The Issue Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes (2016).1/
Findings Of Fact Background on Trauma Centers A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ” § 395.4001(14), Fla. Stat. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat. (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/ In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital. The Parties The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”); § 395.402(2), Fla. Stat. (mandating that “[t]he department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”). Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”). Those rules (see, e.g., rule 64J-2.010) determine how many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida. See § 395.402(4), Fla. Stat. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below. The Statutory Scheme Governing Trauma Centers As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”). The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.” § 395.402(4)(b), Fla. Stat. However, there is a state-wide, statutory cap of 44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”). Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.”). By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”). “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has: the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat. (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.”). (emphasis added). The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants. Assessment of Need for Trauma Centers under the Current Rules The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department to “[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system.”); § 395.402(3), Fla. Stat. (mandating that the Department must consider the following during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; medically appropriate ground and air travel times; recommendations of the Regional Domestic Security Task Force; the actual number of trauma victims currently being served by each trauma center; and other appropriate criteria). As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”). The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”). With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J- 2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population; median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals; (e) Level I trauma centers; and (f) number of severely injured patients. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or 8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points. In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that: The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers. The Department Changes Its Interpretation of “Need” In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular TSA. In 2015, Orange Park submitted another letter of intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order Jan. 27, 2017). Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a particular TSA. Assessment of Need under the Proposed Rules During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department): [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than 10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added). The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.” As a result, there would no longer be TSA-specific caps in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7): The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows: A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA, the Department could conceivably approve every applicant in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of 44 would be met or exceeded and another TSA lacked the statutory minimum of one: Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but there is still not one in Collier County, how does it work at that point as a potential new applicant comes in? A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are 43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe. Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then? A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule: Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical? ALJ: We are still talking about the [Current Rules]? Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you. A: I understand what you are saying. Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number? A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do. Q: Correct. There’s no criteria or standards? A: No, those procedures are not outlined in the rule, no. Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring? A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need, we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum. Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County? A: No. Q: There’s nothing in [the Proposed Rules] that says that? A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances. * * * Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards? A: And have the endorsement of the regional trauma agency, yes. The Potential Utility Associated with Adopting the Proposed Rules All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life: I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.” Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/ Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients: If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma. We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas. The idea of the general surgeon is going away. The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this. The – what I call the voyeur, you bring in a general surgeon to do some trauma because we don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem. If the doctor doesn’t know how to treat the patient, then the patient suffers. And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise. * * * We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise. And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock. There’s this whole sequence of events that takes place. Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/ In addition, an increase in trauma centers would make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site. Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff: But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point: Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences? A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s adding new programs where there’s already a pretty good network of care provided. * * * My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas. This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/ The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.
The Issue Whether Florida Administrative Code Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Bayfront is a 480-bed tertiary hospital located in St. Petersburg, Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. Bayfront had a $3.6 million operating deficit in 2009 and a positive operating margin below one percent ($1.969 million) in 2010. Due to its financial strife in recent years, Bayfront has been forced to defer needed capital projects due to a poor liquidity position, inadequate borrowing capacity and insufficient cash flow. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. TGH also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). TGH is located in Tampa, Hillsborough County, Florida. Like Bayfront, TGH has also experienced significant financial challenges in recent years. For fiscal year 2011, TGH's budget reflected only a $7 million (one percent) operating margin. However, due to subsequent events, including Medicaid cuts and flat utilization year-to-date, TGH now expects to do no better than break-even, and may even incur a $4 million operating loss in FY 2011. This is significant because TGH has reached its borrowing capacity and must rely on its operating margin to build cash that will be used to fund needed capital projects and expenditures. Maintaining a positive and substantial operating margin is therefore critical to TGH's ability to replace equipment and infrastructure. St. Joseph's Hospital has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. SJH offers a broad array of acute care services, including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. SJH operates a Level II trauma center, and in 2010, treated approximately 2,700 trauma patients. SJH also has one of the busiest emergency departments in the state, with approximately 145,000 patient visits in 2010. Shands Jacksonville is an existing Level I trauma center. It is one of only seven such Level I providers in the state of Florida. Located in Jacksonville (Duval County), Shands treats approximately 4,000 trauma victims every year. Respondent Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Intervenor Bayonet Point is a general acute-care hospital located in Pasco County, Florida. Bayonet Point is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Bayonet Point's application for designation as a trauma center was not complete and Bayonet Point was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete. Intervenor Blake Medical Center is a general acute care hospital located in Manatee County, Florida. Blake is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Blake's application for designation as a trauma center was not complete and Blake was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete. Although not a party to this case, HCA/Orange Park Medical Center ("Orange Park") is also currently in the process of applying for trauma center designation. Orange Park is located in Clay County, immediately to the south of Duval County. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to "undertake the implementation of a statewide inclusive trauma system as funding is available." § 395.40(3), Fla. Stat. The statewide trauma network includes not just verified trauma centers, but all other acute care hospitals in the State, as well as ground and air emergency medical services providers, and "every health care provider or facility with resources to care for the injured trauma victim." § 395.40(2), Fla. Stat. The network is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of 9 or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." Because of the necessity for rapid transport, key components of the trauma network are ground and air EMS transportation. It is important to get the trauma victim to the nearest trauma center as rapidly as possible, because "you can't do surgery in the back of an ambulance." Each EMS provider operates pursuant to Uniform Trauma Transport Protocols and inter-facility guidelines which give guidance for how, where and when trauma patients should be transported. Trauma centers are required to have numerous different kinds of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have "a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned." Further, in addition to having at least one "neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center," a Level I provider must also have surgeons "available to arrive promptly at the trauma center" in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Not surprisingly, it is a constant struggle for existing trauma centers to ensure the availability of qualified clinical staff, technicians, specialty physicians and other personnel and resources necessary to continually meet the rigorous programmatic requirements of a trauma center. In general, trauma centers are not profitable due to the intensity of resources necessary to achieve an appropriately functioning trauma program, and the scarcity of such resources. The Challenged Rule In 1992, the Department of Health and Rehabilitative Services ("HRS") adopted Florida Administrative Code Rule 64J- 2.010, (the "Rule"). Respondent Department of Health assumed administration of the Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Rule is a statement of need, sometimes referred to as "open slots" for a specific number of trauma centers allocated among 19 geographic service areas ("trauma service areas" or "TSAs") in the state. The current version1/ of rule 64J-2.010, the subject of this rule challenge, reads in its entirety as follows: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA). The number and composition of TSAs shall be in accordance with section 395.402, F.S. The number of trauma centers in each TSA shall be in accordance with the maximum number set forth in the table below. Each trauma service area shall have at least one Level I or Level II trauma center position. The number of trauma center positions for each TSA is as follows: TSA Counties Trauma Centers 1 Escambia; Okaloosa; Santa 2 Rosa; Walton 2 Bay; Gulf; Holmes; Washington 1 3 Calhoun; Franklin; Gadsden; 1 Jackson; Jefferson; Leon; Liberty; Madison; Taylor; Wakulla 4 Alachua; Bradford; Columbia; 2 Dixie; Gilchrist; Hamilton; Lafayette; Levy; Putnam; Suwannee; Union 5 Baker; Clay; Duval; Nassau; St. 2 Johns 6 Citrus; Hernando; Marion 1 7 Flagler; Volusia 2 8 Lake; Orange; Osceola; 3 Seminole; Sumter 9 Pasco; Pinellas 3 10 Hillsborough 2 11 Hardee; Highlands; Polk 3 12 Brevard; Indian River 2 13 DeSoto; Manatee; Sarasota 3 14 Martin; Okeechobee; St. Lucie 1 15 Charlotte; Glades; Hendry; Lee 2 16 Palm Beach 2 17 Collier 1 18 Broward 3 19 Dade; Monroe 6 TOTAL 42 The trauma center will be assigned by the department according to section 395.402(4), F.S. Specific Authority 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.405 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18-06, Formerly 64E-2.022. A hospital seeking to establish a new trauma center must file an application with the Department. If a TSA has fewer trauma centers than the number allocated to the TSA in the Rule, the Department deems need to exist without reference to any additional analysis or data. Accordingly, if a hospital's application to establish a new trauma center complies with trauma center programmatic requirements, the Department will approve the application. As will be discussed in greater detail infra, the Department believes it is bound by the determination of need set forth in the Rule and that it does not have authority to deny an application that meets programmatic requirements so long as there is an "open slot" for a new trauma center within a particular TSA. Indeed, the Department has never denied an application that met the programmatic requirements when need existed under the Rule. History of the Rule In 1989, the Legislature directed HRS (DOH's predecessor) to submit a report by February 1, 1990, (the "1990 Report"). The 1990 Report was to include a proposal for funding trauma centers that "will result in funding of the number of strategically placed trauma centers necessary to ensure adequate trauma care throughout the state." Ch. 89-275, § 6, Laws of Fla. The 1990 Report was to include "an estimation of . . . the approximate number and generalized location of state-sponsored trauma centers needed to ensure adequate trauma care throughout the state . . . ." Id. The 1990 Report was prepared by the Committee on State-Sponsored Trauma Centers (the "1990 Committee"). Although HRS timely submitted the Committee's report to the Legislature on February 1, 1990, HRS indicated that it did not "fully support all of the conclusions and recommendations contained in the task force report." In its report, the 1990 Committee recommended the creation of 19 trauma service areas. The boundary of each TSA was drawn to include a "nucleus county" along with its sending (later referred to as "feeder") counties. A nucleus county was one that retained at least 90 percent of its resident trauma alert patients, but also included any county that had a retention rate greater than 75 percent (but less than 90 percent) if no contiguous county had the requisite 90 percent retention rate. Any county that retained less than 75 percent of its trauma alert patients was designated a feeder county. This feeder county was then grouped with the nucleus county that received a majority of the feeder county's outbound patients. After reviewing 1988 patient flow data and applying the above rules, the 1990 Committee created and assigned counties to 19 trauma service areas. Under the 1990 Committee's methodology, a nucleus county was a candidate for a trauma center, but a feeder county was not. Table 3.3 of the 1990 Report set forth the Committee's recommendation as to the number of trauma centers to be allocated to each of the 19 TSAs: Table 3.3 Recommended Trauma Service Areas and Number of Trauma Centers 1988 Number Treated 1988 Number Residing Recommended No. Trauma Centers Service Area ISS Level 9+ ISS Level 16+ ISS Level 9+ ISS Level 16+ Min Max 1 1332 275 | 1166 223 2 3 2 489 117 | 452 105 1 1 3 815 185 | 701 152 1 2 4 1183 269 | 1011 226 2 3 5 2268 662 | 2566 546 2 3 6 869 138 | 877 143 1 2 7 1376 225 | 1286 190 2 3 8 3756 698 | 3329 592 3 4 9 3978 626 | 3709 552 3 4 10 2458 604 | 2222 507 2 3 11 1834 302 | 1665 290 3 4 12 1487 220 | 1433 218 2 3 13 1900 264 | 1810 247 3 4 14 687 105 | 698 102 1 2 15 1455 243 | 1386 236 2 4 16 2310 365 | 2233 371 2 3 17 476 73 | 436 75 1 1 18 4238 670 | 4204 652 4 5 19 7346 1370 | 6633 1176 6 7 Total 40857 7411 | 37817 6603 44 60 Table 3.3 indicates a total trauma center need ranging from 432/ to 60 trauma centers, although only 12 trauma centers were in existence at the time of the report. As the table reflects, the need estimate was apparently based on only one factor: the number of trauma patients residing and treated within each TSA in 1988. However, the 1990 Report indicates that members of the "number and location subcommittee" may have considered other factors in arriving at their recommendation: The study design formulated by the CHSPA called for identification and analysis of trauma patient incidence and patient flow for a one-year period based on the HCCB detailed case mix data. This data analysis effort alone, however, would not specifically identify the number of trauma centers needed in the state, nor their generalized location. The patient incidence and flow information needs to be considered in relation to the following factors in order to reach sound recommendations: . . . The injury severity level for which trauma center care is required; the minimum number of cases which should be treated at a trauma center in order to maintain skill proficiencies consistent with high quality outcomes; appropriate travel times from accident location to a trauma center; and, the existing level of facility resources available in an area upon which one or more trauma centers could be built. While information on certain of these points was available through trauma care literature and previous research, its applicability to Florida’s circumstances was not clear in all instances. Therefore, the Department sought recommendations on these issues from the committee and, especially, from the number and location subcommittee. The subcommittee’s recommendations, as ratified by the full committee, were integral to the development to the approximate number and generalized locations of state-sponsored trauma care throughout the state. However, no methodology was provided within the Report to show how the number of trauma centers was allocated among the TSAs based upon the data considered by the committee. The committee also cautioned that their estimate did not take into account other relevant factors or local conditions within each TSA that should be assessed before deciding how many trauma centers were in fact needed, including resource availability. As stated in the 1990 Report: It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. Dialogue between the state and local/regional agency would be essential to making the decision on the number of trauma centers needed. The 1990 Report did not include data or analysis relating to factors such as the availability of physician specialists within geographic areas, existing trauma center patient volumes, patient outcomes, or the capacity and adequacy of existing trauma centers. Following receipt of the 1990 Report, the Legislature amended the trauma statute by adopting the 19 trauma service areas proposed in the 1990 Report. Chapter 90-284, § 5, at 2188-89, Laws of Fla. However, the Legislature did not consider the trauma service area boundaries to be permanent or static. Instead, the Legislature provided that: [t]hese areas are subject to periodic revision by the Legislature based on recommendations made as part of local or regional trauma plans approved by the department . . . These areas shall, at a minimum, be reviewed by the Legislature prior to the next 7-year verification cycle of state sponsored trauma centers. As part of the 1990 trauma statute amendment, the Legislature provided that, in addition to complying with the trauma center standards, a trauma center applicant must "be located in a trauma service area which has a need for such a center." Ch. 90-284, § 6, at 2191, Laws of Fla. In this regard, the Legislature directed HRS to "establish [within each service area] the approximate number of state-sponsored trauma centers needed to ensure reasonable access to high quality trauma services." Id. (emphasis added). This need determination, which must be promulgated via rule, was to be "based on the state trauma system plan and the [1990 Report]." Id.; § 395.402(3)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area"). However, the Legislature rejected the 1990 Report's recommended minimum of 43 and maximum of 60 trauma centers. Instead, the Legislature stipulated that there should be a minimum of 19 trauma centers (i.e., one trauma center in each service area) and "no more than" 44 trauma centers. Ch. 90-284, § 5, at 2189-90, Laws of Fla. In 1992, HRS promulgated rule 64J-2.010. The Rule adopted the column in Table 3.3 of the 1990 Report reflecting the "minimum" recommended number of trauma centers, and stated that "[t]he number of trauma centers in each TSA shall be in accordance with the minimum number set forth in the table.3/” The trauma center need allocated by rule 64J-2.010, which merely replicates Table 3.3, has remained unchanged since 1992 with the exception of TSA 18. Subsequent Developments In 1998, the Legislature directed DOH via a committee (the "1999 Committee") to prepare a report by February 1, 1999, (the "1999 Report") "on how best to ensure that patients requiring trauma care have timely access to a trauma center." In furtherance of this objective, the 1999 Committee was required to "study . . . the strategic geographical location of trauma centers . . . ." Id. In its report, the 1999 Committee recommended that "[t]he goal for timely access to trauma centers should be to assure that every trauma victim can be delivered to a trauma center, either by emergency medical ground or air transport, within 30 minutes of beginning transport." As stated in the 1999 Report: There must be an adequate number of trauma centers distributed statewide in order to ensure timely access. . . [T]he ideal trauma system would assure that every trauma victim can be delivered to a trauma center within 30-minute air or ground transport. The geographical locations of the 19 trauma centers either verified or provisional as of July 1998 are shown on Map 1 in Appendix F. The circles around each trauma center location illustrate a fifty-mile flight radius, which translates into an average 30- minutes transport time by helicopter for a trauma victim. Helicopter transport time is used for this illustration because air medical transport allows trauma victims to be transported further distances within the 30-minute timeframe. The 1999 Committee found that some areas in Florida were not within a fifty-mile flight radius of one of the 19 existing trauma centers, which meant residents in these areas could not access a trauma center within 30 minutes. In fact, at that time, only 80 to 85 percent of Florida residents were within 30 minutes of a trauma center.4/ The committee therefore concluded "Florida does not have an adequate number of trauma centers distributed statewide to ensure timely access to appropriate trauma care." As a result of its findings, the 1999 Committee "developed two additional criteria for use by the department: 1) the overall goal of 30-minute transport time to trauma centers, and; 2) its equivalent, 50 miles, for helicopter flight times." The committee stated that these access criteria "should be considered by [DOH] in developing administrative rules for the planning and development of additional trauma centers . . ." The 1999 Committee made no attempt to quantify the number of additional trauma centers that were needed statewide, or within each TSA, to achieve the 30-minute goal.5/ Nor did the committee seek to update the Rule (i.e., Table 3.3) using the 1990 Report's methodology. However, the committee cautioned that: [r]etaining the limit on the number of trauma centers was . . . essential in order to maintain a reasonable volume of patients who are trauma victims as well as to avoid conflicts between competing trauma centers for recruitment of key professional staff. The 1999 Committee recommended giving DOH the "statutory authority to assign counties to trauma service areas" and that DOH "conduct a review of the regional structure of the 19 trauma service areas and the assignment of the counties between these areas and make changes, if found to be appropriate." The 1999 Report offered the following explanation for this recommendation: The committee did recommend that authority to assign counties to trauma service areas should be given to the department. Current authority resides with the Legislature. Shifting this authority to the department will allow flexibility in the system to more quickly respond to changing needs at the local level. Consistent with the 1999 Committee's recommendation, the Legislature repealed the statutory provision that made the trauma service areas subject to periodic review and "revision by the Legislature." Ch. 99-397, § 195, at 164, Laws of Fla. This repealed provision was replaced with an amendment to section 395.402(3) that delegated to DOH the statutory duty to review and revise the TSA boundaries, which stated as follows: Trauma service areas are to be used. The department shall periodically review the assignment of the 67 counties to trauma service areas. These assignments are made for the purpose of developing a system of trauma centers. Revisions made by the department should take into consideration the recommendations made as part of the regional trauma system plans approved by the department, as well as the recommendations made as part of the state trauma system plan. These areas must, at a minimum, be reviewed in the year 2000 and every 5 years thereafter. Until the department completes its initial review, the assignment of counties shall remain as established pursuant to chapter 90-284, Laws of Florida. Ch. 99-397, § 195, at 163-64, Laws of Fla. (Emphasis added). In response to the Legislature's directive, DOH initiated a review of the service areas and prepared a draft report entitled “Trauma Service Area Study-Year 2000” (the "2000 Draft Study"). However, for reasons unknown in this record, DOH apparently never finalized that study, and it was received in evidence in draft form only. In the 2000 Draft Study, DOH noted that the "primary purpose" of the TSA review mandated by section 395.402(3) "is to determine if the 19 trauma service areas . . . continue to be rational service areas." Based on the 1990 Report's methodology, the draft study's tentative recommendation was not to change the trauma service areas, although DOH "should continue to study and review the trauma service areas . . . to determine if different county configurations might lead to more timely access . . . ." At the same time, after analyzing more recent data, the draft study recommended the allocation of a different number of trauma centers to TSAs 9, 10, 11, and 12 as compared to the Rule.6/ Additionally, the 2000 Draft Study made the following finding: Because of the substantial financial commitment made by a hospital to be a trauma center, patient volume becomes an important factor for a hospital in terms of being financially viable and having enough work for trauma surgeons to maintain their skills. The old adage of practice makes perfect is particularly applicable to those treating the seriously injured trauma patient. . . To meet [the American College of Surgeons] caseload recommendations, locating trauma centers in areas where skill levels can be maintained by trauma surgeons is an important factor. Furthermore, to recruit and retain well-qualified surgeons to work in a trauma center, it is important to have a sufficient number of patients to treat, especially to the surgeon. Thus, the 2000 Study emphasized that trauma centers must see enough patients to be financially viable and for trauma surgeons to maintain their skills, and referenced the American College of Surgeons recommendation that Level I trauma centers treat 600 to 1000 patients annually and Level II trauma centers treat 350 to 600 patients annually. The 2000 Study concluded: -No change in trauma service areas should be made at this time. This study found that minimal change occurred in those counties identified as nucleus counties. Furthermore, the relationship between nucleus counties and those identified as sending or "feeder" counties remains intact. -The 19 trauma service areas should continue to serve as the geographical basis for the allocation of the 44 authorized trauma center slots. -The 44 authorized trauma center slots in chapter 395.401 Florida Statutes [now section 395.402(4)(c) should remain as the maximum number required to meet trauma patient care demands. 