The Issue Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes (2016).1/
Findings Of Fact Background on Trauma Centers A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ” § 395.4001(14), Fla. Stat. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat. (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/ In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital. The Parties The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”); § 395.402(2), Fla. Stat. (mandating that “[t]he department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”). Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”). Those rules (see, e.g., rule 64J-2.010) determine how many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida. See § 395.402(4), Fla. Stat. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below. The Statutory Scheme Governing Trauma Centers As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”). The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.” § 395.402(4)(b), Fla. Stat. However, there is a state-wide, statutory cap of 44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”). Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.”). By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”). “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has: the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat. (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.”). (emphasis added). The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants. Assessment of Need for Trauma Centers under the Current Rules The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department to “[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system.”); § 395.402(3), Fla. Stat. (mandating that the Department must consider the following during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; medically appropriate ground and air travel times; recommendations of the Regional Domestic Security Task Force; the actual number of trauma victims currently being served by each trauma center; and other appropriate criteria). As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”). The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”). With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J- 2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population; median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals; (e) Level I trauma centers; and (f) number of severely injured patients. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or 8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points. In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that: The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers. The Department Changes Its Interpretation of “Need” In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular TSA. In 2015, Orange Park submitted another letter of intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order Jan. 27, 2017). Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a particular TSA. Assessment of Need under the Proposed Rules During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department): [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than 10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added). The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.” As a result, there would no longer be TSA-specific caps in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7): The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows: A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA, the Department could conceivably approve every applicant in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of 44 would be met or exceeded and another TSA lacked the statutory minimum of one: Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but there is still not one in Collier County, how does it work at that point as a potential new applicant comes in? A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are 43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe. Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then? A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule: Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical? ALJ: We are still talking about the [Current Rules]? Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you. A: I understand what you are saying. Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number? A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do. Q: Correct. There’s no criteria or standards? A: No, those procedures are not outlined in the rule, no. Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring? A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need, we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum. Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County? A: No. Q: There’s nothing in [the Proposed Rules] that says that? A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances. * * * Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards? A: And have the endorsement of the regional trauma agency, yes. The Potential Utility Associated with Adopting the Proposed Rules All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life: I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.” Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/ Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients: If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma. We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas. The idea of the general surgeon is going away. The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this. The – what I call the voyeur, you bring in a general surgeon to do some trauma because we don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem. If the doctor doesn’t know how to treat the patient, then the patient suffers. And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise. * * * We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise. And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock. There’s this whole sequence of events that takes place. Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/ In addition, an increase in trauma centers would make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site. Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff: But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point: Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences? A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s adding new programs where there’s already a pretty good network of care provided. * * * My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas. This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/ The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.
The Issue This hearing dealt with the consideration of the adequacy of the proposals by the Petitioner and Intervenor which were offered in response to the Respondent agency's RFP inquiry about a contract for the delivery of health services. Consideration of the dispute was as envisioned by Section 120.53(5), Florida Statutes. Respondent had determined that the Petitioner's proposal was unresponsive, and the proposal of the Intervenor was found to be acceptable. Petitioner challenged this opinion, leading to an assessment through the hearing process of the responsiveness of the proposals submitted by the Petitioner and Intervenor.
