

  9. A hospital enters the process by submitting a letter of intent to the Department, which must be received between September 1 and October 1 of the first year. § 395.4025(2)(a), Fla. Stat.; Fla. Admin. Code R. 64J-2.012(1)(a). Because JSCH timely submitted its letter of intent in 2014, this case involves the 2014-16 application cycle.

  10. By October 15, the Department provides an application package to each hospital that timely gave notice of its intent to apply. The package includes a pamphlet known as DHP 150-9. This pamphlet, a publication of the Department, contains the Trauma Center Standards (the "Standards") with which a trauma center must comply to be verified. DHP 150-9 is incorporated by reference in Florida Administrative Code Rule 64J-2.011.

  11. Having received an application package, a hospital has until the close of business on April 1 of the second year (2015


    in this case) to submit its application. April 1 is not the only day upon which a hospital may submit an application, but rather the last day.

  12. Upon receipt of a hospital's application, the Department must conduct a "provisional review."

    § 395.4025(2)(c), Fla. Stat. The provisional review allows the Department to confirm "that the hospital's application is complete and that the hospital has the critical elements required for a trauma center." Id. "The standards of critical elements for provisional review" (the "Critical Elements"), a subset of the Standards, "are specified in DHP 150-9." Fla.

    Admin. Code R. 64J-2.012(1)(d). There are approximately 300 Critical Elements.

  13. Pursuant to section 120.60(1), Florida Statutes, the Department has a period of up to 30 days after receipt of a hospital's application within which to "notify the applicant of any apparent errors or omissions and request any additional information the agency is permitted by law to require."2/ By rule, the Department has set April 15 as its deadline for notifying each applicant "in writing of deficiencies and giv[ing the hospital] the opportunity to submit additional clarifying or corrective information." Fla. Admin. Code R. 64J-2.012(1)(e). Therefore, if the hospital submits its application at the last minute (on April 1), the Department has only two weeks instead


    of 30 days within which to notify the applicant of any apparent errors or omissions. It is important to note, however, that rule 64J-2.012(1)(e) requires the Department to notify an applicant of deficiencies "[n]o later than April 15"——not on April 15. The rule, in other words, does not preclude the Department from notifying the applicant of errors or omissions before April 15 if it wants or needs to. If the hospital submits its application more than 30 days before April 15, then the Department needs to notify the applicant of any deficiencies before April 15, pursuant to section 120.60(1).

  14. Rule 64J-2.012(1)(f) requires the hospital to "submit [any] requested information to the department by close of business 5 working days after April 15. Failure to provide the requested information, or failure to successfully address the deficiencies identified by the department, shall result in the denial of the hospital's application." This is in accordance with section 120.60(1), which provides that an "agency may establish by rule the time period for submitting any additional information requested by the agency." Thus, an applicant is entitled to at least five business days within which to furnish the Department with additional clarifying or corrective information. If the applicant submits its application on or before March 15, however, the 30-day notice period for errors and omissions prescribed in section 120.60(1) will expire before


    April 15, increasing the time remaining until "5 working days after April 15." If the hospital applies months before

    March 15, it will have months in which to supply the Department with additional information.

  15. The Provisional Review Stage of the application process culminates with the Department's decision either finding the hospital's application "acceptable," or denying it. The Department must notify the applicant of its intended decision on or before May 1. Fla. Admin. Code R. 64J-2.012(1)(g). The applicant is entitled to a hearing under sections 120.569 and

    120.57 if it disputes the Department's intended decision.


    § 495.4025(7), Fla. Stat.; Fla. Admin. Code R. 64J-2.012(2).


  16. It is, of course, a basic tenet of Florida administrative law that intended agency action is ineffective until it becomes final at the conclusion of a formal administrative proceeding, if timely requested, or after the right to a hearing is waived. E.g., Capeletti Bros., Inc. v.

    Dep't of Transp., 362 So. 2d 346, 348-49 (Fla. 1st DCA 1978)("Absent [an express] waiver [of the right to an administrative hearing], we must regard an agency's free-form action as only preliminary irrespective of its tenor. . . .

    Until proceedings are had satisfying Section 120.57, or an opportunity for them is clearly offered and waived, [an agency] is powerless to" determine a party's substantial interests.).


    Therefore, if a hospital contests the Department's intended decision to deny its application after the provisional review, as JSCH has done, the Provisional Review Stage continues until the conclusion of the formal administrative proceeding.

  17. If the Department finds the hospital's application acceptable based on the provisional review, the hospital "shall be eligible to operate as a provisional trauma center."

    § 395.4025(3), Fla. Stat. This means that an agency decision in the applicant's favor at the end of the Provisional Review Stage results in the hospital's receiving a "provisional license" under which it may operate a trauma center "for a significant period of time." Shands Jacksonville Med. Ctr., Inc. v. Dep't

    of Health, 123 So. 3d 86, 94 (Fla. 1st DCA 2013). From that point forward in the process, the hospital seeking to become a verified trauma center is no longer just an applicant, but an actual licensee, albeit a provisional licensee.

  18. Although it might not be as readily apparent, the Department's intended decision (which must be announced on or before May 1) to issue a preliminary license to a hospital whose application has been found acceptable is, no less than a contrary determination, merely preliminary agency action having no legal effect until the conclusion of a formal administrative proceeding, if timely requested, or after the right to a hearing


    is waived. This is of interest for a couple of reasons, one which will be discussed later, one right away.

  19. Presently, it is important to observe that "the intent to issue a provisional license is proposed final agency action that existing trauma centers have a right to challenge." Shands

    Jacksonville Med. Ctr., 123 So. 3d at 87 (emphasis added). So, while the applicant would not request a hearing on a proposed decision to issue a provisional license, the applicant's competitor(s) might——and can. If an existing trauma center requests a formal administrative hearing on the Department's intended decision to grant a provisional license authorizing the operation of a new trauma center, then the provisional license cannot lawfully be issued, or take effect, until the conclusion of the administrative proceeding——and then only if the resulting final order implements the proposed agency action, which is certainly not guaranteed to happen.

  20. Why does this matter? It matters because the Department makes much of the notion, for reasons which will soon become clear, that "[i]f a hospital is granted provisional approval, it is required to begin operation as a provisional trauma center on May 1, and becomes a full member of Florida's integrated trauma system on that day." DOH's PRO at 8. The Department bases this contention on rule 64J-2.012(1)(g)1., which provides that the "department shall notify each hospital


    whose application it has found acceptable upon completion of the provisional review that the hospital shall operate as a Provisional trauma center beginning May 1." The rule is an unartful paraphrase of section 395.4025(3), which states that "[a]fter 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."

    (Emphasis added.)


  21. The statute quite clearly does not require the provisional licensee to commence operations immediately after April 30; rather, it simply says that the licensee may do so after April 30. Put another way, section 395.4025(3) prohibits a newly approved provisional trauma center from opening before May 1, a restriction which is neither tantamount to, nor even implies, a requirement that the provisional licensee start operating on May 1. An affirmative requirement of that nature, if intended, must be stated explicitly, for a license is an authorization to act, not a mandate. § 120.52(10), Fla. Stat. Here, such a directive has not been stated at all.

  22. The Department, moreover, is the hospital's regulator, not its employer; and a regulator does not typically have the authority to direct a freshly minted licensee to open its doors for business as of a particular date. To be sure, the failure or inability to perform might subject a licensee to


    administrative discipline, including revocation, if the law so provides, but the Department has not cited any authority which makes the failure or inability to operate a licensed trauma center on the first day of licensure a disciplinable offense.

  23. At any rate, if rule 64J-2.012(1)(g)1. required a provisional trauma center to begin operating on May 1, then the rule plainly would modify or enlarge section 395.4025(3), which it purports to implement, making the rule an invalid exercise of delegated legislative authority. § 120.52(8)(c), Fla. Stat. Since it is presumed that the Department did not intend to promulgate an invalid rule, it is unreasonable to construe the rule as a command to commence operations on May 1. Far better to read the rule as it was no doubt intended to be understood, namely as a reiteration of section 395.4025(3): a hospital whose application is found acceptable is eligible to begin operating as a provisional trauma center on May 1.

  24. To make the Department's position worse, May 1 is not even the first day of licensure——at least not when the Department gives notice of its intended decision to issue the provisional license on or around that date. For the reasons discussed above, the Department's proposed agency action cannot take effect, legally, until after the right to a hearing is waived, at the earliest. The failure to request a hearing would not constitute a waiver of administrative remedies until at


    least 21 days after receipt by the person whose substantial interests are being determined (e.g., an existing trauma center) of written notice of the intended decision.3/ See Fla. Admin.

    Code R. 28-106.111(2). Thus, for May 1 to be the first day of licensure, the Department would need to give a clear point of entry no later than April 10 to every person whose substantial interests are determined by an intended decision to grant a provisional license, and all persons having a right to request a hearing would need to waive that right. This is, of course, possible, but it is unlikely to occur in most instances, much less every instance.4/

  25. Regardless, as stated above, the Department has until May 1, potentially, to announce its preliminary decision whether to grant provisional licensure, meaning that rule 64J- 2.012(1)(g) specifically contemplates the issuance of provisional licenses that will not take effect until, at the earliest, around May 22. This, then, is yet another reason why rule 64J-2.012(1)(g)1 cannot reasonably be interpreted as a command to commence operations on May 1. The Department's interpretation is unreasonable and clearly erroneous.

  26. The next step in the application process starts on May 1 of the second year and ends five months later, on

    October 1. Between these dates, the Department conducts "an in- depth evaluation of all applications found acceptable in the


    provisional review." § 395.4025(4), Fla. Stat. Rule 64J- 2.012(1) divides the In-Depth Evaluation Stage into three substeps:

    1. The department shall, between May 1 and June 30, complete an in-depth review of all sections of the Provisional trauma center's application. The department shall notify the hospital of any omissions, deficiencies, or problems and request additional information to be submitted by the hospital.


    2. To have additional information considered during the department's in-depth review of the application, the Provisional trauma center shall submit the requested additional information to the department no later than September 1.


    3. By September 30, the department shall determine whether the omissions, deficiencies, or problems have been corrected. The department shall notify each Provisional trauma center on or before October 1 of any omissions, deficiencies, or problems that were not resolved by submission of the requested additional information.


  27. The proposed agency action taken at the end of the In- Depth Evaluation Stage (on or before October 1) is a binary decision: Deficiencies/No Deficiencies. This decision determines the provisional trauma center's substantial interests and (at least if adverse to the hospital) is contestable in a formal administrative hearing. § 395.4025(7), Fla. Stat. A determination that the provisional trauma center has outstanding deficiencies does not provide an immediate opportunity for the


    Department to suspend or revoke the hospital's provisional license, however. This is because "[a]ny Provisional trauma center that was notified by the department on or before October 1 at the conclusion of the in-depth review that omissions, deficiencies, or problems were not resolved shall be given 30 calendar days from the department's notification following the completion of the [subsequent] site visit to provide additional information." Fla. Admin. Code R. 64J- 2.012(1)(k).

