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.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following Findings of Fact: Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0040343. On the morning of October 7, 198A, the Metro-Dade County Rescue Squad called the emergency room at Miami General Hospital and informed the staff that they were enroute to the hospital with a gunshot victim. Dr. Segurola, the emergency room physician, was informed of the victim's condition and immediately ordered a nurse to notify the operating room team and call a surgeon because he knew in advance that "this was going to be a serious surgical case." At approximately 7:42 a.m., the rescue squad arrived at Miami General Hospital with the victim, Samuel Kaplan. Kaplan was taken to the emergency room suffering from a gunshot wound to the abdomen inflicted by a .32 caliber bullet. When Kaplan arrived in the emergency room, his systolic blood pressure was approximately 60, he was wearing a MAST suit, he had an intravenous (IV) line going, and he was receiving oxygen. Although Kaplan was conscious and able to speak, his condition was unstable and very serious. Kaplan was initially treated by Dr. Segurola, the emergency room physician. Three nurses, a respiratory therapist and an x-ray technician were also present in the emergency room. Dr. Segurola conducted a brief physical examination of Kaplan. An entrance wound was found, but there was no exit. After the examination, a second IV line was started in the other arm and a third, central line was started in the subclavin vein. The IV lines were set at maximum or "wide open." The emergency room staff was attempting to rapidly increase Kaplan's blood volume and pressure. Kaplan's hemoglobin level was low (approximately 8 or 9), which is a sign that a patient is anemic due to loss of blood. At approximately 8:00 a.m., Respondent received a message from his telephone answering service to call Dr. Segurola at the hospital's emergency room. At approximately 8:02 a.m., the Respondent returied the telephone call and spoke with Dr. Segurola concerning the patient's condition. During the conversation, the Respondent advised Dr. Segurola to contact the operating room team and anesthesiologist to prepare for surgery. The Respondent arrived at the emergency room of Miami General Hospital in response to the call at approximately 8:12 a.m. Upon the Respondent's arrival at the emergency room, he was informed that Kaplan's blood pressure was 108/50, heart rate 106 and respiration 28. The Respondent spoke to Kaplan and Kaplan stated that he had been shot in the stomach. Respondent then proceeded to conduct a brief, but thorough, physical examination of the patient. When Respondent completed his examination, he was advised that Kaplan's blood pressure was approximately 124/50, heart rate remained at 106 and respiration remained at 28. At this point, the Respondent believed that Kaplan's condition was stabilized. Respondent advised Dr. Segurola that Kaplan should immediately be taken to the operating room for surgery. The Respondent was informed that the operating room was not quite ready and that the anesthesiologist had not arrived. While waiting for the operating room team, Respondent and Dr. Segurola reviewed x-rays of Kaplan. The emergency room nurse continued to take Kaplan's vital signs. Kaplan's blood pressure remained at 124/50. At approximately 8:20 a.m., while Respondent, Dr. Segurola and others in the emergency room were waiting for confirmation that the operating room was ready, a hospital admissions clerk walked in and informed the emergency room staff that Kaplan belonged to the Health Maintenance Organization ("HMO"). An HMO is a plan in which a patient makes pre-payment for services and is then provided medical services from a designated panel of participating physicians. The emergency room maintained two "on-call" lists, one for HMO surgeons and one for non-HMO surgeons. The Respondent was on the non-HMO list. Dr. Segurola and Respondent had a brief discussion wherein both men acknowledged that under existing hospital policy, the HMO surgeon should have been called. Thereafter, Dr. Segurola informed a nurse to telephone the on-call HMO surgeon. The HMO surgeon on call was Dr. Moises Jacobs. A secretary in the emergency room placed a call to Dr. Jacobs at approximately 8:25 a.m. Dr. Jacobs returned the phone call between 8:25 a.m. and 8:30 a.m. Dr. Jacobs spoke with Dr. Segurola. While Dr. Segurola was on the phone, Dr. Jose Selem, the anesthesiologist, arrived in the emergency room. Dr. Jacobs told Dr. Segurola to ask the Respondent to take the patient to surgery immediately and stated that he would arrive at the hospital in about 20- 30 minutes. When the Respondent was told of Dr. Jacobs' request he replied that the patient was stable and could wait for Dr. Jacobs. Dr. Selem, the anesthesiologist, also spoke with Dr. Jacobs on the telephone. Dr. Jacobs told Dr. Selem to advise Respondent that Respondent could take the patient to surgery. When Dr. Selem advised Respondent of what Dr. Jacobs has said, the Respondent replied that since Dr. Jacobs was coming to the hospital and Kaplan was an HMO patient, Respondent preferred to wait for Dr. Jacobs, the HMO surgeon. Dr. Selem then left the emergency room and went to the operating room to prepare the necessary instruments. At approximately 8:30 a.m., the Respondent advised Dr. Segurola that he was going to the hospital cafeteria for a cup of coffee and, if any changes occurred in the patient, he should be contacted. The cafeteria was located across a corridor approximately 20-25 feet from the emergency room. At the time, Kaplan was still alert and his vital signs were being constantly monitored by the nursing staff. Dr. Segurola remained in the emergency room. The operating room and all necessary personnel were ready for surgery at approximately 8:40 a.m. Sometime between 8:40 a.m. and 8:45 a.m., one of the nurses told Dr. Segurola that the Respondent's condition was deteriorating and that his blood pressure was dropping. At approximately 8:45 a.m., Kaplan's blood pressure had dropped to 80/50. Dr. Segurola told the nurse to give more blood to Kaplan (a blood transfusion had already been started). Dr. Segurola then went to the cafeteria to speak with Respondent. Dr. Segurola told Respondent that the patient's condition was deteriorating, a blood transfusion had been started, and he feared that Kaplan might die in the emergency room. The Respondent inquired as to how long it had been since Dr. Jacobs had been called and Dr. Segurola responded twenty (20) minutes. Respondent questioned whether it really had been 20 minutes. Both men looked at their watches and determined that it had been about 15 minutes since Dr. Jacobs had been called. Respondent told Dr. Segurola to call the anesthesiologist. Dr. Segurola went back to the emergency room, believing that Respondent was going to immediately follow him there. When Dr. Segurola arrived back at the emergency room, Kaplan's condition had not improved. Dr. Segurola waited about three (3) more minutes and went back to the cafeteria for the second time. Dr. Segurola again informed the Respondent about Kaplan's deteriorated condition and his fear that Kaplan was going to die in the emergency room. Respondent once more asked Dr. Segurola to call the anesthesiologist. Dr. Segurola told Respondent that the anesthesiologist was there and that "we need you there." Dr. Segurola then went back to the emergency room. The Respondent remained in the cafeteria. Shortly before 9:00 a.m., while Dr. Segurola was away from the emergency room, Dr. Lustgarten, a neurologist, had just finished his rounds and was leaving the hospital through the emergency room to the parking lot. Dr. Lustgarten looked in on Kaplan to determine if there was any neurological damage. Dr. Lustgarten examined Kaplan and concluded that there was no neurological damage and that, in his opinion, Kaplan's condition was stable with a systolic blood pressure of approximately 100. Dr. Lustgarten left the emergency room just as Dr. Jacobs arrived at approximately 9:00 a.m. Dr. Lustgarten told Dr. Jacobs that Kaplan had no neurological damage. Dr. Jacobs conducted a brief examination of Kaplan and determined that Kaplan needed to be taken to the operating room immediately for surgery. The anesthesiologist, Dr. Selem, had by then been summoned to the emergency room and assisted Dr. Jacobs in an unsuccessful attempt to intubate Kaplan prior to taking him to the operating room. Shortly after Dr. Jacobs arrived, the Respondent left the cafeteria and headed towards the emergency room. Before Respondent reached the entrance to the emergency room, he was informed by one of the nurses that Dr. Jacobs had arrived. The Respondent stood at the entrance to the emergency room for a brief period and watched as Dr. Jacobs and others attended to Kaplan. Respondent then left the building, went to his car and drove home. Meanwhile, Dr. Jacobs performed an emergency exploratory laparotomy and left thoracotomy on Kaplan. Between 9:00 am. and 9:15 a.m., after Kaplan was moved from the emergency room to the operating room, his blood pressure went from 90 down to 60, and he went into shock. There are three possible contributing factors for Kaplan's going into shock at this time: (1) moving him may have dislodged ,a blood clot which in all likelihood prevented an earlier complete "bleeding out"; (2) the blood clot may have been diluted by the IV fluid; and (3) the institution of anesthesia. During surgery it was discovered that the bullet had perforated the aorta, a major blood vessel. While still in surgery, Kaplan went into cardiac arrest and was pronounced dead at 10:25 a.m. on October 7, 1984. At the time that Respondent left the emergency room and went to the hospital cafeteria, Kaplan's vital signs were in a relatively stable condition. Kaplan's vital signs de-stabilized while Respondent was in the hospital cafeteria, and his systolic blood pressure dropped from approximately 120 to approximately 80. At all times prior to being taken to the operating room, Kaplan's vital signs were maintained with the assistance of a MAST suit. A MAST suit is an inflatable device used in the treatment of trauma patients which applies pressure to the body and assists in elevating blood pressure. When the MAST suit is removed, the patient's vital signs will deteriorate again. For this reason, many physicians consider vital signs obtained under such conditions to be false readings, and the MAST suit is usually not removed until the patient is in the operating room. Although the Respondent suspected that the bullet might have damaged the small bowels and caused some internal bleeding, the Respondent neglected to ask about the amount of fluids Kaplan had received. Kaplan had received over 4 to 5 liters of fluid prior to arriving at the hospital and received an additional 5 liters of fluid while waiting to be taken to surgery. Although this information would have been useful, it would not necessarily have indicated the extent of Kaplan's massive internal bleeding. The amount of fluids that Kaplan received prior to the Respondent leaving the emergency room was not necessarily a sign that Kaplan's condition was unstable. In the treatment of trauma cases, time is of the essence. A trauma patient with a gunshot-wound to the abdomen should be taken to surgery as soon as possible. In some cases, it may be advantageous to delay surgery in order to stabilize the patient's vital signs or to increase blood volume. Generally, if surgery is performed within the first hour after the injury is sustained (referred to as "the golden hour"), the better the chances of the patient surviving. The golden hour does not apply to injuries of the heart and major blood vessels. In those cases, the patients will "bleed out" in a time much shorter than one hour. Nevertheless, even where the golden hour has passed, the patient should be taken to surgery at the first available opportunity and without delay. While in the emergency room at Miami General Hospital, Kaplan's condition ranged from "serious" to "critical." From the time that Kaplan was initially admitted to Miami General Hospital his condition was such that he required immediate surgical intervention. A reasonably prudent physician in the Respondent's position would have performed surgery at the first available opportunity and would not have waited for the arrival of another surgeon. Although pursuant to hospital and HMO rules, the HMO surgeon should have been called first, where an emergency situation exists the first surgeon available is expected to take the patient to surgery, and that physician will be provided payment by the HMO. The Respondent was aware of the hospital's and HMO's policies regarding HMO and non-HMO patients based on prior experience. The Respondent has never previously been disciplined or investigated by Petitioner or any medical board in any jurisdiction. Respondent maintains an excellent reputation for competence and compassion among his fellow physicians. Respondent is well liked by his patients and has provided medical services in the past to patients with no medical insurance.
The Issue Whether the application timely filed with the Department of Health (“Department”) by Memorial Healthcare Group, Inc., d/b/a Memorial Hospital Jacksonville (“Memorial”), met the applicable standards for approval to operate as a provisional Level II trauma center; and whether the Department’s approval of the application was based upon an unadopted rule.