Findings Of Fact On September 12, 1985, the State of Florida, Department of Corrections, the Respondent in this action, issued request for proposals number 85-CO-2336-R. (A request for proposals is commonly referred to as an "RFP.") The purpose of this RFP was to obtain the assistance of a vendor or contractor in the provision and management of medical services at a newly constructed reception/medical facility located in southern Florida. Following the review of four responses to the RFP a decision was made on October 15, 1985, to award the project to Emergency Medical Services Associates, Inc., the Intervenor. In the face of this intended agency action, the Petitioner, Correctional Medical Systems, Inc., filed a Notice of Intent to Protest on October 18, 1985. This was followed by a Formal Written Protest dated October 23, 1985, which was amended on November 7, 1985. These pleadings raise the issues which are described in this Recommended Order. In particular Respondent, through the RFP, sought the ideas of the contractors necessary for the provision of comprehensive health care services in the new facility which is known as the South Florida Reception Center. Among the specific requirements of the RFP were the supply of medical and psychological personnel physical and psychological examinations, x-ray and laboratory facilities, the provision of an infirmary and an intensive care mental health unit. The RFP called for the provision of the services for three years with an option to renew for a second three-year term upon agreement of the provider and Respondent. In addition to the Petitioner and Intervenor, two other firms submitted responses to the RFP. Those companies were Correctional Health Services, Ltd., and Prison Health Services, Inc. The price quotations given by the four responding vendors were as follows: Correctional Medical Systems, Inc. $11,084,805.00 Correctional Health Services, Ltd. 11,560,000.00 Emergency Medical Services Associates Inc. 13,687,419.00 Prison Health Services, Inc. 15,720,387.00 In issuing the RFP the Respondent had as its goal the ability to select from competitive proposals that proposal which best met the needs of the agency. This method of selection was utilized, notwithstanding the fact that health services are not required to undergo the rigors associated with the bid laws of Florida. The RFP, in its terms, had allowed the unsuccessful bidders to protest the Respondent's decision of the matter of a contract award based upon authority set forth in Section 120.53(5), Florida Statutes. Three of the four proposals submitted by the four companies were rejected by the Respondent as being nonresponsive or irregular. Petitioner's proposal was rejected in view of the Respondent's belief that the proposal failed to contain a firm fixed price. Prison Health Services' bid was depicted as being inadequate, in that it failed to offer a fixed price and to include a legally binding proposal. Correctional Health Services' proposal was deemed nonresponsive for the failure to include resumes of key personnel within that organization. These determinations of irregularity or of lack of responsiveness were based upon a facial review of the submissions by the contractors and no further steps were taken by the Respondent to make an in- depth analysis of those proposals or to compare them to other proposals prior to deciding the ultimate question of which contractor it preferred to engage in this undertaking. The proposals from the four contractors were received and opened on October 7, 1985. William Stancill, the General Services Administrator to the Respondent had reviewed the submissions by the four vendors with an eye for any failings in those documents pertaining to what he perceived to be mandatory requirements of the PEP. This assessment lead Stancill to recommend the rejection of the three vendors for lack of compliance with mandatory requirements. Having reached this conclusion, the vendors other than the Intervenor were told that their proposals were unacceptable. Again, upon the facial examination of the proposals, only that proposal of Emergency Medical Services Associates was found to be responsive. 1/ Before the proposals were received from the various contractors, Respondent held what is known as a responders' conference to discuss the terms of the RFP. In the course of this conference, an indication was given to the potential responding parties on the topic of the Respondent's desires as to a price quotation. In the RFP, paragraph 5.2 [page 28] indicates "The cost proposal will be stated in terms of a fixed price for each year of the contract and option " In the course of the proposal submitted by the Petitioner, it offered the following comments about its price: CMS' price for each year of the contract is shown based on a 5 percent yearly increase. If the Medical Care Component of the Consumer Price Index deviates more than 2 percent from the projected 5 percent increase in a given year, CMS reserves the right to renegotiate its price with the Florida Department of Corrections for that year. This price is not fixed as contemplated by the terms of PEP, and this submission by the Petitioner fails to comply with the PEP on this subject. This failing is not cured by the testimony of Richard Turpenoff, Vice President of Financial Services for the Petitioner, when he describes personal involvement with the submission of seventy-five to a hundred health care proposals for correctional facilities and the fact that this language set forth in the present response to PEP had been used on those occasions. Nor is it beneficial to the Petitioner when it indicates that this type of language set forth in the response to the price demands of the PEP is that which has been used by health care providers throughout the industry. Petitioner's idea of reserving to itself the ability to discuss with the Respondent an equitable adjustment in the price of its services, in what the Petitioner foresees as an unlikely event that the Medical Care Component of the Consumer Price Index were to rise drastically over the period of the contract, is in itself a departure from the terms of the PEP. The PEP does not allow for this interference with the orderly process of the contract terms through any suggested negotiations, and it does not suffice to say that those negotiations are not unilateral in nature. Further, it is insufficient rehabilitation of the response to the PEP to indicate that the Petitioner has not abandoned any of its contracts before the expiration of the terms of those agreements. In this connection, the testimony of Joseph Rowan, Executive Director of Juvenile and Criminal Justice