  28. The last phase of the application process is the Onsite Visit Stage, which begins on October 1 of the second year and ends on June 1 of the third year. § 395.4025(5), Fla. Stat. During this period,

    a review team of out-of-state experts assembled by the department shall make onsite visits to all provisional trauma centers. The department shall develop a survey instrument to be used by the expert team of reviewers. The instrument shall include objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally. The survey instrument shall also include 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.


    Id.


  29. The Onsite Visit Stage is divided into two substeps: the site visit phase (October 1 to May 305/) and the final evaluation (June 1 to July 16/). Regarding the site visit phase, rule 64J-2.016 states in relevant part as follows:

    1. Each Provisional trauma center shall receive an on-site evaluation to determine whether the hospital is in substantial compliance with standards published in DHP 150-9, . . . and to determine the quality of trauma care provided by the hospital.


    2. The on-site evaluation shall be conducted by a review team of out-of-state reviewers with knowledge of trauma patient management as evidenced by experience in trauma care at a trauma center approved by the governing body of the state in which they are licensed.


    3. All Provisional trauma center [sic] shall receive a site visit between October 1 of each year and June 1 of the following year.


    4. The reviewers shall assess each applicant hospital's compliance with the standards published in DHP 150-9, by means of direct observation, review of call schedules, and review of patient charts. Reviewers also shall assess the quality of trauma patient care and trauma patient management by reviewing facility trauma mortality data, by reviewing patient charts and by reviewing trauma case summaries and minutes of trauma quality management committee meetings pursuant to Standard XVIII of DHP 150-9.


  30. Within 30 working days after the completion of the site visit, the Department


    shall notify each Provisional trauma center of the results . . . . The department shall include in the notice any problems that the Provisional trauma center was informed of at the conclusion of the department's in-depth application review. If the Provisional trauma center desires to provide additional information regarding the results of the site visit or in-depth application review to the department to be considered during the final evaluation between June 1 and July 1, the information must be provided in writing and be received by the department within 30 calendar days of the hospital's receipt of the department's notice. If the Provisional trauma center elects not to respond to the department's notice within 30 calendar days, the department shall make the final determination of approval or denial based solely on information collected during the applicant's site visit and in-depth application review.


    Fla. Admin. Code R. 64J-2.016(8).


  31. During the final evaluation, between June 1 and July 1 of the third year, the Department "shall evaluate the results of the site visit review and the in-depth application review of each Provisional trauma center." Fla. Admin. Code R. 64J- 2.016(7). By July 1, the Department shall give notice of its proposed agency action, which shall be either to "issue the certificate to the hospital upon approval as a trauma center" or to deny the hospital's application if the provisional trauma center is "not approved as a [verified] trauma center, specifying the basis for denial and informing the hospital of the next available approval cycle, and the hospital's right to


    an administrative hearing pursuant to Sections 120.57 and 395.4025, F.S." Fla. Admin. Code R. 64J-2.012(1)(m). If the

    Department determines that the provisional trauma center failed to correct "the omissions, deficiencies, or problems noted from the in-depth review within 30 calendar days from the department's notification following the completion of the site visit," then the Department "shall deny the [hospital's] application . . . regardless of the findings of the out-of-state review team regarding the quality of trauma patient care and trauma patient management provided by the Provisional trauma center." Fla. Admin. Code R. 64J-2.012(1)(l). A hospital which is "not approved as a trauma center may, within 30 days of receipt of the denial notice, request a hearing in which to contest the findings of the department." Fla. Admin. Code

    R. 64J-2.012(2).


  32. As mentioned, the proposed agency action at issue is the Department's intended denial, based on a provisional review, of JSCH's Application for failing to demonstrate that JSCH has the Critical Elements required for a trauma center. Because JSCH timely requested a hearing, the Department's intended decision did not become final, and JSCH's Application remains, as of this writing, in the Provisional Review Stage, which will not end until this formal administrative proceeding is concluded with finality. Notwithstanding that proposed agency action is


    neither presumed correct nor entitled to any deference in a typical de novo proceeding, the Department argues that JSCH cannot rely upon proof of any kind, including evidence offered and received at the final hearing of this matter, which was not submitted to the Department on or before April 22, 2015 (the fifth business day after April 15)——even proof of relevant historical events occurring after April 22. According to the Department, JSCH can do no more than argue that its Application, together with the clarifying or corrective information submitted to the Department by April 22 (hereafter, as necessary, the "Complete Application"), should be found acceptable. There are multiple problems with the Department's position, as will be shown, and therefore it must be rejected.

  33. For starters, the Department is conflating the two separate purposes of the provisional review, which are to determine (i) whether the hospital's application is complete and (ii) whether the hospital has the Critical Elements.

    § 395.4025(2)(c), Fla. Stat.; Fla. Admin. Code R. 64J- 2.012(1)(d). The first, technical question is concerned with whether the hospital's paperwork (as opposed to the hospital) is in order; it is answered in the affirmative if there are no material omissions, i.e., deficiencies in the application that deprive the Department of information which it deems necessary to decide whether the hospital is qualified for provisional


    licensure. The second, substantive question, namely whether the hospital (as opposed to the application) has the critical elements, is a matter of substance (not mere paperwork) to be decided on the merits.7/

  34. The Department did not propose to deny JSCH's Application on the ground that it is incomplete. If that were the proposed agency action, which it is not, then the Department's argument——that the Complete Application and nothing else should be considered in this hearing——would have some merit. The narrow question presented in such a case would be whether the Application was complete as of April 22, not (as here) whether JSCH has the Critical Elements. If JSCH were to prevail in this hypothetical case by establishing that the Application was complete as of April 22, then the recommended order would urge the Department to approve or deny the Application within 45 days after issuance of the recommended

    order. § 120.60(1), Fla. Stat.; see MVP Health, Inc. v. Ag. for


    Health Care Admin., Case No. 09-6021, 2010 Fla. Div. Adm. Hear. LEXIS 557, 37 (Fla. DOAH Apr. 22, 2010), rejected in part, Case

    No. 2009012001 (Fla. AHCA May 26, 2010).


  35. In actuality, the Department proposed to deny JSCH's Application on the ground that JSCH does not have the Critical Elements required for a trauma center if one considers only the Application and materials submitted by April 22, 2015, in making


    that determination. Thus, the Department is not saying that JSCH provided too little information with its Application for the Department to determine, one way or the other, whether JSCH has the Critical Elements; rather, the Department is saying that the information JSCH provided with its Application is both insufficiently persuasive to establish that JSCH has some Critical Elements, and also sufficient to demonstrate affirmatively that it lacks others, which is why the Department preliminarily determined, on the merits, that JSCH fails to meet all of the required standards. The issue for determination in this case, therefore, is whether JSCH complies with the Critical Elements. This is a question of ultimate fact susceptible to conventional means of proof that would need to be based solely upon the prehearing "record" assembled by the Department during the non-adversarial free-form proceeding leading up to the intended decision only if this were a review of the proposed agency action, instead of a de novo proceeding to formulate final agency action, a point to which this discussion will return.

  36. Here, though, it is necessary to pause to let sink in the important distinction between a retroactive review of the application, on the one hand, and a de novo proceeding to determine that the hospital has the Critical Elements required for a trauma center, on the other. To make that distinction


    more meaningful, it will be helpful to describe the nature of the factual disputes presented in this case.

  37. The trauma center application, not surprisingly, requires the hospital to provide the Department with a great deal of information about, e.g., the hospital's facilities, services, personnel, and operation. The applicant is expected not only to provide answers to questions, but also to submit corroborating documentation or "evidence" to substantiate the truth of its assertions.8/ The categorical description of Standard II.A, for example, is: "Organizational Requirements-- Is there evidence of a dedicated and defined trauma service for the hospital?"

  38. In reviewing JSCH's Application, the Department made many "findings" about the hospital based upon the evidence JSCH had submitted on or before April 22, 2015. In performing this function, the Department exercised the prerogatives of a fact- finder to assess the credibility and persuasiveness of the proof. In some instances, the Department found that JSCH's evidence was insufficiently persuasive to satisfy the hospital's burden of proving one fact or another necessary to demonstrate compliance with a particular Critical Element. In other instances, the Department found that the evidence before it proved that JSCH failed to meet a Critical Element.


  39. Currently, the Department argues that "[i]n this hearing, the ALJ will formulate final agency action with respect to the application that Jackson South submitted to the Department in April [2015]. . . . The ALJ is now standing in the Department's shoes with respect to Jackson South's April application and must analyze the question originally put before the Department: should the application that Jackson South submitted to the Department in April have been accepted or rejected?" DOH's Post-Hrg. Memo. of Law at 10. These statements are the Department's nod in the direction of section 120.57(1)(k), Fla. Stat. ("All proceedings conducted under this subsection shall be de novo."). At the same time, however, the Department insists that "Jackson South cannot rely on evidence regarding its trauma center in April 2015 that was not provided to the Department because the Department's decision about whether to grant or reject an application must be based solely on the applicant's submission to the Department." DOH's PRO

    at 35.


  40. Notice, therefore, that although the Department might seem at first blush to be describing a de novo proceeding, such is not what the Department has in mind. For if the undersigned's decision needs to be based on a closed record consisting exclusively of the materials received by the Department on or before April 22, 2015, as the Department urges,


    then all of the testimony presented at the final hearing, and much of the documentary evidence received too, would properly be considered dehors the record, useless. This would preclude JSCH from relying upon any evidence supplementing or corroborating the materials that the Department found last April to be insufficiently persuasive, even to prove historical facts as of April 2015, and of course from relying upon proof of events occurring after April 2015 that might reflect favorably upon JSCH's compliance with the Critical Elements.

  41. What the Department ostensibly wants is for the undersigned to conduct a de novo provisional review of the Complete Application (and nothing else) and, based on that, make a new decision as to whether the application is acceptable or not. But what the Department is really asking for is a retroactive review of the Department's file to determine the acceptability of JSCH's Application as if time had stopped on April 22, 2015, freezing the parties in place. By forcing the undersigned to defer to the Department's record and to adhere, ex post facto, to the Department's long expired procedural deadlines, such a retroactive review would protect the Department's proposed agency action against additional evidence of old facts as well as newly available evidence of changed circumstances. That is not a description of a de novo proceeding but, rather, of a quasi-appellate review, albeit


    (perhaps) one conducted pursuant to a de novo standard of review, which if performed would substantially modify JSCH's administrative remedies under sections 120.569 and 120.57(1).

  42. In further support of the retroactive review it contends is appropriate, the Department implies that this case is akin to a bid protest, which is a false analogy. Bid protests arise from competitive procurements. See § 120.57(3),

    Fla. Stat. In such protests, "no submissions made after the bid or proposal opening which amend or supplement the bid or proposal shall be considered." § 120.57(3)(f), Fla. Stat. This unique prophylactic exclusion of potentially relevant evidence ensures that no bidder will be allowed to gain an unfair advantage over another by improving its bid after seeing what the competition has to offer. A bid protest, moreover, is an atypical, quasi de novo proceeding in which the administrative law judge conducts a partial review of the intended agency action under deferential standards, i.e., "whether the proposed agency action was clearly erroneous, contrary to competition, arbitrary, or capricious." Id.