2004 Amendments to the Trauma Statutes and the 2005 Assessment In 2004, the Legislature made substantial revisions to the trauma statute. Chapter 2004-259, Section 6, Laws of Florida amended section 395.402 to direct the Department to complete a statewide assessment of the trauma system by February 1, 2005 ("the 2005 Assessment"). § 395.402(2), Fla. Stat. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One objective of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). §395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature added a sunset provision that, upon completion of the 2005 Assessment, ended the statutory mandate to use the service areas created in 1990. See § 395.402(2) ("[t]rauma service areas as defined in this section are to be utilized until [DOH] completes" the 2005 Assessment) (emphasis added); § 395.402(4) ("[u]ntil the department completes the February 2005 Assessment, the assignment of counties shall remain as established in this section.") The obvious intent of the above statutory change was for the section 395.402(4) service areas to be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. "Annually thereafter" (as opposed to every five years per the 1999 version of the statute) DOH was required to "review the assignment of the 67 counties to trauma service areas . . . ." Ch. 2004-259, § 6, at 13, Laws of Florida (amending § 395.402(3)). Another objective of the 2005 Assessment was to "establish criteria for determining the number and level of trauma centers needed to serve the population in a defined trauma service area or region." § 395.402(2)(c), Fla. Stat. Based on these criteria, DOH was then 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(2)(b), Fla. Stat. As part of this need assessment, DOH was required to consider the "[i]nventories of available trauma care resources, including professional medical staff," as well as the "[r]ecommendations of the Regional Domestic Security Task Force" and "the actual number of trauma victims currently being served by each trauma center." § 395.402(3), Fla. Stat. However, unlike the situation with the 1990 Report, the Legislature did not intend for DOH to rely on the 2005 Assessment indefinitely. To avoid this, the Legislature therefore required DOH to update the 2005 Assessment by annually reviewing "the requirements of paragraphs (2)(b )-(g) and subsection (3)" of section 395.402. This meant that each annual review, like the initial 2005 Assessment, had to "[r]eview the number and level of trauma centers needed for each trauma service area or region" by, among other things, considering "[i]nventories of available trauma care resources, including professional medical staff." §§ 395.402(2)(b) and (3)(e). The need determinations resulting from these annual reviews would then have to be codified in a rule per section 395.402(4)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area"). The 2004 Legislature clearly intended for DOH to rely on the updated need assessments required by section 395.402(4), rather than the need allocation in the 1990 Report (which was incorporated into the Rule). This is evident from the fact that the 2004 Legislature repealed the provision that previously required DOH to establish need based on the 1990 Report. See chapter 2004-259, § 7, at page 14, Laws of Florida (amending section 395.4026(1)), which states in relevant part: 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, and the 1990 Report and Proposal for Funding State Sponsored Trauma Centers, the department shall establish the approximate number of state approved trauma centers needed to ensure reasonable access to high-quality trauma services. The Using the guidelines and procedures outlined in the 1990 report, except when in conflict with those prescribed in this section, the department shall select those hospitals that are to be recognized as state approved trauma centers . . . [emphasis added] By repealing the statutory reference to the 1990 Report, the Legislature expressly required the Department to discontinue any reliance on the 1990 Report as a basis for allocating trauma center need. In addition, the 2004 Legislature imposed a moratorium on the submission of applications for new trauma centers in any TSA that already had one trauma center until the 2005 Assessment was complete, regardless of whether the Rule indicated a need for an additional trauma center within the TSA. § 395.4025(14), Fla. Stat. It is reasonable to infer that the imposition of a moratorium notwithstanding unmet need in several of the TSA's under the Rule indicates that the Legislature considered the Rule to be outdated and no longer valid. The moratorium therefore had the effect of maintaining the status quo until the Rule could be updated with a new assessment. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. The assessment itself was conducted by a group of investigators from the University of South Florida and the University of Florida. This group was assisted by a National Steering Committee "composed of recognized experts in the fields of trauma care and trauma system analysis " In its transmittal letter to the Legislature, DOH specifically noted that the assessment included a recommendation regarding “the number and level of trauma centers needed to provide a statewide integrated trauma system. . . .” In contrast with HRS' contemporaneous objections to the 1990 Report, the DOH transmittal letter identified no areas of disagreement with the 2005 Assessment. The 2005 Assessment included 5 "Recommendations", including: 3. Designation of additional trauma centers should be based on the need as determined by trauma region.7/ Deployment of additional trauma centers should take place based not only on the number of patients served per trauma center, but according to a concept of “trauma center capacity,” which would be determined by the staffing levels of medical specialists and other healthcare professionals. An annual regional assessment is also recommended to analyze pre-hospital resources, ICU beds, capacity, trauma center performance including trauma registry data, and other medical resources based on per population estimates to plan for response and improvements. (Emphasis added) Thus, unlike the 1990 Report (and the Rule), the authors of the 2005 Assessment recommended that the availability of existing resources should be taken into account in determining the need for new trauma centers. In evaluating need based on DSTF region, the 2005 Assessment identified an unmet need for only four more trauma centers in the state,8/ which "would provide access to a trauma center for 99 percent of the people in Florida." Given the 20 trauma centers in existence at the time, this meant that the total trauma center need was 24, which is substantially below the need established by the Rule of 42 trauma centers. This lower need determination was due in part to the fact that the 2005 Assessment took "trauma center capacity," and not just the number of patients served per trauma center, into account. According to the 2005 Assessment, the recommended four new trauma centers were needed in DSTF Regions 1, 2, 3 and 5. However, the assessment concluded there was no need for another trauma center in DSTF Region 4 (Tampa Bay), which was found to have "adequate trauma center access at this time." This contrasts with the Rule, which purports to authorize five more trauma centers in the counties assigned to Region 4. In particular, under the Rule, there is a net need for two new trauma centers in Pasco County (TSA 9), two new trauma centers in Manatee County (TSA 13) and one new trauma center in either Citrus or Hernando County (TSA 6). The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. Likewise, the Department has not amended the Rule to implement the recommendations contained in the Assessment. In 2008, the Department held rule development workshops in order for trauma system constituents to indicate whether trauma center allocations contained in the Rule should be changed. Pursuant to stakeholder requests arising out of the workshops, the Department began consideration of an increase in the maximum number of trauma center positions allocated to TSA 1 (Escambia, Santa Rosa, Fort Walton and Okaloosa Counties). Following numerous public workshops and hearings, the Department filed notice of its intent to amend the Rule to increase the allocation of trauma centers in TSA 1 from 2 to 3. However, the amendment did not become final due to matters unrelated to the determination itself and was withdrawn by the Department.9/ The January, 2011 TSA Report In 2011, a study was completed for DOH entitled "Florida Trauma Service Area Analysis" (the "2011 TSA Report") that relied on the 1990 Report's patient flow methodology for assigning counties to trauma service areas. However, this study did not take into account all of the section 395.402(3) criteria. The 2011 TSA Report disclosed this deficiency, stating: This study provides an analysis of TSAs and counties to assess retention of trauma alert patients within the county. Rules for designating counties as nucleus counties for trauma centers and counties for consideration for trauma centers were defined in analyses of TSAs conducted for the office of Trauma in 1990 and 2000. * * * This report analyzes hospital discharges by TSA from 2000 to 2009. Hospital discharge data from [AHCA] is used to analyze the county of residence and treating facility for all trauma patients with an Injury Severity Score (ISS) of 9 or greater, as deemed by statute . . . . Other considerations required, by statute, in the assignment of counties to TSAs include recommendations of regional trauma system plans, stakeholder recommendations, geographical composition to assure rapid access to trauma care, inventories of available trauma care resources, transportation capabilities, medically appropriate travel times, recommendations by the Regional Domestic Security Task Force, and any appropriate criteria. These considerations are not integrated into this analysis of TSAs. (Emphasis added). Although the 2011 TSA Study used the same methodology as the 1990 Report, the 2011 TSA Study supports a different TSA configuration than the one established in the 1990 Report because patient flow patterns have changed since 1990. For example, in the 1990 analysis, the primary treatment county for Manatee County was Sarasota County. Because Manatee served as a feeder county for Sarasota (a nucleus county), it was grouped in the 1990 Report with Sarasota County in TSA 13. However, the updated information in the 2011 TSA study shows that the primary treatment county for Manatee County residents is now Pinellas (TSA 9's nucleus county), which requires that Manatee County be reassigned to TSA 9 per the 1990 Report's methodology. A similar shift in patient flow also dictates the reassignment of Hernando County from TSA 6 to TSA 10 (Hillsborough County). Indeed, it appears that all of the counties in TSA 6 would have to be merged with other trauma service areas since Marion County, which was designated as TSA 6's nucleus county in the 1990 Report, no longer qualifies as a nucleus county. The Department maintains that its employees are continuously reviewing trauma volume, injury severity scores, population and other data and that this activity qualifies as the annual need and trauma service area reviews required by section 395.402(4). However, DOH has not established a need methodology by rule, policy or otherwise that it could apply to this data to quantify the number of trauma centers needed in each TSA. In the absence of an articulable need methodology, it is not possible to verify or replicate any assessment DOH may have done based on the data it claims to have reviewed. More significantly, the Department has itself acknowledged the problem of not having a methodology or process in place for conducting regular assessments. In its "2011-2015 Florida Trauma System Strategic Plan" (the "2011 State Plan"), DOH identified as a "threat" to the achievement of Goal 8 (Regional Trauma System Evaluation) the "[l]ack of effective evaluation criteria, tools and a systematic and periodic process to evaluate trauma service areas and apportionment of trauma centers." In furtherance of Goal 8, DOH also recognized the need to "[c]onduct a statewide comprehensive assessment of the Florida Trauma System access to care based on s. 395.402, F.S., the Western-Bazzoli criteria and other criteria to evaluate access to care and the effectiveness of the trauma service areas/regions." The specified timeline for this future assessment was "December 2011, with annual reviews thereafter as funding is available." On May 19, 2011, the Department's State Surgeon General signed an "Issue Paper" approving a "Florida Trauma System Special Study." This study is intended to "assist the department in developing a process and evidence-based guidelines to be utilized by [DOH] in determining the need for trauma center locations throughout the state." According to the Department's witness, Susan McDevitt (former Director of the Office of Trauma), DOH intends to use this study to develop a formula or methodology for determining the need for new trauma centers in the state. DOH determined this study was needed because the "trauma network has matured and changed" since 2005 when the "last comprehensive assessment of the Florida trauma system" was done. However, December 2011 is the earliest anticipated date for completion of this study, and DOH has no timeline for when this study may result in any rule amendment. As noted, the 1990 Report forms the basis for the configuration of the existing 19 TSA's as well as the need allocated to each of the TSA's within the Rule (with the exception of the reduction in Broward County). However, Dr. Lewis Flint, an expert in trauma surgery and trauma system assessment, credibly explained how Florida's trauma system has "matured and changed" since the 1990 Study was completed: Q. Now, Doctor, can you describe what changes there have been in the trauma system since the 1990 study was completed? A. Well, in 1990, there were fewer trauma centers than there currently are. I believe there were only about 12 designated centers in 1990. There are 22 now. The availability and the efficiency and quality of pre-hospital care has changed in a major way since 1990. We have far more advanced life support staff on ambulances than we had in 1990. We have far more plentiful air evacuation capability than we had in 1990, and the quality and efficiency of the existing trauma centers has changed in a major way as the centers have matured. So that the combination of greatly improved pre-hospital care and significant improvements in efficiency and in-patient outcomes in the existing trauma centers has meant that this system has matured into a very effective trauma system. It is not free of shortcomings, it is not an entire system yet. It has some holes in it, but the system as such has changed in a major way since 1990, such that it was our view at the close of the 2005 comprehensive assessment, that a decision about deployment of trauma centers that was based solely on distance and geography was not going to be an optimum method of determining how the system should be deployed. Whether or not the 1990 Report was valid when issued, its recommended service area configurations and need allocations have been rendered obsolete by the passage of time, changes in patient flow patterns, and significant advances in the trauma care delivery system since the Rule was adopted. Reasonable health planning requires the use of the most recent data available and systematic evaluation of the multiplicity of factors that determine the appropriate number and location of trauma centers in the state. No doubt that is why the Legislature directed DOH to conduct assessments annually. § 395.402(4). Here, the 1990 Report's recommendations were predicated on 1988 information that is now more than two decades old.10/ It is inappropriate to rely on 1988 data to justify the service area configuration or need allocation in 2011, particularly given the major changes and maturation of the trauma system since 1988. The 1990 Report (and rule) also fails to take into account criteria that must now be considered pursuant to the 2004 amendment to section 395.402. In particular, section 395.402(3) as amended, requires the DOH annual need and service area reviews to take into account Regional Domestic Security Task Force recommendations, transportation capabilities (including air transport), and inventories of available trauma care resources (including professional medical staff). The 1990 Report took none of these factors into account in making the need recommendations that were eventually incorporated into the Rule. Notably, had the availability of professional medical staff been factored into the analysis, need would likely have been reduced, as the 1990 Report itself observed, stating: It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. (Emphasis added). Standing Petitioners TGH and SJH are located in TSA 10 (Hillsborough County). Petitioner Bayfront is located in Pinellas County in TSA 9 (Pinellas and Pasco Counties). Intervenor Bayonet Point is also located in TSA 9, but in Pasco County. Intervenor Blake is located in Manatee County, in TSA 13 (Manatee, Sarasota, and DeSoto Counties), adjacent to TSA 9. Petitioner Shands is located in TSA 5 (Baker, Clay, Duval, Nassau, and St. Johns Counties). Trauma center applicant Orange Park (a non-party) is located in TSA 5 but in a different county (Clay) from Petitioner Shands (Duval). As noted earlier, because of the intensity of resources that must be devoted to a trauma center, hospitals generally lose money in their operation. Specifically, in FY 2010 Tampa General's Level I trauma center had a $15.7 million net loss, while Bayfront's Level II trauma center had a $3 million net loss. Similarly, Shands lost approximately $2.7 million and SJH lost $8.3 million from the operation of their trauma centers in FY 2010. Of the 42 trauma center positions available statewide, the Rule allocates three to TSA 9 and three to TSA 13. Because TSA 9 currently has one designated trauma center (Bayfront) while TSA 13 has none, the Rule establishes a net need for two more trauma centers in TSA 9 and three more trauma centers in TSA 13. The Intervenors' pending trauma center applications propose to establish Level II trauma centers at Regional Medical Center Bayonet Point in Pasco County, (TSA 9), and at Blake Medical Center in Manatee County (TSA 13). The filing of the Intervenors' applications triggered the application review process set forth in section 395.4025(2). Pursuant to this statute, the deadline for submitting a trauma application is April 1 of each year. § 395.4025(2)(c). The filing of an application triggers a 30-day provisional review period (which in this case is delayed until October 1, 2011, due to an 18-month extension request made by Intervenors). The limited purpose of this provisional review is to determine if the hospital's application is complete "and that the hospital has the critical elements required for a trauma center." Id. The "critical element" portion of the review is based on the trauma center standards and includes a review of whether the hospital meets the equipment, facility, personnel and quality assurance standards. Id. Any hospital that (i) submitted an application found acceptable in the provisional review (i.e., meets the trauma center standards) and (ii) is located in a TSA that has a need for a trauma center may operate as a provisional trauma center after the 30-day provisional review period has concluded. §§ 395.4025(2)(d) and (5). Based upon the facts of record, there is a reasonable probability that the Intervenor hospitals will achieve provisional trauma center status by October 30, 2011, (the end of the 30-day provisional review period that will start October 1, 2011). First, Intervenors' witness James Hurst, M.D. (who is assisting Intervenors and Orange Park in recruiting trauma surgeons and in the application process) testified without contradiction that the HCA applications would be complete and in compliance with the applicable trauma center standards by the extended October 1st application submission deadline. Second, both Intervenor hospitals are located in trauma service areas with a need as established by the Rule. As confirmed by Ms. McDevitt, if the applications meet the programmatic requirements as determined by the provisional review, and there is a need indicated by the Rule, DOH will approve the applications and award the Intervenor hospitals in TSA 9 and 13 provisional trauma center status. Likewise, it is reasonable to expect that the Orange Park application will be approved if it meets the programmatic requirements, given the available slot in TSA 5. Upon receiving the provisional trauma center designation, the EMS providers will be required to treat Bayonet Point, Blake, and Orange Park as trauma centers. This means that the EMS providers will have to revise their protocols to redirect the transport of trauma alert patients from other existing trauma centers to the new centers. See, Fla. Admin. Code R. 64J-2.002(3)(g). A "trauma alert" patient is defined as a "person whose primary physical injury is a blunt, penetrating or burn injury, and who meets one or more of the adult trauma scorecard criteria . . . ." Fla. Admin. Code R. 64J-2.001(14). Pursuant to the DOH Trauma Transport Protocols Manual (which all EMS providers must follow), EMS providers must transport all trauma alert patients to the closest trauma center that is "within 30 minutes by ground or air transport or within 50 miles by air transport." As a result, any trauma alert patient who is closest to Bayonet Point, Blake, or Orange Park will have to be transported to one of those hospitals once they are designated as provisional trauma centers. A provisional trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents (the "northern Tampa Bay region"). Trauma alert patients from these counties would therefore have to be transported to Bayonet Point instead of to the existing trauma centers in Hillsborough (SJH and Tampa General) or Pinellas (Bayfront). Likewise, a provisional trauma center at Blake would become the closest trauma center to Manatee and Sarasota (the "southern Tampa Bay region") requiring transport of their trauma alert patients to Blake rather than to the Hillsborough or Pinellas trauma centers. In 2010, 669 trauma alert patients (16 and over) were transported to Bayfront from the counties in the northern and southern regions of Tampa Bay. This represents 42 percent of all the trauma alert patients (16 and over) transported to Bayfront. From the same area and during the same time period, 120 trauma alert patients (16 and over) were transported to Tampa General. All of these trauma alert patients would be redirected away from Bayfront and Tampa General and transported to the closer Intervenor trauma centers per the EMS transport protocols. The redirection of these trauma alert patients to Bayonet Point and Blake would substantially and adversely affect both Bayfront and Tampa General. In Bayfront’s case, the lost contribution margin caused by the annual diversion of even 400 trauma patients would reduce Bayfront's total margin by at least $2.3 million each year. Likewise, the yearly diversion of 120 trauma patients from Tampa General would result in an annual lost contribution margin and reduction in total margin in excess of $1 million. Notably, for both hospitals this represents the minimum potential loss of trauma patients and revenue as a result of the approval of the Intervenors' trauma centers. Annual losses in excess of a million dollars would be material to both Bayfront and Tampa General given the financial challenges both hospitals are already facing. Although physically located in TSA 10 (Hillsborough County) SJH now receives trauma patients from Hillsborough, Pasco, Citrus, Hernando, and Sumter counties. If approved, the trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents and would likely result in the immediate loss of between 149 and 307 from SJH's trauma program. If the Orange Park trauma center is approved, it is reasonable to expect that all of Shands trauma patients originating from Clay County would instead be redirected to Orange Park. This would represent a loss of approximately 1,000 patients annually, or 25 percent of Shands current trauma volume. With fewer cases to absorb the high fixed costs of trauma preparedness, Shands expects that it would lose $3,400 per case, on a fully allocated basis, rather than the $665/case it now loses. Thus, whereas Shands' trauma center currently loses $2.7 million annually, that loss would increase to approximately $10 million per year. And on a contribution margin basis (where fixed costs are excluded) Shands will experience a decline in contribution margin of $6-7 million annually once the Orange Park trauma center becomes operational. In addition to the direct loss of trauma patients and corresponding revenue, it is reasonable to anticipate that the approval of new trauma centers in relatively close proximity to existing centers will result in increased competition for scarce surgical subspecialists currently associated with the existing trauma programs. Specifically, the opening of new trauma centers in TSA's 5, 9, and 13 are likely to increase the difficulty and escalate the cost of ensuring adequate on-call specialty physician coverage for the Petitioner's hospitals and to adversely affect their ability to retain highly skilled nurses, technicians, and other trauma program staff.