International, an expert in health care, states that he has reviewed a large number of proposals and has seen numerous proposals with provisions similar to that set forth in the Respondent's statement on price and concludes that the provision in the proposal is a firm fixed price. That statement is rejected. It is rejected because the interpretation given to this provision on the part of the Respondent in the person of Mr. Stancill is more compelling. Stancill believes that the Petitioner's quotation is not binding and is therefore not a fixed price, and that understanding is accepted. The Petitioner's deviation from the requirement for fixed price is one which may not be considered a minor irregularity, in that it is not an item which does not have an adverse effect on the cost or performance as described in paragraph 4.7 [page 25] of the PEP. The terms of the PEP as paragraph 4.7 and Rule 13A-1.02, Florida Administrative Code, contemplate the waiver of minor irregularities in the proposals submitted by the contractors. By not submitting a fixed price, Petitioner has failed to comply with a mandatory requirement of the PEP, and its offer is unresponsive. Finally, in the last four years, the Medical Care Component of the Consumer Price Index has exceeded 5% in each of those years and has reached as high as 8.7% in one of those years. As with the Petitioner's submittal, in examining the propriety of the submission by the Intervenor, it is the question of mandatory compliance with the RFP that is critical to the qualification of the latter proposal. To this end, the Petitioner has attempted to identify in the course of the final hearing those items within the proposal by the Intervenor which Petitioner argues constitute noncompliance in categories in which compliance is mandated. The first area of concern by the Petitioner pertains to subparagraph 5.1.2 of the RFP [page 27]. This provision relates to job descriptions and resumes of employees included within the FTE count. It says: A job description for all employees to be employed by the Contractor in the institu- tion, must be included. (Format samples are attached.) Resumes of any designated senior administrative/management or professional personnel should be included. As a minimum, the positions equivalent to senior adminis- trator, the chief health officer, and the nursing Director must be designated and a resume provided. Having considered the language of this provision, and the explanation concerning the provision as provided by Stancill, this provision is found to require the submission of job descriptions for all employees that the contractor intends to utilize in the institution. Further, it is necessary that the contractor designate by name and provide resumes for those persons holding the positions within the organization which are equivalent to the senior administrator, chief health officer and nursing director. This provision cannot be construed, as urged by the Respondent and Intervenor, to countenance the idea that only the job descriptions pertaining to positions equivalent to senior administrator, chief health officer and nursing director must be provided. In its submission, the Intervenor failed to submit job descriptions for employees in the classifications clerical assistant, medical records librarian, rehabilitative therapist ward clerk, clerk typist, pharmacy assistant and, arguably, clinical psychologist. Those job descriptions identified were provided at a later date. An additional conference was held between the Respondent and Intervenor following the Respondent's stated intention to select the Intervenor as the contractor, and in the course of this meeting, the Respondent established what it would accept in the way of the provision of services under the term medical assistant. That indication was to the effect that this job title must pertain to licensed nurses and medical technicians. In Florida, there is a specific category of licensed professional referred to as "medical assistant," found at Section 458.34, Florida Statutes, (Ch. 84-543, Laws of Florida) as it deals with assistants to physicians. The job description related to medical assistants as provided by the Intervenor more closely corresponds to the duties of licensed nurses or persons who assist those nurse practitioners, not persons who work under the direct supervision of a physician as described in Chapter 458, Florida Statutes. This job description also refers to the possibility of filling positions with persons who have worked as emergency medical technicians, EMTs. While the Intervenor failed to submit the job descriptions which have been identified in the previous paragraph, and as such violated subparagraph 5.1.2 of the RFP, this noncompliance is not a failure to comport with mandatory terms of the RFP. The mandatory terms as generally described in paragraph 3.1, and as defined by the following paragraphs and subparagraphs, do not point to the idea that the failure to provide the job descriptions is mandatory and a fatal defect in the proposal. While paragraph 3.1 and its ensuing provisions do regard the provision of resumes and background information related to key personnel as being mandatory the provision of job descriptions for the personnel at issue is not a mandatory item. Finally, the omission of those job descriptions in this instance has not been found to have a bearing on cost or performance. In a related vein, the inability, in theory, to compare the job descriptions of one contractor with those of another would impair the purchaser's efforts at selecting between the proposals. However, this comparison is not needed if the other contractors have been excluded based upon noncompliance with mandatory requirements of the RFP. Indeed, the other three proposals were properly discarded for noncompliance, and no comparison has been made. In the absence of the necessity of comparing job descriptions, it was not inappropriate for the Respondent to allow for the provision of the missing job descriptions subsequent to the submission of the basic proposal or to engage in discussion about the needs under the category medical assistant following the submission of the proposal. The Petitioner next challenges the accuracy of the claims which have been made by the Intervenor reference James A. Brigham, a key person in the plans of the Intervenor in its attempts at honoring the terms of a contract with the Respondent. Brigham is the Intervenor's Director of Marketing. On page 3 of the proposal of the Intervenor, in the introductory remarks, it is stated: Mr. Brigham was formerly an executive with and helped to found and manage Correctional Medical Systems, Inc. He has worked directly with the Department of Corrections in the states of Illinois, Alabama, Georgia and Missouri. In fact, Brigham neither founded nor managed Correctional Medical Systems, Inc. Although he has offered advice in the formative years of that corporation through his affiliation with another corporate