  43. Unlike a bid protest, this case arises out of a licensing process. There is neither a contract to be awarded nor a competition afoot here. It is important to emphasize that the Provisional Review Stage does not, under any circumstances, entail a competition between applicants, even if during a


    particular application cycle, as happens to be true for TSA 19 in 2014-16, the number of applicants exceeds the number of slots available. This is because while there is a limit on the number of verified trauma centers that can be licensed in each trauma service area, there is no limit on the number of provisional trauma centers that a trauma service area can have (if it still has one or more open slots). Not until the end of the Onsite Visit Stage can the prospect of a head-to-head competition between applicants possibly arise, and then only "if the number of Provisional trauma centers found eligible for selection by the department in a given TSA exceeds the number permitted." See Fla. Admin. Code R. 64J-2.016(11). During the Provisional

    Review Stage, applications are never mutually exclusive.


  44. The Department lost sight of this fact. Indeed, it openly acknowledges having made a "determination to review . . . all provisional trauma center applications for the one vacant slot in TSA 19 . . . at the same time by the same people [as] a reasonable way to ensure that competing applications would be held to the same standards and to avoid any appearance of favoritism." DOH's PRO at 49 (emphasis added). The mistaken notion that JSCH is presently competing with other applicants for the remaining slot in TSA 19 seems to have colored the Department's judgment and fueled its misguided insistence that JSCH be forbidden from demonstrating compliance with the


    Critical Elements by using evidence extrinsic to the Complete Application. But whatever the Department might think, there is simply no risk of unfair advantage or appearance of favoritism at this stage of the application process that could conceivably warrant placing extraordinary restrictions on the introduction at hearing of, or the fact-finder's reliance on, relevant evidence——not to mention the lack of legal authority for curtailing JSCH's administrative remedies.

  45. In sum, just as granting a medical license to one person gives him no regulatory advantage over another licensed doctor, likewise the issuance of a provisional license to JSCH would not give the hospital a regulatory advantage over any other provisional trauma center, for like physician licensure (and unlike the award of a public contract), provisional licensure is not a zero-sum game. The only question at hand is whether JSCH has the Critical Elements required for provisional licensure as a trauma center. If the evidence adduced at hearing demonstrates that it does, then JSCH is entitled to provisional status, regardless of how many other hospitals also might be.

  46. Noteworthy, too, is the inconsistency between the Department's position and the doctrinal underpinnings of the process by which licenses are granted or denied. When it comes to licensure, questions regarding the applicant's qualifications


    are to be determined based upon the circumstances that exist at the time of the final agency action, not some earlier date.

    This is because otherwise the agency might issue "a permit contrary to existing legislation." Lavernia v. Dep't of Prof'l Reg., 616 So. 2d 53, 54 (Fla. 1st DCA 1993). In Lavernia, an

    applicant for licensure by endorsement was denied a medical license in part because, while his application was pending, a recently enacted statutory amendment took effect, imposing new requirements which he did not meet. As the court explained, "Florida follows the general rule that a change in a licensure statute that occurs during the pendency of an application for licensure is operative as to the application, so that the law as changed, rather than as it existed at the time the application was filed, determines whether the license should be granted." Id. at 53-54.

  47. The same logic applies to factual developments which are material to an applicant's qualifications for licensure.

    If, between the time an application is filed and the time the agency takes final action on the application, some fact material to the applicant's qualifications changes to his detriment, so that he no longer satisfies the conditions for licensure under existing legislation, then the agency need not, and indeed should not, issue the license, even though the applicant was


    eligible for licensure when he applied. See Bd. of Med. v.


    Mata, 561 So. 2d 364, 365 (Fla. 1st DCA 1990).


  48. In Mata, after the agency gave notice of its intent to


    deny the applicant a license on the ground that his prior criminal conviction for practicing medicine without a license "rendered him morally unfit" to be a doctor, the applicant requested a hearing, at which he persuaded the hearing officer that he had rehabilitated himself. Id. While the agency was

    considering the recommended order urging that the license be issued, the applicant was again arrested for the unlicensed practice of medicine. Although the criminal charges were later dismissed, the agency remanded the case to the hearing officer for consideration of whether the applicant's subsequent arrest cast doubt on the finding of rehabilitation. The hearing officer refused the remand, and the agency appealed. Id. at 365-66.

  49. The court, reversing, rejected the notion that the issues are "immutably fix[ed]" when a matter is referred for hearing, "limiting them to the reasons raised in the [agency]'s initial intent to deny the application." Id. at 366. Rather, examining the statutes governing licensure of physicians, the court found as follows:

    Nothing in the statute indicates that this investigative process [for assuring that applicants meet the applicable criteria]


    must end when the [agency] issues an intent to deny the application and refers the matter to a hearing officer. There is no evident statutory intent to exclude consideration of additional pertinent information learned prior to the issuance of the license.


    Id. at 367. Consequently, the court remanded so that the


    hearing officer could consider evidence of the events that had transpired after the final hearing, make additional findings of fact based on such evidence, and recommend whether, in light of the current facts, the applicant was fit to practice medicine. Id. at 377.9/

  50. Here, the pertinent licensure statute, section 395.4025(2)(c), provides:

    This critical [provisional] review will be based on trauma center standards and shall include, but not be limited to, a review of whether the hospital has:


    1. Equipment and physical facilities necessary to provide trauma services.


    2. Personnel in sufficient numbers and with proper qualifications to provide trauma services.


    3. An effective quality assurance process.


    4. Submitted written confirmation by the local or regional trauma agency that the hospital applying to become a trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists.


    As in Mata, there is nothing in the statute either suggesting


    that this critical review must end upon the Department's issuance of a notice of intent to deny a hospital's application or evincing any intent to exclude consideration of relevant factual developments taking place prior to the final decision whether to issue or deny the provisional license. Under the Department's reasoning, if a hospital were to file a petition for bankruptcy protection the day after the Department gave notice of its intent to grant or deny the hospital a provisional license, the Department would be unable to consider the facts relating to the hospital's bankruptcy before taking final agency action, but would have to proceed as if the filing had not occurred. The undersigned doubts that in such a situation the Department would stick to the principle, which it endorses here, of ignoring facts extrinsic to the hospital's application.10/

  51. Just as changing circumstances adversely affecting an applicant's qualification for licensure can be considered by the agency if evidence of the facts is received prior to the final decision, so too is the applicant entitled to present, and have the agency consider, proof of recent developments which positively affect the applicant's qualifications. This has long been recognized. See McDonald v. Dep't of Banking & Fin., 346 So. 2d 569, 584 (Fla. 1st DCA 1977). As the court explained in McDonald,


    The hearing officer's decision to permit evidence of circumstances as they existed at the time of the hearing was correct. The agency may appropriately control the number and frequency of amendments to licensing applications and may by rule prevent substantial amendment of the application in midproceeding. But the hearing officer or agency head conducting Section 120.57 proceedings should freely consider relevant evidence of changing economic conditions and other current circumstances external to the application. Section 120.57 proceedings are intended to formulate final agency action, not to review action taken earlier and preliminarily.


    Id. at 584 (footnote omitted)(emphasis added). What matters, in the end, is that the applicant be qualified (or not) at the time of the final decision, not at some earlier point in the process. See also MVP Health, Inc. v. Ag. for Health Care Admin., Case

    No. 09-6021, 2010 Fla. Div. Adm. Hear. LEXIS 557, 37 n.13 (Fla.


    DOAH Apr. 22, 2010).


  52. Finally, the shaky foundation upon which the Department's entire position rests is the undue significance the Department attaches to its preliminary agency action. In effect, the Department is arguing that because the Department necessarily based its intended decision on the Complete Application, the administrative law judge must do the same, lest the Department be unfairly second-guessed for failing to take into account evidence that had not been presented, or events that had not yet occurred, before the proposed agency action was


    announced.11/ The agency's notice of intended decision, however, is just not that important——at least not where, as here, the party whose substantial interests are being determined timely requests a hearing. Proposed agency action, when challenged, is merely the end of the beginning, marking the close of the free- form decision-making process, which is followed by a more structured proceeding that leads to the entry of a final order. See, e.g., Ft. Myers Real Estate Holdings, LLC v. Dep't of Bus.

    & Prof'l Reg., 53 So. 3d 1158, 1161 (Fla. 1st DCA 2011).


  53. As the court noted in Mata, the "Administrative


    Procedure Act makes the hearing officer's fact finding function in licensing proceedings an integral part of the whole process by which the agency determines whether to issue or deny the license." 561 So. 2d at 367. Section 395.4025(7), which assures the right of a hospital to "protest a decision made by the department based on the department's preliminary or in-depth review of applications or on the recommendations of the site visit review team," states——without imposing special conditions——that any hospital which wants to take advantage of its administrative remedies "shall proceed as provided in chapter 120" and be afforded a hearing "conducted in the same manner as provided in ss. 120.569 and 120.57." In other words, the hospital is entitled to a typical chapter 120 hearing as an


    integral part of the whole process by which the Department determines whether to grant or deny the license.

  54. If the legislature had intended for the administrative law judge to conduct a quasi-appellate review of the Department's preliminary decision based only on the facts available to the agency when it made its decision, as the Department wants the undersigned to do, then the legislature would not have prescribed a chapter 120 hearing conducted pursuant to sections 120.569 and 120.57 as the hospital's administrative remedy "because those [hearing] procedures contemplate the presentation and consideration of new evidence." J. D. v. Dep't of Child. & Fams., 114 So. 3d 1127, 1132 (Fla.

    1st DCA 2013). In contrast to, for example, sections 120.57(3)(f) and 435.07(3)(c), which provide special appellate- like administrative remedies for, respectively, bid protests and proceedings relating to exemptions from disqualification from employment, section 395.4025(7) plainly and unambiguously directs the administrative law judge to "conduct a 'typical' chapter 120 hearing to formulate final agency action in which the agency's preliminary decision is given no deference." Id.

  55. The Department's insistence that the scope of this proceeding should be limited to the record created during the agency's free-form deliberative process leading to the notice of intended action is simply without legal support. The


    undersigned will consider all relevant evidence in the record, including evidence extrinsic to the Complete Application, and will not ignore the relevant events that occurred after

    April 22, 2015.


  56. The parties dispute the degree of compliance with the Critical Elements which an applicant must demonstrate as a condition of provisional licensure. JSCH argues that "substantial compliance" suffices to establish that the hospital has the Critical Elements required for a trauma center. As JSCH sees it, substantial compliance is a less demanding standard than "full compliance." A hospital is in substantial compliance with (and thus "has") a Critical Element, according to JSCH, so long as it meets all of the standard's fundamental qualities with no material deviations that likely would have an adverse effect on patient safety or quality of care. Minor or insubstantial irregularities are not disqualifying under JSCH's theory.