The Issue The issue for consideration in this matter is whether Respondent, NME's application for a Certificate of Need to provide comprehensive medical rehabilitation beds in Department District X should be approved.
Findings Of Fact At all times pertinent to the allegations contained herein, the Department was the state agency with the authority to and the responsibility for evaluating and approving CON applications for health care facilities in this state. Department District X is a single county district which encompasses the whole of Broward County, Florida. Broward County consists of two distinct service areas for health care providers; the north and the south. Facilities located in the northern part of the county, for which the dividing line is accepted as State Road 84 and Interstate 595, which run east/west across the county, primarily serve the northern area of the county. By the same token, those providers located south of the dividing line are primarily in service to residents in the southern portion of the county. Legitimate basis exists for the distinction between the north and south county segments. The county is divided into two taxing districts which generally follow the service district boundaries and these taxing districts are utilized to provide and reimburse for health care services. In addition, physician practice patterns show generally that physicians stay, refer, and admit to facilities within that portion of the county where they live and practice. There is little medical intercourse between the sections. A third basis for distinction is the fact that generally patients follow physicians, and will normally present for treatment at those facilities located in the section in which they reside and their practitioner locates. At the present time, of the five providers which offer CMR services in Broward County, (District X), four are located in the northern section of the county, and the fifth, Memorial, is located in the south. Memorial currently has 22 of the 213 existing and approved CMR beds in the District. This constitutes approximately 10% of the total number or approved and existing beds in the District while 32% of the population of the District resides in that service area. By the same token, if one considers the number of CMR beds per 100,000 population, the number in the north service area is approximately 4 times that in the south. Petitioner, Memorial, is a 618 bed acute care regional public hospital providing numerous specialized acute care services to District X as well as adjoining areas in the southeast region of the state. It is operated by the South Broward Hospital District, a taxing entity created by the Florida Legislature in 1947, and has a history of being a disproportionate share provider of medical services to the indigent through Medicare and Medicaid programs as well as other charity care programs. In fact, Memorial provides the sixth highest level of indigent care in this state. Memorial currently has provided CMR services since 1985 and operates a 22 bed CMR unit. It also offers open heart surgery, neurosurgery, pediatric cardiac catheterization, pediatric trauma, pediatric open heart surgery, and pediatric oncology and hematology. The facility has recently submitted a letter of intent to the Office of Emergency Medical Services requesting to be designated as a regional adult trauma center. HMC is a 334 bed acute care hospital also located in the southern service area of District X, in a six story building containing approximately 300,000 square feet and an adjacent five story medical office building. It also offers a broad range of general acute care services as well as specialized programs in the treatment of diabetes, laser surgery, eating disorders and oncology. It also provides intensive care, coronary care, and progressive care beds, though all may not be considered as active tertiary care services. HMC has a large medical staff consisting of over 400 physicians representing almost all medical specialties. More than 90% of the staff are board certified and the rest are board eligible. The medical staff of HMC and Memorial tend to overlap almost in its entirety. HMC's medical staff also includes five physicians who specialize in physical medicine and rehabilitation, (physiatry), all of whom are board certified except for one who has recently taken the board examination. HMC is a subsidiary of NME Hospitals, Inc., a national publicly held health care company which owns, manages or operates more than 150 acute care, rehabilitation, and pediatric hospitals throughout the United States and overseas. NME has a rehabilitation division which specializes in comprehensive rehabilitation services. This division would manage the CMR unit at HMC if approved. HMC is accredited by the Joint Commission of Accreditation of Health Care Organizations and maintains extensive quality assurance activities. On March 11, 1991, HMC filed a Letter of Intent to apply for a CON to convert 30 existing acute care medical surgical beds to 30 CMR beds. Somewhat later, but still during March, 1991, both Memorial and HMC filed applications for a CON for CMR beds. Memorial's application sought the addition of 4 CMR beds to its existing 22 bed unit. Both applications were preliminarily approved by the Department. Thereafter, both Memorial and HMC filed Petitions in opposition to the preliminary approval of the other applicant's application. HMC ultimately dismissed its Petition in opposition to Memorial's 4 beds, and that application is not in issue here. Prior to hearing, the parties agreed that the provisions of Section 381.705(1)(m), Florida Statutes, as they relate to costs of construction and construction methods and itemization and costs of equipment of HMC and its application are not in issue. Memorial, however, did not waive its right to challenge the plan and design of the plan as to quality care considerations in HMC's application. The parties also agreed that Section 381.709(2)(c), Florida Statutes, was in issue but that sup-paragraphs a, b, and d of that section were not. The Hearing Officer's resolution of Petitioner's objections on this matter established that the Letter of Intent was timely filed in the appropriate place and the proper notice published. HMC's Letter of Intent included therewith a resolution of the NME Board of Directors which was accompanied by a certificate as to its accuracy. The corporate resolution certificate, dated March 5, 1991, indicating the resolution was enacted on February 19, 1991, was executed by Mr. McKay, Vice President and Assistant Secretary of NME Hospitals, Inc. Memorial questioned Mr. McKay's authority to sign the certificate as custodian of the corporate records. The evidence presented indicated, however, that Mr. McKay is a keeper of the corporate seal and custodian of corporate records pertinent to the eastern region of NME Hospitals, Inc., and as such he was an appropriate custodian of the records and competent to execute the certificate. The issue as to the date on the certificate appears to be no more than a scrivener's error. The errors which exist are harmless. The documentation contains all certification necessary for a valid Letter of Intent. Daniel J. Sullivan, a consultant in health care management, did a need analysis study of the Broward County District for HMC to determine whether a CMR facility was needed within the District and if so, where. He first looked at the planning area and what services were available, both those in existence and those approved but not yet on line. He also looked at utilization of CMR services in the area and trends toward service utilization, geographic distribution of existing services, the fixed need pool, relevant Department rules relating to numeric need and other factors, and in that connection, any other unusual factors bearing on need. Mr. Sullivan's study clearly established to his satisfaction that HMC does not serve all of Broward County - only, primarily, those patients residing in Hollywood, Hallendale, and Dania, all of which are in the southeast corner of Broward County. The secondary service area goes down into Dade county and up to Ft. Lauderdale. The data for this study and the need analysis comes from the Hospital Cost Containment Board, (HCCB), and is considered to be reliable. Mr. Sullivan also did an analysis of areas served by other providers in the county and determined that Memorial's service area is similar to that of HMC. North Broward Medical Center serves the very northeast part of the county. Holy Cross Hospital serves the lower north to northeast part of the county. Based on this, he concluded that facilities in the northern part of the county serve the northern county area. Only Petitioner and HMC serve the southern part of Broward to any measurable extent. Utilization of CMR beds is very high district-wide, both historically and currently. Occupancy in the District for the relevant period was 91.21% county-wide, with Memorial Hospital having an occupancy rate of 99.32%. This is not, in Sullivan's opinion, a historical aberration. The same trend goes back to the mid 1980's. In 1989 for example, utilization was at 89% and it has gone up since that time. In Sullivan's opinion, the system is now near capacity and the occupancy rate remains high. Both Holy Cross and North Broward Medical Center have 20 new beds each as of the last quarter of 1991. When those beds came on line, the utilization rate still remained very high NBMC's new program was at about 75% occupancy after less than one year operation. These north county beds will be used by north county patients and will not, for the most part, be available to south county residents. Rule 10-5.039, F.A.C., is the Department's rule regarding need determination, and it contains a numeric need formula for projecting future needs for service ((2)(a)). The Department publishes a fixed need pool every six months to identify need. The last one published before this application showed a zero bed need in the fixed need pool. Mr. Sullivan believes, however, this is not an accurate predictor of bed need since the realities of the market place are not related to the Department's fixed need pool. Mr. Sullivan's calculations show a gross bed need in 1990 of 88 beds considering the existing 213 licensed and approved beds. Since these are running at an occupancy rate higher than 90%, this shows the rule grossly underpredicts the need for the service. In fact, the Department has prepared State Agency Action Reports, (SAAR), in both the NBMC and St. Joseph applications and the Memorial application which reflects this trend. Mr. Sullivan believes the need formula is not a good predictor of future needs because it assumes, incorrectly, that the number of patients needing the service is directly related to acute care hospital discharges. Historically, however, this has not been the case. Since 1986, the ratio of CMR discharges to acute care discharges has grown and has never closely approximated the rule's standard ratio of 3.9. Other factors are provided for in subparagraph (2)(b) of the rule. The District's population trends show a relatively older population, (more than 20% of the population is over 64 years old), and by 1996 that percentage will increase somewhat. Since July, 1989 approximately 33% of the people with the top ten conditions utilizing CMR services were from South Broward County. Extrapolating this indicates a net need of 11 beds if an 85% occupancy rate is experienced. Since the actual occupancy rate remains, in fact, higher than 85%, Mr. Sullivan believes this method is accurate. A modification of this need, relating to discharge rates, was done in the Omissions Response herein which shows a need, by 1996, of 39 beds, not including the 4 beds approved for Memorial. As to population, the elderly are most at risk for conditions requiring CMR care since they, by far, experience the largest percentage of strokes and orthopedic related conditions. With the elderly and very elderly percentage of the total population increasing, this would tend to drive the need for CMR services and beds. Mr. Sullivan calculated need for the purposes of the application for the southern portion of the District along, utilizing a method which, though not officially recognized, uses the same criteria for analysis used in the District analysis. Doing so, he concluded there would be a 1990 need for 53 additional beds. Utilizing the 17(a) method to project into the future, he calculates a 1996 need for 57 beds. Concerning subparagraph (2)(B)3 of the rule, considering the growth rate of CMR admissions per 1,000 population, (from 1.41 to 2.24 during the period 1986 through 1990), at HMC, Mr. Sullivan also concluded that the growth rate would be plus or minus 4.5% over the next 5 years. He also concluded that the length of stay will remain at 21 days over the next 5 years and feels this is conservative when compared to the rest of the state and the 28 day figure used in the rule. There is some pressure to have patients discharged as soon as possible which impacts on length of stay. Considering all these factors, Mr. Sullivan expects a District X need as a whole of 65 beds in 1996, not including the 4 beds approved for Memorial. This would result in an actual 61 bed need by 1996. All this means that if the number needed is the same for the South County and the County as a whole, then the number is acceptable and all the need is in the South County. As to trends in the utilization by third-party payees, this factor has driven the growth. Medicare and insurance companies recognize the efficacy of CMR services as opposed to the fragmented treatment otherwise provided. They consider that every dollar spent on CMR saves money for the health care system. Subparagraph (c)1 of the rule requires a unit have at least 20 beds. In the instant application, HMC is seeking 30 beds and this clearly meets the rule criteria. The occupancy standard of 65% in the first year, as outlined in sub- paragraph (c)2 of the rule, is estimated to be met easily, and the 85% requirement for existing providers will also be met. All together, there appears to be a high demand for CMR services in Broward County in general and in the south half of the county in particular, and it is reasonable to assume that the 30 beds for HMC, as well as the additional beds sought by Memorial, could be approved without adversely affecting any existing providers. Regarding the rule's accessibility standard which requires 90% of the target population to reside within 2 hours diving time of the proposed facility, this is clearly met since all of Broward is within 2 hours driving time of both HMC and Memorial. Turning to the provisions of Section 381.705, Florida Statutes, specifically (1)(a), (b) and (2)(a),(b) and (d), all are highly interrelated. While geographic availability may not be of concern, the availability of empty beds is of great concern. Historically, the District has operated well above the 85% occupancy rate for over 3 years. The system currently is clearly inadequate and the existing alternatives, home care and outpatient services, do not replace the services in issue but supplement and are follow-ons to inpatient CMR care. Concerning economies of shared service, Mr. Sullivan feels certain economies will accrue as a result of this conversion if approved. Existing space will be used and can share administrative and overhead expenses; the contractor to be used to accomplish the project is qualified and experienced and knows how to economize. Impacts on competition will be minimal if any, given the high level of need. As to any impact on HMC, the sharing of costs and services between the integrated portions of the facility would generate economies. At the present time there is no existing competition other than the beds at Memorial. If HMC is granted its certificate and becomes an existing provider, the resultant competition should be beneficial to both institutions. There are no alternatives to this service which are less costly or more efficient. Any alternatives would be either more expensive or inappropriate. The facilities are currently being used in a very efficient manner and this would not change. If the application is not approved, according to Mr. Sullivan there are and will be patients who are in need of and who will be denied CMR services in South Broward County. He believes the 1989 Florida State Heath Plan and the District's 1990 Health Plan, those applicable here, are consistent with this application. The preferences called for in the plans will be met and satisfied. HMC agrees to accept Medicaid patients and has committed 1% of its service to the indigent. It should be noted that Memorial's projected need for CMR beds is identical to that of this applicant, and this tends to indicate Memorial also feels there is a need for additional beds in the south county. It's application was filed subsequent to the initial approval of the 30 beds in issue here. It is immaterial at this point that District X has more CMR providers and more licensed CMR beds than any other district in the state. Also not controlling is the fact that under the state's bed need methodology, as outlined in the rule, there is a 125 bed excess projected by 1996 for District X. It must be noticed here that CMR services are defined by rule as tertiary health services which are generally specialized services using specialized equipment and personnel. They should be centralized in a centralized location to encourage better utilization of resources. HMC is a community hospital which does not now have any other tertiary hospital services but Dr. Jay S. Mendelsohn, a psyiatrist testifying on behalf of HMC claims that the majority of rehab problems are not so specialized as to require tertiary services and are mainstreamed. Dr. Mendelsohn, a specialist in physical medicine and rehabilitation, as a physiatrist, coordinates care on a rehabilitation unit including actual treatment, nursing care, and social work relative to the patient's condition. A physiatrist sees, on an inpatient basis, patients with such infirmities as stroke, hip fractures, multiple sclerosis, multiple trauma, and other similar conditions. The patients are usually those with neuromuscular or musculoskeletal problems, though he does, on occasion, see those with arthritis complications. Dr. Mendelsohn has privileges at several hospitals in Broward County including both Memorial and HMC. He practices mostly at Memorial where he was, from 1985 through 1991, Medical Director of the rehabilitation unit. His associate, Dr. Novick, is the current Medical Director. CMR patients are usually referred for this service by other physicians. Hip fractures and strokes are primarily from orthopaedic surgeons and neurologists, but internists, family practitioners, and physicians practicing in other disciplines also refer as appropriate. To Dr. Mendelsohn's knowledge, South Broward County is somewhat unique. Physicians there generally stay in that area and do not practice or draw patients from north of I-595. Another group practices primarily in the northeast portion of the county and a third group practices in the northwest county. Most physicians use the hospitals in the area in which they practice. In the south county, patients needing inpatient rehabilitation can at present, from a practical standpoint, go only to Memorial Hospital since it has the only rehabilitation beds available in the area. His experience indicates substantial difficulty in getting patients admitted to that unit since it generally fills its rehabilitation beds with patients primarily from it own patients already admitted to other services. Patients from other hospitals or from the community normally have great difficulty getting admitted, and this problems has existed for quite some time, (over 5 years). He has encouraged Memorial's staff to apply for more rehabilitation beds. If a Memorial patient is unable to get into the rehabilitation unit at Memorial, that patient then has to obtain the needed rehabilitation treatment on an acute care ward. Patients at other facilities often are not admitted at all, and this situation affects the course of treatment and reduces the amount and the beneficial effects of therapy by approximately one-half. The providers in the northern part of the county are not a good source of therapy to patients from the southern portion of the county because: Since south county physicians normally do not go to the north portion of the county, the patient has to have a different physician who is not familiar with either the patient or the condition and who must, therefore, do repeat tests and other diagnostic procedures. The patients' families find it harder to visit the patients in the north part of the county and therefore do not visit as frequently. Family visits are important to the success of the therapy. When the patient goes home, his family does not know how to help out because they did not receive the training they would have ordinarily have received had they been able to visit in the inpatient facility more frequently. Older patients' spouses often do not drive or, if they do, find the extra distance to the north portion of the county too much to travel. As a result of all the above, the continuity of care concept, which is important from a medical care standpoint, is adversely affected. Patients needing treatment at HMC's facility, if approved, would be much like those treated at the currently existing Memorial facility. Dr. Mendelsohn is familiar with Rehabilitation Hospital Services Corporation, which will be contracted with to run the HMC facility if approved. To his knowledge, the quality of care provided by it is good and comparable with that provided elsewhere. Dr. Mendelsohn anticipates he would refer 5 to 10 patients a week from his and his associate's practice to HMC's CMR facility if approved. He feels he could keep the 30 beds filled without taking any patients from Memorial's unit which would still remain operating at capacity. The 21 day stay average at Memorial is shorter than he would expect to see. This is consistent with Sullivan's conclusion, supra. If more beds were available, the stay at both facilities would probably be longer. This is in part because now the patient is getting therapy on the acute care ward while waiting to get into the rehab unit. This pretreatment would be accomplished on the CMR unit if the space were available. As a result, then, the opening of HMC's CMR unit would, in his opinion, in no way adversely affect Memorial's ability to keep its unit full. Dr. Mendelsohn's comments are not biased by the fact that he is a financial investor in the corporation which will operate HMC's unit. Within the pertinent medical community there is a great deal of frustration and anger over the inability to get patients into a rehabilitation center and keep them there for the appropriate length of time. The alternatives to the proposed facility, such as inpatient treatment on other services or in other hospital facilities in the county, or in nursing homes, are not as good. By the same token, outpatient care is not as good because of the unavailability of sufficient treatment due to Medicare and other financial restraints. The difficulties experienced by physicians practicing in the southern Broward County area who desire to admit their patients for CMR service is typified by that of Dr. Jeffrey A. Crastnopol, an orthopedic surgeon practicing in Hollywood since 1984, and a member of the staff at Memorial, HMC, and other hospitals in the area. Dr. Crastnopol sees a wide range of patients from children to the elderly. His practice deals mostly with trauma in children, sports trauma, and trauma related to bone brittleness in the elderly. Almost all his patients live within the southern Broward area. All hospitals where he is on staff are in that area as well. Dr. Crastnopol has chosen not to take patients from outside his geographical area because he has sufficient patients from in his area to keep him busy. In his experience, of all the other orthopedists he knows, none practicing in the southern Broward area is on staff in any of the hospitals in the northern Broward area. Most are on staff at both Memorial and HMC. Most of Dr. Crastnopol's patients are elderly, suffering hip fractures; pelvic, lumbar and spinal fractures; herniated discs; and the complications of arthritis as well as other symptoms. He and his associate saw between 10 and 15 patients with these conditions in the two weeks prior to the hearing. Of that number, he referred at least 3 for inpatient rehabilitation at Memorial and has an additional 4 or 5 other patients now in acute care services who will need CMR services. His trauma cases usually go to the emergency room first or the patient will call him or their primary care physician. The patients frequently request a particular hospital but, if a patient is already admitted to Memorial, he would try to keep that patient there for rehabilitation services. If the patient is at HMC, and if there were a rehab unit there, he would try for admission at that facility. At the present time, only Memorial has rehab beds available for Dr. Crastnopol to refer to and he often has trouble getting a bed for a patient there since it is usually full. The wait for an opening may be from 4 to 5 days or the patient may not be admitted at all. The delay is controlled by physiatrists at Memorial and though they try to be accommodating, frequently patients from outside that facility cannot be admitted. When that happens he then has to consider other institutions further away or nursing homes with less than full rehabilitation services. According to his experience, patients at Memorial will almost always be admitted to Memorial's rehab unit. Patients at HMC may not, and he, as well as all other physicians testifying, indicate there is a difference in the waiting lists. Dr. Crastnopol believes the best thing for the patient is for the doctor to be able to treat these injuries in a rehab unit. To transfer to one where he cannot come is not as good. He believes that patients on rehab units recover faster than those who are in alternative treatment plans. He also contends that home care and outpatient care are not suitable alternatives to inpatient care, especially for the elderly. He agrees with Dr. Mendelsohn that the northern Broward facilities are generally too far from the families of patients from the south. Since he is not on staff up there, he would not be able to provide the continuity of care which he, and all other physicians testifying, feel is so important. Dr. Crastnopol contends that from a clinical standpoint there is need for additional rehab beds in south Broward County. HMC provides a good service, and he has no doubt that it would provide a rehab service of the highest quality if its unit were approved. He