entity which was associated with Correctional Medical Systems, Inc., that experience cannot be elevated, even under the most liberal construction, to a level of founding and managing. Brigham has never been employed by Correctional Medical Systems per se and has not served in any executive capacity with that organization. The resume of Brigham, which is a part of the proposal by the Intervenor, also sets forth that Brigham served as the Executive Vice President of Spectrum Emergency Care, Inc., in the years 1977-1983. (Spectrum is the other corporation previously mentioned which Brigham was associated with when advising Correctional Medical Systems.) His service as Executive Vice President lasted from 1977 through October 1, 1982. He did serve as an employee of Spectrum Emergency Care between the years 1977 and 1983. In the course of that employment, he prepared proposals and consulted with various states in the area of provision of medical care within correctional facilities. In that regard he had some contact with the states of Illinois, Georgia, Missouri, Arkansas and Alabama. Correctional Medical Systems was organized in 1979 to promote comprehensive medical services within correctional facilities throughout the United States. The focus of Spectrum in this regard had been primarily the provision of physician staffing in correctional facilities. It is not evident from what has been presented in the course of this hearing why these inaccurate statements were set forth in the RFP in describing Brigham's association with Correctional Medical Systems and Spectrum. On balance, having considered those statements and having reviewed the deposition of the witness Brigham on the subject of his experience, these inaccuracies within the RFP response are not found to be sufficient to recommend the rejection of this proposal. Paragraph 2.7 [page 1O] of the RFP states: The proposal shall indicate the contractor's plans to secure and maintain standards of the Commission on Corrections accreditation of the health services program, regardless of whether the entire institution may be accredited. This refers to standards established by the American Correctional Association. Petitioner claims that the Intervenor did not describe in its proposal how it intends to provide access information to the incoming prisoners pertaining to health care. As argued by the Petitioner, this is a requirement by the American Correctional Association in its standards dealing with the provision of medical care access information to prisoners. However, the RFP cannot be construed as requiring a contractor to identify how it would comply with that provision as a feature of its response to the RFP. The RFP is read to stand for the proposition that the contractor, in cooperation with the Respondent, shall make efforts to gain accreditation by the American Correctional Association and does not extend to the idea of a separate statement in its proposal of how it will provide access information to incoming prisoners. Moreover, it was established in the course of the hearing that at the point of intake of inmates into the Florida system of corrections, those inmates are routinely made aware of their right to receive medical services. At paragraph 2.1, lettered section C, [page 7] of the RFP, there is a discussion of the length of stay contemplated in the mental health unit of the facility. In particular it states: The patients in this mental health unit are expected to be successfully treated or stabi- lized within 30 to 60 days so as to permit assignment to another institution. This obligates the contractor to the establishment of a program varying in length from thirty to sixty days which will meet those requirements of successful treatment or stabilization. In preparing a budget to address this requirement, it leaves to the contractor the decision on whether the program needs to be thirty or more days. The latitude is afforded to use as few as thirty days in preparing the budget, which the intervenor did. By its terms, the RFP calls for the processing of eighty adult offenders and twenty youthful offenders per week for a total of a hundred inmates a week to be seen at reception for routine physical exams. This requirement of the RFP has been addressed in the budget statement of the Intervenor in Attachment D [page 2], described as a hundred physicals times 52 weeks or fifty-two hundred examinations. This item is separate from another item set forth on that page dealing with physical examinations which are on an annualized basis with a calculation being made that approximately five persons will be examined per day in the category of annual examinations. It has not been shown that the Intervenor budgeted for five examinations a day related to the intake function of receiving and processing inmates, when twenty per day was called for by the RFP. None of the other claims of the Petitioner set forth in the formal protest and its amendments on the subject of alleged infirmities within the Intervenor's response to proposal have been proven. The Emergency Medical Services Associates proposal had been reviewed by the evaluation committee of the Respondent which had the responsibility to make decisions on the sufficiency of such proposals and was found to be satisfactory. This determination has not been shown to be in error through proof in this hearing.
Conclusions Competent substantial evidence supports the conclusion that Adrian Fuentes disabilities are the result of the failure to deliver him before his mother loss amniotic fluid, or up to an estimated 12 hours earlier. An earlier delivery was the standard of care expected in a case of IUGR. His permanent and severe disabilities were directly and proximately caused by the failure of SBHD employees to handle an ultrasound report expeditiously as directed and as their policy provided. ATTORNEYS’ FEES AND LOBBYISTS’ FEES: In compliance with s. 768.28(8), F.S., but not with Section 3 of this claim bill, Claimant's attorneys' fees are set at 25 percent. There is no lobbyist for the bill at this time. As of October 9, 2007, the attorneys reported having incurred costs of $115,246.02 for representing the Claimant. The Claimants entered into an agreement to pay attorneys’ fees and costs. RECOMMENDATIONS: For the reasons set forth in this report, I recommend that Senate Bill 60 (2008) be reported FAVORABLY. Respectfully submitted, Eleanor M. Hunter Senate Special Master cc: Senator Jeremy Ring Representative Evan Jenne Faye Blanton, Secretary of the Senate House Committee on Constitution and Civil Law Tom Thomas, House Special Master Counsel of Record
The Issue Whether the application filed on April 1, 2016, by Orange Park Medical Center, Inc., d/b/a Orange Park Medical Center (Orange Park), to operate as a Level II trauma center met the applicable statutory and rule criteria to receive provisional approval? Whether the Department of Health’s (Department) approval of the application was based upon an unadopted rule?