  57. The Department contends that nothing less than "full compliance" is required. By "full compliance" the Department means absolute, maximum, nearly perfect compliance with every jot and tittle, so that even the slightest deviation from tiniest detail of just one standard having no discernable real- world effect is enough to scuttle the applicant. Under the Department's theory, compliance is an all-or-nothing


    proposition, and anything short of near perfection is equivalent to zero compliance.

  58. JSCH's position is grounded in several statutory definitions, beginning with that of "provisional trauma center," which provides as follows:

    "Provisional trauma center" means 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 provisional Level I trauma center, Level II trauma center, or pediatric trauma center.


    § 395.4001(10), Fla. Stat. (emphasis added). The definitions of "trauma center," section 395.4001(14); "Level I trauma center," section 395.4001(6)(a); "Level II trauma center," section 395.4001(7)(a); and "Pediatric trauma center," section 395.4001(9), all likewise stipulate that verification by the Department of "substantial compliance" with the Standards is required for approval.

  59. The Department stakes its position on rule 64J- 2.011(1), which provides as follows:

    The standards for Level I, Level II and Pediatric trauma centers are published in DH Pamphlet (DHP) 150-9, January 2010, Trauma Center Standards, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4),

    F.A.C. Any hospital that has been granted Provisional trauma center status or has been granted a 7 year Certificate of Approval to operate as a verified trauma center at the time this rule is amended must be in full


    compliance with the revised standards one year from the date the rule is amended. On or after the effective date of the amended rule, completed applications for Provisional trauma center status that do not demonstrate full compliance with these standards shall be denied.


    (Emphasis added).


  60. Assuming (as both the parties do) that substantial compliance contemplates a more forgiving test than full compliance, so that a hospital could be at once in substantial compliance with a standard and also be not in full compliance therewith, then JSCH's argument based on the statutory definitions is clearly correct as a matter of pure logic. Had the legislature intended to require outright compliance rather than substantial compliance for verification, then its use of the term "substantial compliance" would be inexplicable if not irrational, given that (where "substantial" denotes less than "full" compliance) full compliance is necessarily also substantial compliance, but substantial compliance is not necessarily also full compliance. Reason dictates that a legislative intent to impose an exacting standard of strict compliance would have been expressed with an adjective other than "substantial," which at a minimum can reasonably be understood as implying a measure of leniency, as indeed both parties read it.


  61. More important, under section 395.4001(10) and the related definitions, substantial compliance with the Standards is plainly and unambiguously both necessary and sufficient for verification; no other reasonable meaning can be attached to the statutory language. Since substantial (meaning possibly but trivially incomplete) compliance is sufficient, it follows that full (meaning outright) compliance is unnecessary even if desirable.

  62. The Department attempts to minimize the significance of the "provisional trauma center" definition by insisting that it "does not change anything" and "does not purport to alter the statutory requirements set forth in section 395.4025(2)(c)." DOH's Post-Hrg. Memo. of Law at 21. This is unpersuasive. True, the definition does not change anything; but then, it is the thing. There is no higher authority to which the definition must yield. Similarly, it is true that section 395.4001(10) does not purport to alter the requirements of section 395.4025(2)(c). But this is a red herring. The definition tells us that "substantial compliance with the requirements in

    s. 395.4025"——necessarily including those in subsection (2), paragraph (c)——is sufficient for verification; and that, not whether section 395.4001(10) amends section 395.4025(2)(c), is the point of contention.


  63. The parties are in agreement that substantial compliance is a subset of full compliance. If true, and if as the Department contends full compliance is necessary, then full compliance is also sufficient (since there can be no greater degree of compliance than full compliance as the Department defines it). If full (meaning outright) compliance were necessary and sufficient (which is the logical import of the Department's position), then the statutory reference to substantial compliance would be wholly unnecessary and gratuitously misleading——the worst kind of surplusage. The legislature could not have expressed itself that poorly; instead, its intent, expressed with reasonable clarity, was to prevent the unfortunate disapproval of solid applications that might fail if subjected to unnecessarily strict scrutiny. The Department's reading of the statute is clearly erroneous.

  64. What about rule 64J-2.011(1)? It does require "full compliance" with the "revised standards" that had been recently updated in 2010 when the rule was last amended. The undersigned disagrees with the Department, however, that "full compliance" as used in the rule means absolute or unconditional compliance. The first reason for rejecting the Department's interpretation is that it effectively redefines "provisional trauma center" as a hospital that has been verified by the Department to be in full (i.e., near perfect, better than substantial) compliance


    with the requirements in section 395.4025. Such a definition would substantively modify section 395.4001(10), imposing more stringent conditions upon applicants than the legislature has prescribed——and enlarging the Department's authority. The undersigned presumes that the Department did not intend to modify the statutes when it promulgated the rule.

  65. The second reason is that the Department's interpretation is not the most natural reading of text. "Full" is a richly textured adjective having many meanings. In ordinary discourse, the word can mean maximum or perfect, but it can also mean complete in number. As used in rule 64J-2.011(1), the term "full compliance" seems clearly to convey the quantitative sense of the adjective. The context is the announcement of newly revised standards imposing additional or different requirements. The directives are for previously approved trauma centers to come into full compliance with the revised standards within one year, and for hospitals seeking approval to be in full compliance with the revised standards at the outset, as a condition of licensure. Full compliance here means compliance not only with the standards that predated the amendment of rule 64J-2.011, but also with the revised standards newly incorporated therein——with all (i.e., the complete number of) existing standards, in other words.


  66. The elegance of this interpretation is underscored by its consistency with section 395.4025(10) and the related definitions. When full compliance is understood in a quantitative sense, thereby leaving substantial compliance alone to describe the requisite degree of qualitative obedience, it is not tautologous to state that a hospital is in both full and substantial compliance with the Critical Elements; the statutory term "substantial compliance" is not reduced to mere surplusage; and the rule does not enlarge, contravene, or modify the statute.

  67. Consequently, the undersigned, reading rule 64J- 2.011(1) together with section 395.4025(10) and the related definitions, concludes that substantial compliance and full compliance refer to different measurable quantities, and that the necessary and sufficient degree of qualitative compliance is that which is "substantial."

  68. The trauma statutes do not define "substantial compliance" for their purposes. Both parties view the term through the prism of enforcement. This is understandable because substantial compliance is an equitable defense to liability based on a technical statutory violation, although it might not apply "when there is a partial failure to comply with regulatory requirements." Birnholz v. 44 Wall Street Fund,

    Inc., 559 So. 2d 1128, 1132 (Fla. 1990).


  69. Here, however, the primary emphasis should be on the applicant's virtues, the undersigned believes, not its possible violations. In the context of an initial licensure, where substantial compliance is required, it seems preferable to focus on what the applicant has, rather than what it might lack.

  70. One possible understanding of substantial compliance which must be rejected up front, however, is compliance with a significant percentage of the Critical Elements. That is to say, substantial compliance does not mean that an applicant who meets, for example, 295 out of 300 applicable Standards, but lacks five, has the Critical Elements required for a trauma center. The quantitative interpretation of "full compliance" (from rule 64J-2.011(1)) comes into play here, making sure that substantial compliance is determined, not collectively, but on standard by standard basis.

  71. The undersigned believes that the adjective "substantial," which like "full" has multiple meanings, is best understood in the context of section 395.4001 as connoting substance: substantial compliance is essential compliance, real compliance, compliance with the important, essential, substantive aspects of each standard. Of course, to apply "substantial compliance" in this fashion, it is necessary to know what is truly important in a standard, which requires that


    the Standards be interpreted correctly when disputes about compliance arise, as here.

  72. This question of how the Standards should be interpreted gets to the heart of many disputes in this case and seems to the undersigned to be the real disagreement behind the argument about substantial compliance versus full compliance. As it happens, the Department has strictly construed the applicable Standards against JSCH. Taking a highly legalistic approach to the text of the Standards, the Department has tightened them to maximum rigidity. Armed with hundreds of detailed and hairsplitting Standards, the Department flyspecked the Application in search of every arguable deficiency,

    including even trifling flaws, which was like shooting fish in a barrel. It is no wonder that JSCH has reached for substantial compliance as the means of persuading the Department to overlook trivial shortcomings.

  73. The undersigned believes, however, that substantial compliance is better understood here as an instruction to give the Standards, not a hypertechnical reading that elevates form over substance, but a sensible, pragmatic construction which keeps in mind that a hospital is a complex system whose strengths and weaknesses are unlikely to be fully and fairly represented in the trauma center application, as lengthy as it is. Compliance with a properly interpreted standard is


    substantial compliance. Conversely, deviation from a properly interpreted standard is no mere trifle but a substantive, disqualifying fault.

  74. JSCH submitted its letter of intent to seek approval as a Level II trauma center in TSA 19 on October 1, 2014. Two weeks later, JSCH filed with the Department its first application, which was received on October 16, 2014 (hereafter, the "October Application").

  75. In October 2014, the Department received letters of intent from other hospitals besides JSCH interested in opening new trauma centers in TSA 19. As mentioned above, the Department made the incorrect decision that these hospitals would be competing for provisional licensure, and based on this erroneous premise concluded that the best course of action was to disregard the time frames prescribed in section 120.60 (another clear error) and wait until the application deadline (April 1, 2015) to review JSCH's application together with any others that might be filed. The Department perceived no need to notify JSCH that, notwithstanding section 120.60, its October Application would be shelved for nearly half a year, and so no such notice was provided.

  76. In fact, however, the Department did review the October Application, as revealed by a document——belatedly and rather dramatically produced at the final hearing——entitled


    "Jackson South Community Hospital Trauma Center Application Review Summary" (the "Review Summary"). The Review Summary sets forth the "findings [made,] and key discrepancies" noted, by the Department's "Trauma Section" after conducting a "preliminary review" of the October Application. The Review Summary states, in conclusion, that "[i]t is the recommendation of the review team that [JSCH] should not be granted provisional status by the department at this time."

  77. Remarkably, neither the Review Summary nor its findings and conclusions were contemporaneously provided to JSCH. Indeed, the Department never communicated any response to JSCH regarding the October Application. Despite this inaction, JSCH never made a claim under section 120.60(1) for licensure by default.12/ Instead, JSCH submitted a second application for licensure as a Level II trauma center, on April 1, 2015, the Application which precipitated the proposed agency action at issue.

  78. Before leaving the subject of the October Application, which is not directly in dispute here, it is worth noting that pursuant to section 120.60(1), the Department should have informed JSCH of any apparent errors or omissions in the October Application, and requested any additional information necessary to complete that application, no later than November 17, 2014. Had the Department complied with section 120.60(1) and given


    JSCH timely notice of the alleged deficiencies of the October Application, JSCH would have had, not the mere five business days it was afforded with regard to the Application at issue, but five months (until April 22, 2015) within which to provide the Department additional information.