would refer patients to it. He treats Medicaid and indigent patients, and in all fairness to Memorial, that installation has never tried to dissuade him from admitting that category of patient to its facility. Dr. Crastnopol took time from his busy practice to travel to Tallahassee to testify here because he feels there is a need for the service applied for. He, too, is an investor in the limited partnership which owns the building in which the hospital is situated, but in no way would this interest prejudice or bias his testimony. At the present time, only between 30 and 40% of his patients are treated at HMC, whereas between 60 to 70% are treated at Memorial. Similar testimony came from Dr. Jose M. Muniz, an internal medicine specialist practicing in Hollywood, Florida for the past 17 years. Dr. Muniz is on staff at both HMC and Memorial and serves as Chief of Staff at HMC. He is also on the utilization review and quality assurance committees there. As with Dr. Crastnopol, his patients are mainly older, 70% of whom are over 65. The other 30% are adult to middle age. Ninety-eight percent of his patients come from Hollywood and the south Broward area. As a result, Dr. Muniz has no hospital affiliation in the north Broward area. Dr. Muniz refers to rehabilitation patients who experience bone fractures and strokes, and he sees patients at both hospitals. He has had some referral problems at Memorial. He feels very strongly about the necessity for continuity of care and asserts it is important for him to continue to see his patients in a rehabilitation unit because they still have an underlying medical problem which he must continue to treat. It is not good for his patients to go far afield for rehabilitation service due to a lack of availability in the immediate area. He cannot continue to treat the patient who thereby feels abandoned, and the family also has additional difficulties in getting to see the patient. Nursing homes, while an alternative to a rehab unit, are not, in Dr. Muniz' opinion, an acceptable one. They have neither the staff nor the equipment to provide the appropriate treatment, and in his opinion, placing a patient who needs rehabilitative services in a nursing home is no more than warehousing that patient. HMC's application has a high level of support in the local medical community. A second rehab unit has been sought by numerous physicians in the area, and Dr. Muniz believes there is a definite need for additional rehabilitation beds to satisfy the need for rehab availability after the acute care condition has been stabilized. He is satisfied that if HMC gets its rehabilitation unit, its quality of care will be as high as that in the other services already provided there. Dr. Jubran Hoche, a Board certified neurologist at Memorial, HMC, and other facilities in the southern Broward area, often has patients who need inpatient rehabilitation services. Most are elderly stroke victims and younger patients with multiple sclerosis, a demographic consistent with prior evidence considered. He sees between 2 and 3 such patients per week. He begins to evaluate his stroke patients for rehabilitation when they stabilize, somewhere between 7 and 10 days after suffering their stroke. He has found rehabilitation beneficial to recovery and currently refers such patients to Memorial from all facilities where he is on staff. He often has trouble getting beds there, however, and over the years has found that patients already in Memorial have a priority over outsiders when it comes to getting into the inpatient CMR unit. Patients from other facilities face a waiting list and as a result, many are transferred outside the southern part of the county for inpatient rehabilitation. This is not a good alternative because it interferes with the beneficial continuity of care cycle and raises numerous other problems. Noting that Memorial plans to open a satellite facility in southwest Broward County and shift beds there, he contends that this will still increase the need for CMR beds in the county. There is already a clear need for more inpatient CMR beds in south Broward. In his experience, HMC provides a good quality service and would provide the same in any approved CMR unit to which he would refer patients from those who presently he cannot get into Memorial's unit. As with the other physicians who testified here, he has taken the time from his practice to travel to Tallahassee on HMC's behalf because of his sincere concern with continuity of care. Testimony in the form of depositions from Drs. Klotz, Bennett, Petti, and Moskowitz, and Mr. Jensen support and reiterate, fundamentally, the direct testimony of the above physicians and administrators. According to Holly Lerner, Administrator and Chief Operating Officer at HMC for several years, NME Hospitals, Inc. is a wholly owned subsidiary of National Medical Enterprises, an international health care corporation. The local facility is a six story hospital with approximately 300,000 square feet in addition to an adjacent office building. Over 400 physicians are on staff from most medical specialties including 5 physiatrists. HMC practices on an open staff basis meaning any qualified physician can apply. Almost all physicians on staff currently are Board certified and there is an internal requirement that all be at least Board eligible. The hospital is accredited by appropriate accrediting agencies. HMC is located approximately 1 mile from Memorial Hospital. It has an active quality assurance program, and any inpatient rehabilitation unit approved would be subject to the same quality review. HMC pays property and indigent care taxes to the taxing authorities. In contrast to Memorial, however, it gets no funds from those taxing authorities for treating indigent patients. It has a Medicare contract and has never turned away a patient because of an inability to pay. If the requested rehab unit is approved, the hospital's current outpatient physical therapy program will move off-site. The new inpatient rehab unit will have physical therapy capability on site. Management of the facility will be by an experienced firm well qualified to run it. All services required for physical therapy by Department rule are currently available and will continue to be provided. The new unit, if approved, will seek CARF accreditation. All variable services are currently provided and will continue to be provided. All optional services, except therapy for children, will be provided. HMC now has transfer agreements with Memorial and various nursing homes within the area. It also has a rehab agreement with Sunrise Hospital and a contract with the state to treat patients at a Medicaid contract rate. If at all possible, management intends to continue this on an inpatient basis. Discussions have been held with the Dean of a nearby osteopathic medical school to have a residency and intern program at the hospital and though it is still in negotiation, the parties have, in essence, formulated a tentative agreement to effectuate this development. Though disputed by Memorial, manpower requirement estimates are considered adequate to properly staff the facility if approved and the personnel costs are also considered reasonable even with cost of living increases over the next 5 years. In that regard, overhead staff has surveyed salaries within the area and tried to stay at the 70% level. HMC's salary levels are somewhat lower than that of Memorial but, nonetheless, HMC has had no difficulty in getting and retaining qualified support staff. Petitioner's evidence in opposition was not persuasive. According to Paul Echelard, Administrator and Chief Executive Officer of Pincrest Rehabilitation Hospital, and Florida Vice President of Rehabilitation Hospital Service Company, (RHSC), a subsidiary of NME which manages rehab hospitals throughout the country and which will operate the rehab unit at HMC, inpatient rehabilitation assesses an individual who has had a debilitating injury, after medical stabilization, for improvement potential, and helps improve his living capabilities. Inpatient rehabilitation helps to restore both motor and cognitive functions. The minimum requirements for a CMR program include 3 hours per day of speech therapy, occupational therapy, and physical therapy, 5 days a week. The actual program administered is tailored to the patient's individual needs. If, for example, the patient cannot take 3 hours per day, it may be less, if such reduction is documented. RHSC operates 31 rehab hospitals ranging from 60 to 101 beds. The contract management division also operates hospitals for others. All are accredited except those which have not yet been open the required 6 months. The management company brings the expertise of NME's rehab division, which has access to hundreds of experts in numerous fields, and provides program management, program development, and program education. Program Management involves the day to day running of the program. Rehabilitation programs and staffing are different from acute care functions. Management personnel are supplied. Program development defines the methodology to be followed in each type of case. It works with the staff, with physicians, and with the community to develop programs designed to fit the needs of that facility and that community. The program education division provides information on benefits of rehabilitation in areas where such is not well known. It educates hospitals in the area as well as physicians and the community. For these services, the company charges a fee of $105.00 per patient per day which includes the salary of the medical director of the rehab unit and several other supervisory personnel. Though one might see complex, high level cases at HMC, where there is a need for a lot of high level supplemental medical treatment or procedures, the patient probably will not be treated at HMC. If HMC's program is approved, transfer agreements will be entered into with Sunrise or Pinecrest Rehabilitation Hospitals to take care of those patients whose conditions are too severe or too complex for the inpatient CMR unit at HMC. South Florida's normally more elderly population generates a higher need for medical rehab services. Also, medical science now saves people who, before, would not survive their basic illness, and these people generate a greater need for medical rehab services. The utilization of rehab services has increased significantly since 1988 as the result of Medicare, and due to an increased awareness of the service by physicians. Also, insurance companies now recognize the benefits of dollar savings of rehab over acute care treatment. Another factor involves the implementation of DRG's which exempted rehab, among other areas, from the DRG limits. With this development, however, services and personal criteria for inpatient rehabilitation patients were developed to insure against abuses. Not all hospitals can meet these criteria, but the number of providers has grown fivefold due to the recognition of the health and financial benefits to society. In Mr. Echelard's opinion, the payer projections by categories of payer found in the application are reasonable and based upon the applicant's experience. The personnel costs are in addition to the $105.00 per day fee charged by RHSC. The assumed 65% utilization figure for the first year can easily be accommodated by the staff which is more than adequate to meet the requirements of good quality of care. Much the same can be said for the second year with the increase in both patient census and full-time employees. The salaries projected in the application are generally reasonable, though a few may be somewhat low. RHSC would help to recruit personnel for HMC's facility. It has a national recruiting program and sends recruiters to universities and conferences across the country. All RHSC facilities are open to serve as clinical training facilities. They advertise widely for personnel though they do not "head hunt" at other hospitals. As a result, Mr. Echelard feels HMC would have no trouble getting enough qualified personnel, and it is so found. Turning to the unit itself, from a physical standpoint Mr. Echelard has no trouble with the currently existing physical therapy unit being geographically separated from the bedroom area. In fact, this may be beneficial as it tends to simulate the real world and may increase patient mobility skills. He considers the proposed layout to be acceptable and to meet accreditation standards. The proposed patient charges of $1,078 per day is considered reasonable and closely approximates the $1,050 per day charged at Pinecrest as well as other competing providers. Sharon Gordon-Girvin, a health care consultant and formerly the chief of the Department's Office of Community Health Services, reviewed HMC's instant application for Memorial. HMC's application describes it as a provider of primary and secondary services, a general description of a normal acute care hospital. It has no licensed tertiary services. Five hospitals in Broward County are licensed to offer CMR services. They include Petitioner, Holy Cross, North Broward Regional Medical Center, St. Johns Hospital and Sunrise . Only one of these, Memorial, is in the south Broward region. District X, with the 5 providers offering a total of 213 CMR beds, has more CMR beds than districts in the rest of the state with the exception of Dade County. Other districts have greater population with fewer licensed beds, but it must be noted that without information on demographics, that statistic is of little import. Under the pertinent Department rule, the planning horizon for CMR beds is 5 years into the future. Bed need determination is provided for in Rule 10- 5.039, F.A.C., and consistent therewith, the Department did a projection of bed need for 1996 which showed a new need of 88. Because the number of existing beds exceeded that figure it determined the need to be zero. Even if there is a zero need, however, the rule provides 4 other factors for consideration, (Rule 10-5.039(2)(b)1-4), but in her opinion, HMC's application is not consistent with these 4 factors. One of these deals with historic, current and projected incidents of illness. This witness does not believe there is adequate evidence or discussion in the application of any historic incidents of disease sufficient to support any future prevalence. There is no data as to sex or group of patients. The second deals with trends by categories. Here the application, she feels, contains no detail of payment trends shown as to categories of payor. As to the third criterion, dealing with existing and projected inpatients in need of rehabilitation services, the application does contain some information in its Exhibit 17. The fourth criterion relates to availability of specialized staff, and the application discusses how the staff will be recruited, but not the availability of qualified personnel to fill the positions. In that regard, it is well recognized, she contends, that this type of staff is in short supply. Other evidence of record would tend to confirm this opinion. Ms. Gordon-Girvin indicates that the 1989 State Health Plan is pertinent to this application. This plan contains 5 preferences to be used in evaluating applications. These include: Conversion of excess acute beds. Here, the application conforms but Ms. Gordon-Girvin cannot say if the per diem costs would be lower by conversion. Specialty rehab services not currently found in the District. Here, no services not already available were proposed. Teaching hospitals. This is not truly a statutorily mandated teaching hospital even though evidence shows staff may be made available as faculty at the osteopathic medical school with which HMC plans a collaboration. A disproportionate share of charity care. Here, Ms. Gordon-Girvin feels that HMC is not such a provider and that its application is not consistent with this preference. Existing comprehensive outpatient rehab facility. This, again, is not met by the applicant. These preferences are, it must be noted, not mandatory for approval. The 1990 Broward Regional Health Plan is also applicable, and it outlines 3 priorities in its review criteria. These are: The applicant agrees to cooperate and provide data on utilization. In this regard, HMC's application is consistent. Unserved populations. Here, Ms. Gordon-Girvin contends that the instant application does not meet the preference since it is not for construc- tion of a new facility. Situations where the institution's occu- pancy is greater than 85%. Here, clearly HMC does not meet this criteria because it does not have a history of 85% occupancy. Again, however, these are merely guidelines to apply among competing applications and are not preconditions to approval. Ms. Gordon-Girvin points out that the need for CMR services is not considered on a less than district-wide basis, since the rule directs an evaluation of tertiary services on a district-wide basis, and, therefore, the breaking down of the district into north and south services areas is inappropriate. She asserts that in her opinion, the existing rule based on need is not an adequate predictor of need within a district. Instead, she feels the methodology used in Exhibit 17 to the application and omissions response is reasonable. However, she disagrees with HMC's calculations therein because, while the model is credible, the wrong data (the length of stay from 1984, rather than the actual current length of stay) was used. She feels district experience for length of stay (21 days) should be used. Ms. Gordon-Girvin also feels that the methodology used on Application Exhibit 18 is also not appropriate because the variables were not kept constant. It used some date from the sub-area which should not be done because of the rule requirement to treat tertiary services on a district-wide basis. She does not explain, however, that if the rule shows a need for 88 beds and there are already 173 beds licensed, the rationale for a subsequent approval of those excess beds. In that regard, then, the question she does not answer is, if one aspect of the rule is disregarded, cannot another also be disregarded with equal validity? HMC has urged the calculation as set forth in Exhibit 20 of its application, but Ms. Gordon-Girvin does not agree with that because it uses a constant rate of increase in the admissions rate. It also does not ground its assumptions on any existing realities. The initial figure for admissions in 1991, she opines, is overstated, and it, too, does not use accurate real information. If the 3,009 figure were corrected to an "actual" figure, it would result in a net loss of 27 beds and an increase of only 9 additional beds by 1996. She contends that Exhibit 20 is not consistent with the existing rule methodology, because the proposed facility to open in 1993, not 1996. As a result, she sees no need to compute the need in 1996. As to her disagreement with the 4.5% growth in annual admissions, she claims the actual rate shows a decrease from 1990 to 1991. Therefore, the table containing that growth assumption is not justified. She also disagrees with Exhibit 21 because it is applied to a subdistrict and her other objections, (no historical basis for utilization numbers), are also pertinent here. Accepting that the current rule is not a good predictor, she looked at the dispersion of population and beds and determined that there are about twice as many elderly in the northern part of the county as there are in the south. Applying this to the southern area, there should be a total of 46 beds there. Therefore, she asserts, that while there is a need for new beds in District X, all should be in the south, but not as many as requested. If the 30 beds applied for by HMC are approved as well as those approved for Memorial, this would result in 56 beds or 10 too many. In her opinion, based on the incidence model with some adjustment, the actual need is for somewhere between 5 and 20 beds district-wide which should all be located in the south county. Her reasoning and conclusions, however, are not persuasive. Ben F. King, Vice-President for Finance of the Florida Region, Eastern Division of NME, and an expert in health care finances, is satisfied from his familiarity with the application in issue here that the project is financially feasible in both the short and long term. The proforma submitted by HMC in the application, and amended in the omissions response, refers, among other things, to patient day projections. These are converted to revenue by taking the days listed and multiplying by the charge for room and board for each year, and he is satisfied that the rates listed are reasonable. The listed revenues are not what is actually collected, however. They are reduced by deductions for Medicare, Medicaid, indigent, and write-offs (discounts) for health maintenance organizations and insurance companies. In year 1, Medicare contractual is calculated based on reimbursement founded not on cost but on DRG (diagnostic related grouping). This results in no additional reimbursement for patients already in the hospital on an admitting DRG. Therefore, the first year revenues are much lower than in the second and subsequent years. Moving on to year 2, however, the operator gets paid for costs of operation of the unit. Medicare tracks the per-diem costs and income from the hospital, and to be conservative in the preparation of this pro forma, HMC took the existing reimbursement rate of slightly more than $700.00. In calculating reductions, indigents are assumed to be a 100% write-off. Private payments are considered to be a 50% write-off, HMO's a 20% write-off, and insurance an 11% write-off. Mr. King considers all these to be reasonable and consistent with the current experience not only of HMC and NME but of other providers as well. In Broward County, indigent patients are funneled to the county hospitals which receive tax funding for that purpose. This is different from other counties which contract with hospitals to provide indigent care. HMC calculates its revenue estimate in what it considers a conservative manner. Taking off the contractual allowances for Medicare and Medicaid and the other write-offs results in a reduction of more than 50% of gross revenue, and from that figure is taken the expenses, depreciation, interest, etc. to get to the net revenue figure. All the expense categories and the factors they include are considered reasonable by Mr. King. The salary and wages figure includes an add- on of 20% for benefits, which is above the figure for salary and wages found in Table 11 of the application. Supplies includes the provision of housekeeping services, laundry and linen, and dietary services. These, too, he considers reasonable. RHSC's management fee of $105.00 per day includes the personnel provided, the marketing services, the management services, and manuals. This is considered a valuable benefit and the fee is considered comparable with other units. The personnel sent to do the actual work are RHSC employees and not hospital employees. The indigent care assessment is 1.5% of net revenue and is a tax paid to the state. Contract costs are ancillary expenses for ancillary services such as laboratory, pharmacy, etc., already provided by the hospital. The cost listed in the pro forma is only for additional patients generated on the unit in issue. General and administrative - other expenses (joint venture rent, recruitment, insurance, utilities, property taxes, maintenance, education, etc.) are also deducted, and taken together, the above results is an operating revenue net loss for the first year. Depreciation and amortization are self explanatory as is interest expense which is calculated at 10%. Interest rates are anticipated to drop in the future, however, and this will help the picture. The net loss projected for the first year does not necessarily mean that the project is not financially feasible since financial feasibility is calculated over a 5 year basis. In the second year of operation, revenues are projected to increase by 6.5%, a figure considered to be reasonable. Expenses were inflated at 5% except for those not fixed to inflation (indigent care assessment and the joint venture rent). NME has the funds to commit the initial capital and working capital for the first year. The 1989 and 1990 NME financial statements submitted with the application are those most current to filing. These statements, along with the 1991 capital budget, show more than $750,000.00 committed to the start-up of HMC's program. Much of the information presented by Mr. King in his testimony comes from the pro forma and the amendment thereto. Primarily, the difference is only in the amount provided for RHSC's management fee. Any other inconsistencies or errors shown to exist are, for the most part, minor. The entire project is based on 30 beds. The figures assumed for both revenue and expense are reasonable, considering the "other" factors testified to by the physicians and noted previously. This is so notwithstanding the fact that HMC has experienced only a 30% use rate in its acute care beds. However, in light of these other factors, there may not be any correlation between acute care and rehab either from the Medicare or other standpoints. According to Madeline Hellman, Administrative Director of Rehab Services for Memorial, CMR is a high intensity program as well as a high cost program because it uses a large number of professionals to treat the patient in a multi-disciplinary program. Memorial's existing unit has 22 beds in semiprivate rooms. It has an admissions process designed to insure that appropriate patients only are admitted. These patients are made up of a high percentage of stroke, orthopedic, and spinal cord and head injury patients. Memorial's program is a program accredited by the state and the unit is accredited by CARF, a national certifying organization dealing with quality of care. The average length of stay on Memorial's unit is presently just under 25 days which constitutes an increase over time due to the more complicated types of cases taken in. In 1991 the occupancy rate was between 98 and 99%. Memorial gets referrals from both in-house and other facilities. The patients are evaluated by the medical director for the potential to go through the rehab process. If inpatients at Memorial, they are evaluated by the therapy staff and a meeting is held to decide on admission. If the patient comes from another facility, he/she gets priority behind Memorial's patients. In order to be admitted, a patient must have a rehab diagnosis; be able to withstand the 3 hour sessions; be motivated; and have the potential to improve his/her own independence. The refusal to admit a patient does not necessarily indicate a Memorial was too full to accept that patient. It may just be the patient is not an appropriate candidate for