Findings Of Fact The Parties The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes (2016). The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001, 395.40(3), and 395.401(c), Fla. Stat. A "trauma center" is a "hospital that has been verified by the Department to be in substantial compliance with the requirements in section 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. Petitioner, UF Health Jacksonville, operates a licensed 695-bed hospital and a Level I trauma center in Jacksonville, Duval County, Florida. UF Health Jacksonville's Level I trauma center is in TSA 5. The number of trauma patients treated by UF Health Jacksonville has declined sharply since the Department authorized Orange Park to operate as a trauma center. UF Health Jacksonville projects an annual loss of 320 to 540 trauma cases as a result of Orange Park's operation of a trauma center. Orange Park is a 317-bed acute-care hospital located in TSA 5, Clay County, Florida. Orange Park provides a wide range of services, including inpatient pediatric care, open-heart surgery, and a comprehensive stroke program. Orange Park is also a teaching hospital with residency programs in internal medicine and family practice. It provides behavioral health services and is the only Baker Act receiving facility in Clay County. Orange Park applied for provisional approval to operate a Level II trauma center in TSA 5. Pursuant to the application decision that is the subject of this litigation, Orange Park has operated as a provisional Level II trauma center since May 2016. Subsequent to the initiation of this proceeding, Orange Park worked with the Department to purportedly complete the in-depth review of its application and has scheduled a final verification survey. The Trauma Center Application and Review Process Chapter 395, Part II, Florida Statutes, codifies the process and substantive standards for licensing trauma centers in Florida. As noted, the Department has primary responsibility for administering the trauma center statute, including licensing trauma centers pursuant to chapter 395, Part II, and Florida Administrative Code Chapter 64J-2. The Legislature has capped at 44 the total number of trauma centers that may operate in Florida at a given time. Pursuant to section 395.402(4)(b), the Department has adopted rule 64J-2.010(3), which currently allocates one trauma center to TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns counties. Section 395.4025(2) establishes a 21-month process a hospital must follow to obtain verification--i.e., final approval--as a trauma center, and the Department has, by rule, established additional procedures governing the selection of trauma centers. During this multi-stage process, there are discrete decision points at which the Department must take action on a hospital's application to become licensed as a trauma center. The first stage of the trauma center review and approval process--which is the stage at issue in this proceeding--is the provisional review stage. This stage commences when the Department receives a hospital's application to be licensed as a trauma center. § 395.4025(2)(c), Fla. Stat. At the provisional review stage, the Department determines whether the hospital has the critical elements required for the level of trauma center for which the hospital has applied. Id. The provisional review stage culminates with the Department announcing its decision that the application is acceptable, or denying the application. If the proposed decision is to deny the application, the applicant is entitled to challenge that decision; if the proposed decision is to find the application acceptable, other hospitals must be given an opportunity to "protest," or challenge, that decision. Section 395.4025(7) requires challenges to the Department's trauma center licensure decisions to be conducted pursuant to sections 120.569 and 120.57. Procedural History and the Processing of Orange Park's Application On or before October 1, 2015, Orange Park filed a letter of intent to establish a new Level II trauma center in TSA 5. Thereafter, on or before April 1, 2016, Orange Park filed an application with the Department to become a Level II trauma center. Consistent with statute, the Department sent the application for review by out-of-state reviewers. On or about April 14, 2016, the Department set forth a list of omitted items that prevented Orange Park's application from being deemed complete. Critical elements missing from Orange Park's application included proof of adequate and up-to- date training of several trauma surgeons and emergency room physicians. In particular, reviewers selected by the Department noted that Orange Park failed to meet the following requirements: at least one qualified trauma surgeon to be on backup trauma call at all times to provide trauma service care; documentation that the medical director shall approve all trauma-related patient care protocols before implementation; a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary and backup trauma coverage 24 hours a day at the trauma center when summoned; evidence that an orthopedic surgeon is available to arrive promptly at the trauma center when summoned; all specialists are board-certified or actively participating in the certification process and granted medical staff privileges by the hospital to care for adult and pediatric patients; at least one scrub nurse technician and one circulating registered nurse in the operating room and post- anesthesia recovery; at least eight hours of continuing education every two years for the rehabilitation unit; a radiologist, board-certified or actively participating in the certification process and granted privileges by the hospital to provide