Findings Of Fact The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes. The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has a primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001 and 395.40(3), Fla. Stat. Shands is an acute-care hospital located in Trauma Service Area (“TSA”) 5, which lies in Baker, Nassau, Duval, Clay, and St. Johns counties. Shands has been designated by the Department as a Level I trauma center. Memorial is an acute-care hospital also located in TSA 5. Memorial operates a provisional Level II trauma center. The application that was submitted by Memorial and approved by the Department on May 1, 2017, is the subject of this proceeding. 5. Chapter 395, Part II (§§ 395.40 – 395.51), Florida Statutes (“Trauma Statute”), sets forth the statutory framework for the development of a statewide trauma system. The Department is charged with the planning and establishment of the statewide inclusive trauma system. See, § 395.40(3), Fla. Stat. The Legislature recognized the benefits of trauma care provided within an “inclusive trauma system,” that is “designed to meet the needs of all injured trauma victims.” § 395.40(2), Fla. Stat. Section 395.401(2) directs the Department to “adopt, by rule, standards for verification of trauma centers based on national guidelines, including those established by the American College of Surgeons.” The Trauma Center Standards are published in DH Pamphlet (DHP) 150-9, which is incorporated by reference in Florida Administrative Code Rule 64J-2.011 (the “Trauma Standards”). Section 395.4025 (the “Application Statute”) describes the application process for hospitals seeking to become designated as a trauma center. Section 395.4025(2)(c) requires the Department to conduct a “provisional review” of each trauma center application to determine if “the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” This “critical review” shall be based on “trauma center standards” and shall include 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; and (3) an effective quality assurance process. Id. Notably, the provisional review described in section 395.4025(1)(c) looks only to the application to determine whether an application “has [met] the critical elements required for a trauma center.” Id. Section 395.4025(13) authorizes the Department to “adopt, by rule, the procedures and processes by which it will select trauma centers.” Pursuant to this authorization, the Department issued rule 64J-2.012, which provides detailed regulations governing the application process. Rule 64J-2.012(1)(d) includes a detailed list of elements that a provisional trauma center applicant must satisfy (the “critical elements”) to receive provisional approval from the Department. The Trauma Standards contain other elements that were not designated by the Department as “critical” (the “non-critical elements”). These standards pertain primarily to ensuring the programmatic integrity of a trauma center. Provisional trauma center applications must eventually establish compliance with the non-critical elements, but the non-critical elements are not examined by the Department until after a provisional trauma center application is granted. See Fla. Admin. Code R. 64J-2.012(1)(h). The process for obtaining designation as a provisional trauma center begins on October 1 each year. By that date, hospitals must submit to the Department a letter of intent to file a provisional trauma center application. See § 395.4025(2)(a), Fla. Stat.; Fla. Admin. Code R. 64J- 2.012(1)(a). If a hospital timely submits a letter of intent, the Department must provide the hospital with a provisional trauma center application and instructions for submitting it to the Department. § 395.4025(2)(b), Fla. Stat. April 1 of the following year is the deadline for the hospital to submit a provisional trauma center application. See Fla. Admin. Code R. 64J-2.012(1)(a). The Department conducts a review of the application to determine whether it is complete and has established compliance with the critical elements. See Fla. Admin. Code R. 64J-2.012(1)(d). The Department does not conduct a site visit until a provisional trauma center application is approved and the trauma center is operational. § 395.4025(2)(d) and (5), Fla. Stat. By April 15, the Department must provide the applicant with written notice of any deficiencies in the critical elements and gives the hospital the opportunity to submit additional clarifying or correcting information. See Fla. Admin. Code R. 64J-2.012(1)(e). Applicants then have five working days to address the identified deficiencies and submit additional information. See Fla. Admin. Code R. 64J-2.012(1)(f). On or before May 1, the Department must send written notification to each applicant hospital advising whether its application was approved or denied. See Fla. Admin. Code R. 64J-2.012(1)(g)1.-2. If 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. § 395.4025(3), Fla. Stat.; Fla. Admin. Code R. 64J-2.012(1)(g)1. The Department also immediately notifies EMS providers of the newly operational provisional trauma center. Providers are required immediately to begin transporting “trauma alert” victims, as identified pursuant to field triage criteria, to the newly designated provisional trauma center for trauma care when it is the nearest trauma center to the location of the incident. See Fla. Admin. Code R. 64J-2.002(3)(g). In the summer of 2016, Memorial received a letter from the Department notifying Memorial of the opportunity to submit a letter of intent to become a trauma center. Memorial timely submitted a letter of intent to the Department in September 2016. This letter indicated that Memorial would seek approval from the Department to operate as a Level II trauma center. After Memorial submitted its letter of intent, the Department responded by sending Memorial a notice accepting its letter of intent and providing information on the application process. The notice directed Memorial to the Department’s trauma center application and contained instructions for the completion and submission of the application. Once Memorial received the Department’s notice confirming acceptance of its letter of intent, it began making significant investments of resources and capital to develop its trauma program. It did so to ensure that its application would be compliant with the Trauma Standards. In order to implement its trauma program and meet the required Trauma Standards, Memorial made investments in a number of areas, including the renovation of its emergency department (“ED”) to accommodate two dedicated trauma resuscitation bays; the hiring and recruitment of new physicians and staff; conducting significant staff education; and beginning work towards the construction of a new helipad. By May 1, 2017, Memorial had invested over $4 million to develop its trauma program. This capital investment included approximately $2.5 million in construction and equipment. Memorial also invested $1.7 million in recruiting physicians and staff, as well as trauma-related training and education. Memorial was well positioned to develop its trauma program, since many of the needed surgical specialties were already offered at the hospital. The hospital recruited additional physicians to fill the more than 20 non-surgical specialties required by the Trauma Standards. In addition to new physicians, Memorial recruited many new specialized nurses needed to serve trauma patients. Memorial ultimately provided over 6,000 hours of trauma training before May 1, 2017, and continues to train new nurses. The hospital ensured that over 200 nurses received training in Trauma Nurse Core Competencies, which ensures that nursing staff can provide high quality care for severely injured patients. Memorial made all of the above investments prior to March 31, 2017, the date on which Memorial submitted its application to the Department. Memorial’s Application was prepared by a core team, headed by Eleanor Lynch, senior vice president of operations at Memorial. The key members of the team included Memorial’s trauma medical director, trauma program director, as well as representatives from the intensive care unit (“ICU”) and operating room. In order to ensure Memorial’s Application met the Trauma Standards, the team preparing the application met at least three times each week. Those meetings sometimes consisted of 30 different individuals from a variety of disciplines, including the trauma program director, trauma medical director, registration, respiratory, ICU, and the ED. The process was comprehensive and inclusive to ensure the hospital was fully prepared to address each Trauma Standard in its application. This team reviewed the application before it was submitted to the Department to ensure that it complied with the Trauma Standards. Memorial also received assistance from K.C. Pidgeon, vice president of trauma for HCA South Atlantic Division--which includes Memorial. Mr. Pidgeon, who has significant experience in developing trauma programs in Florida, participated in each of the team meetings. He provided guidance into making sure the hospital and its application met the Trauma Standards, including updating policies and procedures, purchasing equipment, recruiting staff, and development of nurse leaders. The final application submitted to the Department consisted of 32 separate binders encompassing thousands of pages of information. In order to be ready to operate by May 1, 2017, Memorial set an internal deadline of February 27, 2017, for the hospital to meet each of the Trauma Standards. Memorial met this internal deadline and included a letter in its application from Memorial’s CEO confirming this milestone. Memorial timely submitted its trauma center application to the Department on March 31, 2017. In developing its trauma program and preparing its application, Memorial ensured that it met all of the Trauma Standards that are required for provisional approval. After receiving Memorial’s Application, the Department arranged for it to be reviewed by two outside experts, Dr. Marco Bonta and Nurse Marla Vanore. Both Dr. Bonta and Nurse Vanore have reviewed numerous trauma applications on behalf of the Department, and are very familiar with the Trauma Standards. Following their review, Dr. Bonta and Nurse Vanore sent the Department a checklist identifying alleged deficiencies in Memorial’s Application. Both reviewers concluded that the quality of the application on initial review was excellent, and reflected a serious effort to meet the Trauma Standards before beginning operations. On April 14, 2017, the Department sent Memorial a letter notifying it of the deficiencies that Dr. Bonta and Nurse Vanore had identified. The few deficiencies identified by the Department were mainly clerical in nature or required simple clarifications. For instance, one of the noted deficiencies included updating the curriculum vitae of Memorial’s trauma program director. Memorial timely responded to each deficiency identified by the Department on April 22, 2017. Memorial’s deficiency response was also reviewed by Dr. Bonta and Nurse Vanore. Following their review of Memorial’s deficiency response, the expert reviewers concluded that Memorial properly addressed each deficiency identified during the Department’s initial review. On May 1, 2017, the Department informed Memorial that its application was in compliance with the applicable Trauma Standards and directed it to begin trauma operations on that same day. As indicated by the parties’ stipulation, Shands takes issue with only a few of the hundreds of requirements that comprise the Trauma Standards. The only aspects of Memorial’s Application which Shands disputes are the standards related to trauma surgeon call coverage (Standards II.A.4-5, II.B.2, and III.A) and the helipad (Standard V.A.5). Shands does not dispute that the application meets the remaining Trauma Standards. Standard III of the Trauma Standards details the surgical staffing requirements that each trauma center must meet. Standard III.A specifically addresses the requirements for general trauma surgeons. Standard III.A.1 requires that “[t]here shall be 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 a trauma center when summoned.” Standard III.A.2 requires each trauma surgeon to sign the General Surgeons Commitment Statement, which confirms that each surgeon on primary and backup call will comply with certain conditions, including arriving promptly when summoned. Standard III.A.3 lists the minimum qualifications for each trauma surgeon taking call, such as certifications and hospital privileges. Memorial submitted substantial documentation which demonstrated its compliance with the requirements in Standard III.A. Although the Trauma Standards only require five trauma surgeons, Memorial secured nine trauma surgeons for its program. For each of these surgeons, Memorial provided proof of hospital privileges, board certification, state licensure, Advanced Trauma Life Support (“ATLS”) certification, proof of participation in past trauma cases, completion of continuing medical education courses, attestation by the Chief of Neurosurgery, and the commitment statement, among other documentation. Memorial’s documentation for this section totaled more than 500 pages. Memorial also submitted primary and backup call schedules for February, March, April, and May 2017, indicating when each trauma surgeon was scheduled to take trauma call. In addition, Memorial submitted a number of policies and procedures, including Memorial’s credentialing criteria, which is more stringent than what the Department requires. In order to be credentialed at Memorial, a trauma surgeon must agree to the following requirements for primary trauma call: be physically present in-house to meet all trauma patients in the trauma resuscitation areas at the time of the trauma patient’s arrival; perform no elective surgery or procedures during the on- call period that would render the trauma surgeon unavailable to arrive promptly to a trauma alert patient; and refrain from taking general surgery emergency call at any other facility or trauma call at any other facilities while on trauma call at the primary facility. Similar requirements exist for trauma backup call. Standard II of the Trauma Standards sets forth the trauma call coverage requirements that each trauma center must meet. Specifically, Standards II.A.4 and II.A.5 require “[a]t least one qualified trauma surgeon (as described in Standard III.A) to be on primary trauma call at all times to provide trauma service care” and “[a]t least one qualified trauma surgeon (as described in Standard III.A) to be on backup trauma call at all times to provide trauma service care.” Simply put, there must be one trauma surgeon on primary call and one trauma surgeon on backup call at all times. As part of its application, Memorial submitted detailed information about each of the nine trauma surgeons on its monthly call schedules, including the call schedules themselves. The call schedules detail each of the trauma surgeons scheduled to take primary and backup trauma call for February through May 2017. Memorial secured and submitted commitment statements (DH Form 2043E) from each of the trauma surgeons on its call schedule. These signed commitment letters indicate that each trauma surgeon agreed to commit to the call schedules submitted to the Department and be available as indicated. These letters also indicate that each surgeon pledged not to take trauma call at any other facility while on trauma call at Memorial. Trauma Standard II also includes a requirement that the hospital ensure any new trauma surgeons are appropriately qualified and sign the commitment statement. Specifically, “[a]s surgeons change, the trauma medical director must ensure that the new surgeons have the qualifications delineated in Standard III.A.3 and that they sign the General Surgeons Commitment Statement. The trauma service shall keep a current and up-to- date commitment statement on file in the hospital’s trauma center application at all times for Department of Health review.” In response to this subpart, Memorial appropriately submitted the commitment statements for its initial nine trauma surgeons. Because this was Memorial’s provisional application, none of the new trauma surgeons who have subsequently joined its program after May 1, 2017, were included with this submission. After completing their initial review of Memorial’s Application, the Department’s expert reviewers identified only one issue to be addressed in the above sections. For one of the trauma surgeons, Dr. Alton Parker, there was a question as to whether he had met all the required continuing medical education (“CME”) requirements. As requested, Memorial submitted additional documentation with its Deficiency Response confirming that Dr. Parker had in fact completed the required CME courses. With this concern resolved, the expert reviewers ultimately concluded that Memorial’s Application met every requirement. At hearing, Shands alleged that because some of the trauma surgeons listed in Memorial’s Application do not live in Jacksonville year round, the application did not meet the Trauma Standards detailed above. However, there is no requirement in the Trauma Standards that trauma surgeons must live full time in the same community as the hospital at which they take trauma call. Rather, the Trauma Standards require that trauma surgeons on primary and backup trauma call in Level II trauma centers be available within 30 minutes once summoned. In actuality, Shands’ criticisms appear to be a matter of preference or imagining the ideal situation, rather than substantive questions about compliance with the legal requirements for trauma surgeon call. Memorial has not had any gap in trauma call coverage or similar issues since it began operations on May 1, 2017; every shift has been covered and each trauma surgeon available as required. Memorial’s trauma surgeons are committed members of the trauma team, including active participants in the quality improvement process, regardless of where their permanent residence may be. As part of its mission to ensure high-quality care, Memorial requires its trauma surgeons on primary trauma call to be physically present at the hospital during the entire shift, which is beyond what the Trauma Standards require for Level II trauma centers. Memorial established this requirement in part to ensure that there would be no issues with response time for trauma surgeons. Any