  79. The prejudice to JSCH from the Department's noncompliance with section 120.60 is largely mitigated if JSCH's administrative remedies include a typical de novo hearing, as the undersigned has found they do for reasons discussed at length above. But if, contrary to the undersigned's conclusions, JSCH's hearing were required to be as tightly controlled and narrowly focused as the Department would like, with JSCH being prohibited from relying upon any evidence except that which was in the Department's file as of April 22, 2015, then the Department's noncompliance with section 120.60 would produce an undeniably prejudicial effect, for the Department, wittingly or not, would have sharply curtailed JSCH's right to submit the only evidence upon which its substantial interests ultimately would be determined.

  80. Upon the filing of the Application on April 1, 2015, both parties proceeded as if the earlier October Application had never existed. The Department arranged for the Application to be reviewed by two outside consultants, a physician and a nurse, each of whom evaluated the Application for compliance with a


    different set of the Critical Elements, so that only one person handled any single element. The consultants recorded their respective judgments on the Department's Checklist for Provisional Review, a form comprising a series of Standard- specific tables which contain descriptions of the hundreds of Critical Elements in separate rows, one element per row, and have two columns on the right titled "Yes" and "No," creating checkboxes for the reviewer to mark with an X to signal compliance or noncompliance with the row's element. Below each table is a comment box wherein the reviewers provide an explanation of the "deficiencies" and identify the information or action needed to correct them.

  81. The consultants found that JSCH failed to meet more than one-third of the 300 or so Critical Elements. By correspondence dated April 15, 2015 (the "Deficiency Notice"), the Department provided JSCH with a copy of the completed checklist and advised the hospital that it had until April 22, 2015, to supply the requested corrective information.

  82. JSCH timely submitted a package of additional information (the "Deficiency Response") to the Department on April 22. JSCH's Complete Application, therefore, consists of the Application plus the Deficiency Response.

  83. Thereafter, the Department's Trauma System Administrator, Susan Bulecza, DNP, reviewed the Deficiency


    Response to determine whether JSCH had corrected the alleged deficiencies. Dr. Bulecza13/ did not evaluate JSCH for compliance with all of the Critical Elements but instead limited her review to the alleged deficiencies that the consultants had identified. Dr. Bulecza recorded her findings on the previously completed checklist, which she revised to reflect whether in her opinion each alleged deficiency had been corrected or not corrected. Dr. Bulecza determined that JSCH had failed to correct more than 40 deficiencies, for reasons she summarized in the comment boxes on the form. In many instances, Dr. Bulecza found JSCH to be noncompliant with an element, despite having submitted the information requested in the Deficiency Notice, on the ground that other information was missing.

  84. By letter dated April 30, 2015 (the "Denial Letter"), the Department notified JSCH that it intended to deny JSCH's Application. Included with the Denial Letter was the amended checklist, which included Dr. Bulecza's comments. Dr. Bulecza was the only person within the Department who had reviewed the Deficiency Response to determine JSCH's compliance, and the intended decision to deny JSCH's Application had been hers alone to make.

  85. Of the deficiencies identified in the Denial Letter, two groups stand out: those relating to the hospital's quality management program and those relating to its helipad. The rest,


    broadly speaking, mostly relate to the qualifications of JSCH's professional personnel (e.g., credentials and continuing education) and administrative issues such as staffing levels.

  86. The majority (around 60%) of the alleged deficiencies in dispute are in Standard XVIII, which comprises roughly

    50 elements under the heading of Quality Management. As used in this Standard, the term "quality management" refers generally to the trauma center's procedures for reviewing trauma patient records to identify areas in which performance might be improved by taking corrective measures.

  87. The root cause of every alleged deficiency in this category is the Department's insistence that, to be compliant, the applicant must already have implemented a trauma quality management program by the time it submits its application, even though the hospital cannot begin treating "trauma patients" as a trauma center until it receives provisional licensure. JSCH maintains that the Department's interpretation of the Standard is unreasonable in the context of a provisional review and contends that evidence of a quality management program that is fully implementable upon the commencement of operations as a trauma center demonstrates substantial compliance.

  88. The Department's position is founded on the following sentence in Standard XVIII.B: "Is there written evidence on file indicating an active and effective trauma quality


    improvement program?" (Emphasis added). The Department seized on the word "active" as support for rejecting JSCH's quality management program on the ground that, notwithstanding the "detailed plan and schedule of Multidisciplinary conferences to begin [upon licensure] in May 2015" which had been provided, the hospital had failed to demonstrate that "there has been any review of trauma patients or implementation of any elements to date [i.e., as of April 24, 2015]."

  89. The term "trauma patient" is defined in section 395.4001(15) as meaning "a person who has incurred a physical injury or wound caused by trauma and has accessed a trauma center." 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[.]" § 395.4001(14), Fla. Stat. JSCH is therefore correct that until a hospital becomes a licensed trauma center, it cannot serve "trauma patients" as that term is used in the trauma statutes. Clearly, then, it is reasonable for an applicant's proposed quality improvement program to be considered "active" if it is complete, current, and actionable, so that the hospital, after receiving its license, is positioned to put the plan in motion as soon as the trauma center opens for business.

  90. At the same time, the Department's strict construction of the Quality Management elements, which would disqualify an


    otherwise acceptable plan (such as JSCH's) solely because the applicant has yet to implement a program to improve the trauma service it has yet to start, is precisely the sort of legalistic interpretation that the term "substantial compliance" guards against. The essential purpose of a quality management program for a trauma center is to improve the trauma service; it makes little or no sense to require that the program actually be operating ahead of the trauma service it is supposed to improve. No purpose is served, moreover, by rejecting a program that is presently capable of being implemented once the trauma center starts operating. The Department's interpretation is unreasonable in the face of a statute which authorizes licensure upon verification of substantial compliance with the Critical Elements.

  91. In any event, by the time of the final hearing, having learned that the Department would consider the hospital's plan to be "active" if the trauma quality management committee met to review the records, not of "trauma patients" as the Standard requires, but of patients with traumatic injuries, JSCH had begun doing just that. In other words, JSCH achieved compliance with the elements of Standard XVIII relating to a hospital's quality management program even under the Department's strict interpretation of these requirements.


  92. The other elements of Standard XVIII that are in dispute pertain to the trauma registry that the hospital must maintain for the collection of trauma patient data. In its Deficiency Response, JSCH explained that it had hired a trauma registrar and installed the database management system that would serve as the electronic trauma registry. JSCH provided screenshots as proof that the software was operational and ready to receive data as soon as the hospital began receiving trauma patients. The Department deemed this deficient because "the system is [not] actually being utilized"——which was true because JSCH is not actually licensed to operate a trauma center.

  93. The Department's interpretation of Standard XVIII as requiring that the applicant's trauma registry actually be in service prior to licensure is contrary to the concept of substantial compliance, and it creates a near Catch-22. There is no genuine question that JSCH's trauma registry was (and remains) ready for use upon licensure; that should have been (and is) sufficient.

  94. At any rate, by the time of the final hearing, JSCH had begun tracking patients with severe injuries in its trauma registry, as the only possible substitute for inputting actual trauma patient data, which by definition is unavailable to JSCH. By any measure, JSCH is in compliance with the elements of Standard XVIII dealing with the trauma registry.


  95. Standard V contains the Critical Elements falling under the category labeled Emergency Department. Among the requirements is a mandate for the hospital to have a helicopter landing site in close proximity to the resuscitation area. The helipad must be "licensed by the Florida Department of Transportation" ("DOT") and make "use of airspace approved by the Federal Aviation Administration" ("FAA"). The Department found JSCH's helipad to be unacceptable because, as of April 22, 2015, (i) the DOT license had been applied for but not issued, and (ii) although the Deficiency Response "note[d that] the FAA ha[d] granted approval [of the airspace] . . . , no updated documentation from [the] FAA [was] provided."

  96. The airspace approval is a nonissue, as the Department all but conceded in this proceeding. In fact, the FAA had granted approval of the use of the airspace over JSCH's helipad as of April 22, 2015. JSCH clearly has this Critical Element.

  97. As for the DOT license, the Department's position hinges entirely on the imposition of April 22 as the deadline for obtaining licensure, because it is undisputed that on April 29, 2015, DOT granted JSCH's request for private airport site approval, issuing an Airport Site Approval Order that took effect on June 13, 2015. (The reason for the 45-day waiting period is rule 14-60.005(7)(b), which delays the effective date of an approval order to allow enough time after publication of


    the notice of intended agency action for affected airports, local governments, and property owners to request an administrative hearing.) Thus, as of the final hearing, JSCH's helipad was licensed by DOT.

  98. For reasons discussed, the undersigned has rejected the Department's contentions that, in this de novo proceeding,

    1. the evidentiary record is limited to the Complete Application and (ii) the findings of historical fact must stop as of April 22, 2015. Because JSCH's helipad has been licensed since June 13, 2015, the hospital currently has this Critical Element; whether it did so on April 22 is irrelevant.

  99. Although it is not necessary to dig deeper on this point, having found that JSCH holds the requisite DOT license, the Department has relied so heavily on the purported lack of a helipad license, which it views as an impregnable basis for denying the Application, that some further discussion is in order. The Department's faith in this issue derives from its belief, which the undersigned has rejected as unfounded, that a provisional trauma center must begin operating on May 1, i.e., more or less immediately upon receipt of the Department's notice of intent to approve the hospital's application. From this premise, the Department argues that had JSCH been granted provisional status, there would have been a period of perhaps six weeks (or longer if someone challenged the Site Approval


    Order) when helicopters could not land at the new trauma center, resulting in longer flights to other trauma centers in Miami- Dade County. The Department claims that a trauma center operating without a fully licensed helipad even for a short period of time (e.g., May 1 to June 13) would be worse somehow than no trauma center at all and thus could not be permitted to exist.

  100. Apart from the fact that nothing in the trauma statutes would have prevented JSCH from delaying its opening as a provisional trauma center until June 13, 2015, the logic of the Department's position completely escapes the undersigned. Consider that, right now, no trauma patients are brought to JSCH; they must be transported, whether by ambulance, helicopter, or other means, to other trauma centers in the area, even if JSCH is a shorter distance away, because JSCH is not a trauma center. This is the status quo, which JSCH is trying to make better by proposing to add to the area's capacity for treating trauma patients. If JSCH had opened as a trauma center on May 1, 2015, there would immediately have been more capacity to serve trauma patients in TSA 19, not less, even without the helipad.

  101. Yet, the Department is arguing that because for a few weeks some trauma patients arriving by air might have had to bypass JSCH, just as they have always done, it is necessary to


    take action to prevent all trauma patients from being brought to JSCH, not just for six weeks, but indefinitely, perhaps forever. The Department has fallen victim to the perfect solution fallacy, rejecting an improvement in the present situation because the proposed solution is less than ideal. This is not to minimize the importance of a helicopter landing site; everyone agrees that a helipad is necessary and desirable. But no one believes that most——or even a substantial minority——of a trauma center's patients arrive by air, either. The point is that had JSCH's trauma center operated for several weeks without an active helipad, the trauma patients taken to JSCH (rather than more distant hospitals) via ground transportation would have been better off, their treatment unaffected by the helipad; the trauma patients delivered by helicopter to other facilities before June 13, 2015, would have been no worse off, their situations being exactly the same as if JSCH's Application had been denied; and all trauma patients served by JSCH would have been better off after June 13, 2015.