radiological services for adult and pediatric patients, on trauma call and can arrive promptly at the trauma center when summoned; adequate quarterly reporting to the Department of Health; and adequate in-hospital trauma registry minimum data set. The Department made Orange Park's lengthy trauma application available to UF Health Jacksonville through a public records request. Cynthia Gerdik, who holds a Ph.D. in nursing, spent over 40 hours reviewing Orange Park's application on behalf of UF Health Jacksonville. Like the outside reviewers used by the Department, Dr. Gerdik found several discrepancies related to qualifications and training of trauma surgeons and personnel proposed to serve Orange Park's trauma center. Specifically, Dr. Gerdik's review found that one trauma surgeon's advanced trauma life support (ATLS) certification had expired on June 27, 2016, and that an emergency department physician's ATLS certification had expired on June 29, 2016. Orange Park’s witness, Keri Deaton, testified that Orange Park retained documentation that the certifications were renewed but never provided the documentation to the Department. At hearing, it was revealed that one of the physicians, who had ostensibly missing education requirements, had been married and was the same person identified by a different last name in the application. After April 14, 2016, Orange Park supplemented its application, and the Department deemed the application complete. Section 395.4001(10) defines “provisional trauma center” 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. (emphasis added). Notwithstanding her criticisms of the Orange Park application, Dr. Gerdik conceded that Orange Park’s application met the required trauma program standards. At hearing, Ms. Gerdik testified: Q. Did you form an opinion that the Orange Park application met the minimum criteria for critical elements? A. Yes, sir. I did testify to that. Q. Did you also conclude that they were in substantial compliance with all critical elements set forth in 150-9? A. Correct. (Tr. 492-93). With the exception of need, as evidenced by an available allocation slot determined pursuant to rule 64J- 2.010(3) as discussed below, the Orange Park application is in substantial compliance with the statutory and rule requirements for provisional approval. On April 28, 2016, the Department sent a letter to Orange Park indicating that the Department intended to approve Orange Park's application. The same letter informed Orange Park that it may open its trauma center immediately and "begin to operate as a Provisional Level II trauma center beginning May 1, 2016." The Department informed emergency responders to alter their trauma transport protocols, effective that same date, so that trauma patients that would have otherwise been seen at UF Health Jacksonville or another trauma provider could instead be sent to Orange Park for trauma services. Beginning on May 1, 2016, and throughout the course of this administrative proceeding, Orange Park has operated a provisional Level II trauma center. UF Health Jacksonville timely filed a petition challenging the provisional approval of Orange Park's application. The Department referred UF Health Jacksonville’s petition to DOAH so that a fact-finding hearing could be conducted to resolve the question of whether Orange Park's application should be provisionally approved to operate a trauma center. After UF Health Jacksonville's petition was transferred to DOAH and the instant proceeding begun, the Department continued to process Orange Park's application through the in-depth review phase. During the in-depth review stage, the Department informed Orange Park of five additional deficiencies that needed to be corrected in order to be approved. Orange Park participated in the Department's in-depth review of its application by submitting responses to the Department's listed deficiencies. On or before September 30, 2016, Orange Park received a letter from the Department indicating that the in-depth review stage was complete, and the verification site survey had been scheduled. The Department never published its decision that the in-depth review was complete and, until this activity was revealed at the final hearing, never notified UF Health Jacksonville of its action. The Department and Orange Park also worked to arrange the verification site survey, now scheduled for some time in February 2017. The Department's Consideration of Need When Reviewing Orange Park's Application The Department's existing rule 64J-2.010 is titled "Allocation of Trauma Centers Among Trauma Service Areas." The rule allocates the maximum number of trauma centers needed in each of 19 trauma service areas. See Id. Rule 64J-2.010(3) allocates a need for only one trauma center in TSA 5. Rule 64J-2.010 references an Amended Trauma Service Area Assessment, dated March 14, 2014. See Fla. Admin. Code R. 64J-2.010(3). That assessment contains most of the data relevant to assess "points," the sum of which determines the number of trauma programs needed in a trauma service area. When data relevant to population, transport times, the number of severely injured patients, where they are served, and the presence of UF Health Jacksonville's existing Level I trauma center were scored and tallied, a total of five points was found for TSA 5. See Fla. Admin. Code R. 64J-2.010(1)(b)1. This number of points led to the allocation of just one program needed for TSA 5. The 2014 Assessment incorporated into rule 64J-2.010 makes no reference to community support for an additional trauma center in TSA 5, or anywhere else in the state. The 2014 Assessment does not contain any information that could result in the award of an additional point for TSA 5 