trauma surgeons on backup call that do not have permanent residences within 30 minutes response time of the hospital, typically stay at a hotel close to the hospital in order to comply with the Trauma Standards and Memorial’s own requirements. For any trauma surgeons who do not live full time in the Jacksonville area, Memorial requires that they report well in advance of beginning the call coverage to ensure there are no issues, e.g., a trauma surgeon beginning call at 9:00 a.m. Monday morning must report to the hospital by 9:00 p.m. the night before. Memorial’s trauma surgeons have positive working relationships with other team members, like the ED physicians, and have collaborated well with local EMS. Memorial has worked to build a full-time trauma surgeon roster, with the hope that recruited physicians will ultimately decide to make the Jacksonville area their home. Memorial currently has three trauma surgeons, including the trauma medical director, Dr. Michael Samotowka, who live full time in Jacksonville and plans to continue recruiting until all six current spots are filled by full-time residents. Both Dr. Bonta and Nurse Vanore determined that Memorial’s trauma call coverage met the applicable Trauma Standards, including Standards II.A.4-5, II.B.2, and III.A. Both expert reviewers confirmed at hearing that the Trauma Standards only require trauma surgeons on primary and backup call to be readily available--they do not dictate where surgeons must reside full time. Nurse Vanore also testified that many trauma centers across the country utilize physicians who do not live in the immediate vicinity of the hospital. These physicians either stay at the hospital or make arrangements to stay nearby when on call. This reflects a common trend in trauma centers nationwide, which often use the rotation of trauma surgeon (both on- and off-call) shifts to enhance patient care. Most trauma centers do not use trauma surgeons to provide longitudinal care (one surgeon with the patient throughout the care process). Instead, there is a comprehensive patient handoff to the next trauma surgeon. There was no indication in Memorial’s Application that its trauma surgeons would not fulfill their call obligations. The general trauma surgeon call schedules submitted by Memorial adequately demonstrated that Memorial would be able to fulfill its trauma call coverage requirements. Since beginning trauma operations, Memorial has not had any gaps in coverage or other issues related to trauma call. Therefore, Memorial satisfied Standards II.A.4-5, II.B.2, and III.A. The helipad became a central issue at hearing. Standard V addresses the facility requirements relating to the ED, including the helipad. Standard V.A.5 requires that each hospital must have a “helicopter-landing site in close proximity to the resuscitation area.” “Close proximity” is defined to mean that “the interval of time between the landing of the helicopter and the transfer of the patient into the resuscitation area will be such that no harmful effect on the patient’s outcome results.” In addition to this requirement, the helipad must be properly licensed by state and federal authorities, and have appropriate policies and procedures for helipad operations. Memorial has used the helipad in its current location since 1993. Before it began operations as a trauma center, Memorial effectively used its helipad to transport trauma patients out of its ED to Shands and other trauma centers without incident for the entirety of that time period. The helipad is located approximately 1900 feet from Memorial’s ED. To meet this Trauma Standard, Memorial hired Liberty Ambulance Service, a private ambulance service, to staff the helipad 24/7, so that at all times there is an advanced life support ambulance with two paramedics ready to transport patients from the helipad to the ED. In addition, the ambulance driver has received emergency vehicle operations course training. Memorial also provided training to the ambulance crew members to ensure they were proficient in helicopter safety. This training included in-depth interaction with air crew of TraumaOne, which is one of the region’s air transport providers. Memorial hires deputies from the Jacksonville Sheriff’s Office to be present at all times for helicopter arrivals. These deputies can be used to block any pedestrian or vehicle access to the transport route or otherwise provide transport assistance, although this has not been needed. Memorial conducted numerous time studies, almost daily since February 27, 2017, to ensure it could quickly move patients from the helipad to the ED without delaying treatment. The time trials entailed actually loading a stretcher onto an ambulance at the helipad, driving the ambulance to the ED, and unloading the stretcher at the ED. These time trials, which were conducted beginning in December 2016 and continue today, showed an average transport time of two to three minutes. Each time trial was attended by Memorial’s EMS Coordinator, Greg Miller, and signed off by each ambulance crew that participated. These time trials helped familiarize the ambulance crew with the short route from the helipad to the ED, as well as to identify an alternate route that can be used if needed. Admittedly, the trials were performed using hospital personnel posing as patients, rather than actual trauma patients, but the methodology, while presenting a best case scenario, was nonetheless reasonable. In addition to the time trials, actual air transports of non-trauma patients confirm the close proximity of the helipad. It only took five minutes to transport a recent non- trauma patient from the helipad to the ED, as documented by the LifeFlight air crew which transported the patient. Since beginning trauma operations, there have not been any issues with trauma patients arriving by helipad. At the time of hearing, Memorial had only had one trauma patient delivered by helicopter since May 1, 2017. Memorial has only had 24 total non-trauma patients delivered by helipad in 2017. In fact, very few patients are transported by air in TSA 5, generally. As part of ongoing renovations, Memorial is currently constructing a new helipad, which will be situated one floor directly above the ED. The new helipad is scheduled to be completed in July 2018. Shands alleged at hearing that Memorial’s helipad was not optimally located and voiced general concerns about its potential impact on patient care. While 1900 feet from the ED cannot be considered the “optimal location” for the helipad, the claims of adverse impact on patient care were not supported by evidence produced at hearing. None of Shands’ witnesses suggested that the patient transport times reflected in Memorial’s Application would adversely impact patient care, or that any adverse incidents had occurred on Memorial’s helipad. Actually, none of Shands’ witnesses had even reviewed any of the time trials or actual patient transport information included in Memorial’s Application. The time it takes to transport patients from Memorial’s helipad to the ED is not substantially different from other trauma centers in the region. Shands’ own witnesses confirmed that Shands’ helipad sits atop a six-story parking garage across the street from its ED, which requires patients to be transported down an elevator and wheeled on a stretcher across a road while security blocks traffic access. Despite their criticisms, none of Shands’ witnesses knew how long it took to transport patients from Shands’ helipad to the ED. Moreover, with the construction of its new helipad atop the ED, any concerns about the current transport times will be eliminated. Both Dr. Bonta and Nurse Vanore determined that Memorial’s helipad met the applicable Trauma Standard, namely Standard V.A.5. Based on the time studies provided by Memorial which showed the average transport time from the helipad to the ED was only two to three minutes, the expert reviewers determined that the helipad was in “close proximity” to the resuscitation area. Based on their experience, the expert reviewers concluded that two to three minutes was typical of other trauma centers, including hospitals with rooftop helipads. This duration of transport time is actually quite good and would not adversely affect patient care. Memorial’s helipad is in close proximity to the trauma resuscitation area, as the Department properly concluded based on the information provided in Memorial’s Application. The two-to- three minute transport time for trauma patients is well within the acceptable range and demonstrates that Memorial met Standard V.A.5. Memorial elicited testimony from a longtime expert in health care planning, Gene Nelson of Health Strategies, Inc. Mr. Nelson spoke at length in an effort to establish need for an additional trauma center in TSA 5 through a feasibility study employing well recognized health planning concepts. He focused primarily on access to trauma care for patients needing the comprehensive specialized care offered by trauma centers. Mr. Nelson noted that many trauma patients were being treated in general acute care hospitals without trauma centers which fell short of the care provided in centers like Shands and the proposed Memorial trauma center. He concluded that a substantial need exists for another trauma center in TSA 5 and that Memorial would fulfill that need. Shands objected to this discussion of need by Mr. Nelson on behalf of Memorial, and argues that the letter of intent and application filed by Memorial should not have been accepted in the first place, since there was not a documented need for another trauma center in TSA 5. As will be discussed in the Conclusions of Law below, the need for an additional trauma center is not a determination to be made at the time of a hospital’s filing for authority to begin operating a provisional trauma center. Shands testified that Memorial’s operation of a trauma center in TSA 5 has already resulted in injury to its operations and profitability. This injury will only continue in the future as Memorial gains a stronger foothold in the TSA. The negative impacts include fewer trauma patients at Shands resulting in a longer period for trauma nurses to acquire and maintain the specialized skills necessary for operating in a trauma center versus a general acute care hospital. The opening of Memorial’s provisional trauma center has caused the number of severely injured trauma patients at Shands to decrease. Shands predicts an annual loss of 324 trauma cases due to Memorial’s opening, translating to a $2.25 to $2.7 million annual loss of revenues. If outpatient cases are included in this analysis, Shands projects an annual loss in revenues of $12,422 per case over the 324 lost cases, resulting in an annual total loss of approximately $4 million. Memorial argues that sufficient trauma volume exists in TSA 5 for both facilities to operate their trauma centers. Memorial projects that it will treat 1,556 trauma patients per year, well above the American College of Surgeons’ (“ACS”) recommendation of at least 1,200 patients per year as a minimum volume level. Mr. Nelson estimates that, annually, only between 300 and 500 trauma patients will be treated at Memorial that otherwise would have been treated at Shands. The rest likely would have received treatment at an acute care hospital, not a trauma center. Mr. Nelson believes that Memorial’s trauma program has had, at most, a minimal impact on Shands. An analysis produced by Shands demonstrates that Shands’ own projections estimate a loss of only 154 trauma patient admissions, well below the numbers projected by Memorial. Even with Memorial’s trauma program being fully operational, Shands will continue to receive in excess of 2,000 trauma patients admitted annually. That volume is well above the ACS’s recommended minimum patient volume of 1,200 for Level I trauma centers. Shands’ own data shows that it will continue to see over 4,600 total trauma patients annually, including inpatient and outpatient cases. Estimates prepared by Shands’ associate vice president of finance, Dean Cocchi, demonstrate that even with a potential impact from Memorial, Shands will still have a contribution margin of well over $30 million. Mr. Cocchi also testified that Shands’ projected financial impact from Memorial operations will not endanger the continued operation of its trauma program. While the presence of Memorial in the TSA 5 market will have a small negative financial impact on Shands, it is not projected to be substantially adverse. The quality of care provided at Shands has not been impacted by the opening of Memorial’s trauma center. Shands remains a high-quality provider of trauma care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Memorial met its burden of establishing that its trauma center application met the applicable standards; awarding provisional Level II status to Memorial; and dismissing Shands’ petition. DONE AND ENTERED this 13th day of June, 2018, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of June, 2018. COPIES FURNISHED: Stephen A. Ecenia, Esquire Gabriel F.V. Warren, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32302-0551 (eServed) Seann M. Frazier, Esquire Marc Ito, Esquire Parker, Hudson, Rainer & Dobbs, LLP 215 South Monroe Street, Suite 750 Tallahassee, Florida 32301 (eServed) Daniel Ryan Russell, Esquire Jones Walker, LLP 215 South Monroe Street, Suite 130 Tallahassee, Florida 32302 (eServed) Michael Jovane Williams, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399 (eServed) Martin B. Goldberg, Esquire Lash & Goldberg, LLP 100 Southeast Second Street, Suite 1200 Miami, Florida 33131 (eServed) Jeffrey L. Frehn, Esquire Radey Law Firm, P.A. 301 South Bronough Street, Suite 200 Tallahassee, Florida 32301 (eServed) J. Stephen Menton, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32302-0551 (eServed) Nichole Chere Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed) Shannon Revels, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1703 (eServed) Celeste M. Philip, M.D., M.P.H. State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 (eServed)
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0025685. For 18 years prior to the event complained of herein, Respondent worked at Indian River Memorial Hospital, where he practiced as an anaesthesiologist. Also prior to the event complained of herein, Respondent was a tri- athlete, training in swimming, biking, and running. During the summer of 1992 he competed in five or six tri-athalons and did quite well in his age class. Respondent was also a snow skier. In accordance with his physical fitness values, Respondent does not drink alcoholic beverages or smoke cigarettes. He is also a vegetarian. Peter G. Wernicke is an orthopedic surgeon in the Vero Beach area. After arriving there, he and Respondent became social friends and went on ski trips together. He also became Respondent's treating physician, caring for Respondent when Respondent suffered broken bones, strains, and sprains as a result of his sporting activities. In early winter of 1992 Respondent seriously injured his knee while snow skiing. Respondent discussed his need for surgery with Wernicke after Respondent returned to the Vero Beach area. Wernicke was insistent that he perform Respondent's knee surgery, but Respondent wanted to have the surgery performed by Dr. Richard Steadman in Vail, Colorado, since he believed that Dr. Steadman was probably the best in the world at taking care of that particular kind of knee injury. Wernicke then insisted that Respondent allow Wernicke to perform the knee surgery with Respondent awake, and once the knee was opened up, Wernicke and Respondent would look at it and decide whether it was something Wernicke was able to take care of or if the knee should be closed and Respondent would then go to whomever he wanted to have the surgery performed. Respondent would not agree to that approach since he well understood that opening the knee twice would double Respondent's risk of infection in that injured knee. Up to the time that Respondent left to travel to Vail for his knee surgery, Wernicke maintained that he was not giving Respondent his blessing for having the surgery performed by someone else. Respondent went to Vail and had Dr. Steadman perform the surgery in early December of 1992. Respondent remained in Vail post-operatively undergoing physical therapy which commenced within hours of surgery being completed to increase his chances of obtaining full range of motion with that knee by keeping it moving and preventing scarring. Respondent returned to Vero Beach on December 13 and returned to work the next morning, working a full shift that day. After his shift was over, he drove himself to Orlando for a meeting. While in Orlando, Respondent began to have very severe pain and swelling in his knee. He drove back to Vero Beach, arriving at his home at approximately 9:30 p.m. Upon his arrival, he telephoned Wernicke, told Wernicke he was in a great deal of pain, and begged Wernicke to help him by meeting him at the hospital and looking at Respondent's knee. Wernicke told Respondent that he would not go to the hospital to meet Respondent, that Respondent should elevate his knee and apply ice, and then see Wernicke in the morning. Respondent elevated his leg and applied ice for the next few hours. By approximately midnight the pain had become "absolutely excruciating," unlike any Respondent had experienced with all of his broken bones and other sports injuries. Although Respondent's tolerance for pain was high enough that he had gone through the surgery performed by Dr. Steadman without pain pills and had tolerated getting on an exercise bike 12 hours after that surgery, Respondent knew that he could no longer endure the pain, that he had a serious problem with his post-operative knee, and that he needed to get help immediately. Respondent got himself up with crutches and got in the car to drive himself to the emergency room. While driving, he telephoned the emergency room at Indian River Memorial Hospital and told the staff he was on his way there and asked the name of the orthopedist who was on call. He was advised that Dr. Wernicke was not only on call, but was present in the emergency room at that moment. Respondent told the emergency room staff to tell Wernicke to wait for him. Respondent then called the operating room at Indian River Memorial Hospital and asked if an anaesthesiologist were there so he could get something to relieve his pain. He was