rehab, or the patient may die or recover without rehab before getting through the admission process. Some may be referred to nursing home placement instead. Ms. Hellman's figures reflect that in 1990, approximately 42% of those referred to Memorial's unit were admitted. Approximately 35% of those referred were deemed inappropriate. Only 4% were refused admission due to bed unavailability. Many of the non- admittees went home without treatment, went to home care, or came back as outpatients. This witness examined Memorial's admissions records and determined that in 1990/1991, Dr. Hoche, who testified on behalf of HMC's application, referred 9 patients to Memorial of whom 6 were admitted. One went to another facility by choice, 1 was not appropriate, and 1 was not accounted for. Neither Dr. Klotz nor Dr. Pettie referred any patients during that period. Dr. Moscowitz referred 1 in 1990 who was admitted. One patient was referred in 1991 but was not admitted because the patient was not an appropriate candidate. Dr. Bennett referred 1 in 1990 but the patient was not an appropriate candidate. In 1991 he referred 2 but both went to nursing homes instead. During this period Dr. Mendelsohn was the medical director. Dr. Crastnopol referred 12 patients in 1990. Four were admitted; 2 were referred to other facilities; 2 were not considered appropriate candidates, and 2 were not accounted for. In 1991 he referred 17 patients, 8 of whom were admitted. Two of the remainder went to another facility by choice; 1 was refused due to no room; 1 went home; and the rest were unaccounted for. Dr. Manning referred 1 in 1990 who was admitted. Admittedly, according to Ms. Hellman, there is a waiting period of from 1 to 5 days from referral to admission - on the average, probably 3 days. This has decreased somewhat since the summer of 1991. The situation depicted by Ms. Hellman's figures differs radically from that described in the testimony of the physicians to whom she refers. On balance, the physicians' recollections and impressions of the situation are deemed of greater probative value than the bare statistics. Memorial staff salaries went up 9% last year across the board and are anticipated to go up again this year. The ancillary staff devotes 75% of its time to patient care and the other 25% to administration. This extra non- patient time is considered in assessing staffing to insure there is enough staff to do the full therapy load. There is a great deal of competition in the market for both nurses and therapists. A shortage exists which is nationwide and requires heavy recruitment efforts. At Memorial, no contract labor is used to assist in the unit. Benefits constitute an additional 24 - 25% of the salary cost and is not included in Memorial's determination of the salary and wage costs. Ms. Hellman reviewed HMC's proposed staffing as outlined in its application and feels that after taking out 25% clerical time and weekends, the social worker, for example, will only be able to handle 65% of the beds. Speech therapy would require additional people to take up the extra time on other therapies. Taken together, it is her opinion that the staff proposed by HMC is insufficient to provide a quality program. As to salaries, she feels the amount designated by HMC is low. The salaries proposed would be enough to get only new graduates and would force a high turnover. A CMR unit requires an experienced staff, (at least half of the therapy staff), to provide a quality program. Ms. Hellman is of the opinion this cannot be accomplished at the salaries proposed by HMC. In regard to both salaries and staffing level, however, Ms. Hellman's negative comments are offset by those in support of the application, and there is insufficient evidence to the negative to support a finding by a preponderance of the evidence as required that the proposed staffing levels and salaries are insufficient. HMC's 30 bed unit would compete directly with Memorial's existing unit. They are less than a mile apart and use many of the same physicians. They attract the same patients. In addition, Ms. Hellman does not believe HMC's unit will offer any new service not already offered by Memorial, nor will it operate services not already present or offered by existing providers in District X. It is her confirmed opinion that if HMC's unit is approved, it will be difficult for both facilities to attract and retain an adequate professional staff. The majority of patients that Memorial cannot accommodate are referred to Sunrise Hospital, also located in Broward County, which offers a good CMR program. Total referrals in 1990 exceeded 800 patients, and in 1991, in excess of 600 patients. The referral log maintained by Memorial does not include patients who were not referred because their physician felt there was no room anyway. Memorial's records supposedly indicate that in the last two years, only 80 to 90 referrals to its unit came from other institutions. The records were not introduced into evidence, however. Edward J. Maszak, Director of Financial Planning for Memorial, and an expert in health care financing and third party reimbursement, noted that Memorial is a disproportionate share provider under both Medicaid and Medicare. It is a taxing authority which uses funds received in taxes for the care and treatment of indigent patients. It gets $20 million in tax revenue but gives $23 million worth of indigent care in addition to taking $27 million of bad debt write-off. About $10 million of the indigent care cost is funded out of operations. The Hospital Cost Containment Board, (HCCB), statistics submitted by HMC for 1989- 1991 reflect no deduction for charity care in either the 89-90 or 90-91 time-frame. Mr. King, testifying for HMC, indicated there was no advantage to reporting charity care to the HCCB, and it is for that reason that the statistics show no deduction. Mr. Maszak disagrees with Mr. King on this point, and states that to the extent it provides any charity care at all, a facility can raise the prices it charges to some degree. Mr. Maszak reviewed HMC's application and the "incidental cost analysis" basis for the financial pro forma, and in his opinion, HMC's application does not contain a true feasibility study. The projected statement of revenue and expense in the omissions response reflect incremental costs only and do not include the actual, full costs. In a financial statement one looks at a lot of other revenue factors including operating projections and total margins, cash flows and the like, none of which are included in HMC's financial information. The financial feasibility study done by HMC here is not, in Mr. Maszak's opinion, consistent with generally accepted practices and standards. Memorial's CMR unit has lost money over the last 3 years due to the fact that it provides about 70% of its care to Medicare patients. Under that system reimbursement does not fully meet costs. Therefore, the loss has to be covered by income from other payees, (cost shifting). This is not specific to Memorial only, however. Most hospitals experience the same problem. As a result, it is hard to make up the losses from Medicare, Medicaid, and HMO operations from the 9% of patient mix representing full pay patients. In Mr. Maszak's opinion, if HMC gets its approval, in year 3 it would be subject to the same problems experienced by Memorial. Mr. Maszak asserts that with the new beds, HMC's overhead cost allocation will, under Medicare rules, increase by 19% in the first year and by 25% in the second year. This will add at least $570,000.00 additional costs in year 1 and $800,000.00 additional costs in year 2 to expenses. In year 2 the cost will be shifted to Medicare so the expense item in that year will be more by slightly more or less than $200,000.00. With regard to specific defects in HMC's proposal, Mr. Maszak points, with regard to managed care plans, to the HCCB documents which show that the HMC writes off about 65% of its revenue from HMO's. This was for 1991. Pinecrest, for example, wrote off somewhere around 38.5% that year. He believes, therefore, that HMC's figures are inaccurate. Regarding charges for CMR services in District X, HMC's 1993 charges, using its own projections, would be $1,077.00 per day. Sunrise would charge $1,765.00 per day, and Pinecrest, $1,683.00 per day. Memorial will charge $557.00 per day; Holy Cross, $747.00; and North Broward, $564.00 per day. Based on these figures, Mr. Maszak concludes that HMC's HMO estimated income is unreasonable. He contends it will be much less than estimated and more comparable to that of the other providers starting at a discount from $557.00, plus or minus, per day. Mr. Maszak is of the opinion that the insurance estimate indicated by HMC also is unreasonable. The 4% estimated by Mr. King is too low by far, and there are no national HMOs for HMC to contract with for rehab services in District X, he contends. He also believes that as to the salaries and benefits, in 1991 Memorial showed 57.8 full time employees, (FTEs), with an average nursing salary of $27.4 thousand per year. In that regard, benefits as a percent of salary was 32.2%. Sunrise showed an average nursing salary of $29.4 thousand with benefits at 27%. Pinecrest reflected $27.7 thousand and 41% respectively. Based on this, Mr. Maszak believes that the HMC projection of $22.5 thousand for salaries and benefits of 20% are far below current salaries at other NME facilities. It is unreasonable to assume, he asserts, that a provider can start up a competing unit in an open area and attract staff at those figure. Taken together, he considers that the difference between Memorial and HMC's salary figures is a $4 thousand difference for a total of $125 thousand low for HMC without considering inflation for 2 years to 1993. Turning to the issue of payor mix, according to Mr. Maszak, Medicare is reflected at 65% by HMC, but the HCCB data shows only 58% for 1991. The County reports for Memorial showed a rate of 60%. Mr. Maszak believes that HMC's estimate overstates a patient days percentage by 5% which could result in an overstatement of income revenue. Therefore, he believes the entire rehabilitative program, as suggested by HMC, is not feasible in the short term because of a number of expenses which are not figured in. He admits that HMC's current financial position is fair. It is reported to be slow in paying its bills and lost $1 million last year alone. In addition, the interest due NME has not been paid and is increasing. These claims were not supported by actual evidence, however. In addition, 65% of the population in the service area is under Medicare which limits increases to 3.2 % per year. Notwithstanding that, expenses are going up at a higher rate, (5%), and, therefore, he contends, HMC's program is not feasible as well over the long run. According to Mr. Maszak, the opening of HMC's facility would also affect Memorial's status. The staff is much the same for both facilities and many of the physician's on staff at Memorial are also investors in the HMC facility. If HMC gets its unit, Maszak feels many patients will be referred to that facility by its investors instead of to Memorial where they would now go. Based on the number of projected patients, however, this really should not result in a reduction in Memorial's numbers. The rehab service is not the only consideration, however. In addition, the admitting services , (neurology, neurosurgery and orthopedics), would also be impacted. Considering various potential scenarios, from a loss of all HMC business in all services, and no reduction of expense, through others including loss of all services with some expense reduction, loss of rehab only with some expense reduction, to a loss of 50% of all services with some expense reduction, the loss impact on Memorial would extend from a low of $264.5 thousand to $3.1 million. The most likely loss figure, he estimates, would be somewhere around $800 thousand. Therefore, approval of HMC's project, he contends, would have a large impact on Memorial's, operation because of its ongoing expansion plans and their attendant expenses, plus the recent sale of $40 million in revenue bonds. As to the latter, the underwriters of that issue are already unhappy with Memorial's financial picture. Any loss of income might likely result in a need to raise prices, but Memorial is constrained in that regard by the dictates of the HCCB. A second option is to raise taxes in the District, but there the District only has .4 of a mill leeway before reaching its limit of 2.5 mills. A third option is to cut services, but with the economy as it is, and the high level of charity care already being provided, that would be hard to do. Thomas R. Bayless, President of Future Health, Incorporated, a health care consultant and an expert in health care finance, also reviewed HMC's application and omissions response, its audited financial reports, the HCCB reports for HMC and others, and other documents. He believes the cost projections outlined in HMC's omissions response do not account for all contract costs. Thirty new beds would have a greater impact on costs than is estimated. The amount shown on the HCCB cost report for the whole hospital is more than the estimated costs for the whole hospital including the rehab unit in year 1. Mr. Bayless believes that the $366,308.00 figure for the unit in year 1 should be more than $1 million. In year 2 he sees it as $1.3 or $1.4 million as opposed to the $512,602.00 projected. By the same token, the general and administration costs reported at over $6 thousand for the whole hospital in 1991, with the 19% increase for the year, would be over $1 million and a great increase in year 2 over the $394,941.00 projected. Therefore, since all costs were not included to the appropriate degree, he contends in reality there would be a significant increase in the cost of operation of the rehab unit which would result in a much larger net loss than was projected, (plus or minus $2 million) in year 1. In year 2, due to the commencement of reimbursement from Medicare, the impact would be less. Nonetheless, the net income profit would not be as great as projected and might instead result in a loss of some $300 thousand to $400 thousand. Taken together, he concludes that expenses and some allowances are significantly understated. For example, the "other deductions" figure of $477,108.00 should be higher due to the percent of HMO discount which, in Bayless' estimate, should be 60% rather than the 20% utilized. This nearly doubles the amount of the deduction. He also disagrees with HMC's indicated deduction for rent, corporate overhead, salaries and wages, and other expense items, all of which, he believes, should be increased. The "benefits" aspect of salaries should be increased as well since the 20% projected is, in his opinion, insufficient. Memorial's figure, at 24.8%, is the standard for the area, he contends. Making those changes, the year 1 net loss for HMC's operation would be almost $3 million rather than $485,739.00. By the same token, year 2, even with Medicare cost reimbursement would result in a loss of almost $700 thousand rather than a profit of almost $1.4 million as projected. In further years out, ( years 3 - 5 ), due to the limits imposed by TEFRA and projected cost increases of 5%, the loss would be compounded somewhat. This would constitute a continuing loss and Mr. Bayless believes the project is not feasible in either the short or the long term, especially considering the fact that the hospital has been losing money without this unit and, it appears, will continue to do so. The hospital has been living on an infusion of money from the parent corporation, and this does not, to him, appear to be an appropriate use of capital. Mr. Bayless contends that most of what he said about the unit projections applies as well to the consolidated hospital rehabilitative unit projections. The losses from the operation of the rehab unit and the other defects show a loss of $7 million in year 1 and almost $6 million in year 2. Year 3 would also show a loss of almost $6 million. As another problem, Mr. Bayless opines that the statute requirement to provide information on costs during construction and the effect of the project on the applicant's and others' operations was not met. Considering the parties' respective positions, however, it is found that though subject to some debate, HMC's projections as to patient revenue, expenses, and its ability to attract a quality work force without seriously damaging Memorial's ability to provide quality care have not been shown to be unsupportable. They are, therefore, accepted. Morgan Gibson, a review consultant with the Department's Office of Community Medical Facilities, and an expert in health planning, reviewed the instant application in early 1991. When the application was deemed complete, he initiated the formal comparative review of this application and of Memorial's request for 4 beds; did an analysis; and completed the required State Agency Action Report, (SAAR), for each. A fixed need pool was published for this cycle, (January, 1996), showing a "0" numerical need. Gibson's review indicated the project was consistent with the 1990 District X Comprehensive Health Plan which establishes various priorities for the award of CONs. Priority 1 relates to an applicant who demonstrates a willingness to publish information. Both applicants met this priority. Priority 2 relates to applicants who agree to construct additional facilities to provide service to the unserved public. Here, neither application involved new construction, but both applicants were willing to provide charity care with HMC's to be at 1%. Priority 3 applies to those applicants who have a history of operating at greater than 85% utilization. HMC's hospital alone could not meet this level, but the proposed unit was projected to meet it by year 2. Priority 1 of the 1989 Florida State Health Plan relates to facilities which will convert excess beds to comprehensive beds. HMC proposes to do this which is cost effective and gets more beds to the patients. Priority 2 of this plan relates to those who propose specialty services not currently offered. HMC's answer was vague but it agreed to provide a wide range of rehab services, and the fact that it does not focus on a single specialty does not make it less desirable. Priority 3 relates to teaching hospitals. HMC is not a teaching hospital but it has agreed to affiliate with a school of osteopathic medicine in the area. Priority 4 relates to those facilities with a history of providing a disproportionate share of charity and Medicaid. HMC does not now do this but has agreed to provide 1% charity care. Priority 5 relates to those facilities showing a willingness to provide outpatient follow-up rehabilitation services, and HMC has agreed to do this. Mr. Gibson concluded that the HMC project would increase availability and access to services and would improve quality of care. He also reviewed the application against the Rule 10-5 criteria. Existing rehabilitation beds in the area are highly utilized, (Memorial is at a figure close to 100% and is the only provider in the service area). Because of this, he considered the establishment of new beds in South Broward to be better than forcing patients to go to existing beds in the North Broward area. He found that the 30 beds proposed by HMC met the unit size minimum of 20 beds and the projected utilization met the standard of 65% for the first year and 85% for the second year. He concluded that the utilization rates in the district support the program. All but one provider are operating at above 90%. In that regard, since there are only 22 beds currently existing in the south portion of the county, and all providers but one are utilized at over 90%, the new unit could not help but improve the availability to the service in the District. It is so found. The local health council data revealed to Mr. Gibson that while admissions generally decreased by 4.5% from 1985 to 1989, rehab admissions went up 189.4% in the same period. This indicated to him a potential need and increasing utilization. He also concluded that the information provided by HMC was reasonable and not fairly disputable. In that regard, Mr. Gibson concluded that HMC presented information to justify the beds regardless of the rule methodology showing "0" need. The supporting factors for this conclusion were: (1) the high current utilization; (2) the relationship of rehab admissions to discharges; (3) the service pattern; (4) the existing waiting period; (5) the elderly population in the service area; (6) the potential rehabilitation discharges; (7) the conversion of underutilized acute care beds; and (8) the maldistribution of beds between the north and south part of the county. Taken together, Mr. Gibson concluded that the addition of 30 new beds by HMC would have a positive effect, not an adverse one, on the provision of service in the community. HMC indicated its intention to seek CARF accreditation, and it appeared to meet the other quality of care standards. CARF accreditation is important. All the facilities operated by the proposed management corporation are accredited by CARF. In addition, Mr. Gibson saw no adequate alternative to the program. Maintaining the status quo was obviously not effective. Neither was building a new facility. As a result, the conversion of underutilized beds appeared to be the most appropriate resolution of the problem. He also concluded that the proposed plan was reasonable. There was a demonstrated need for additional beds and it appeared this project would meet that need without the necessity to expend millions of dollars to create a new facility. The project did not involve cooperative services or shared facilities, but this is not a disqualifier. By the same token, there is no teaching facility currently available. Neither factor really applies to this project, however. Mr. Gibson determined that HMC had the financial resources to accomplish the proposed project. Its financial statement showed that it and its parent company both were in good financial health. The project cost could easily be met by existing resources. The applicant indicated that staffing levels would be met and the retaining of a management company to operate the facility was a plus factor. Before rendering his opinion, Mr. Gibson consulted with the Department's financial consultants, and based on the applicant's projections and assumptions, if the utilization levels of 65% and 85% for years 1 and 2 respectively were met, the project would be financially feasible in both the short and the long term. Mr. Gibson concluded that the utilization projections were reasonable based on current utilization of existing beds. As to fostering competition and cost effectiveness, Mr. Gibson determined that based on the current high utilization rate, the new beds should have no impact on existing services provided by Memorial in the south and the other existing providers in the north. With regard to charity care, HMC admitted that up until this time it had reported little or no charity care provided. Because HMC admitted that, however, Mr. Gibson was willing to accept its assertion as to what it proposed to do in the area in the future. Turning to the criteria outlined in Section 381.705(2), Florida Statutes, Mr. Gibson found: (1) there was, practically, no less costly or more appropriate alternative to the proposed service; (2) the existing service was being utilized efficiently; (3) there were no reasonable alternatives to conversion; and (4) there was some showing of a shortage of available service and no showing of serious problems existing in providing those services. Based on all the above, Mr. Gibson recommended both this application and Memorial's application be approved conditioned on the provision of a certain percentage of charity care. Mr. Gibson admits there is, on balance, a general shortage of rehabilitation personnel, but cannot say whether or not there is a shortage in Broward County. His conclusion that staff was available to HMC was based on several other factors such as the management contract and the proposed recruitment - all representations by the applicant and not based on his own experience. By the same token, he did not test any of the tables for revenues, costs, salaries, etc. Here again he relied on representations by the applicant. In addition to those aforementioned statutory criteria Mr. Gibson evaluated this application against the Section 381.707 criteria as well, and determined it was complete. It is clear, however, that his evaluation was not done in great detail, nor did he attempt to verify much of the other information submitted in support of the 381.705 criteria. The financial aspects of the project were analyzed by an in-house departmental CPA, Mr. Bell. Gibson's involvement was limited to examining the projected admissions, utilization, charges and the like, and based on those, he relied on Mr. Bell's determination they are reasonable and his opinion on feasibility. Nonetheless, Gibson drew his own positive conclusion of feasibility which was cited above. There appears to be no legitimate reason to reject any of the findings of conclusions drawn by Mr. Gibson. Therefore, they are accepted. Elizabeth Dudek, the Chief of the Department's Office of Community Medical Facilities, met with Mr. Gibson, Mr. Bell, and the architect after reading both the applications and the SAAR and, thereafter recommended the project be approved. After considering the application, the projected utilization, the existing inventory, the state and local health plans, the area where the facility was to be located, and at the provisions of the pertinent statutes and rule, she believed the project proposed was justified. She concluded both HMC and Memorial should be awarded the beds requested. Her reasons therefore conform to the findings of Mr. Gibson regarding existing providers and the high utilization rate. The trade patterns support a division of service between the north and the south. She determined that because this application did not meet all preferences and priorities as outlined in the various health plans did not necessarily mean it should be denied. By the same token, the fact that comprehensive rehab services are considered by the Department to be a tertiary service does not mean that the service must be provided only in teaching hospitals. Ms. Dudek recognizes that Section 381.707(2)(d) requires a detailed statement of income and revenue which includes the two year pro forma assumptions, Table 25, and the list of capital projects. Her review of the matters provided by the applicant and the audit and source of funds referenced led her to the conclusion that requirement was met. There is no basis shown upon which to reject that conclusion or to conclude otherwise.