due to community support. Thus, at all times relevant to the consideration of Orange Park's application, rule 64J-2.010 allocated a need for just one trauma center in TSA 5, and UF Health Jacksonville's long-standing Level I trauma center fills that need. No party disputed the allocation for just one trauma center in TSA 5 under the current version of rule 64J-2.010. Pursuant to the Department's existing trauma application processing rule, the lack of an available slot for an additional trauma program in TSA 5 should have caused the rejection of Orange Park's letter of intent and application. The Department's existing rule 64J-2.012(1)(a) provides as follows: The department shall accept a letter of intent, DH Form 1840, January 2010, “Trauma Center Letter of Intent”, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4), F.A.C., postmarked no earlier than September 1 and no later than midnight, October 1, from any acute care general or pediatric hospital. The letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA. If the hospital does not submit a completed application or does not request an extension to complete its application by April 1 of the following year, in accordance with Rule 64J-2.013, F.A.C., the hospital’s letter of intent is void; Fla. Admin. Code R. 64J-2.012(1)(a)1/(emphasis added). Though the Department made proposals to amend rule 64J-2.010 on several occasions, no amendments have been made to rule 64J-2.010 since July 29, 2014. At all times relevant to this proceeding, rule 64J- 2.010 allocated a need for only one trauma center in TSA 5, and rule 64J-2.012(1)(a) only permitted the filing of a provisional trauma center application "if an available position, as provided in rule 64J-2.010, F.A.C., exists in the hospital’s TSA." Prior to 2015, the Department's practice was to reject a letter of intent when there was no allocated need available for an additional trauma center in the relevant TSA under rule 64J-2.010. This practice was consistent with the requirements of rule 64J-2.012(1)(a). In October of 2014, pursuant to its prior practice, the Department rejected Orange Park's letter of intent because there was no need for an additional program allocated in TSA 5. However, the Department changed its practice beginning in 2015, at which time it began accepting letters of intent and applications regardless of whether any need for an additional trauma center was allocated to the TSA under rule 64J-2.010. In October 2015, the Department accepted Orange Park's letter of intent pursuant to its new practice, despite the lack of any allocated need for an additional trauma center in TSA 5. As noted above, Orange Park was approved to operate a provisional trauma center beginning May 1, 2016. On September 1, 2016, many months after the Department's preliminary decision to approve Orange Park's provisional application, and many months after this proceeding was initiated, the Department proposed amendments to rules 64J-2.010 and 64J-2.012. See Fla. Admin. Reg., Sept. 1, 2016, Vol. 42, No. 171. The Department offered no testimony or evidence to demonstrate why it was not feasible or practicable to adopt the Department's new policies into rules before applying them. If adopted, those new amendments would alter the Department's consideration of the number of trauma centers allocated in rule 64J-2.010. However, those proposals have been challenged and are the subject of separate administrative proceedings. See Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health, DOAH Case Nos. 16- 5837RP, 16-5838RP, 16-5839RP, 16-5840RP, and 16-5841RP. The Department's recently proposed changes to its trauma allocation and trauma application processing rules have not been adopted and are not presumed to be valid or invalid. See § 120.56(2)(c), Fla. Stat. The Department's newly proposed amendments to its trauma rules reveal the unadopted rule that the Department began to implement in 2015, when it accepted Orange Park's letter of intent, despite the lack of an available slot allocated for an additional trauma center. Pursuant to rule amendments that the Department now proposes to codify, but which presently constitute unadopted rules, the Department will now accept and process applications to operate as provisional trauma centers, regardless of any allocated need set forth in rule 64J-2.010. UF Health Jacksonville has alleged that the Department's approval of Orange Park cannot be sustained because the approval violates the Department's own rules and governing statutes, but also because the approval is based upon an unadopted rule–-a new policy that would allow the approval of provisional trauma centers regardless of any need allocated in rule 64J-2.010. Ms. Colston acknowledged that no statute changed in 2014 or 2015 to inspire the Department to change its practice. However, she indicated that the Department's position was evolving due to consideration of a recent Recommended Order stemming from litigation over a trauma center application. That Order, The Public Health Trust of Miami-Dade County Florida, d/b/a Jackson South Community Hospital v. Department of Health, Case. No. 15-3171 (Fla. DOAH Feb. 29, 2016), was rejected as moot in a Final Order issued by the Department on July 7, 2016. Nevertheless, Ms. Colston cited the rejected Order as the basis for the Department's new interpretation of rule 64J-2.012 and processing of provisional trauma applications in the absence of an allocated need: Q: I did read the language correctly? Is that what the existing rule required when Orange Park was approved? A: I would start with our full reading of the rule, which says that we shall accept the letter of intent. We, again, looked at these rules and we looked at the