told that Dr. Brennan had just finished with surgery and had taken the patient to the intensive care unit. Respondent then asked for two things: (1) to have Dr. Brennan go to the emergency room to take care of Respondent and (2) to bring Respondent's anaesthesia cart to the emergency room. The operating room staff agreed. Respondent's requests resulted from his experience with that hospital's emergency room staff and procedures. He knew he needed medication for his knee and for his pain. He knew that Dr. Brennan was not employed by the hospital and did not have his own anaesthesia cart there. He knew that the emergency room staff were notoriously slow in responding to patient needs or doctor requests. Therefore, over the years, Respondent had learned that whenever he was called to the emergency room, the patient was better served if Respondent took his own anaesthesia cart and supplies with him. As a result of his telephoning ahead, Respondent's arrival was expected. Dr. Wernicke waited for him. Someone took Respondent's anaesthesia cart to the emergency room and placed it next to a stretcher. Dr. Brennan was paged and told that Respondent needed him in the emergency room, and Dr. Brennan went to the emergency room to assist his colleague. When Brennan got there, Respondent had not yet arrived, but Wernicke was present. Brennan told Wernicke he was there to help with Respondent. For whatever reason, Wernicke told Brennan that Brennan was not needed and told him to leave. Before leaving the emergency room, Brennan told Wernicke that if he were needed he would be nearby in the intensive care unit and to please summon him. Respondent arrived at the hospital emergency room on crutches. The emergency room was currently under construction and had no dividing walls or partitions so that it was simply one room in which everyone could see everything occurring. There were no patients in the emergency room when Respondent arrived, but there were three or four nurses and the emergency room doctor at the nurses' station. Respondent went to the nurses' station to be admitted. He was told that he should wait in the lobby and he would be called when they were ready to begin the admission process. Respondent refused to do that, told them he was in excruciating pain, and insisted that he be given the emergency room release form and financial responsibility form to sign and be taken to one of the emergency room stretchers. He was given the forms to sign, which he did, and he was then escorted to the stretcher next to his anaesthesia cart. For the remainder of his time in the emergency room, Respondent remained on that stretcher which was no more than 30 feet from the nurses' station. No chart for his emergency room visit was prepared by the hospital personnel. Further, no one took his vital signs; no one took his blood pressure; no one asked what his problem or complaints were which caused his visit; and no one asked whether Respondent had any allergies or had recently eaten. Respondent lay on the stretcher waiting for Wernicke to return to the emergency room for approximately five minutes. When Wernicke came in, he was wearing a big smile. He remarked to Respondent that Wernicke could see that Respondent had a problem with his knee. Wernicke then gave one swipe across Respondent's knee with an alcohol swab and prepared to jab an 18 gauge needle into the knee to aspirate it, i.e., to drain the fluid. Respondent became terrified and told Wernicke to stop. Respondent's terror was caused by two fears. First, it was apparent that his knee was full of blood. He knew that blood outside of its normal confines is an irritant which causes inflammation and he knew that it was also the perfect medium in which bacteria could grow. He also knew that the risk of infection in his knee was substantial because it was a post-operative knee. Infection in such a knee presents a best-case scenario of a damaged knee and a worst-case scenario of rendering him a cripple, requiring a total knee replacement. Yet, Respondent saw that Wernicke intended to stick the needle into Respondent's dirty knee without even using a Betadine preparation to remove bacteria from the skin. Second, Respondent was in "unbelievable" pain from the significant swelling in his knee. The surgical incisions above and below his knee had ruptured from the pressure caused by the swelling. In order for Wernicke to aspirate Respondent's knee, it would be necessary for him to poke his fingers into the swollen knee area in order to locate the right place to stick the needle, and it was impossible for Respondent to hold his leg still for Dr. Wernicke to palpate, let alone insert the needle in the correct location. Respondent told Wernicke that he needed an I.V. started; that he needed Kefzol, an I.V. antibiotic, to prevent infection; that he needed Toradol intravenously for its anti-inflammatory effect; and that he was in very, very severe pain and needed pain medication so he could hold his leg still for Wernicke to aspirate. Although Wernicke recognized that Respondent was in significant, severe pain, he told Respondent he would agree to the antibiotic and he would agree to the anti-inflammatory, but that he didn't think Respondent needed anything for pain. Respondent's anaesthesia cart was not equipped with I.V. fluids. Someone brought an I.V. bag and set-up. Respondent does not know who brought the I.V. and whether it was on Dr. Wernicke's order or ordered by the emergency room doctor, but Respondent did not order the I.V. brought. No one offered to start Respondent's I.V. for him, and Wernicke did not tell Respondent that Dr. Brennan had come to the emergency room, had been sent away by Wernicke but was nearby, and had told Wernicke to summon him if he were needed. Wernicke kept telling Respondent to hurry up because it was late and he wanted to go home. He told Respondent that they needed to get finished because Wernicke was doing Respondent a favor just by being there. Respondent, while still lying on his stretcher, started his own I.V. Wernicke assisted Respondent by handing him tape for the I.V. since Respondent was performing the task with one hand. Respondent then removed his medication box from the bottom of his anaesthesia cart. He took out an ampule of Kefzol, a dry powder. He took a syringe and drew fluid from the I.V. that was running into him and mixed up that dry powder antibiotic by flushing it back and forth. He then gave the antibiotic to himself. He attempted to delay Wernicke from inserting the needle into his knee until after the antibiotic could circulate through his system and get to his knee before any bacteria was introduced, a process which would take approximately six minutes to complete enough circulations. Respondent next prepped his own knee with Betadine solution while Dr. Wernicke continued to stand there by his side, watching him. Respondent then took an ampule of Toradol, a new anti-inflammatory medication, and gave himself 60 milligrams intravenously, while Wernicke stood and watched. Although that anti-inflammatory medication would also serve to reduce Respondent's pain, Toradol is a slow-acting medication in that regard, having a slow onset but thereafter lasting for a number of hours. Respondent then removed from his medication box a 5 cc ampule of Alfenta. That ampule is a 2 1/2 inch object made of glass with its name in blue lettering on the outside, large enough to read. Alfenta is a Schedule II controlled substance and is a narcotic. Alfenta has a fast onset and a fast offset; it works in 30 to 60 seconds, and its effect lasts for approximately 10 minutes. While Dr. Wernicke watched, Respondent filled a needle and gave himself 1 cc of Alfenta which is a very conservative test dose for a man weighing 190 pounds who is in good condition. Respondent then waited a minute or a minute and a half to see what effect it had on his pain level and trembling leg. It had very little effect. Therefore, Respondent injected an additional 1/2 cc and waited. That additional amount was sufficient. Wernicke watched as Respondent gave himself the Alfenta, standing, as he had been, within inches of Respondent. As he injected the medications, Respondent filled out the chart on his anaesthesia cart, noting the medication, the dosage, and that he was the patient. Respondent then laid back on the stretcher, closed his eyes, and then told Wernicke he was ready. Wernicke then palpated Respondent's knee and inserted the needle to aspirate Respondent's knee. The pressure in his knee was so high that it blew the syringe back. Wernicke commented that he had never before seen that happen and had never seen pressure like that. Wernicke withdrew approximately 100 ccs of fluid from Respondent's knee, commenting that he did not think he'd seen one with more volume. Although initially Wernicke had said that he did not agree that Respondent needed any pain medication, Wernicke totally acquiesced in everything Respondent did to assist Wernicke in treating Respondent. Wernicke accepted Respondent's judgment and watched Respondent execute step by step the course of treatment Respondent said was needed to render proper medical treatment. Wernicke totally agreed and acquiesced with the use of Alfenta as much as he did the antibiotic and the anti-inflammatory as evidenced by Wernicke's own conduct. Wernicke never told Respondent to stop doing Wernicke's work for him. Wernicke never told him not to administer the medications. Wernicke never suggested that he or someone else perform the administration. Wernicke could have easily stopped Respondent who was laying on a stretcher but did not. Wernicke knew that Alfenta was a pain killer and a narcotic. He did nothing to stop or prevent Respondent from injecting a medication Respondent needed. Further, Wernicke continued to treat Respondent after the administration of Alfenta by thereafter performing the aspiration. After he completed the aspiration, Wernicke left. Respondent lay on the stretcher for a little while. The nurses and the emergency room doctor remained at the nurses' station, and there were still no other patients in the emergency room. Respondent asked if someone would bring him a wheelchair so he could leave, and he was told that they were too busy. Respondent took his crutches and hobbled out of the emergency room. The next morning Respondent reported to work for his regular shift which began at 7:00 a.m. After Respondent completed the first case on his shift that day, at approximately 10:30 to 11:30 a.m. he called Haynes McDaniel, the hospital's pharmacist, and told him what had happened the night before, what medications Respondent had used, and that he had used the medications on himself. Respondent said he needed to do whatever paperwork the pharmacist wanted and specifically asked the pharmacist to bill him for the medications he had used. McDaniel told Respondent that there was no problem regarding the Kefzol and the Toradol and that he would simply send Respondent a bill for those medications; however, as to the Alfenta, the pharmacist needed a prescription for his records. McDaniel asked Respondent who the attending physician had been, and Respondent told him that Peter Wernicke was the attending doctor. McDaniel told Respondent to get a prescription from Wernicke for the Alfenta so that the hospital record keeping would be proper. Respondent went to Wernicke and asked him for a prescription for the Alfenta that had been used, and Wernicke refused. Respondent then personally went to McDaniel and told him that Wernicke would not write the prescription and told McDaniel why, i.e., that Wernicke was still mad that Respondent had not considered him good enough to do Respondent's surgery. McDaniel asked Respondent who could write the prescription because Respondent needed a prescription from somebody and Respondent could not write the prescription for himself. Respondent told McDaniel that he had asked Dr. Brennan to be there to give him the pain medication, that Dr. Brennan had never showed up, but that Brennan was in the hospital at the time the medication was administered. McDaniel suggested that Respondent see if Brennan would sign a prescription. Respondent went to Brennan's office and told Brennan exactly what had happened. He told Brennan he had given himself 1 1/2 ccs of Alfenta and that Wernicke was the attending physician. He told Brennan that Respondent had self- administered and why, that Wernicke had refused to write the prescription and why, and that Haynes McDaniel had suggested that Brennan could sign the prescription for the hospital's records. Dr. Brennan became upset that he had not been there to help when his colleague needed him, agreed to sign the prescription, and offered Respondent pain pills or anything else Respondent needed for what remained a painful knee and leg. Respondent declined the offer of any additional medication. In good faith and in the course of his professional practice, Dr. Brennan signed a prescription for 1 1/2 ccs of Alfenta for Respondent. Respondent then hand- delivered that prescription to the pharmacist. After receiving the prescription from Respondent, the pharmacist wrote an Unusual Occurrence Report dated December 16, 1992. In January of 1993 the hospital summarily suspended Respondent's privileges, and he has been unable to practice medicine since that time. Respondent's emergency room visit happened on a Monday evening. On the following Thursday, Respondent and Wernicke's partner Dr. Jim Cain were in the doctor's lounge together. Respondent told Cain that his leg really hurt him and was swollen, and Cain offered to look at it. Respondent pulled up his scrub suit and showed Cain his calf which was twice its normal size and "hot". Cain suggested that Respondent get an ultrasound and get some blood thinner since it looked as though Respondent had developed phlebitis, a dangerous condition. Respondent immediately went to the x-ray department and had an ultrasound performed. The ultrasound revealed that Respondent had compartment syndrome in his calf, four days after the aspiration was performed. Dr. Wernicke's office notes regarding Respondent's emergency room visit, supposedly dictated that same evening or the following day, discussed the ultrasound that Respondent had. Accordingly, Dr. Wernicke did not dictate his notes regarding his treatment of Respondent on Monday evening or on Tuesday. Those notes, however, do bear Tuesday's date and are included in the hospital's medical record for Respondent's emergency room visit. The medical chart created by the hospital was likely created on December 21, 1992, the date stated on the Unusual Occurrence Report as the date the chart was initiated. The chart which thereafter purports to be Respondent's emergency room record is actually a composite of different patients' charts. To the extent it purports to be Respondent's chart, the entries contained therein are false. The Alfenta used by Respondent was an appropriate drug for the purpose for which it was used. It is a rapid but short-acting narcotic analgesic when given in the amount in which it was given. Further, the amount of Alfenta administered was an appropriate dose. Respondent used the Alfenta because it was an appropriate drug for immediate relief so he could endure the palpation and aspiration of his knee and so he could stop his leg from trembling allowing Wernicke to aspirate it. He knew the Alfenta would be worn off even before the analgesic effect of the anti- inflammatory medication was felt. It is noteworthy that all physicians who testified in this proceeding rated the pain Respondent was in as between eight and ten on a pain scale where ten is the worst. Respondent did not use Alfenta as a result of any addiction, and his use of the drug under the circumstances in this case was not related to any abuse of narcotics. Respondent has not exhibited any of the behavior of a drug user. Respondent did not engage in any attempt to "cover up" his administration of Alfenta to himself. He called the hospital and requested his anaesthesia cart be brought and that an anaesthesiologist come to the emergency room to administer the medication. The administration occurred with the implicit consent of Wernicke and it took place in front of Wernicke, in front of three or four emergency room nurses, and in front of the emergency room doctor. At the time, he filled out the narcotics record on his anaesthesia cart and telephoned the hospital's pharmacist the following day to tell him what had occurred and request that he be billed for the medication he used. His giving the hospital a prescription from Dr. Brennan was caused by Wernicke's refusal to document the treatment he rendered to Respondent, by Respondent's inability to write his own prescription, and was in response to the hospital's specific request that a prescription be written for the purpose of the hospital's record keeping. Further, Dr. Wernicke knew what had happened, as did the other emergency room personnel present that evening, and Respondent fully disclosed the events that had occurred to both Dr. Brennan and to the hospital pharmacist. Respondent's use of Alfenta on December 14, 1992, was not in any way related to patient care and had no impact on any patient care rendered by Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 28th day of March, 1995, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 2-6 and 9-12 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Petitioner's proposed findings of fact numbered 7, 8, 13, 14, and 16 have been rejected as not being supported by the weight of the competent evidence in this cause. Petitioner's proposed finding of fact numbered 15 has been rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 1, 3-19, 21-31, 33-35, 38-40, 42, 43, and 45 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 2, 20, 32, 36, 37, and 44 have been rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Respondent's proposed finding of fact numbered 41 has been rejected as being subordinate to the issues herein. COPIES FURNISHED: Arthur B. Skafidas, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Joseph L. Mannikko, Esquire 215 South Federal Highway, Suite 100 Stuart, Florida 34994 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Tom Wallace, Assistant Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue in this case is whether an application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital (“Wolfson”), to operate a pediatric trauma center should be approved.