  102. The Department unintentionally highlights the irrationality of its position by arguing that if a catastrophic event such as a terrorist attack or hurricane occurred before the effective date of JSCH's helipad license, the absence of an active helicopter landing site at JSCH's trauma center would mean fewer places to which casualties could be airlifted. Put


    aside the improbability, in the wake of large-scale disaster, of casualty-laden choppers bypassing JSCH's fully functional helipad because the preliminary agency approval of the landing site is a few days or weeks from becoming final; the undersigned assumes (and hopes) that in such exigent circumstances the EMS pilots would be more concerned with saving lives than the pending status of JSCH's helipad license. If such an event had occurred before June 13, 2015, the hospital situation certainly would have been no worse (were JSCH provisionally licensed) owing to the lack of JSCH's helipad, which has never been in service, and probably would have been better due to the presence of its trauma center; and if the disaster took place after

    June 13, then the JSCH helipad would have been active, averting the parade of horribles the Department envisions. Denying JSCH's Application only serves to lessen, indefinitely or permanently, the contribution that JSCH could make in the event of a mass-casualty catastrophe.

  103. Adding a dash of irony to the mix, JSCH's helipad license was no less final or effective as of April 30, 2015, than its provisional license would have been, if instead of issuing the Denial Letter on that date the Department had announced its intent to approve the Application. Just as third parties can challenge a proposed private airport license, so too can third parties challenge a proposed provisional trauma center


    license. In either case, the proposed license does not actually become final and legally effective until (at the earliest) the right to a hearing is waived after receiving a clear point of entry. The Department wants to make hay with the uncertainty arising from the possibility of an administrative challenge to the intended issuance of JSCH's helipad license (which in the event did not materialize), while ignoring the same possibility as it relates to the intended issuance of a provisional trauma center license. If the Department, like DOT, acknowledged the possibility of a challenge and explicitly deferred the effective date of a proposed provisional trauma center license to take that possibility into account (as it should), then the gap between JSCH's licensure as a provisional trauma center (had its Application been given preliminary approval on April 30) and the effective date of its helipad license would have been, at most, about three weeks.

  104. When it comes to JSCH's helipad, the Department apparently lost sight of the big picture, deciding that a short wait for this asset justified depriving the community served by JSCH of its benefits for the foreseeable future, if not forever. Regardless, JSCH currently has a DOT-licensed helicopter landing site that uses airspace in accordance with FAA approval. JSCH is in compliance with the helipad-related Critical Elements.14/


  105. The rest of the alleged deficiencies, in which the Department puts much less stock, can be addressed in broader strokes. The evidence in the record, if not the Complete Application on its own, establishes that JSCH has these Critical Elements, as the Department's witness, Dr. Bulecza, admitted at hearing.

  106. Standards II.B.1.a, II.B.1.b, II.D.2.c, III.A.3.d, V.C.1.b, VII.B.2, VIII.A.2, VIII.A.3, and VIII.A.4 contain Critical Elements prescribing trauma-related continuing education requirements for the physicians and nurses who staff the trauma center. Dr. Bulecza determined that JSCH did not have these Critical Elements, largely because, after weighing the credibility of the information supplied with the Complete Application, she found that JSCH had failed to present sufficient proof of its professional employees' continuing education credits. She also interpreted several Critical Elements very strictly, disallowing some credits for being allegedly not trauma-related.

  107. The Department now acknowledges, however, that "[a]t the hearing [JSCH] presented evidence that the trauma continuing education requirements had been satisfied." DOH's PRO at 26. The undersigned agrees and so finds.

  108. Standard III.A.3.c requires the hospital to document that its general surgeons manage at least 28 trauma cases per


    year. Dr. Bulecza deemed the documentation JSCH supplied with the Complete Application insufficient to prove compliance with the case count requirement because it was unclear to her whether the cases each doctor was shown to have handled were trauma cases. Credible evidence received at hearing persuades the undersigned to find, pace Dr. Bulecza, that the cases in question were, in fact, trauma cases, which the surgeons had managed at Ryder. JSCH has the Critical Element relating to per-physician surgical case counts.

  109. Standard II.B.5 states that the hospital must have "[e]vidence on file" that the trauma medical director ("TMD") is an "active" member of either the "local or regional trauma agency" if there is one, or else the "local health planning council or advisory group." "Active membership is evidenced by attendance . . . at no less than 75 percent of the scheduled meetings." JSCH represented in its Deficiency Response that, because the local trauma agency "was disbanded years ago," the TMD attends quarterly meetings as "an active member of" the City of Miami EMS and additionally maintains active membership in several state and national organizations, including the Florida Committee on Trauma ("FCOT"). Some corroborating documentary proof of the TMD's attendance at FCOT meetings was submitted with the Complete Application.


  110. Dr. Bulecza found JSCH's evidence to be insufficient because, in her opinion, membership in FCOT——a state, not a local, advisory group——does not count, and no documentation "like minutes" supported the naked assertion (which if proved would satisfy the Standard) that the TMD attended EMS quarterly meetings. Tr. at 1344.

  111. The undersigned finds JSCH's unequivocal representation in its Deficiency Response to be sufficient "evidence . . . on file" of the TMD's active membership in the local EMS. Such a statement of material fact in an application for trauma center approval is no small matter because a misrepresentation is cause for the Department to "deny, suspend, or revoke the approval of any Provisional trauma center." Fla. Admin. Code R. 64J-2.012(3). JSCH has this Critical Element.

  112. Standard II.C.3 seeks "documentation [showing that] the medical director shall approve all trauma related patient care protocols before implementation." JSCH submitted its trauma policies, procedures, and protocols, which are in a manual whose cover sheet bears the TMD's signature under the words "reviewed" and "approved." Dr. Bulecza deemed this insufficient because the signature page did not establish with certainty the TMD's specific approval of each individual policy, which in her view is what the Standard requires. The undersigned considers this interpretation of the Standard to be


    unduly strict, especially since "substantial compliance" therewith is sufficient for licensure, and Dr. Bulecza's standard of proof too stringent. The undersigned finds that the TMD approves all trauma related patient care protocols and therefore that JSCH has this Critical Element.

  113. Standard V.C.1.a requires that at least "two RNs per shift . . . be in-hospital and take primary assignment for the resuscitation area." Dr. Bulecza found that although JSCH had submitted "a list of nurses" who were "assigned to [the] emergency department," the hospital was noncompliant for failure to submit a "staffing schedule" so that she could determine if the nurses were "actually scheduled and assigned" to the resuscitation area. The Standard, however, does not require the production of a staffing schedule, and the Department never requested one, instead notifying JSCH in the Denial Letter for the first time that this alleged "omission" was fatal to its Application. At hearing, JSCH moved into evidence the nurse's staffing schedule that had been prepared in advance of the trauma center's anticipated opening on May 1, 2015. JSCH persuasively has demonstrated its compliance with Standard V.C.1.a.

  114. Standards VI.A.1-2 state that the "trauma center shall have at least one adequately staffed operating room immediately available for all trauma patients 24 hours a day"


    and "shall have a second adequately staffed operating room available within 30 minutes after the primary operating room is occupied with a trauma patient." JSCH submitted its policies on operating room availability and staffing, which comply with the Standards at issue, but Dr. Bulecza found the documentation insufficient because "no call schedules or staffing schedules were submitted to validate actual staffing coverage." The Standards do not require the hospital to produce schedules, and JSCH did not learn that the Department considered such information essential until it received the Denial Letter, which mentioned this alleged "omission" for the first time. At hearing, JSCH introduced an operating room staffing schedule, which is additional, if cumulative, evidence that it has the Critical Elements under consideration. JSCH persuasively has demonstrated its compliance with Standards VI.A.1-2.

    CONCLUSIONS OF LAW


  115. The Division of Administrative Hearings has personal and subject matter jurisdiction in this proceeding pursuant to sections 395.4025(7), 120.569, and 120.57(1), Florida Statutes.

  116. As the applicant for approval of its trauma center, JSCH has the ultimate burden of persuasion and must prove, by a preponderance of the evidence, that it has the Critical Elements required for a trauma center. § 120.57(1)(j), Fla. Stat.; see


Fla. Dep't of Transp. v. J.W.C. Co., 396 So. 2d 778 (Fla. 1st


DCA 1981).


117. Paragraphs 13, 14, 16, 18, 19, 21, 23 through 25, 32,


33, 35, 41, 45 through 55, 60 through 67, 70, 71, 73, 78, 79,


89, 90, 93, and 98 are incorporated by reference in this section of the Recommended Order and adopted as conclusions of law.

  1. The Department argues that its interpretations of the trauma statutes and rules, including the Standards, are entitled to deference since the Department is charged with administering them. True enough: "Judicial deference is, of course, owed an agency's interpretation of a statute the agency is charged with administering." Fla. Elec. Comm'n v. Davis, 44 So. 3d 1211,

    1215 (Fla. 1st DCA 2010); Fla. Hosp. (Adventist Health) v. Ag. for Health Care Admin., 823 So. 2d 844, 847 (Fla. 1st DCA

    2002)(The court is "required to be highly deferential to the agency's interpretation of" a statute the agency is empowered to enforce.). But the Department's argument assumes that the prudential doctrine of judicial deference constrains administrative law judges——a common misunderstanding which confuses the role of the ALJ with that of the court.

  2. Unlike the judiciary, ALJs are participants in the decision-making processes that lead to administrative interpretations of statutes and rules——the very administrative interpretations to which courts defer. The ALJ's duty is to


    provide the parties an independent and impartial analysis of the law with a view towards helping the agency make the correct decision. In fulfilling this duty, the ALJ should not defer to the agency's interpretation of a statute or rule, as a court would; rather, the ALJ should make independent legal conclusions based upon his or her best interpretation of the controlling law, with the agency's legal interpretations being considered as the positions of a party litigant, entitled to no more or less weight than those of the private party.15/ Otherwise, whenever a private litigant is up against a state agency and the outcome depends upon the meaning of an ambiguous statute or rule administered by that agency, the agency's thumb would always be on the scale, even during the putatively de novo administrative hearing, and the non-agency party's interpretive arguments would never be heard by a judge who could be completely neutral in deciding such questions of construction.

  3. The ALJ's independence in this regard in no way diminishes the primary authority of the agency to formulate the administrative interpretation of a statute it is charged with enforcing because the "agency is not required to defer to the administrative law judge on issues of law" over which it has substantive jurisdiction. State Contr'g & Eng'g Corp. v. Dep't of Transp., 709 So. 2d 607, 609 (Fla. 1st DCA 1998). Instead,

    the agency may reject such legal conclusions if it "state[s]


    with particularity [the] reasons for rejecting or modifying such conclusion[s]" and finds, in each instance, "that its substituted conclusion of law . . . is as or more reasonable than that which was rejected or modified." § 120.57(1)(l), Fla. Stat. So, while a court, which has the last word in disputes over the meaning of a statute, can bind the agency to an unwelcome interpretation of a statute within the agency's substantive jurisdiction, an ALJ cannot; the agency, not the ALJ, is ultimately in control of the administrative interpretation of a statute it enforces, allowing the ALJ to speak freely while examining the dispute from a disinterested perspective. The undersigned therefore rejects the Department's contention that its interpretations of the relevant statutes, rules, and Standards are entitled to deference by the ALJ; they are not.