Recommendation Based on the foregoing Findings of fact and Conclusions of Law, it is, therefore recommended that NME Hospitals, Inc.'s application for a Certificate of Need, Number 6643, for a 30 bed inpatient comprehensive medical rehabilitation unit at Hollywood Medical Center be approved, but that its Motion For Attorney's Fees and Costs be denied. RECOMMENDED this 2nd day of June, 1992, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 2nd day of June, 1992. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-5698 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. Accepted and incorporated herein. 2. - 4. Accepted and incorporated herein. 5. Accepted and incorporated herein. 6. Accepted. 7. & 8. Accepted and incorporated herein 9. Accepted and incorporated herein except for last sentence of first paragraph which is rejected as contra to the evidence. The second paragraph is accepted but is considered irrelevant to the issues. & 11. Accepted and incorporated herein. Accepted. Not a Finding of Fact but a restatement of testimony. First and third sentences are restatements of terstimony. Second and fourth sentences are accepted. Accepted. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Rejected. Not a Finding of Fact but argument. Accepted as to witness' testimony but not as to an an evaluation of its worth. All but the last sentence is a restatement of the witness' testimony. Last sentence is accepted as Petitioner's position. First two sentences accepted and incorporated herein. Balance, though a restatement of testimony is fundamentally accurate and consistent with the evidence. Though consistent with Petitioner's position, and perhaps factually accurate,this ppoposed Findings is rejected as overlooking the "other basis" provisions of the need rule. Accepted as an accurate statement of the factors involved, but this position was rejected in the Findings of Fact portion of the Recommended Order. - 28. Rejected as contra to the weight of the evidence. All but last sentence accepted and incorporated herein. Last sentence rejected. Accepted and incorporated herein. Rejected as argument and contra to the weight of the evidence. Rejected as argument. - 37. Accepted as an accurate restatement of the evidence, but rejected as to the ultimate factual conclusions drawn. 38. - 40. See next above which is reiterated here. & 42. Accepted as to the testimony presented but rejected as to the efficacy of the analysis. Accepted as to content but not as to analysis. & 45. Contents accepted as an accurate restatement of the testimony but conclusions drawn are rejected. Rejected. First paragraph accepted. Second paragraph rejected as speculation. Accepted and incorporated herein. Accepted. First sentence accepted. Remainder rejected as speculative with no historical basis. FOR THE RESPONDENT, NME: - 8. Accepted and incorporated herein. Accepted and incorporated herein. - 14. Accepted and incorporated herein. - 19. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. & 23. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Not a finding of fact but a comment on the evidence. 27. - 29. Accepted and incorporated herein. 30. Accepted and incorporated herein. 31. Accepted. 32. - 34. Accepted and incorporated herein. 35. - 37. Accepted. 38. - 40. Accepted. 41. & 42. Accepted and incorporated herein. 43. Accepted. 44. - 46. Accepted and incorporated herein. 47. & 48. Accepted and incorporated herein. 49. Accepted. 50. - 52. Accepted. 53. & 54. Accepted and incorporater herein. 55. Accepted. 56. - 58. Accepted and incorporated herein. 59. Accepted. 60. Accepted and incorporated herein. 61. - 63. Accepted. 64. - 68. Accepted and incorporated herein. 69. - 75. Accepted and incorporated herein. 76. Accepted and incorporated herein. 77. Accepted. 78. Accepted. 79. Accepted. 80. Accepted and incorporated herein. 81. & 82. Accepted. 83. - 86. Accepted and incorporated herein. 87. Accepted and incorporated herein. 88. Accepted. 89. Accepted and incorporated herein. 90. Accepted. 91. Accepted and incorporated herein. 92. Accepted and incorporated herein. 93. Accepted and incorporated herein. 94. - 97. Accepted and incorporated herein. 98. - 100. Accepted and incorporated herein. 101. & 102. Accepted. 103. - 106. Accepted and incorporated herein. 107. Accepted and incorporated herein. 108. Accepted and incorporated herein. 109. Accepted. 110. Accepted. 111. - 114. Accepted. 115. Accepted and incorporated herein. 116. Accepted. 117. & 118. Accepted but more a comment on evidence than finding of fact. 119. & 120. Not a finding of fact but a comment on evidence. 121. Accepted. 122. - 125. Not findings of fact but comments on the evidence. 126. Accepted. 127. Not a finding of fact. 128. Accepted. 129. Not a finding of fact but more an argument. 130. Accepted. 131. Accepted. 132. - 133. Accepted and incorporated herein. 134. & 135. Accepted. Not a finding of fact but argument. Accepted. Not a finding of fact. Accepted. - 148. Not findings of fact but argument. 149. & 150. Accepted. 151. Not a finding of fact but argument. FOR THE RESPONDENT, DHRS: 1. Accepted and incorporated herein. 2. - 4. Accepted and incorporated herein. 5. - 11. Accepted and incorporated herein. 12. - 15. Accepted and incorporated herein. 16. - 19. Accepted and incorporated herein. 20. Accepted. 21. - 23. Accepted and incorporated herein. 24. Accepted and incorporated herein. 25. - 28. Accepted and incorporated herein. 29. - 35. Accepted and incorporated herein. 36. - 40. Accepted and incorporated herein. 41. Accepted. 42. Accepted and incorporated herein. 43. Accepted. 44. - 46. Accepted and incorporated herein. 47. & 48. Accepted and incorporated herein. 49. Accepted. 50. - 52. Accepted and incorporated herein 53. - 61. Accepted and incorporated herein. 62. & 63. Accepted. 64. Accepted and incorporated herein. 65. Accepted. 66. Accepted and incorporated herein. 67. Accepted. 68. - 75. Accepted and incorporated herein. 76. & 77. Accepted and incorporated herein. Not a finding of fact but a restatement of evidence. Accepted. - 84. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. & 89. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. COPIES FURNISHED: R. Terry Rigsby, Esquire F. Philip Blank, Esquire Blank, Rigsby & Meenan, P.A. 204-B South Monroe Street Tallahassee, Florida 32301 Thomas R. Cooper, Esquire Department of Health and Rehabilitative Services 2727 Mahan Drive - Suite 103 Tallahassee, Florida 32308 C. Gary Williams, Esquire Michael Glazer, Esquire Ausley, McMullen, McGehee, Carothers & Proctor 227 South Calhoun Street Tallahassee, Florida 32302 John Slye General Counsel DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
The Issue At issue is whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the hospital.
Findings Of Fact Fundamental findings Jackson Joseph Fischler (Jackson) is the legally adopted son of Kenneth J. and Laura P. Fischler. He was born a live infant on June 1, 1992, at Memorial Hospital West, a hospital located in Pembroke Pines, Florida, and his birth weight was in excess of 2,500 grams. During the course of labor, delivery or resuscitation in the immediate post-delivery period in the hospital, Jackson sustained an injury to the brain or spinal cord caused by oxygen deprivation and/or mechanical injury which rendered him permanently and substantially mentally and physically impaired. As a consequence of the foregoing, the sole issue to be resolved in deciding whether this claim should be accepted for compensation is whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital, as required by Subsections 766.309(1)(b) and 766.31(1), Florida Statutes. The birth of Jackson Joseph Fischler At or about 7:09 p.m., June 1, 1992, the Pembroke Pines Fire Department, Emergency Medical Services (EMS), arrived at the residence of Shirley George, Jackson's birth mother, in response to a 911 call. At the time, Ms. George reported that she was at term, with a caesarean section scheduled 5 days hence for a breach presentation and that her "water may have broken." Subsequent medical records reflect a spontaneous rupture of the membrane at 7:00 p.m. When examined by EMS, Ms. George was experiencing contractions approximately 2 minutes apart, lasting 30-40 seconds. EMS transported Ms. George to Memorial Hospital West, where she was admitted through the emergency room at approximately 7:15 p.m., in labor. Ms. George was then taken to an examination room, and the labor and delivery unit was requested to provide a nurse to examine her. At or about 7:17 p.m., a labor and delivery nurse performed a pelvic examination of Ms. George and immediately diagnosed a prolapse of the umbilical cord, and a fetal heart rate of approximately 60 beats per minute. A prolapsed umbilical cord is a obstetrical emergency, which in the instant case required prompt surgical intervention to address fetal distress. Consequently, Ms. George was immediately rushed to the operating room for an emergency caesarean section. At the time, the on-call obstetrician, Robert Klein, M.D., was at Hollywood Memorial East, where he had been called for surgery. Therefore, shortly after 7:17 p.m., Dr. Klein was advised by telephone of the emergency involving Ms. George, and was requested to come to Memorial Hospital to attend to the situtation. Consequently, according to Dr. Klein, he "unscrubbed the patient of mine at Hollywood Memorial East . . . and in my greens I drove to Memorial Hospital West." Following notice to Dr. Klein and prior to his arrival at Memorial Hospital West, an overhead page was made for any obstetrician or surgeon in house to call the operating room, and 2-3 minutes later a blue alert to the operating room was called. The emergency room physician responded to the blue alert. Upon arrival in the operating room, he was apparently advised that the fetal heart rate was in the 40 beat per minute range and was asked if he could perform a caesarean section. The emergency room physician, not being qualified to perform the operation, declined, and Rudy Zepeda, M.D., the house physician, who was also present, agreed to perform the caesarean section "to save the baby's life." At this point in the factual narrative it is worth observing, considering the central issue in this case, that Dr. Zepeda, an unlicensed house physician, was not, at anytime material to this case, a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Conversely, Dr. Klein, the on-call obstetrician, albeit not in attendance at the time, was a "participating physician" in the Plan. In the operating room, Ms. George was on the table at 7:23 p.m., anesthesia was started at 7:25 p.m., and Dr. Zepeda commenced the operation at 7:38 p.m. Jackson was delivered at 7:48 p.m., and the placenta at 7:49 p.m. Upon delivery, Dr. Zepeda handed Jackson to Dr. McIntyre, the on-call neonatologist, and he was immediately intubated and bagged with 100 percent oxygen, with good response in heart rate and color only, and first gasp was noted at 7 minutes. Apgar scores were 2 at one minute, 3 at 5 minutes, and 4 at 10 minutes, and at or about 8:00 p.m. Jackson was transferred to the neonatal intensive care unit (ICU) with positive ventilator support. Following Dr. Zepeda's delivery of Jackson and the placenta, but before Jackson's transfer to the neonatal ICU, Dr. Klein entered the operating room. Observing the situation, Dr. Klein reportedly asked Dr. Zepeda to finish the case on his own, but Dr. Zepeda "told him to scrub in." Dr. Klein was noted to have entered the operative field at 7:55 p.m., at which time he observed "the uterus was closed in the first layer," which would be the first step in the procedure after delivery of the placenta, and he proceeded to complete the operation. According to his operative report, Dr. Klein provided, inter alia, the following services incident to the caesarean section: . . . UPON ENTERING THE OPERATIVE FIELD THE UTERUS WAS [observed to have been] CLOSED IN THE FIRST LAYER AND I USED NUMBER 0 CHROMIC TO CLOSE THE SECOND LAYER. IT WAS VERY DIFFICULT TO FIND THE BLADDER FLAP WHICH WAS NOT CREATED UPON ENTRY TO THE UTERUS. TWO VIALS OF METHYLENE BLUE WERE INJECTED INTRAVENOUS BY THE ANESTHESIOLOGIST. APPROXIMATELY TEN MINUTES LATER METHYLENE BLUE DYE WAS NOTED IN THE FOLEY BAG. UPON CLOSURE OF THE UTERUS THE OVARIES AND TUBES WERE FOUND TO BE WITHIN NORMAL LIMITS. THE PERITONEUM WAS NOT CLOSED BUT APPROXIMATED. THE MUSCLE WAS CLOSED IN THREE SEGMENTS CREATING NORMAL LOOKING MUSCLE, APPROXIMATING LONGITUDINAL AND VERTICAL INCISION OF THE MUSCLE WHICH WAS DONE UNDER EMERGENCY CONDITIONS BY THE SURGICAL RESIDENT. THERE WAS MODERATE AMOUNT OF BLEEDING, HOWEVER, THIS WAS CONTROLLED WITH THE BOVIE AND THREE PIECES OF SURGICEL WERE PLACED OVER THE MUSCLE ABOVE THE FASCIA. THE FASCIA THEN WAS CLOSED WITH NUMBER 0 VICRYL IN A CONTINUOUS INTERLOCKING FASHION IN TWO SEGMENTS. SUBCUTANEOUS TISSUE WAS IRRIGATED. HEMODYNAMICALLY THE PATIENT WAS UNDER GOOD CONTROL AND THERE WAS NO EVIDENCE OF LOW PRESSURE DURING THE SURGERY. SHE WAS GIVEN FLUIDS AND PITOCIN 20 UNITS AND FULL LITER OF HALF NORMAL SALINE. SHE WAS ALSO GIVEN TWO GRAMS OF MEFOXIN BY THE ANESTHESIOLOGIST THE SKIN WAS APPROXIMATED AND CLOSED WITH STAPLES. COVERED WITH TELFA, 4X4, STERILE TAPE. THE URINE OUTPUT WAS ADEQUATE MIXED WITH METHYLENE BLUE. ROUTINE POSTOP ORDERS WERE WRITTEN IN THE CHART. The services Dr. Klein provided Ms. George, albeit post-delivery, were an integral part of the caesarean section delivery procedure, and were unquestionably obstetrical services. 1/ Moreover, such services were provided, at least in part, while Jackson was being resuscitated in the immediate post- delivery period. 2/ 16 As heretofore noted, Jackson was transferred to the neonatal ICU, with positive ventilator support, at or about 8:00 p.m. Upon arrival in the ICU, Jackson was placed on a respirator ("Baby Bird" mechanical ventilator support), with initial settings being an IMV of 50, pressure of 22/4 and 100 percent oxygen. Jackson's first movement, which consisted of some flexion of the extremities, was noted at or about 30 minutes of life, and there was some associated twitching of the lower jaw, which was thought to represent seizure activity. At or about 10:30 p.m., June 1, 1992, Jackson was discharged from Memorial Hospital West and transported to the neonatal ICU at Hollywood Memorial East. At the time he was on stable ventilator settings, and his seizures were under control with phenobarbital. Diagnosis on discharge was perinatal asphyxia secondary to prolapsed cord, and seizure disorder. Jackson remained at Memorial Hospital until discharged on June 23, 1992. At the time, examination revealed "slight increased tone, intermittent arching of back and retracting of head, cortical thumbs bilaterally with excessive fisting, brisk DTR's bilaterally, moro present, . . . and oral thrush." An MRI of June 6, 1992, "showed abnormal brain signal in each parietal lobe and decreased white matter signal in the basal gaglion, brain stem, mid brain and cerebellar hemispheres, possible watershed ischemia." Following maturation, neurologic examination revealed evidence of four limb spasticity with double hemiparesis, marked expressive language and motor delay. Severe swallowing and sucking difficulties necessitated gastrostomy placement.