Findings Of Fact The following findings of fact are derived from the stipulation of the parties, the admitted exhibits, and the testimony at final hearing. DOH is the state agency responsible for, inter alia, the review and approval (or denial) of applications to operate trauma centers, including pediatric trauma centers. DOH denied the trauma center application filed by Wolfson, not due to an absence of need in the area, but due to Wolfson’s failure to comply with some requirements set forth in the application. Wolfson is a 216-bed not-for-profit children’s hospital located in Jacksonville, Duval County, Florida. It is part of the Baptist Health organization and is one of three hospitals operated under that entity’s license. Wolfson is located on the same campus as Baptist Medical Center – Jacksonville. The two hospitals share a pharmacy which is located in the children’s hospital and a laboratory located in the adult hospital, but no other services or staff. Interestingly, Wolfson was developed by the sons of Morris Wolfson, a Jewish immigrant to the United States. One of Mr. Wolfson’s children had died at an early age due to lack of access to health care services. Later in his life, after acquiring a small fortune from his business, Mr. Wolfson asked his five remaining sons to develop a children’s hospital accessible to every child, regardless of race, creed, or religious affiliation. By 1951 the sons had raised over half a million dollars and were prepared to construct a hospital. They approached the Baptists, who agreed to build the children’s hospital as part of their development of Baptist Hospital. In 1955, Mr. Wolfson’s dream became a reality. Wolfson provides a wide range of services to children, including but not limited to: two neonatal intensive care units; cardiac catheterization; open heart surgery; bone marrow transplants; and extracorporeal membrane oxygenation, a less complex bypass procedure. There is an emergency department at Wolfson. It receives approximately 60,000 patients per year. Wolfson also operates three satellite emergency departments and has three mobile ICUs (known as “Kids Kare” mobile units). Wolfson’s service area is quite large, comprised of a triangle identified by the vertices of Savannah, Georgia – Dothan, Alabama – and Daytona Beach, Florida. About ninety percent of Wolfson’s patients come from within that area. There is not currently a pediatric trauma center in Jacksonville, which is located in Trauma Service Area (“TSA”) 5. There are five counties in TSA 5: Duval, Baker, Clay, Nassau, and St. Johns. The closest pediatric trauma center to Jacksonville is located in Gainesville, Alachua County, Florida, some 60 miles away. There is a Level II trauma center located at UF Health Jacksonville, but it is not specifically for pediatrics. There are differences in the provision of care to pediatric patients versus adult trauma patients, including specialized equipment, age-appropriate drugs, and modified procedures. Pediatric trauma patients from TSA 5 must be transported to UF Health Jacksonville or Shands in Gainesville. Some of those patients are designated as “trauma alert patients.” Those are individuals identified by emergency medical services as requiring immediate, high-level treatment by skilled professionals. Not all trauma patients are trauma alert patients. Once a pediatric trauma patient has been stabilized at UF Health Jacksonville or Shands, the patient can be transferred to Wolfson for further treatment. Wolfson then undertakes the care needed by the patient. UF Health Jacksonville transfers about 20 to 30 pediatric trauma patients per month to Wolfson. Not all of those patients have previously been deemed trauma alert patients, but Wolfson has extensive experience treating patients with significant needs. It is Wolfson’s desire to operate its own pediatric trauma center, thereby obviating the need for a trauma patient to first go to UF Health Jacksonville or Shands before being transferred. There are times when a delay in transfer can have negative consequences for the patient. The number of such occurrences was not quantified by Wolfson, but Wolfson considers it a significant problem. There is, by rule, a very precise process for a hospital to obtain verification as a trauma center. There are three stages to the process: provisional review, in-depth review, and site visit. Hospitals are given only one opportunity each year to apply for verification. In order to apply, a hospital must file a letter of intent (“LOI”) between September 1 and October 1. On or before October 15, the Department sends an application package to each hospital which had timely submitted an LOI. After receiving the application package, a hospital has until April 1 of the following year to complete and submit the application. DOH must complete its provisional review of the application and notify the applicant, by April 15, of any deficiencies which should be addressed. The hospital then has five business days to submit clarifying or corrective information. In accordance with this process, Wolfson timely filed its application to operate a pediatric trauma center. By rule, the application must contain responses and support relating to nineteen “critical elements” related to trauma care. The Department then reviews the application to make sure that all minimum standards for approval have been met. An applicant is not required to necessarily satisfy each element or subpart of a standard in order for it to be approved by the Department. However, failure to comply with a critical element overall can result in denial of the application. The initial review of an application by the Department is extremely important because, if provisionally approved, the applicant can immediately commence operating as a trauma center. In the present case, Wolfson’s application was reviewed by two persons under contract with the Department: Dr. Robert Reed and Susan Cox, RN. The Department deems each of those persons to be an expert in the field of trauma care based on their background and training. The provisional review by the reviewers was for the purpose of determining whether the application was complete and whether the hospital satisfied the critical elements required for a trauma center. After completion of their initial review, the reviewers sent a letter to Wolfson identifying certain deficiencies they had found in the application. There were a number of deficiencies identified by Dr. Reed and Nurse Cox in Wolfson’s application. However, the most important of those (and the ones at issue in this proceeding) were as follows: Standard II.B.1.b relates to trauma-related continuing medical education (“CME”) requirements for emergency physicians; Standard XVII relates to required multidisciplinary conferences which must be held throughout the year; and Standard XVIII addresses Quality Management a/k/a Quality Improvement (“QI”), also referred to as Performance Improvement. Wolfson was given an opportunity to address each of the stated deficiencies and did, in fact, submit some additional information. Despite the additional information, Wolfson’s application was still deemed insufficient and was denied. The Department now concedes that the CME standard was satisfied in Wolfson’s application. The same is true for the standard relating to multidisciplinary conferences. The QI standard (Standard XVIII), however, remains in dispute. DOH contends that the information submitted by Wolfson in its initial application and deficiency response falls short of proving compliance with this critical element. The QI standard requires a system of procedures and protocols that will promote performance improvement while maintaining patient safety. The goal is to establish processes to ensure a hospital is continually improving the quality of care provided. The subparts of the QI standard require detailed demonstrations of various processes, including: A.2 – A clearly defined performance improvement program for the trauma population; – Review of all trauma patient records from five specified categories; – Monitoring of six indicators relevant to the respective facility (which are in addition to four state-mandated indicators); – Review of cases relevant to the six indicators by the trauma medical director (“TMD”) and trauma program director (“TPD”), to decide whether the cases should be referred to the quality management committee (“QMC”). B.5 – Evaluation by QMC of the effectiveness of action taken to ensure problem resolution; – Preparation and submittal of a quarterly report showing which cases have been selected for corrective action; and – Maintenance of an in-hospital trauma registry with information on patients being treated. The gist of Wolfson’s QI program is set forth on a flow chart contained in the application. That chart is entitled, “Trauma PI Process: Levels of Review.” Though not explained at final hearing, the “PI” in the chart is presumably “Performance Improvement.” The flow chart indicates there to be a primary (daily) review, a secondary (weekly) review, and a tertiary (monthly) review involving certain designated persons. In each of the “boxes” for the respective reviews, there is a stated purpose for the review. For the primary review, the purpose is stated as: Identification of opportunities for Improvement/Validation. The secondary review’s purpose is: Adverse Event/Audit Filter Review. And the purpose of the tertiary review is: Peer Review/Accountability Determination, Loop Closure Plan, Trended Data Review. Phases of care identified in the flow chart are: Pre- hospital, Resuscitation, Inpatient Care Review, and Readmission Review. There is a list of “actions” in the flow chart: Education; Counseling; Trend Report; Guidance/Policy/Protocol Development; and Hospital PI Project. From that list, there is an arrow pointing back toward the primary review box. There is no narrative in the flow chart to explain how the various boxes interconnect or how the information therein ties to the requirements as outlined in the application form. Wolfson asserts that all relevant information is contained in the flow chart, whether in narrative form or not. There is also additional information in the application, attached as a “Scope of Services” addendum, which further elucidates what is found in the flow chart. The Department deems the flow chart and scope of services information insufficient for determining whether the proposal satisfies the critical elements. Wolfson says the flow chart is a “clearly defined performance improvement program.” It is, in fact, only an outline of a clearly defined program. The testimony provided at final hearing by Wolfson’s TPM explained how that outline would work to improve performance. With that explanation, the flow chart/scope of service information minimally satisfies this critical element of the application. Wolfson maintains that the information provided supports the requirement for review of all records from five specified categories, i.e., all trauma alert cases, critical or ICU admissions, operating room admissions for traumatic injury, critical trauma transfers, and in-hospital deaths. Upon review of the flow chart there is insufficient evidence concerning those five areas. However, the scope of information addendum at least minimally refers to those areas as part of the review process. The flow chart/scope of service information addresses the four state-required indicators. The other six indicators required in the application are listed as “to be determined by the [Quality Management] committee.” Wolfson points out that in the minutes from a QMC meeting in February (which was included in the application), nine additional indicators are listed. So, although not easily found, the application does provide sufficient response to the required element. The application is also supposed to identify cases relevant to the six selected indicators in order to determine whether any of those cases should be referred to the QMC. The determination to refer cases is followed up by an evaluation of the effectiveness of actions taken by the committee. The flow chart can be interpreted to address this requirement, but it is fairly nebulous. The scope of services information provides some additional support, but only in general terms. The required quarterly reports are supposed to show which cases have been selected for corrective action by the committee. Wolfson asserts that it cannot submit any such reports until it is operating as a pediatric trauma center, i.e., until it actually has patient cases to report. That position is plausible. The Department did not provide any evidence as to how other applicants satisfied this requirement, so Wolfson’s position cannot be measured against other providers.1/ The same is true as to the requirement for an in- hospital registry of information concerning patients who are being treated. Wolfson has purchased the software needed to commence its registry once patients are being admitted, but it cannot do so at this time, again because it has no such patients. All things considered, Wolfson’s application was not a superlative response to the question of its abilities, but it at least minimally met the requirements for approval of a provisional license. Considering, de novo, all of the evidence concerning Wolfson’s proposed trauma center operations, the application is complete. Wolfson provided extensive testimony and evidence as to the need for a pediatric trauma center in the service area and its willingness and ability to meet that need. There is no doubt that, if approved, the pediatric trauma center would be beneficial to the area. However, need was not an issue in the proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent, Department of Health, enter a Final Order approving the pediatric trauma center application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital. DONE AND ENTERED this 14th day of November, 2017, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN 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 14th day of November, 2017.