statute, and we have some "shall" language in both the statute and the rule that tells us what we shall do that's interpreted by the Department in general and by me as something that we shall do. So we shall accept the provisional application, we shall receive the letter of intent. And then the other part that would have inspired us to act the way we did was a ruling that said that we are required to accept these--that we shall accept and shall act and shall do these things at the risk of being sued. So that was a consideration that the Department was also taking into-– under consideration when we did these actions. Furthermore, I mean, there's been some discussion about need. But what we've seen and what was upheld especially in the latest lawsuit was that need is not determined on the front end during the provisional review and during the letter of intent process. So all of these things contributed to the Department's decision. Q: I may have mislead [sic] you with the timing of my question. I thought I understood you to say the policy processes that are announced in the September changes did not come into fruition in the Department's mind, become a firm way of doing things until they were proposed in September, is that true? A: No. (Tr. 420-421). Ms. Colston had difficulty explaining the Department's position regarding its interpretation and compliance with existing versions of rule 64J-2.010 and rule 64J-2.012. Ms. Colston offered conflicting testimony regarding whether the Department was operating under the process set forth in the Department's newly proposed rule: Q: Okay. Did that process described in the newly proposed rule, was that in place as a process that the Department would use when Orange Park was approved in late April 2016? A: We can't function under an unadopted rule. So we would have been functioning under the current rule. (Tr. 418). At hearing, Ms. Colston confirmed that the Department considers "preliminary" and "provisional" reviews required by Florida law to be synonymous. She further testified that the Department makes three separate decision points during its review of trauma center applications: provisional status; in- depth review; and then final verification. Ms. Colston then testified that the availability of allocated need (pursuant to rule 64J-2.010) is now only dispositive at the final stage of review-–the verification stage which follows site reviews and inspections. According to Ms. Colston, the Department now takes the position (and took the position during its review of Orange Park's application) that the availability of an allocated TSA slot is only applicable at the final verification stage. Ms. Colston acknowledged that the establishment of a provisional trauma center involves millions of dollars of investment in equipment, staff, and expertise. When asked if it was reasonable to interpret Department rules in a way that would allow the operation of provisional trauma centers only to be told, at the final stage of review, that the lack of an available allocation “slot” prevents the trauma program's final verification, Ms. Colston admitted that the interpretation was not reasonable. By approving Orange Park's provisional application in the absence of an available slot allocated by rule 64J-2.010, the Department failed to follow its own rules and precedent. Its new interpretation constitutes a generally applicable, unadopted rule that the Department is only now attempting to codify. The Department's new "interpretation" of its existing rule is unsupported by the facts adduced at hearing and is, as admitted by the Department's representative, not reasonable. But for the Department's reliance on an unadopted rule, the Department would have never processed Orange Park's application, nor permitted Orange Park to operate as a provisional trauma center. Impact of Orange Park's Trauma Center on UF Health Jacksonville High volumes of patients with high injury severity are necessary for trauma centers to improve and maintain quality through educational opportunities to their trauma staff. Trauma nurses require a year and a half to two years of experience with severely injured patients to enable them to be a primary nurse in a trauma critical care unit. Reduced volumes of trauma cases cause a trauma center to have fewer educational opportunities to enable trauma nurses to gain experience. UF Health Jacksonville is a teaching hospital that trains nurses and trauma surgeons. The decline in trauma volumes caused by Orange Park's operation as a trauma center has reduced training opportunities at UF Health Jacksonville. The opening of Orange Park's trauma center has caused the average injury severity score (ISS) for trauma patients to decrease at UF Health Jacksonville, thereby reducing the educational opportunities for UF Health Jacksonville's trauma nurses to treat the most severely injured patients. During the first three months after Orange Park opened its trauma center in 2016, UF Health Jacksonville's volume of its most severely injured patients decreased by 17 percent. Overall, UF Health Jacksonville projects an annual loss of 320 to 540 trauma cases caused by Orange Park's operation of a trauma center. UF Health Jacksonville projects that a contribution margin loss of approximately $3.5 million to $5.9 million annually will be caused by Orange Park's operation of a trauma center.
Recommendation Based on the forgoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order denying Orange Park's Application to operate a provisional trauma center in TSA 5. DONE AND ENTERED this 27th day of January, 2017, in Tallahassee, Leon County, Florida. S W. DAVID WATKINS 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 27th day of January, 2017.