The Issue Whether the Proposed Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Shands operates an 852-bed hospital and Level I trauma center in Gainesville, Alachua County, Florida. Its business address is 1600 Southwest Archer Road, Gainesville, Florida. Shands treats about 2,500 trauma patients each year. Shands is located within trauma service area (TSA) 4, which is comprised of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union counties. St. Joseph’s is a regional tertiary hospital and has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. St. Joseph offers a broad array of acute care services including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. St. Joseph operates a Level II trauma center and a Level I pediatric trauma center. St. Joseph is located in TSA 10, consisting of a single county, Hillsborough. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. Tampa General also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). Tampa General is located in Tampa, Hillsborough County, Florida, TSA 10. Bayfront is a 480-bed tertiary hospital located in Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. It is located in TSA 9, composed of Pinellas and Pasco counties. The Public Health Trust of Miami-Dade County, is an entity which governs and operates the Jackson Health System, including the Ryder Trauma Center at Jackson Memorial Hospital. It is in TSA 19, consisting of Dade and Monroe counties. The Florida Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes, and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Osceola is a licensed acute care general hospital, located at 700 West Oak Street, Kissimmee, Florida. Osceola provides a wide array of high quality health services to the residents and visitors within its service area. It is located in TSA 8, consisting of Lake, Orange, Osceola, Seminole, and Sumter counties. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to undertake the implementation of a statewide inclusive trauma system as funding is available. § 395.40(3), Fla. Stat. The need for a trauma system is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of nine or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." A trauma center is a hospital that has a collection of resources and personnel who are charged with taking care of trauma patients. They are recognized by the community as a resource for care of severely injured patients. The International Classification Injury Severity Score (“ICISS”) methodology, considered with discharged patient data from the Agency for Health Care Administration database, was used by DOH to determine severely injured patients. An ICISS score is the product of the survival risk ratios (i.e., the probabilities of survival) calculated for each traumatic injury a single patient suffers. Level I trauma centers are generally larger and busier and treat more patients than Level II centers. Level I trauma centers are required to engage in education and research. Trauma centers are required to have several types of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned. Further, in addition to having at least one neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center, a Level I provider must also have surgeons available to arrive promptly at the trauma center in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Little if any credible evidence was presented in the present case to suggest that the ability to hire qualified clinical staff, technicians, specialty physicians and other personnel would be severely impacted if the Proposed Rule is implemented. Rather, the existing trauma centers lamented the possibility of reduced case loads which could make it more difficult to retain proficiency. Invalidation of Former Rule 64J-2.010 In 1992, the Department of Health and Rehabilitative Services (HRS), the Department of Health's predecessor, promulgated Florida Administrative Code Rule 64J-2.010, titled "Apportionment of Trauma Centers within a Trauma Service Area," (hereinafter referred to as the “Former Rule”). The Department of Health assumed administration of the Former Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Former Rule regulated the number of trauma centers that could be established in Florida. The Former Rule divided the state into TSAs as set forth in section 395.402(4), and for each TSA, announced the number of trauma center "positions" available. In 2004, the Florida Legislature amended section 395.402 to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and Legislature no later than February 1, 2005 (the 2005 Assessment). The scope of the assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. One objective of the assessment was to consider aligning trauma service areas within the trauma region boundaries as established in section 395.4015(1). It required the Department to establish trauma regions that cover all geographic areas of the state and have boundaries that are coterminous with the boundaries of the Regional Domestic Security Task Forces (“RDSTF”) established under section 943.0312. In a related 2004 amendment, the Legislature added a provision that gave the Department the option to use something other than the trauma service areas codified in section 395.402(4) upon completion of the 2005 Assessment. See § 395.402(2), Fla. Stat. ("Trauma service areas as defined in this section are to be utilized until the Department of Health completes" the 2005 Assessment.) § 395.402(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section."). As part of the 2004 amendments to the trauma statute, the Legislature also required the Department to conduct "subsequent annual reviews" of Florida's trauma system. In conducting such annual assessments, the Legislature required the Department to consider a non-exhaustive list of criteria set forth in section 395.402(3)(a)-(k). Further, the Legislature required the Department to annually thereafter review the assignment of Florida’s 67 counties to trauma service areas. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. With respect to its review of the trauma service areas, the 2005 Assessment recommended against the continued use of the 19 trauma service areas. The 2005 Assessment instead suggested that it may be feasible for the existing trauma service areas to be modified to fit the seven RDSTF regions to facilitate regional planning. Following receipt of the 2005 Assessment, the Department took no action to amend the Former Rule and adopt the recommendations of the 2005 Assessment. As a result, in June 2011, several existing trauma centers challenged the validity of the Former Rule pursuant to sections 120.56(1) and (3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health, DOAH Case Nos. 11-2602RX, 11-2603RX, 11-2746RX, 11-2796RX (Fla. Div. Admin. Hear., Sept. 23, 2011). On September 23, 2011, an administrative law judge of the Division of Administrative Hearings entered a final order holding that the Former Rule was an invalid exercise of delegated legislative authority. The administrative law judge concluded that the Former Rule was invalid because it contravened the laws it purportedly implemented, including section 395.402. The judge found: The authority granted by section 395.402 for the use of the [nineteen] identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plan. Thus, section 395.402 can no longer service as a valid basis for the Rule. However, as set forth below, the authority to utilize the 19 TSAs was not rescinded; rather, the mandated requirement to use only the TSAs was rescinded. The Department was required to review the assignment of Florida’s 67 counties to trauma service areas, taking into consideration the factors set forth in paragraphs (2)(b)-(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its [Former] Rule to allocate the number of trauma centers determined to be needed within each designated area through systematic evaluation and application of statutory criteria. On November 30, 2012, the First District Court of Appeal affirmed the administrative law judge's determination that the Former Rule was an invalid exercise of delegated legislative authority. See Dep't of Health v. Bayfront Med. Ctr., Inc., 134 So. 3d 1017 (Fla. 1st DCA 2012). After noting that the Former Rule claimed to implement sections 395.401, 395.4015, and 395.402, the appellate court held that the Former Rule was invalid because it failed to reflect the substantial amendments to those laws that were enacted in 2004. The appellate court held: Both the pre-and post-2004 versions of the statute require the Department to establish trauma regions that "cover all geographic areas of the state." However, the 2004 amendment requires that the trauma regions both "cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312." § 395.4015(1), Fla. Stat. (2004). Similarly, the rule fails to implement the 2004 amendments to section 395.402. The version of the statute in effect at the time the rule was promulgated set forth the nineteen trauma service areas reflected in the rule. [T]he 2004 version of the statute required the Department to complete an assessment of Florida's trauma system no later than February 1, 2005. It further provides that the original nineteen trauma service areas shall remain in effect until the completion of the 2005 Assessment. Bayfront, 134 So. 3d at 1019-20 (Emphasis added). It should be noted that the 2004 version of the statute does not specify at what point in time the 19 TSAs could no longer be utilized, only that they would have to be used at least until completion of the 2005 Assessment. Rule Development The Department thereafter initiated rule development workshops to commence construction of a new rule. The first workshop concerning this rule was in Tallahassee, Florida, on December 21, 2012. In January and February 2013, workshops were then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami, as DOH continued working on a new rule. Each of the sessions involved input from interested persons both live and by telephone. Written comments and oral presentations by these persons were considered by the Department. After these first six workshops, held in various regions of the State to make them more accessible to more citizens, DOH then scheduled three more workshops in March 2013, to be held in areas where there were no existing trauma centers, specifically Ft. Walton Beach, Naples, and Sebring. DOH also considered the recommendations of a report issued by the American College of Surgeons (“ACS”), the lead professional group for trauma systems and trauma care in the United States. The ACS sent a consultation team to Tallahassee, Florida, to conduct a three-day site visit and hold public workshops in February 2013. The ACS ultimately issued a report entitled “Trauma System Consultation Report: State of Florida,” in May 2013. The report included as one of its recommendations the use of RDSTF regions as the TSA areas to be used in determining need for additional trauma centers. In November 2013, DOH released a draft proposed rule and a draft of its first TSA Assessment (the January TSA Assessment). The Department then conducted three additional workshops in Pensacola, Orlando, and Miami. Again, DOH solicited comments from interested persons and entered into a dialogue as to what the proposed rule should look like upon publication. On January 23, 2014, DOH conducted a Negotiated Rulemaking Committee meeting at the Department’s headquarters in Tallahassee, Florida. The committee consisted of seven persons: Karen Putnal, Esquire and Dr. Fred Moore--representing existing trauma centers; Steve Ecenia, Esquire and Dr. Darwin Ang-- representing new trauma centers currently under challenge; Dr. Patricia Byers--representative of the EMS Advisory Council; Jennifer Tschetter, Esquire and Dr. Ernest Block--representing DOH. The public was invited to attend the session but was not afforded an opportunity to speak. The Department considered all the input from each of the workshops, the ACS Report, and the negotiated session, as well as all the applicable items enumerated in section 395.402(3)(a)-(k). The Proposed Rule On February 3, 2014, the Department published Notice of Development of Proposed Rule 64J-2.010 (the "Proposed Rule") in Florida Administrative Register, Volume 40, Number 22. The Department's Notice cited section 395.405, as rulemaking authority for the Proposed Rule. The Notice also cited sections 395.401, 395.4015, 395.402, and 395.405 as the laws intended to be implemented by the Proposed Rule. The following day, February 4, 2014, the Department published a Notice of Correction in Florida Administrative Register, Volume 40, No. 23, to correct the history notes of the Proposed Rule. In the corrected Notice, the Department cited section 395.402 as its rulemaking authority in addition to section 395.405. The correction also removed reference to sections 395.401, 395.4015, and 395.405, as laws implemented by the Proposed Rule. Following the Department's correction, the Proposed Rule was intended only to implement section 395.402. The Proposed Rule established 19 TSAs and determined the number of trauma centers to be allocated within each TSA, based upon a scoring system established in the Proposed Rule. Under the scoring system, TSAs were awarded positive or negative points based on data in an annual Trauma Service Area Assessment relating to the following six criteria: (1) population; (2) median transport times; (3) community support; (4) severely injured patients not treated in trauma centers; (5) Level 1 trauma centers; and (6) number of severely injured patients (in each TSA). Ms. Tschetter added the last two criteria (Level I Trauma Centers and Number of Severely Injured Patients) in response to comments received at the negotiated rulemaking session. Subsequent to a final public hearing held on February 25, 2014, DOH revised its January TSA Assessment and the earlier version of the Proposed Rule. The revised TSA assessment (the “March TSA Assessment”) reflected more conservative calculations (as gleaned from input and discussions with stakeholders) and documents the statutory patient volumes for the existing Level I and Level II trauma centers in each TSA. The March TSA Assessment further recalculated the Median Transport times, including all transports from 0-10 minutes (as opposed to only those transports greater than 10 minutes) and only transports to trauma centers (as opposed to transports to all hospitals). On March 25, 2014, a Notice of Change was published in the Florida Administrative Register. The Proposed Rule, as published on that date, is as follows: Notice of Change/Withdrawal DEPARTMENT OF HEALTH Division of Emergency Medical Operations RULE NO.: RULE TITLE: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA) NOTICE OF CHANGE Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the Florida Administrative Register. 64J-2.010 Allocation of Trauma Centers Aamong the Trauma Service Areas (TSAs). Level I and Level II trauma centers shall be allocated among the trauma service areas (TSAs) based upon the following: The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment. Population A total population of less than 0 to 600,000 receives 2 points. A total population of 600,001 to 1,200,000 receives 4 points. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6 points. d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000 receives 8 points. e. A total population greater than 2,400,000 2,300,000 receives 10 points. Median Transport Times Median transport time of less than 0 to 10 minutes receives 0 points. Median transport time of 101 to 20 minutes receives 1 point. Median transport time of 21 to 30 minutes receives 2 points. Median transport time of 31 to 40 minutes receives 3 points. Median transport time of greater than 41 minutes receives 4 points. Community Support Letters of support for an additional trauma center from 250 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before April 1 annually. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before April 1 annually. Severely Iinjured Patients Discharged from Acute Care Hospitals Not Treated In Trauma Centers Discharge of 0 to 200 patients with an International Classification Injury Severity Score (“ICISS”) score of less than 0.85 (“severely injured patients”) from hospitals other than trauma centers receives 0 points. Discharge of 201 to 400 severely injured patients from hospitals other than trauma centers receives 1 point. Discharge of 401 to 600 severely injured patients from hospitals other than trauma centers receives 2 points. Discharge of 601 to 800 severely injured patients from hospitals other than trauma centers receives 3 points. Discharge of more than 800 severely injured patients from hospitals other than trauma centers receives 4 points. Level I Trauma Centers The existence of a verified Level I trauma center receives one negative point. The existence of two verified Level I trauma centers receives two negative points. The existence of three verified Level I trauma centers receives three negative points. Number of Severely Injured Patients If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives 2 points. If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives 1 point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives one negative point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives two negative points. 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. An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015. The number of trauma centers allocated for each TSA based upon the Amended Trauma Service Area Assessment, dated March 24, 2014 January 31, 2014, which can be found at www.FLHealth.gov/licensing- and-regulation/trauma-system/_documents/trauma-area-service- assessment.pdf, is as follows: TSA Counties Trauma Centers 1 Escambia, Okaloosa, Santa Rosa, Walton 1 2 Bay, Gulf, Holmes, Washington 1 3 Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla 1 4 Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union 1 5 Baker, Clay, Duval, Nassau, St. Johns 12 6 Citrus, Hernando, Marion 2 7 Flagler, Volusia 1 8 Lake, Orange, Osceola, Seminole, Sumter 3 9 Pasco, Pinellas 23 10 Hillsborough 1 11 Hardee, Highlands, Polk 1 12 Brevard, Indian River 1 13 DeSoto, Manatee, Sarasota 2 14 Martin, Okeechobee, St. Lucie 1 15 Charlotte, Glades, Hendry, Lee 12 16 Palm Beach 1 17 Collier 1 18 Broward 2 19 Dade, Monroe 3 Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18- 06,Formerly 64E-2.022, Amended . DOH did not incorporate the March TSA Assessment by reference in the rule. After exchanges of communications with the Joint Administrative Procedures Committee (“JAPC”), wherein DOH sought guidance concerning this matter, there was no directive by JAPC that such adoption by reference would be required. DOH revised the population criterion in the Proposed Rule to have even breaks in intervals of 600,000 people. The February proposed rule awarded 6 points in TSAs with a population of 1,200,001 to 1,700,000 people (i.e., a 500,000 person interval), where all other measures were based upon a 600,000 person interval. This discrepancy is corrected in the newly Proposed Rule. DOH revised the community support criterion in the Proposed Rule to no longer award a point to TSAs where 0-50% of the city and county commissions send letters of support, because this could have reflected the need for a trauma center (by awarding points to the TSA) when no letters of support were received. The Proposed Rule now awards a point to TSAs where 25-50% of the county commissions send letters of support. DOH chose twenty-five percent as the minimum necessary community support because the smallest number of city and county commissions in all of the TSAs is four, which ensures everyone has a voice. DOH revised the title of the fourth criterion from “severely injured patients not treated in trauma centers” to “severely injured patients discharged from acute care hospitals,” which more accurately depicts the function of the criterion. DOH revised the sixth criterion to include citations to the statutory minimum volumes for Level I and Level II trauma centers in response to a request by the staff attorney for the Joint Administrative Procedures Committee. DOH also revised the rule to reference the March TSA Assessment in place of the January TSA Assessment. Finally, DOH revised the Proposed Rule’s allocation table based on the revisions to the rule and assessment. The Proposed Rule as amended allocates a total of 27 trauma centers throughout Florida’s 19 TSAs. Each TSA is still allocated at least one trauma center. The Proposed Rule allocates only Level I and Level II trauma centers, not pediatric trauma centers. The rulemaking directive in section 395.402(4) is interpreted by DOH to be limited to the allocation of Level I and Level II trauma centers. In addition, the allocation of stand-alone pediatric centers would not be feasible because pediatric trauma patients make up such a small percentage of the population and all of the Level I and II trauma centers have the ability to become pediatric trauma centers. Currently, all of the existing Level I trauma centers provide pediatric care and there are only two stand-alone pediatric centers in Florida. The Proposed Rule’s allocation of 27 trauma centers is conservative. There are currently 27 verified trauma centers in the state, including two verified trauma centers under administrative challenge. There are several elements of the Proposed Rule which Petitioners have raised as evidence of the Department’s failure to comply with its rulemaking authority. Petitioners maintain that DOH failed to consider all of the items enumerated in section 395.402(3)(a)-(k). Each of those criteria is addressed below. (a) The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies-- There is only one regional trauma agency in Florida. DOH reviewed the regional agency’s plan, but it was devoid of any recommendations related to trauma center allocation within the TSAs. The regional agency did not amend its plan or submit any separate recommendations throughout the year-long, public rulemaking process. (b) Stakeholder recommendations--Petitioners complain that DOH did not do enough to solicit input from everyone who would be affected by the Proposed Rule. The Department, however, obtained stakeholder testimony from 171 individuals and written comments from 166 stakeholders through the course of the 12 rule development workshops conducted around the state. The workshops were held in several cities to allow for geographic access by more residents. Over 400 people attended the workshops. The January TSA Assessment was also modified prior to its publication as a result of the stakeholder discussions at the workshops and the negotiated rulemaking session. The March TSA Assessment was further amended after its publication as a result of testimony at the public hearing for the Proposed Rule. (c) The geographical composition of an area to ensure rapid access to trauma care by patients--While Florida contains no mountains, its geography is unique to other states in that it contains several inlets, bays, jetties, and swamplands. As such, the DOH data unit examined the coastal areas versus non- coastal areas. The unit also analyzed urban versus rural areas. The unit also looked at the communities surrounding Lake Okeechobee. Ultimately, the analysis was not meaningful because the effect geography has on access to trauma centers is captured by Florida’s transport time records for emergency vehicles and helicopters. Thus, by reviewing the Emergency Medical Services Tracking and Reporting System (“EMSTARS”) database, DOH could know the actual effects of Florida’s geography on access to trauma centers. (d) Historical patterns of patient referral and transfer--This item was considered, but the January TSA Assessment does not address it because it was neither measurable nor meaningful. The data was not measurable because of limitations of data quality in the Trauma Registry. Even if the data were measureable it would not have been meaningful because it would have only illustrated the catchment areas--i.e., the geographic distribution of patients served by existing trauma centers. As recommended by the ACS, DOH’s primary focus is on the trauma system as a whole, not individual trauma centers. Moreover, transfer and referral history is not meaningful to an assessment designed to inform an allocation rule because, again, DOH does not have the authority to define where new trauma centers are developed within a TSA. See § 402.395(4)(b), Fla. Stat. (charging DOH with allocating by rule the number of trauma centers in each TSA, not trauma center location within a trauma service area). (e) Inventories of available trauma care resources, including professional medical staff--Petitioners suggest that DOH should have made a determination of existing professional medical staff, but suggest no viable means of doing so. The January TSA Assessment catalogues several trauma care resources within TSAs, including financing, trauma centers, acute care hospitals, and EMS response capabilities. The January TSA Assessment does not catalogue available professional medical staff. DOH is unaware of any database that compiles this information. DOH sent a survey to the existing trauma centers requesting information as to their resources and professional staff, however it was not useful due to the limited responses and potential for bias. The data unit also reviewed the DOH Division of Medical Quality Assurance health professional licensure database (COMPASS), however, it was not helpful because physician specialty reporting is voluntary. Similarly, the data unit reviewed AHCA’s inventory of licensed acute care hospitals and the DOH annual physician workforce survey results, but neither data source provided trauma-specific information. As such, the information was not complete and so was not included in the January TSA Assessment. (f) Population growth characteristics--In response to this criterion, the DOH data unit