The Issue The issue in this case is whether Respondent should be sanctioned for an alleged violation of Chapters 395 and 401, Florida Statutes (1989).
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made. HCA Raulerson is the only hospital in Okeechobee County, Florida. As such, it serves all of Okeechobee County and parts of the surrounding counties. It is a small community hospital that is best characterized as a primary care receiving facility as opposed to a secondary hospital or a tertiary care or trauma center hospital. The Hospital does not provide heart-bypass surgery, cardiac catherization, neuro-surgery services or even obstetrical services (other than the emergency delivery of babies.) The Hospital provided approximately three million dollars in uncompensated care to indigent residents of Okeechobee County in the year preceding the incident involved in this case. Under existing Florida law, a hospital is not required to provide either orthopedic surgery services or peripheral vascular services and there is no requirement for a hospital to have on its medical staff any orthopedic surgeons or peripheral vascular surgeons. The Hospital does not have the angiography equipment necessary for peripheral vascular surgery. As a result, the Hospital does not provide peripheral vascular surgery and there are no vascular surgeons on staff. Such services were not offered at the Hospital for at least several months prior to the incident in question. The Hospital has a single orthopedic surgeon on staff, Dr. Zafar Kureshi. Dr. Kureshi is board certified in orthopedic surgery. He has been engaged in the private practice of medicine in Okeechobee, Florida since October of 1986. While many of Dr. Kureshi's patients are treated at the Hospital, Dr. Kureshi is not employed by or under contract with the Hospital. This arrangement is not unusual since surgeons, including orthopedic and vascular surgeons, do not typically become employees of hospitals or enter into contracts with hospitals. The Hospital has tried to recruit additional orthopedic surgeons and other specialists for its medical staff, but has been unsuccessful. There is a shortage of orthopedic surgeons in Florida, especially in rural areas, and recruiting orthopedic surgeons to such areas is extremely difficult. It is unrealistic to expect that the Hospital would be able to recruit or retain any orthopedic surgeons if it required them to be "on call" at all times. For a short time after he first obtained staff privileges, Dr. Kureshi provided "on call" services for the Hospital's emergency room several nights per month. On those occasions, he treated patients irrespective of their financial status. At the time of the incident in question, however, Dr. Kureshi had ceased providing "on call" services. His decision was consistent with the Hospital medical staff by-laws. The by-laws of the Hospital medical staff state that, if there is only one physician on staff in a specialty, then that specialty does not have to make emergency department call rosters available to the emergency room. Since he was the only specialist on staff in his area of practice, Dr. Kureshi was not required to provide "on call" coverage. Subsequent to the incident involved in this case, Dr. Kureshi, at the request of the Hospital, has voluntarily agreed to be "on-call" several nights per month. Even when Dr. Kureshi is not formally "on call," the emergency room staff often contacts him when a patient presents at the emergency room in need of orthopedic care. On some such occasions, Dr. Kureshi will treat the patient if he was capable of doing so. When an orthopedic patient or a peripheral vascular patient presents at the Hospital and Dr. Kureshi can not or will not treat the patient, the Hospital (1) provides such care as can be rendered by the emergency room physician or others on HCA Raulerson's medical staff, (2) stabilizes the patient for transfer, (3) calls hospitals and their on-call physicians to arrange transfer, and (4) arranges suitable transportation and transfers the patient. In the months preceding the incident in question, the Hospital arranged the transfer to other hospitals of approximately eleven patients who presented at the Hospital's emergency room in need of orthopedic care. Four of those patients were "paying" patients covered by third party insurers, four were covered by Medicare or Medicaid and the remaining three were self-pay patients. There is no indication that financial status and/or the ability to pay in any way influenced the Hospital's actions with respect to these patients. HRS contends that Sections 395.0142, 395.0143 and 401.45, Florida Statutes, require a hospital that provides any given specialty service (e.g., orthopedic surgery services) to arrange 24-hour a day, seven day a week coverage for that service, either by providing coverage through physicians on staff or entering into advance transfer agreements with other hospitals to cover any such patients who may present in need of such services. The Hospital has attempted, but has been unsuccessful in its attempts, to obtain advance transfer agreements from other hospitals regarding the transfer of patients presenting themselves at the Hospital's emergency room in need of orthopedic surgery services or in need of peripheral vascular surgery services. The Hospital has limited bargaining power in attempting to induce other hospitals to enter into an advance transfer agreement. Because the Hospital is a small rural hospital, virtually all the services it offers are already available at the neighboring hospitals which are potential transfer partners. The only advance transfer agreements that the Hospital has been offered would require the Hospital to assume full responsibility for payment for services rendered to transferred patients by the transferee hospital. Those proposals have been rejected because the financial burden of such an arrangement would probably cause the Hospital to close. As of August 24, 1989, the date of the incident which is the subject of the Administrative Complaint in this case, HRS had not notified the Hospital of any rule or policy interpreting Sections 395.0142, 395.0143, and 401.45, Florida Statutes. As of August 24, 1989, HRS had not adopted any rule which stated a specific requirement that hospitals which provide orthopedic surgery must staff or provide on-call orthopedic surgery services on a continuous basis, i.e. twenty-four (24) hours per day, 365 days per year or have in place an agreement with another hospital(s) to provide such coverage. HRS contends that this requirement is imposed by the clear language of the statutes. On the evening of August 24, 1989 at approximately 7:45 p.m., K.H., a 28 year old male, presented himself at the Hospital's emergency room for treatment of a shotgun wound to his lower left leg. Dr. Charles Vasser, the emergency room physician on duty when K.H. arrived, stabilized the Patient and provided all the treatment that could be provided by an emergency room physician not trained in orthopedic surgery or vascular surgery. The radiology report prepared at the Hospital diagnosed the Patient's condition as follows: "focal soft tissue injury, with multiple metallic fragments of variable size, super imposed over soft tissues of distal right leg are noted. Comminuted compound fracture of distal tibial shaft, as well as linear fracture through distal fibula at same site, are observed. Findings are due to gun shot injury with residual bullet fragments within soft tissues. Correlation with patient's clinical findings is recommended." Because of the nature of the injury and the extent of the damage to the soft tissue of the Patient's lower leg, Dr. Vasser and the attending staff were concerned about the possibility of vascular damage. They frequently checked and charted the Patient's distal pulses. While the distal pulses appeared normal, the presence of distal pulses does not rule out vascular injury. A vascular injury is possible with a comminuted fracture even when the distal pedal pulses appear normal. A vascular problem is especially likely when the wound was inflicted by a shotgun blast and numerous metallic fragments are involved. After providing initial emergency room services to the Patient, Dr. Vasser felt that the assistance of appropriate specialists, i.e., an orthopedic surgeon and at least a consult with a vascular surgeon, would be required for further treatment. Dr. Vasser called the only orthopedic surgeon on the Hospital's medical staff, Dr. Zafar Kureshi, at 8:50 p.m. Dr. Kureshi was not on call that evening. Based on Dr. Vasser's description of K.H.'s condition, Dr. Kureshi stated that he was not capable of treating K.H. without the backup availability of a vascular surgeon and advised that K.H. should be transferred. This recommendation was made not only because Dr. Kureshi was not on call, but also because Dr. Kureshi was not capable of treating the Patient at an acceptable level of medical care without the availability of a vascular surgeon. As indicated in Findings of Fact 3 above, there are no vascular surgeons on staff at the Hospital and the Hospital does not offer vascular surgery services. In determining whether a patient needs the services of a physician in a particular specialty, the Hospital relies upon the medical judgment of the attending physician and any consulting physician. The Hospital did not and should not have ignored the medical determination made by the emergency room physician, in consultation with Dr. Kureshi, that the Patient, K.H., needed vascular backup in order to be properly treated. With the assistance of emergency technician Wendy Johns, Dr. Vasser began placing calls to other hospitals and their on-call physicians at 9:15 p.m. in an effort to arrange a transfer of the Patient. The first physician contacted through another hospital, Dr. Floyd, indicated that he would be unable to treat the Patient because of the extent of the soft-tissue injuries and the corresponding likelihood of vascular involvement. A number of additional hospitals and physicians were contacted and they also refused to accept the transfer of the Patient. All told, nineteen different physicians and/or hospitals were contacted between 9:00 p.m. and 12:00 a.m. A variety of reasons were cited by those who refused to accept the transfer. Many of the reasons given for refusing the transfer were arguably a pretext and/or contravened the language and intent of Sections 395.0142, 395.0143 and 395.0144, Florida Statutes. Several of the doctors who were contacted confirmed that the treatment of the Patient would require the availability of a vascular surgeon as well as an orthopedist. After numerous unsuccessful attempts to transfer the Patient, Dr. Vasser contacted a general surgeon on the Hospital's medical staff, Dr. Husain, at approximately 12:10 a.m. Dr. Vasser and Dr. Husain again contacted Dr. Kureshi. The three physicians concurred that they were unable to treat the Patient because of the need for a vascular backup and the Hospital's inability to provide the necessary vascular backup. After he talked to Dr. Kureshi the second time, Dr. Vasser resumed calling other hospitals and their on-call physicians. The next call was to a vascular surgeon, Dr. Viamentes. Dr. Viamentes was reached through his beeper, but was unable to accept the transfer because he was out of town. At approximately 12:30 a.m., a social worker for the Hospital, Terry Cooper, contacted St. Mary's Hospital in West Palm Beach. After some discussion and deliberation, St. Mary's agreed to accept the transfer of K.H. The Patient was transferred in stable condition via ambulance to St. Mary's Hospital where he arrived at approximately 3:00 a.m. Surgery was initiated at approximately 4:30 a.m. After the Patient was admitted to St. Mary's Hospital, the administration of that hospital filed a complaint with HRS pursuant to Section 395.0142, Florida Statutes. That complaint recites the facts surrounding the transfer of the Patient and the refusal of several other hospitals to accept the transfer. It is not clear whether St. Mary's was questioning the medical necessity of the transfer or simply the refusal of the other hospitals to accept the transfer. HRS initiated an investigation of the transfer of the Patient and submitted the Patient's medical records from both HCA Raulerson and St. Mary's to its expert, Dr. Slevenski, for review. Dr. Slevenski is an emergency room physician who has no specialized training in orthopedic surgery or vascular surgery. Dr. Slevenski testified that he saw no evidence in the Hospital's medical records that a vascular evaluation or consultation was necessary to treat this Patient and that the Hospital inappropriately transferred the Patient to another hospital. Dr. Slevenski's opinions are rejected. Dr. Slevenski erroneously assumed that the Hospital had not attempted to contact an orthopedic surgeon regarding the Patient. In fact, the Hospital contacted Dr. Kureshi, the only orthopedic surgeon on its staff, who indicated he was not qualified to treat the Patient's injury. The evidence established that both the emergency room physician and the orthopedic surgeon who was contacted at home felt that a vascular consult was necessary. These opinions were reasonable under the circumstances. The testimony of Dr. Henderson, the Respondent's expert, is accepted and confirms that the opinions of the emergency room physician and the orthopedic surgeon were reasonable under the circumstances and given the nature of the Patient's injury. There is no evidence that the Patient's care was deficient in any respect at either St. Mary's or the Hospital. The Patient progressed normally and a good result was achieved. In sum, the evidence established that the Hospital secured appropriate treatment for K.H. by providing an on-site emergency room physician and supporting staff who (1) provided immediate emergency care and stabilized the patient for transfer, (2) confirmed with the orthopedic surgeon on the Hospital's medical staff that a transfer was medically necessary, (3) called hospitals and their on-call physicians to arrange the transfer, and (4) arranged suitable transportation and transfer of the patient. The Hospital provided all the care that it could within its service capability. In view of his injury, the Patient's best interests were served by transferring him rather than treating him at the Hospital. The evidence did not establish whether K.H. was a paying or nonpaying patient. The evidence did establish that the decision to transfer K.H. was not based on his financial status.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered which dismisses the Administrative Complaint filed against HCA Raulerson Hospital. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 17th day of January, 1991. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of January, 1991.
The Issue The issue in this case is whether the application filed with the Department of Health (“Department”) on March 31, 2017, by Galencare Inc., d/b/a Northside Hospital (“Northside”), to operate as a provisional Level II trauma center met the applicable criteria and standards under Part II, Chapter 395, Florida Statutes (2017),1/ and Florida Administrative Code Chapter 64J-2.