  4. As for the ultimate facts in dispute, JSCH


proved that its "application is complete and that the hospital has the critical elements required for a trauma center."

§ 395.4025(2)(c), Fla. Stat. JSCH's trauma center is, accordingly, entitled to provisional status.

RECOMMENDATION


Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order (i) deeming JSCH's Application acceptable,


  1. verifying that the hospital is in substantial compliance with the requirements in section 395.4025, and (iii) approving JSCH to operate as a provisional Level II trauma center until the 2014-16 application cycle is concluded with finality vis-à- vis TSA 19.

DONE AND ENTERED this 29th day of February, 2016, in Tallahassee, Leon County, Florida.

S

JOHN G. VAN LANINGHAM

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 29th day of February, 2016.


ENDNOTES


1/ The facts of this case are better understood when presented in the context of the legal framework under which the disputes have arisen. As a result, there are some findings herein that might be classified as legal in nature and others that clearly are. To the extent the undersigned is breaching the dichotomy between fact and law, it is only to organize the material in a way which, hopefully, improves readability and facilitates comprehension.


2/ The Department takes the position that it is not obligated to comply with section 120.60 in connection with the licensing of


trauma centers. The Department, however, does not get to decide which provisions of the Administrative Procedure Act ("APA") to follow, and which to ignore. Rather, like all agencies, the Department must obey the APA in its entirety, except as might be specifically provided otherwise in a statutory exemption or exception. See Dep't of Child. & Fam. Servs. v. I.B., 891 So.

2d 1168, 1173 (Fla. 1st DCA 2005)(agency lacks authority to "declare itself exempt from" APA requirements); Comm'n on Ethics v. Sullivan, 449 So. 2d 315 (Fla. 1st DCA 1984). No exemption relieving the Department of its duties under section 120.60 in relation to trauma centers has been cited or located. Nor is there any conflict or inconsistency whatsoever between sections 395.4025 and 120.60 that would require the general licensing provisions of the latter to yield to the specific provisions regarding trauma center licensing in the former. See Palm Beach Cnty. Canvassing Bd. v. Harris, 772 So. 2d 1273, 1287 (Fla.

2000)("[W]here two statutory provisions are in conflict, the specific statute controls the general statute."). The Department, it must be concluded, is required to comply with section 120.60 in taking agency action on applications for licensure submitted pursuant to section 395.4025.


3/ A hospital which has been denied provisional status or denied approval as a verified trauma center is afforded 30 days from the receipt of the denial notice within which to request a hearing. Fla. Admin. Code R. 64J-2.012(2). The rule does not specifically provide that an existing trauma center likewise has

30 days from notice of intended agency action within which to file a petition objecting to the proposed approval of another hospital's application to open a trauma center.


4/ The instant record gives the undersigned no confidence that the Department routinely provides a clear point of entry even to the applicant, as the April 30, 2015, letter to JSCH regarding the intended denial of its Application does not contain the information required by section 120.569(1). This is a serious shortcoming because the agency must grant the affected party a clear point of entry into formal or informal proceedings under chapter 120, which cannot be "so remote from the agency action as to be ineffectual as a vehicle for affording [the affected party] a prompt opportunity to challenge" the decision. See, e.g., Gen. Dev. Utils., Inc. v. Dep't of Envtl. Reg., 417 So. 2d 1068, 1070 (Fla. 1st DCA 1982). Unless and until a clear point of entry is offered, "there can be no agency action affecting the substantial interests of a person." Fla. League of Cities, Inc. v. Admin. Comm'n, 586 So. 2d 397, 413 (Fla. 1st DCA 1991).


Indeed, absent a clear point of entry, "the agency is without power to act." Id. at 415 (emphasis added).


5/ Fla. Admin. Code R. 64J-2.012(1)(k).

6/ Fla. Admin. Code R. 64J-2.016(8).

7/ The Department rather awkwardly argues that JSCH "has failed to meet its burden of establishing that that the . . .

Application met applicable standards," DOH's PRO at 50, as if, pursuant to section 395.4025(2)(c), it is the application, rather than the hospital, that must have the Critical Elements required for a trauma center. This does not make sense, since trauma patients receive treatment in hospitals and not in applications. Translated, the Department's unusual locution is an allegation that JSCH lacks the Critical Elements if all that one considers as proof of the relevant facts is the Complete Application.


8/ The term "evidence" is used somewhat loosely in this context, inasmuch as the application process before the Department is not an evidentiary proceeding, and the hospital's supporting documentation is not tested or weighed against potentially conflicting rebuttal evidence.


9/ Another example of an agency's reliance upon post-application factual developments adversely affecting an applicant's qualification for licensure is MVP Health, Inc. v. Ag. for Health Care Admin., Case No. 2009012001, 2012 Fla. Div. Adm.

Hear. LEXIS 392 (Fla. AHCA May 26, 2010).


10/ To be sure, if in the course of a formal administrative proceeding arising from the denial of provisional licensure the Department wants to rely upon newly discovered facts, it must timely move to amend its notice of intended agency action, for due process and section 120.60(3) require that the applicant be informed in writing of the particular grounds for denial of the license.


11/ The Department expresses concern that if hospitals are allowed at hearing to introduce (i) additional evidence to supplement proof that the Department deemed insufficiently persuasive to establish facts extant circa the proposed agency action and, especially, (ii) evidence of circumstances postdating the notice of proposed agency action, then applicants will disregard the Department's procedural deadlines and "buy


more time" by the "simple expedient" of requesting hearings. DOH's Post-Hrg. Memo. of Law at 14. The undersigned cannot help but observe that the high cost of one of these hearings, which instead of being expedient might be the worst way to settle a dispute except for all others, is probably a sufficient disincentive to casual litigation to preserve the sanctity of the Department's deadlines. Further, most hospitals likely view litigation not as an opportunity for purchasing "more time" but as a last resort resulting in lost time. But still, if an applicant decides strategically to "buy more time" to come into compliance, so what? Requesting a hearing is the applicant's right; formal hearings are a legitimate and integral part of the licensing process; and formal administrative proceedings impose their own deadlines——it is not as if an applicant can "buy" an indefinite amount of time by demanding a hearing or even be assured that its expensive purchase will be sufficient. And if the applicant manages to correct all perceived deficiencies during the pendency of an administrative proceeding, again, so what? The final agency action has not yet been taken, and the licensing agency should be delighted to issue a license to an applicant who is fully qualified at the time of the final decision. Nothing prevents the Department, when formulating its intended decision on a trauma center application, from taking into account the likelihood of a hospital's satisfying some criterion prior to hearing, and taking proposed agency action with that possibility in view.


12/ Section 120.60(1) provides as follows:


An application is complete upon receipt of all requested information and correction of any error or omission for which the applicant was timely notified or when the time for such notification has expired. An application for a license must be approved or denied within 90 days after receipt of a completed application unless a shorter period of time for agency action is provided by law. . . . Any application for a license which is not approved or denied within the 90-day or shorter time period . . . is considered approved[.]


Because the Department did not timely notify JSCH of any deficiencies in the October Application within 30 days after the agency's receipt thereof on October 1, 2014, the


Department had 90 days from that date to approve or deny the provisional license, which made the deadline for such decision December 30, 2014. See Tuten v. Dep't of Envtl. Prot., 819 So. 2d 187, 189 (Fla. 4th DCA 2002). The Department missed the deadline, however, meaning that the October Application "is considered approved" by operation of section 120.60(1). To activate the default license, JSCH would need to notify the agency clerk of its intent to operate thereunder, id., which it has not done.


13/ Dr. Bulecza holds a Director of Nursing Practice degree and thus is a nurse properly addressed as "Doctor."


14/ The Department contends that JSCH's helipad is noncompliant because it is too small to accommodate the allegedly huge helicopters used in Miami-Dade County. There is no competent or persuasive evidence in the record to support this contention.

More important, the Department neither included this allegation in the original Denial Letter as a basis for denying JSCH's Application, as required by section 120.60(3), nor sought leave to amend its notice of intended agency action. Thus, JSCH was not given fair notice of the issue. Nor did JSCH allow the issue to be tried by consent; to the contrary, it objected vigorously (and successfully) to the introduction of evidence bearing on the size of the helicopters that would land at JSCH. The undersigned declines to resolve questions concerning the physical capacity of JSCH's helipad as they are outside the scope of this proceeding.


15/ To the extent the undersigned suggested otherwise in Lakesmart Assocs. Ltd. v. Fla. Hous. Fin. Corp., Case No. 00- 4408RU, 2001 Fla. Div. Adm. Hear. LEXIS 2432, 29-30 (Fla. DOAH

Feb. 7, 2001), he recedes from that opinion and blames it on his youth.


COPIES FURNISHED:


Thomas F. Panza, Esquire Paul C. Buckley, Esquire Elizabeth L Pedersen, Esquire Panza, Maurer & Maynard, P.A. 3600 North Federal Highway

Fort Lauderdale, Florida 33308 (eServed)


Jay Patrick Reynolds, Esquire Department of Health Prosecution Services Unit

4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399 (eServed)


Stephen A. Ecenia, Esquire

J. Stephen Menton, Esquire Rutledge Ecenia, P.A.

119 South Monroe Street, Suite 202 Tallahassee, Florida 32301 (eServed)


Shannon Revels, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1703 (eServed)


Nichole Geary, General Counsel Department of Health

4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)


John H. Armstrong, M.D., F.A.C.S. State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 (eServed)


NOTICE OF RIGHT TO SUBMIT EXCEPTIONS


All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.