Findings Of Fact Parties The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes. The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has a primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001 and 395.40(3), Fla. Stat. Northside is a 288-bed acute-care hospital located in TSA 9, Pinellas County, Florida. Northside provides a wide range of services, including inpatient cardiovascular and neuroscience services. Northside has developed a trauma program and submitted an application to operate as a provisional Level II trauma center in March 2017. The Department’s preliminary determination to deny Northside’s application on May 1, 2017, is the subject of this proceeding. Bayfront is an acute-care hospital located in TSA 9, Pinellas County, Florida. Bayfront has been designated by the Department as a Level II trauma center. Northside’s Trauma Center Application Northside Submitted a Timely Letter of Intent In the summer of 2016, Northside received a letter from the Department notifying Northside of the opportunity to submit a letter of intent to become a trauma center. Northside timely submitted a letter of intent with the Department in September 2016. This letter indicated that Northside would seek approval from the Department to operate as a Level II trauma center. Northside was well-situated for a trauma center because of the resources and services already in place at the hospital. Moreover, Northside was prepared to open a trauma program because it already had extensive experience treating critically ill patients. After Northside submitted its letter of intent, the Department responded by sending Northside a notice accepting its letter of intent and providing information on the application process. The notice directed Northside to the Department’s trauma center application and contained instructions for the completion and submission of the application. Northside Established a Full Trauma Program after the Department Accepted its Letter of Intent Once Northside received the Department’s notice confirming acceptance of its letter of intent, it began making significant investments of resources and capital to develop its trauma program. It did so to ensure that its forthcoming application was compliant with the requirements set forth in DOH Pamphlet (DHP) 150-9 (the “Trauma Standards” or “DHP”), which is incorporated by reference in rule 64J-2.011. As part of the development of its trauma program, Northside hired Doreen Gilligan in October 2016 to serve as director of Trauma Services. The hospital also worked with Angie Chisolm to draw on resources from other approved trauma centers, such as trauma-related policies and procedures and best practices for trauma center operations. Northside’s expertise in advanced, life-saving care, including cardiovascular and neuroscience programs and its intensive care unit (“ICU”), made it a well-qualified candidate to open a new trauma center. Between October 1, 2016, and April 1, 2017, Northside invested over $4 million to develop its trauma program. Northside invested $2.5 million in physical plant improvements and equipment. These improvements included: A helipad, which is properly licensed by the Department of Transportation and FAA. The helipad is operational and Northside is already receiving patients from helicopters on a daily basis in its capacity as an acute- care hospital. Two state-of-the-art trauma resuscitation bays in the emergency department (“ED”) that are in immediate proximity to the helipad. These new trauma bays can accommodate up to four trauma patients at the same time. The expansion of the ICU to include 12 beds that are specifically designated for trauma patients. The expansion of one of the operating rooms because trauma patients often require care from multiple doctors simultaneously. The purchase of new equipment, including new ICU monitors, operating room equipment, and equipment to support physician subspecialists. The purchase of a blood track machine for the emergency department. This machine dramatically reduces the amount of time it takes for patients to receive blood transfusions. The purchase of a platelet function testing machine and a thromboelastography machine. These machines help identify where a trauma patient is bleeding. These machines also play a critical role in quickly stopping bleeding – one of the key functions that every trauma center must perform. The purchase of a second computed tomography (“CT”) machine dedicated solely to the provision of radiology services needed by trauma patients. Northside invested approximately $1.7 million in physician and staff employment and recruitment. This investment has enabled Northside to do the following: Provide continuous, around-the-clock trauma surgeon coverage, 7 days a week (beginning February 16, 2017). Provide continuous, around-the-clock anesthesiology coverage. Provide hospital coverage for the required 19 physician sub-specialty groups. These physicians are able to arrive at the hospital within 30 minutes or less. Hire more than 30 additional full-time nurses to meet the staffing requirements in the Trauma Standards. These hires have allowed Northside to provide a continuous, in-house presence of operating room nurses and technicians. Hire specialized administrative staff for the trauma program, including Doreen Gilligan (Director of Trauma Services), a trauma registrar, and a performance improvement coordinator dedicated solely to ensuring Northside’s trauma patients receive high quality care. Once Northside’s trauma program becomes operational, Northside plans to hire a second trauma performance improvement coordinator. Between January and March 2017, Northside provided over 5,000 hours of trauma training to its staff, including the CEO and CFO of the hospital. The major focus of this training was the Trauma Nursing Core Course (“TNCC”) for nursing staff, which is the foundation of emergency nursing education and ensures that the nursing staff can provide high-quality care for the most severely injured patients. The hospital implemented nursing education requirements which exceeded the Trauma Standards. Some of this training included actual operational practice using simulations and mock trauma drills. Northside implemented over 200 new facility policies related to trauma during this period. Northside subsequently trained its staff on these new programs. Northside made all of these investments prior to March 31, 2017, the date on which Northside submitted its application to the Department. Northside Timely Assembled and Submitted Its Trauma Center Application and Deficiency Response to the Department Northside’s application was prepared by a core team whose mission was to ensure that the application fully complied with the Trauma Standards. The key members of that team were Peter Kennedy, chief operating officer; Doreen Gilligan, director of Trauma Services; Dr. Erik Barquist, interim trauma medical director; and Angie Chisolm, assistant vice president of Trauma Services for HCA East and West Florida Divisions. The final application submitted to the Department encompassed over 10,000 pages of information. Because the application was too voluminous for any one person to prepare alone, each of the team members played an important role in ensuring the application addressed each Trauma Standard. Preparation of the application involved thousands of staff hours and required close cooperation with the physicians, staff, and community members. Northside timely submitted its trauma center application (“Northside Application”) to the Department on March 31, 2017. After receiving the Northside Application, the Department arranged for it to be reviewed by two outside experts, Dr. Lawrence Reed and Nurse Susan Cox. Both Dr. Reed and Nurse Cox have reviewed trauma applications on behalf of the Department in the past. On April 14, 2017, the Department sent Northside a letter notifying it of the deficiencies that Dr. Reed and Nurse Cox had identified (the “Deficiency Notice”). The Department provided a checklist (Department of Health Initial Provisional Review Checklist for Northside, April 5, 2017, hereafter referred to as the “Initial Checklist”) based on the Trauma Standards with boxes marked “Yes” or “No” to indicate whether the reviewers found evidence to demonstrate that each particular Trauma Standard and subpart was met. The checklist also contained written comments from the reviewers for subparts which were checked “No.” Of the more than 350 subparts that make up the Trauma Standards, the reviewers only identified 35 about which they had concerns or additional questions. Most of the comments from the reviewers consisted of simple requests for clarification. In some cases, the reviewers asked for information that Northside had already submitted with the initial application on March 31, 2017. Northside timely responded to each deficiency identified by the Department on April 21, 2017 (the “Deficiency Response”), five business days after receipt of the Deficiency Notice. The Deficiency Response was prepared by the same team that prepared the initial application. Much like the initial application, the team’s role was to ensure that each concern was addressed and that the application demonstrated that the hospital met the Trauma Standards. The Deficiency Response included 78 supporting exhibits consisting of hundreds of pages. The Deficiency Response was divided in two sections: (1) a narrative table; and (2) supporting exhibits to the narrative table. In the narrative table, Northside addressed each Trauma Standard subpart identified in the Initial Checklist as an area not met or an area of concern. The table was organized into three columns: the first reciting the subpart language; the second copying the reviewer concern from the Initial Checklist; and the third detailing Northside’s narrative response or explanation to each comment. The Deficiency Response was also reviewed by Dr. Reed and Nurse Cox. These reviewers determined that Northside addressed and corrected the vast majority of deficiencies identified in the initial review. Only three Trauma Standard subparts were identified as remaining areas of concern: Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G). Each of these issues was identified by Dr. Reed. Neither Dr. Reed nor Nurse Cox recommended to the Department that Northside’s application be denied. On May 1, 2017, the Department informed Northside that its application was not in compliance with the applicable Trauma Standards and would be denied (“Denial Letter”). The Denial Letter did not identify which (if any) of the Standards that the Department believed that Northside had not met. Instead, the Denial Letter attached a checklist indicating concerns with only three subparts. The Department now takes the position that Northside’s application is deficient because it did not satisfy Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G), although the Department has not stated whether each one of these Standards, standing alone, would have (in its view) warranted denial of the application. The Denial Letter did not afford Northside any opportunity to address the potential issues identified with respect to the three Standards. Instead, it informed Northside that its only options were to seek an administrative hearing challenging the Department’s denial or to submit a trauma center application the following year. Northside therefore did not submit any additional documentation to the Department. Northside’s Evidence Establishes That It Satisfied Each of the Three Standards the Department Claimed Were Deficient Standard V(B)(3)(a)(1) Standard V addresses the facility requirements relating to the emergency department. It includes requirements for a trauma resuscitation area, helipad, emergency physicians, support staff, and trauma flow sheet, among other criteria. This Standard also details the required qualifications for emergency room physicians who may provide care to trauma patients. Emergency room physicians must be board certified in emergency medicine or meet stringent alternate criteria demonstrating their qualifications. There are two ways to meet the alternate criteria. The first includes attestation from the trauma medical director that there is a critical need for the physician, completion of an accredited residency training program, documentation that the physician participated in the Advanced Trauma Life Support (“ATLS”) program, 48 hours of trauma-related continuing medical education in the past three years, evidence that the physician attends at least 50 percent of the trauma performance improvement meetings, evidence of membership or attendance at regional or national trauma meetings during the past three years, and attestation by the trauma medical director and emergency department director that the physician compares favorably with other physicians on the trauma call schedule. The second way for a physician to meet the alternate criteria is by providing evidence of board certification in a primary care specialty and attestation by the emergency department director that the physician has worked as a full-time emergency physician for three of the last five years. As part of its initial application, Northside provided the Department with staffing schedules for March, April, and May 2017, which documented the physicians on staff in the emergency room during those months and the shift times they would cover. Northside also submitted substantial evidence regarding the qualifications of each of these emergency room physicians. One of these emergency room physicians was Dr. Abraham Wilks. At the time it submitted its initial application, Northside believed Dr. Wilks met both paths of the alternate criteria. In preparation for the initial application, Dr. Wilks, working with Northside, went to extraordinary lengths to secure the seven required components under the first alternate criteria path. Northside also provided evidence that Dr. Wilks qualified under the second alternate criteria path since he was board eligible for family medicine and had been working as an emergency physician for the past five years. The staffing schedules submitted with Northside’s application on March 31, 2017, showed that Dr. Wilks was scheduled to be the sole physician provider for short periods of time on a limited number of days. During his review of the initial application, Dr. Reed concluded that Dr. Wilks did not meet either of the alternative criteria because he did not complete an emergency medicine residency and was no longer board-certified in family medicine. Because Dr. Wilks did not meet these qualification requirements in Standard V(B)(3) as an emergency department physician, he could not be the sole physician provider in the emergency department. After receiving the Deficiency Notice and Initial Checklist, Northside immediately took steps to address Dr. Reed’s comments. Northside’s leadership worked with the director of the emergency department to ensure that Dr. Wilks would not be the sole physician provider in the emergency room. After April 18, 2017, Dr. Wilks never served as the sole physician provider in the emergency room. The emergency department physician staffing schedule for April and May 2017, was updated to reflect these changes (“Updated Staffing Schedule”). The other physicians listed on the staffing schedule were appropriately qualified, and the staffing schedule provided for appropriate physician coverage. In its Deficiency Response, Northside noted these operational changes regarding Dr. Wilks and specifically addressed Dr. Reed’s concerns. Northside informed the Department that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately.” Dr. Reed agreed at his deposition that if Dr. Wilks were removed from the staffing schedule, Northside would be in compliance with Standard V(B)(3)(a)(1). The Deficiency Response also referenced a related exhibit, which Northside intended to be the amended staffing schedule. However, due to a clerical error, Northside’s Deficiency Response included the old staffing schedule from the initial application, which incorrectly showed Dr. Wilks as the sole provider for limited periods. The old staffing schedule contradicted the narrative explanation of Northside’s operational changes included in the Deficiency Response and was clearly submitted in error. Dr. Reed himself noted this contradiction: The response document also states that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately. However, it appears that Dr. Wilks is the only ED physician on site from 6a-8a on May 4, May 7, May 20, and May 21. Please clarify this contradiction.” The Department did not follow Dr. Reed’s recommendation. It never contacted Northside to ask why the staffing schedule listed Dr. Wilks as the sole provider for limited periods of time when Northside’s submission expressly stated that Dr. Wilks would no longer be the sole provider. Had the Department contacted Northside, it would have learned that the “old” staffing schedule had been submitted rather than the current and correct staffing schedule, i.e., the one that did not include Dr. Wilks as the sole provider. Thus, there can be no dispute that, as of April 18, 2017, (1) Northside’s operative emergency department staffing schedule was updated to reflect that Dr. Wilks would never be the sole provider; and (2) at all times, Northside’s emergency department was fully staffed by properly qualified emergency department physicians. Under these circumstances, the Department erred in taking the position that Northside did not satisfy Standard V(B)(3)(a)(1) simply because it mistakenly submitted an outdated staffing schedule to the Department in conjunction with its clear narrative explanation. Standard V(B)(3)(d) The physician qualifications included in Standard V also require that each physician maintain a current ATLS provider certification. The ATLS certification is required only of emergency department physicians and trauma surgeons because these are the physicians who treat trauma patients when they first arrive at the trauma center. One of the emergency department physicians included in