Docket for Case No: 15-003171
Issue Date Proceedings
Jul. 07, 2016 Agency Final Order filed.
Feb. 29, 2016 Recommended Order (hearing held October 8, 9, and 12 through 15, 2015). CASE CLOSED.
Feb. 29, 2016 Recommended Order cover letter identifying the hearing record referred to the Agency.
Jan. 05, 2016 Intervenor's Joinder in Department of Health's Response to Jackson South's Motion to Strike filed.
Jan. 05, 2016 The Department of Health's Opposition to Jackson South's Motion to Strike filed.
Dec. 31, 2015 Petitioner's Motion to Strike Portions of Department's Reply Post-hearing Memorandum of Law filed.
Dec. 30, 2015 Intervenor's Joinder In Department of Health's Reply Memorandum of Law filed.
Dec. 30, 2015 The Department of Health's Reply Post-hearing Memorandum of Law filed.
Dec. 30, 2015 Petitioner's Reply to the Department's Post-hearing Memorandum of Law filed.
Dec. 29, 2015 Order Increasing Page Limit for Reply Memoranda.
Dec. 29, 2015 Petitioner's Motion to Enlarge Page Limitation of Reply Memoranda filed.
Dec. 21, 2015 Intervenor's Joinder in Department of Health's Proposed Recommended Order and Memorandum of Law filed.
Dec. 21, 2015 The Department of Health's Post-hearing Memorandum of Law filed.
Dec. 21, 2015 DOH Proposed Recommended Order filed.
Dec. 21, 2015 Proposed Recommended Order of Jackson South Community Hospital filed.
Dec. 21, 2015 Petitioner's Memorandum of Law in Support of its Proposed Recommended Order filed.
Dec. 18, 2015 Order Enlarging Page Limit.
Dec. 17, 2015 Joint Motion for Enlargement of Page Limitation of Proposed Recommended Orders, Legal Memoranda and Replies filed.
Dec. 08, 2015 Order on Motions for Reconsideration, Extension of Time, and to Strike Papers.
Dec. 08, 2015 CASE STATUS: Motion Hearing Held.
Dec. 07, 2015 Jackson South's Response to and Motion to Strike Department of Health's Motion for Reconsideration and Affidavit of Leah Colston filed.
Dec. 07, 2015 Notice of Filing (deposition transcript of Michael Leffler) filed.
Dec. 07, 2015 The Department of Health's Motion to Extend Due Date for Proposed Recommended Orders filed.
Dec. 04, 2015 The Department of Health's Motion for Reconsideration filed.
Dec. 01, 2015 Order Supplementing the Record.
Dec. 01, 2015 Motion for Supplemental Hearing on December 2, 2015 filed.
Nov. 30, 2015 Respondent Department of Health's Response to Order on Petitioner's Motion to Supplement the Record filed.
Nov. 25, 2015 Notice of Filing filed.
Nov. 19, 2015 Order on Petitioner`s Motion to Supplement the Record.
Nov. 10, 2015 Respondent Department of Health's Memorandum in Opposition to the Petitioner's Motion to Supplement the Record filed.
Nov. 05, 2015 Order Granting Enlargement of Time.
Nov. 04, 2015 Agreed Motion to Enlarge Period of Time for Filing Proposed Recommended Orders and Replies to Same filed.
Nov. 04, 2015 Notice of Filing (Notice of Taking Deposition Duces Tecum of Susan Bulecza) filed.
Nov. 04, 2015 Notice of Filing (Deposition Transcript of Michael Leffler) filed.
Nov. 04, 2015 Notice of Filing (Deposition Transcript of Susan Bulecza) filed.
Nov. 04, 2015 Motion to Supplement the Record of Administrative Hearing filed.
Nov. 03, 2015 Order Regarding Proposed Recommended Orders.
Nov. 02, 2015 Transcript of Proceedings (not available for viewing) filed.
Oct. 30, 2015 Petitioners Notice of Status Report filed.
Oct. 22, 2015 Notice of Taking Deposition of Michael Leffler filed.
Oct. 08, 2015 CASE STATUS: Hearing Held.
Oct. 08, 2015 Respondent's Motion for Official Recognition filed.
Oct. 07, 2015 Petitioner's Memorandum of Law in Opposition to Department's Motion in Limine filed.
Oct. 07, 2015 Department of Health's Amended Motion in Limine (Amended to reflect the position of the parties) filed.
Oct. 06, 2015 Petitioner's Motion in Limine filed.
Oct. 06, 2015 (Petitioner's) Motion to Designate Petitioner as Party to Introduce Evidence First at Final Hearing filed.
Oct. 06, 2015 Notice of Petitioner's Intent to File Response to the Department's Motion in Limine filed.
Oct. 06, 2015 Department of Health's Motion in Liminie filed.
Sep. 30, 2015 Notice of Taking Deposition of Steve Smith filed.
Sep. 30, 2015 Joint Pre-hearing Stipulation filed.
Sep. 25, 2015 Order on Petitioner`s Motion for Protective Order.
Sep. 24, 2015 Notice of Cancellation of Deposition of Laura Hunter filed.
Sep. 24, 2015 Cross-notice of Taking Deposition of Laura Hunter as Corporate Representative of Petitioner filed.
Sep. 23, 2015 Notice of Taking Deposition Duces Tecum of Marla Vanore, R.N filed.
Sep. 23, 2015 Cross Notice of Taking Deposition of Marlys Yu filed.
Sep. 23, 2015 Cross Notice of Taking Deposition of Camille Baptiste-Smith, M.D filed.
Sep. 22, 2015 Notice of Taking Deposition of Chief Antonio Hernandez filed.
Sep. 22, 2015 Notice of Taking Deposition Duces Tecum of R. Lawrence Reed, II, M.D filed.
Sep. 22, 2015 Petitioner's Motion for Protective Order filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Ana Russo filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Camille Baptiste-Smith, MD filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Enrique Ginzburg, M.D filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Olga Quintana filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Maryls Yu filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Kimberly Clark filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Nicholas Namias, M.D filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Nicholas Namias, M.D filed.
Sep. 18, 2015 Notice of Taking Deposition Duces Tecum of Laura Hunter filed.
Sep. 01, 2015 Notice of Taking Deposition Duces Tecum of Susan Bulecza, R.N filed.
Aug. 31, 2015 Department of Health's Noitce of Serving Unverified Answers and Objections to the Public Health Trust of Miami-Dade County, Florida d/b/a Jackson South Community Hospital's First Set of Interrogatories and Response to Request for Production filed.
Aug. 27, 2015 Petitioner's, The Public Health Trust of Miami-Dade County, Florida d/b/a Jackson South Community Hospital, Response and Objections to Respondent's, Department of Health's First Request for Production Served July 28, 2015 filed.
Aug. 27, 2015 Petitioner, the Public Health Trust of Miami-Dade County, Florida d/b/a Jackson South Community Hospital's Notice of Servung Unverified Answers and Objections to Respondent, Department of Health's First Set of Interrogatories Served July 28, 2015, filed.
Aug. 27, 2015 Order Granting Motion to Intervene.
Aug. 14, 2015 Petitioner's Memorandum of Law in Response to Kendall Regional Medical Center's Petition to Intervene filed.
Aug. 07, 2015 Kendall Regional Medical Center's Petition to Intervene filed.
Aug. 05, 2015 Amended Notice of Hearing (hearing set for October 8, 9 and 12 through 16, 2015; 9:00 a.m.; Tallahassee, FL; amended as to severance of Case Nos. 15-3169 and 15-3170 and hearing dates).
Aug. 04, 2015 Order of Severance.
Aug. 03, 2015 Petitioners Response and Objections to Intervenors First Request for Production filed.
Aug. 03, 2015 Notice of Serving Unverified Answers to Intervenors First Set of Interrogatories filed.
Jul. 31, 2015 Joint Response to Order to Show Cause filed.
Jul. 31, 2015 South Broward Hospital District d/b/a Memorial Regional Hospitals Response to Order to Show Cause filed.
Jul. 31, 2015 Petitioner's Response to Order to Show Cause Why This Case Should Not be Severed filed.
Jul. 30, 2015 Jackson's First Request for Production to Intervenor, Aventura Medical Center filed.
Jul. 30, 2015 Jackson's First Requests for Production to Department of Health filed.
Jul. 30, 2015 Jackson's Notice of Serving First Set of Interrogatories to Aventura filed.
Jul. 30, 2015 Jackson's Notice of Serving First Set of Interrogatories to Department of Health filed.
Jul. 28, 2015 Department of Health's First Request for Production of Documents to the Public Health Trust of Miami-Dade County, Florida (filed in Case No. 15-003171).
Jul. 28, 2015 Department of Health's Notice of Serving First Set of Interrogatories to the Public Health Trust of Miami-Dade County, Florida (filed in Case No. 15-003171).
Jul. 22, 2015 Order Denying Aventura`s First Amended Petition to Intervene and Directing the Parties to Show Cause.
Jul. 17, 2015 Petitioner's Memorandum of Law in Opposition to Aventura's First Amended Petition to Intervene filed.
Jul. 13, 2015 Miami Beach Healthcare, Group, Ltd.'s First Amended Petition to Intervene filed.
Jul. 02, 2015 Miami Beach Healthcare, Group, Ltd.'s First Request for Production of Documents to South Broward Hospital District filed.
Jul. 02, 2015 Miami Beach Healthcare, Group, Ltd.'s Notice of Serving First Interrogatories to South Broward Hospital District filed.
Jul. 02, 2015 Miami Beach Healthcare, Group, Ltd.'s First Request for Production of Documents to The Public Health Trust of Miami-Dade County, Florida filed.
Jul. 02, 2015 Miami Beach Healthcare, Group, Ltd.'s Notice of Serving First Interrogatories to The Public Health Trust of Miami-Dade County, Florida filed.
Jul. 02, 2015 Order on Aventura`s Motion to Intervene.
Jun. 30, 2015 Order on Intervenor`s Motion to Strike, for Summary Final Order, and for More Definite Statement.
Jun. 26, 2015 Petitioner's Memorandum of Law in Opposition to Aventura's Motion to Strike, Motion for Summary Final Order, and Motion for More Definite Statement filed.
Jun. 26, 2015 Petitioner's Memorandum of Law in Opposition to Aventura's Petition to Intervene filed.
Jun. 19, 2015 Order on Intervenor`s Motions to Strike, for Summary Final Order, and for More Definite Statement, and on Petitioner`s Request to Stay.
Jun. 18, 2015 (Respondent's) Motion to Consolidate filed.
Jun. 18, 2015 (Respondent's) Motion to Consolidate (filed in Case No. 15-003171).
Jun. 18, 2015 Order of Consolidation (DOAH Case Nos. 15-3171).
Jun. 17, 2015 Notice of Transfer.
Jun. 16, 2015 (Respondent's) Motion to Consolidate filed.
Jun. 16, 2015 Notice of Appearance (Brian Vidas) filed.
Jun. 12, 2015 Notice of Appearance (Elizabeth Pedersen) filed.
Jun. 11, 2015 Joint Response to Initial Order filed.
Jun. 11, 2015 Notice of Appearance (Jay Reynolds) filed.
Jun. 10, 2015 Order Granting Extension of Time.
Jun. 08, 2015 Petitioner's Agreed Motion for Extension of Time to Respond to Miami Beach Healthcare Group, LTD's Petition to Intervene filed.
Jun. 03, 2015 Initial Order.
Jun. 02, 2015 Miami Beach Healthcare Group, Ltd.'s Petition to Intervene filed.
Jun. 02, 2015 Agency action letter filed.
Jun. 02, 2015 Petition for Formal Administrative Hearing to Contest the Decision to Deny Jackson South Community Hospital's Application to Operate a Provisional Level II Trauma Center filed.
Jun. 02, 2015 Notice (of agency referral) filed.

Orders for Case No: 15-003171
Issue Date Document Summary
Jul. 07, 2016 Agency Final Order
Feb. 29, 2016 DOAH Final Order Petitioner is in substantial compliance with the requirements in section 395.4025 and, therefore, has the critical elements required for a trauma center, so Respondent should approve Petitioner to operate as a provisional trauma center.

Source:  Florida - Division of Administrative Hearings

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