Northside’s application is Dr. Joseph Nelson. Dr. Nelson also serves as the emergency department’s pre-hospital trauma care expert for the Committee of Emergency Preparedness and Readiness, meaning that he is the state’s expert on issues relating to the emergency care provided on-site before patients are brought to the hospital. Northside’s application included an extensive set of documents that established Dr. Nelson’s credentials, including the following: a compilation of Dr. Nelson’s certifications, proof of his osteopathic board certification, his Florida Department of Health medical license, his physician profile with the American Medical Association, proof of his continuing medical education hours, his letter of privileges at Northside, and his most recent ATLS certificate. Dr. Nelson’s ATLS certificate included a letter from ATLS that recognized Dr. Nelson for high scores on his written and practical tests and recommended that he apply to be an ATLS course instructor, an honor that is accorded only to doctors who attain the best performances at the training course. At the time Northside submitted its initial application, Dr. Nelson’s ATLS certification had recently expired and he was planning to take a course to renew his certification. Dr. Nelson was aware of the expiration before the submission and made a concerted effort to complete the course in advance by registering for a course in February 2017. However, the course Dr. Nelson was originally scheduled to take in February 2017 was cancelled due to a snowstorm. Because ATLS courses are in high demand and often full, Dr. Nelson was not able to immediately reschedule for a course in his region. After working with Northside and Angie Chisolm, he registered for another course to be held in Tallahassee on April 23, 2017. Northside included proof of his course registration with its initial application. In the Deficiency Notice and Initial Checklist provided by the Department, Dr. Reed noted that Dr. Nelson’s ATLS certificate had expired and acknowledged that he was scheduled to take his ATLS course on April 23, 2017. Dr. Reed asked the hospital to “provide evidence of successful completion of the ATLS course he is scheduled to take on 4/23/2017.” Dr. Reed did not ask the hospital to submit any further documentation before the certificate arrived. On multiple occasions, Northside sought clarification from the Department regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). Before Northside submitted its initial application to the Department, it informed the Department that Dr. Nelson was registered for and planned to take the ATLS course on April 23, 2017, and asked for guidance regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). The Department advised Northside to provide proof of registration with its initial application, and Northside did just that. Northside returned to the Department for guidance after receiving the Deficiency Notice and reminded the Department that Dr. Nelson planned to complete the ATLS course on April 23, 2017. Once again, the Department directed Northside to submit documentation of course registration and to later submit Dr. Nelson’s updated ATLS certificate when available. In its Deficiency Response, Northside reiterated that Dr. Nelson was registered for and scheduled to complete the ATLS certification course on April 23, 2017, just two days later. Based on the Department’s guidance, Northside also included Dr. Nelson’s ATLS course registration, which demonstrated that he was scheduled to take the course in Tallahassee on April 23, 2017, as well as email communication from the course host confirming that Dr. Nelson paid for and secured a seat at that course. Northside further indicated that it would provide evidence to the Department of Dr. Nelson’s ATLS recertification following successful completion of the course. Northside also informed the Department that if Dr. Nelson did not attend and pass the course on April 23, 2017, he would be removed from the call schedule effective May 1, 2017. Dr. Nelson successfully completed the course on April 23, 2017, and thus satisfied his ATLS requirement that day. Northside immediately confirmed with the ATLS coordinator that Dr. Nelson had passed the course and concluded that he was in compliance with Standard V(B)(3)(d). Dr. Reed’s review of Northside’s Deficiency Response stated: “Upon receipt of a copy of Dr. Nelson’s updated ATLS certification, compliance with this standard will have been met.” Northside subsequently received Dr. Nelson’s updated ATLS certification. It did not arrive at Northside until after May 1, 2017, due to normal delays in processing by the American College of Surgeons. At hearing, Northside presented Dr. Nelson’s updated ATLS certification reflecting his successful completion on April 23, 2017. In sum, Dr. Nelson was ATLS-certified as of April 23, 2017, which is before the Department’s May 1, 2017, deadline. Northside also provided a litany of information to the Department with its initial application and Deficiency Response detailing Dr. Nelson’s efforts to secure his ATLS certification. Northside therefore satisfied Standard V(B)(3)(d). Standard XVIII(G) Standard XVIII addresses quality management, which is one of the core requirements of a trauma program. Since the time that Northside began building its trauma program, it has prioritized quality management. Northside began developing its trauma quality management program in early December 2016. As part of this effort, Northside developed a trauma quality management plan, which is essential for any quality management program. Following the beginning of limited trauma-related operations on February 16, 2017, Northside held its first peer review meeting on February 22, 2017, to discuss patient treatment issues. Dr. Barquist attended these meetings and minutes were kept. Northside also began to hold nursing and ancillary staff meetings, known as trauma quality management (“TQM”) meetings, during this time. The directors of each department at the hospital attended these meetings, as well as the chief operating officer and chief financial officer. The objective of these meetings was to operationalize the more than 200 trauma-specific policies and procedures put in place during the trauma program development. Any issues identified in these meetings were addressed immediately with the whole trauma staff to ensure program-wide compliance. To demonstrate compliance with this Standard, Northside submitted nearly 400 pages of documents with its initial application. These included Northside’s Trauma Performance Improvement and Patient Safety Plan, policies and procedures, and peer review minutes. As part of its application, Northside submitted the minutes of its peer review meetings at which quality management issues were discussed. Even though Northside was not receiving trauma alert patients from local emergency medical services (something it could not do prior to becoming a provisionally approved trauma center), it routinely conducted quality management activities with regard to patients in the hospital with trauma injuries. With this patient population, Northside employed its trauma improvement processes to identify areas in which there was room for improvement in care, and to determine how education, training, and equipment could be enhanced to improve care for similar patients in the future. In his review of Standard XVIII(F), Dr. Reed affirmed that Northside held quality management meetings at which the following issues were discussed: The subject matter discussed, including an analysis of all issues related to each case referred by the trauma service medical director to the trauma program manager, cases involving morbidity or mortality determining whether they were disease related or provider related and the preventability, and cases with other quality of care concerns. A summary of cases with variations not referred to the committee. A description of committee discussion of cases not requiring action, with an explanation or each decision. Any action taken to resolve problems or improve patient care and outcomes. Evidence that the committee evaluated the effectiveness of any action taken to resolve programs or improve patient care and outcomes. Northside also submitted documents addressing Standard XVIII(G). This subpart addresses a quarterly report prepared by the trauma quality management committee which must be submitted to the Department by approved trauma centers 15 days after the end of each quarter. If approved as a provisional trauma center, Northside would have submitted its first quality report to the Department on August 15, 2017. The report, which is only submitted by provisionally approved and verified trauma centers, must include information related to patient case reviews, select clinical indicators, and patient complications. The report is only made available by the Department to approved trauma centers; it is not provided to applicants. The report form is not referenced in any Department rule, the Trauma Standards, or the Department’s website. However, to establish that Northside was prepared to provide the required report once it received provisional approval, Northside obtained a copy of the template from an affiliated operating trauma center and included that template in its application. Because it was not an approved trauma center, Northside ultimately submitted a detailed template of the quality report to be submitted following approval as required. The detailed template included blank fields with the quality indicators selected by the Department and the hospital, benchmarking data points, patient complications, and case review information. The fields in the report regarding patient complications and case review information can be taken directly from the peer review minutes, which Northside submitted with its initial application and were located directly in front of its detailed template. In his review of Northside’s initial application, Dr. Reed concluded that Northside provided much of the required evidence, demonstrating “an active and effective trauma quality improvement program” and met the vast majority of subparts in this Standard. However, regarding Standard XVIII(G), Dr. Reed identified deficiencies on the basis that “[a] template of a report was submitted, but there were no cases recorded.” Dr. Reed confirmed that he reviewed the peer review minutes Northside submitted with its application. In response to Dr. Reed’s comment, Northside submitted updated templates with additional information. The quality indicator and benchmarking templates were populated with data from its trauma registry regarding the patients with traumatic injuries that the hospital had treated since February 16, 2017. In addition to these documents, which specifically addressed Standard XVIII(G), Northside also submitted more peer review minutes from subsequent meetings since the initial application, which were included directly in front of Exhibit 75. Dr. Reed ultimately concluded that Northside had not demonstrated compliance with Standard XVIII(G)(1)-(3). That conclusion, however, is unsupportable by the evidence at hearing. Dr. Reed acknowledged that Northside’s Deficiency Response provided the “quarterly data regarding the state required indicators and the additional institution-specific indicators.” The only reason he believed that Northside’s application remained deficient was that it did not “address the individual case quality review issues required in Standard XVIII.G.1-3.” This conclusion is undermined by Dr. Reed’s recognition-–as reflected in his review of Standard XVIII(F)-–that Northside was conducting case quality reviews. In his deposition, Dr. Reed agreed that Northside’s Deficiency Response “did include information regarding the number of cases and indicators and that sort of thing.” Indeed, Dr. Reed’s true concern appears to have been that Northside’s “numbers,” i.e., the number of patient cases reviewed by Northside, were “still kind of thin.” But Dr. Reed himself recognized that prior to the time that a trauma center application is provisionally approved and the trauma program begins treating trauma alert patients, a trauma program is unlikely to have a large number of patient cases to review. The Department’s view that Northside did not satisfy Standard XVIII(G) is not supported by the evidence. The section of the quality report addressing individual case reviews is simply a summary of the information contained in the hospital’s peer review minutes-–and Northside conducted the required peer review meetings. Northside demonstrated at hearing that it was capable of preparing a table summarizing its peer review cases and the corrective action taken for each case. All the information contained in the completed table was taken verbatim from the peer review minutes that Northside submitted with its initial application and Deficiency Response. If approved, Northside was prepared to submit the quarterly report as required on August 15, 2017. Thus, at worst, Northside did not copy and paste information from one place to another. To the extent possible, Northside complied with this Standard. The Department’s review of an earlier trauma center application confirms that the Department should not have determined that Northside did not satisfy Standard XVIII(G). In April 2016, the Department approved an application to operate as a provisional Level II trauma center submitted by Jackson South Community Hospital. As part of its approval, the Department-- based on a review by Dr. Reed--determined that Jackson South met each of the requirements in Standard XVIII(G). However, Jackson South only submitted hospital policies, promising to prepare and submit the required quality report if approved. Jackson South did not submit any quality report or even a template of such a report. Despite submitting far less evidence demonstrating compliance, Dr. Reed did not note any deficiencies for this Standard with regard to Jackson South’s application. The Department ultimately approved the application. Dr. Reed confirmed that Northside’s quality management program was significantly more developed than the one for Jackson South Community Hospital that Dr. Reed himself had recommended be approved only two years earlier. At hearing, Chief Dick could not explain the inconsistency. In sum, the Department erred in concluding that Northside had not satisfied Standard XVIII(G) because Northside had an active and effective quality management program that involved thorough case reviews and Northside demonstrated that it was capable of submitting the required forms once its program was approved and its fully operational. Contemporaneous Emails Demonstrate That the Department Denied Northside’s Application for Reasons Having Nothing to Do with the Merits of Northside’s Program The Department’s decision to deny Northside’s application was not made in a vacuum. On April 28, 2017-–only two days before the Department sent Northside the Denial Letter-– a circuit judge in Leon County entered an order (“Injunction Order”) temporarily enjoining Northside from operating as a trauma center and enjoining the Department from permitting Northside to operate as a provisional trauma center. This injunction was based exclusively on issues of administrative law and did not in any manner address the merits of Northside’s application. In fact, the Department strongly opposed the injunction. The injunction did not prevent the Department from approving Northside’s application. The Department’s internal correspondence demonstrates that the injunction led the Department to deny Northside’s application, presumably because it was concerned about the ramifications of provisionally approving Northside’s application while the injunction was pending and Northside could not begin trauma center operations. On April 28, 2017, just hours before the Injunction Order was issued, Kate Kocevar, head of the Department’s Trauma Section, emailed Dr. Reed’s final conclusions to Chief Dick and informed her that in her opinion “Northside Hospital appears to have passed the reviewers [sic] survey and will be granted Provisional status.” Chief Dick confirmed at hearing that her initial impression based on Ms. Kocevar’s email was that Northside passed the survey. Later that day, Chief Dick received the injunction order and immediately emailed other Department personnel, “[l]ooks like the letter to Northside will not be going out on Monday as originally written.” Three days later, on May 1, 2017, the Department sent Northside the Denial Letter, notifying the hospital that its application had not met the Trauma Standards and would be denied. Given the looming injunction order, the Department’s internal correspondence, and the fact that the three alleged deficiencies are minor, at the very most, the Department’s decision to deny the application was apparently motivated by an administrative decision that it should not approve an application while the injunction was in place-–not by any genuine concerns regarding the merits of Northside’s program. Northside Has Expended, and Continues to Expend, Millions of Dollars to Maintain an Operational Trauma Program Northside has continued to maintain its trauma service capability, including retaining physicians and staff, while proceeding with its challenge of the Department’s preliminary denial. As part of its readiness efforts, Northside’s quality management program remains in place, meaning that Northside is still holding peer review and quality improvement meetings. Maintaining a continued state of readiness to initiate operations as a provisional Level II trauma center will cost Northside approximately $13 million this year.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department enter a final order finding that Northside met its burden of establishing that its trauma center application met the applicable standards, and awarding provisional Level II status to the applicant. DONE AND ENTERED this 20th day of December, 2017, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2017.
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.