analyzed the potential for growth in all of the TSAs, but the January TSA Assessment did not include this analysis because it was not meaningful given DOH’s requirement to conduct the assessment annually. The January TSA Assessment does however document the population in each TSA. DOH decided that in light of the continuing change of population in Florida, the best it could do would be to make a finding as to the population in each TSA and use it--year by year--to look at the potential need for additional (or presumably fewer) trauma centers in an area. Obviously the population of an area is not directly commensurate with the number of severely injured patients that might be found. Not all areas have equal percentages of severely injured patients; urban areas would have higher percentages than rural areas, in general. Areas through which a major interstate highway runs would expect a higher percentage. There are a number of factors that could potentially affect an area’s expectation of trauma services. Inasmuch as they could not all possibly be included in an analysis, DOH defaulted to a more general view, i.e., the total population. The total population figure became the first measurement in the Proposed Rule. (g) Transportation capabilities; and (h) Medically appropriate ground and air travel times--DOH considered these two factors together and determined to cover them by way of a determination of median transport time, which was to become the second measurement in the Proposed Rule. The data unit gathered transport capability data by reviewing the COMPASS licensure database and archived paper applications to discern the number of licensed emergency medical stations, helicopters, and vehicles in each TSA. The data unit further calculated the number of ground vehicles per the population in each TSA and every 100 square miles. The January TSA Assessment included this information because it was meaningful and gathered from a reliable database. DOH considered the testimony from a number of trauma surgeons during the 12 workshops regarding transport times and learned that the medically appropriate transport time depends on the nature of injuries and individual patients, which are not always discernable at the scene of an accident. Because of this, the sooner a patient can be transported to a trauma center, the better it is for patient outcomes. In light of the patient-specific realities of establishing a medically appropriate transport time, the data team used EMSTARS to calculate the median emergency transport times in each TSA for the assessment. Granted the EMSTARS is a fairly new system under development, and it reports all 911 calls voluntarily reported (not just trauma patients), so it is not a completely accurate measure. But it is a reasonable approach based upon what is available. Also, the transport times do not reflect whether pre-hospital resources are sufficient for the patient or how far away the closest trauma center may be. It is not an absolutely perfect measurement, but it is reasonable and based on logic. (i) Recommendations of the Regional Domestic Security Task Force--Like Florida’s lone regional trauma agency, the RDSTF did not offer any input throughout the year-long, public rulemaking process. However, DOH considered the testimony of numerous emergency management and law enforcement officials during the rule development process. For example, Chief Loren Mock, the Clay County fire chief and also a member of the Domestic Security Oversight Council, testified at the Jacksonville workshop. There is no evidence DOH directly contacted a RDSTF representative to solicit input. (j) The actual number of trauma victims currently being served by each trauma center--The March TSA Assessment included the annual trauma patient volume reported to the Trauma Registry by the existing trauma centers. When comparing the average patient volume reported to trauma registry from 2010- 2012 to the data unit’s calculation of the average number of severely injured patients treated in trauma centers during this same time span, the volumes reported by the trauma centers were approximately 333% greater. This large disparity prompted DOH to follow the example of many other states and use population as a proxy for the number of potential trauma patients in each TSA in its Proposed Rule. DOH found that: greater population means a greater need for health care; population is a good indicator of need for medical services; population is a reasonable proxy for patient volume; and, more people in a given area results in more trauma cases in a given area. (k) Other appropriate criteria: It was well documented in literature presented to DOH during the rulemaking process that there were a large percentage of severely injured patients in Florida not being seen by trauma centers. The data unit confirmed this by evaluating the AHCA administrative database, which identifies the injuries suffered by patients as well as the type of hospitals discharging those patients, i.e., comparing the total number of severely injured patients with the number of severely injured patients discharged from acute care hospitals in each TSA. This disparity was worrisome to DOH and therefore included in the March TSA Assessment. As pointed out by Petitioners, the Department’s figures include patients who may have received treatment outside the TSA in which the injury occurred. The figures may not have contained patients who needed trauma care but could not access it for other reasons. The Proposed Rule, however, makes as complete an evaluation of the potential patient base for trauma centers as is possible. Notwithstanding complaints about how the Department addressed some of the criteria set forth in the statute, it is clear that all criteria were considered and implemented into the Proposed Rule to the extent feasible and possible. The most credible testimony at final hearing supports the Department’s process. Criticisms of the various elements within the Proposed Rule expressed by Petitioners at final hearing seemed to be based on the concept that the Proposed Rule may allow competition to existing trauma centers rather than real complaints about the elements themselves. All agree, for example, that population, transportation times, number of patients, and the existence of nearby trauma centers are important factors that should be considered. Petitioners just seemed to want those factors expressed in different (though unspecified) terms. Petitioners did enunciate certain shortcomings they felt made the Proposed Rule less than complete. St. Joseph lamented the absence of all the Department’s analysis and background for each of the proposed measurements contained in the Proposed Rule. Jackson Memorial pointed out that pediatric trauma centers were not specifically included in the Proposed Rule. Shands showed that odd or unusual results could arise from implementation of the Proposed Rule. For example, the March TSA Assessment showed a total of 216 severely injured patients in TSA 6, comprised of Marion, Citrus, and Hernando counties. The Proposed Rule called for two trauma centers in that TSA. Although the number of patients necessary to maintain a trauma center’s proficiency was disputed by various experts in the field, it is clear that 108 patients per center would be extremely low. However, the figure appearing in the March Assessment is not absolute or necessarily completely definitive of need. There are other factors concerning population and patients that may affect that figure. The Six Measurement Criteria in the Proposed Rule Petitioners also took exception to the measurement criteria in the Proposed Rule. Each of those six criterion is discussed below. Population The Proposed Rule awards from two to ten points to a TSA, depending on the TSA total population. Two points are awarded for a population of less than 600,000 and ten points are awarded for a popu1ation greater than 2.4 million. The Department used total population as a "proxy" for the actual number of trauma patients in the state rather than using the actual number of trauma victims in the state. The Proposed Rule does not define “population” or “Total Population,” nor are those terms defined in the trauma statute, but those words are subject to their normal definition. The Proposed Rule does not re-state the source of the summary Total Population data; it is already contained in the TSA Assessment. Neither the Proposed Rule nor the March TSA Assessment contains any data or analysis reflecting population by age cohort, population density, or incidence of trauma injury in relation to these factors, and the Department did not specifically conduct any analysis of the significance of any aspect of population data as it relates to the need for new trauma centers, other than determining the total population growth rate in the TSAs. Rather, DOH decided upon total population as the most reliable measure available. Traumatic injury rates and the severity of traumatic injury vary widely based on a number of factors, including whether the area is urban or rural, the population age cohort, and the infrastructure and physical characteristics or features of the geographic area. Thus, the most reasonable way to measure possible need was to look at the total population of an area and extrapolate from that basis. The Department presented no specific data or analysis to support the incremental cutoff points for the Total Population scale contained in the Proposed Rule. Rather, the Department took population as a whole because it was the most readily available, annually updateable, and understandable factor it could access. The use of population as a proxy is not without problems, however. In TSA 19, for instance, the population has increased by about thirty-eight percent in recent decades, but the number of trauma victims has declined by approximately twelve percent. As stated, the Proposed Rule as written is not inerrant. Median Transport Times The Proposed Rule awards from zero to four points to a TSA, depending on the Median Transport Time within a TSA. “Median Transport Time” is not defined in the Proposed Rule, nor is the methodology for determining the summary “Median Transport Time” statistics set forth in the TSA Assessment and relied on in the Proposed Rule. Information concerning transport times is, however, contained within the TSA Assessment. The Median Transport Time used in the Proposed Rule represents the average transport time for all 911 transports voluntarily reported to the state EMSTARS database. EMSTARS is a database that is under development and that collects information voluntarily provided by emergency medical transport providers throughout the state. Although not all EMS providers currently report to EMSTARS (most notably, Miami-Dade County EMS does not participate), the database is useful for research and quality improvement initiatives. The Median Transport Time set forth in the March TSA Assessment and used in the Proposed Rule includes transport time for all patients, regardless of the nature of the emergency, whether the call involved trauma, other types of injury, or illness, and regardless of whether the transport was conducted with the regular flow of traffic or required “lights and siren.” The Median Transport Time used in the Proposed Rule includes all EMS transports of up to two hours in duration. The Median Transport Time excludes transports of patients to trauma centers operating pursuant to the initial stage of trauma center licensure known as “provisional approval.” The Department addressed “medically appropriate air or ground transport times,” as required by section 395.402(3)(h), by its generally accepted conclusion that "faster is better." Not all injured patients, however, benefit from receiving care at a trauma center. Thus, while an existing trauma center is an appropriate destination for all patients with any level of injury who live in the area of a trauma center, the trauma center’s value beyond its immediate area is as a resource for the most severely injured patients whose problems exceed the capabilities of their nearest hospital. The Department did not undertake any analysis to balance its "faster is better" approach to trauma planning against the reality that the resources necessary to provide high quality trauma care are limited, as is the number of severely injured patients. There is a general (but not universal) consensus among trauma experts that access to a trauma center within 30-50 minutes is an appropriate benchmark for access to trauma care. Other than "faster is better," the Department did not determine a medically appropriate travel time for any type of trauma or any geographic area, but recognizes the general consensus as appropriate. The Proposed Rule awards from one to four points that weigh in favor of approval of a new trauma center within a TSA if the Median Transport Time of patients transported in response to any 911 call is between 10 and 42 minutes, i.e., within but faster than the generally accepted consensus. Community Support The Proposed Rule awards from one to two points to each TSA depending on the number of letters of support written by elected city or county commissioners. The Proposed Rule allows for consideration of stakeholder recommendations by way of allowing letters of support from local governments. “Stakeholders” in the state trauma system include existing trauma centers, as well as all acute care hospitals, and pre- and post-hospital care providers, including emergency transport services, air ambulances, and emergency management planning agencies. The Department could find no better way to acknowledge support from those stakeholders, and citizens in general, than to have their elected representatives listen to their constituents and then reflect those people’s desires and comments. Severely Injured Patients Discharged from Acute Care Hospitals The Proposed Rule awards from zero to four points to a TSA, depending on the number of severely injured patients discharged from acute care hospitals (non-trauma centers). The Proposed Rule addresses the number of severely injured patients, i.e., those with an ICISS score of < 0.85, discharged from hospitals other than trauma centers. The Proposed Rule does not specifically define “severely injured patient,” but it is obvious from the context in which that term is used. The summary data in the TSA Assessment labeled "number of severely injured patients” within each TSA is intended to reflect the number of severely injured patients who “didn’t get to trauma care.” The Department's numbers may include patients who received treatment at a trauma center outside of the TSA in which the injury occurred. The Department did not conduct any analysis of the "number of severely injured patients not treated at a trauma center" to determine whether the patients not treated at a trauma center received timely and appropriate care at a non-trauma center hospital with the capability to treat the patient's injuries. The number of “severely injured patients who did not get to trauma care” as reported by the Department is unlikely to reflect the actual number of patients who required care at a trauma center but did not have access, and suggests that this number is far higher than it actually is. The Department, for example (and in response to discussion with stakeholders), excluded from its analysis all patients with isolated hip fractures as well as all patients who were released from the hospital within 24 hours, which resulted in fewer severely injured patients. Neither the Proposed Rule nor the TSA Assessment considers demographics or outcomes for "severely injured patients" treated at general acute care hospitals or outcome data for these patients. The Proposed Rule does not include any method for projecting the actual demand for trauma services in the future; it is used to determine need at a single point in time (and will be done so annually). The Proposed Rule does not include any criteria or method for evaluating whether there are any capacity problems at existing trauma centers, or other barriers that impede access to trauma care. The Department intended this criterion to show a highly conservative estimate of patients who definitely need trauma care. Level I Trauma Centers With respect to “Level I Trauma Centers,” the Proposed Rule awards from negative one to negative three points to a TSA, depending on whether the TSA already has one, two, or three verified Level I trauma center(s), respectively. The Proposed Rule creates the opportunity for establishment of both additional Level I and also additional Level II trauma centers, pursuant to the allocation of need, but the Proposed Rule does not assign or subtract points for the existence of Level II trauma centers. This criterion reflects the recommendations of stakeholders at the rule workshops. It was the consensus of many stakeholders that Level I trauma centers should be protected in order to safeguard the research and teaching missions of those centers. The earlier proposal of a “halo” around existing centers, i.e., not approving a new trauma center within a certain radius of existing centers, was not incorporated into the Proposed Rule. This criterion, however, offers some protection for existing centers. Number of Severely Injured Patients The Proposed Rule awards negative two to two points based on the "number of severely injured patients" in a TSA. The criterion awards points based on the number of Severely Injured Patients which exceed the target trauma center patient volumes as provided in section 395.402(1). If the annual number of Severely Injured Patients exceeds the statutory volumes by more than 500 patients, the TSA will receive two points; if it exceeds it by less than 500 the TSA receives one point; if the number of Severely Injured Patients is less than the statutory volumes by zero to 500 patients, the TSA receives one negative point; if it is less than the volumes by more than 500 patients, the TSA receives two negative points. The Proposed Rule does not include any criterion addressing the actual number of trauma victims currently being served by each trauma center. Instead, Section 6 of the Proposed Rule substitutes the "minimum statutory capacity" of existing trauma centers for the actual capacity of existing trauma centers. The Department could not find “a meaningful” way to measure actual capacity of existing trauma centers. The most accurate way to measure capacity was a contentious topic at rule workshops, and the Department spent a good deal of time working with stakeholders on how to measure capacity in such a way that it could be included as a factor in the Proposed Rule. One suggestion as to how to measure trauma center capacity is by how often existing trauma centers actually divert trauma patients to other facilities. However, trauma centers rarely admit that they are not able to take any more patients, and this is not a realistic method to evaluate capacity. The capacity of an existing trauma center may be measured by various means, including the number of beds at the trauma center, the number of ICU beds, the number of trauma bays, number of operating rooms, as well as the frequency of and reasons for diversion. The trauma center’s clinical staff, including medical and surgical specialists, and supporting clinical personnel, are also indicators of capacity. The Department already routinely collects data reflecting trauma center capacity as part of the quarterly and annual reports that all existing trauma centers are required to submit, and by way of on-site licensure surveys. None of those means, however, provided DOH with sufficiently reliable information and data. The Proposed Rule comports with the DOH Mission to protect, promote, and improve the health of all Floridians through integrated state, county, and community efforts. While by no means perfect, the Proposed Rule is based upon logic and reason derived from an extensive analysis of all relevant factors. History of the Rule The rationale for DOH’s inclusion of those particular six criteria in the Proposed Rule can be better understood by considering some more history of the trauma rule. As stated earlier herein, in 2004 the Legislature made substantial revisions to the trauma statute and ordered the Department to complete an assessment of Florida’s trauma system. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One proposal of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). § 395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature ended the statutory mandate to use the service areas created in 1990. The obvious conclusion from the above statutory change is that the section 395.402(4) service areas could be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. Unlike the prior statute, there is no mandate for specific new service areas, only the option not to use the prior service areas. The 2005 Assessment included five "Recommendations": Trauma centers should be placed in Tallahassee and in Bay County, which do not currently have a trauma center . . . . It is reasonable to set, as a system goal, that 65 percent of trauma center patients will be treated at a trauma center. . . . Designation of additional trauma centers should be based on the need as determined by trauma region. Deployment of additional trauma centers should take place based, not only on the number of patients served per trauma center, but according to the concept of “trauma center capacity” which should be determined by the staffing levels of medical specialists and other healthcare professionals. . . . The data support the feasibility of transforming the Florida Trauma Services Areas so that these would coincide with the Domestic Security Task Force Regions. . . . It is reasonable to fund trauma centers with public funds, based on the unrecoverable financial burden incurred by trauma centers. The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. The Legislature did not repeal the statute establishing the current 19 TSAs. Likewise, the Department has not amended the Rule to implement the recommendations contained in the 2005 Assessment until the present Proposed Rule. The Department, instead, reviewed existing statutes, interpreted section 395.4015 to mandate the establishment of a trauma system plan (which plan would include trauma regions that have boundaries coterminous with those of the regional domestic security task force boundaries). The development of the trauma system plan is distinct from the determination of need for new trauma systems addressed by the Proposed Rule.
The Issue The issues are whether Respondent withdrew controlled substances from the narcotics dispensing system and failed to document the administration or wastage of those substances; if yes, whether this conduct fails to conform to minimum acceptable standards of prevailing nursing practice; and, if yes, what penalty should be imposed on Respondent's license as a registered nurse.
Findings Of Fact The Department is the state agency charged with regulating the practice of nursing in the State of Florida. Respondent Marla Gunderson ("Respondent") is, and has been at all times material hereto, a licensed registered nurse in the State of Florida, having been issued license number 2832622 by the Florida Board of Nursing in 1994. Respondent was employed by Lee Memorial Health Care System Rehabilitation Hospital ("Lee Memorial") as a registered nurse from about January 29, 2001, until about March 22, 2001. During the first three or four weeks of Respondent's employment, she participated in a full-time training program through Lee Memorial's education department. A part of this training included training in the administration of medications to patients. After completing the three or four-week training program, Respondent began working directly with patients. From about mid-February 2001 through early-March 2001, Respondent had no problems with documenting the administration of medications to patients. Some time in or near the middle of March 2001, Melanie Simmons, R.N. ("Simmons"), Lee Memorial's Nursing Supervisor, received a complaint from the night nurse following Respondent's shift. The complaint alleged that a patient's wife reported that the pain medication her husband was given by Respondent was not the Codeine that had been ordered by the physician. Pursuant to Lee Memorial's policies and procedures, Simmons conducted an investigation into the allegations of the above-referenced complaint regarding the Respondent. Lee Memorial's policies and procedures set out a specific method for conducting investigations regarding the administration of medications to patients. First, the physician's orders are checked to see what medications have been ordered for the patient. Next, the Pyxis records are pulled to determine if and when medications were withdrawn for administration to patients. The Pyxis system is a computerized medication delivery system. Each nurse has an assigned user code and a password, which must be entered before medication can be withdrawn from the Pyxis system. Then, medication administration records (MARs), the documents used by nurses to record the administration of medications to patients, are checked to verify whether the nurse documented the administration of the medications to the patients for whom they were withdrawn. Finally, the Patient Focus Notes, the forms used by nurses to document non-routinely administered medications, are also checked to determine if, when, and why a medication was given to a patient. If after comparing the physician's orders, Pyxis records, MARs, and Patient Focus Notes, it is determined that medications were not properly administered or documented, the nurse making the errors is advised of the discrepancy and given an opportunity to review the documentation and explain any inconsistencies. Simmons' investigation, which included comparing the physician's orders, Pyxis records, MARs and Patient Focus Notes, revealed discrepancies in medications withdrawn by Respondent and the MARs of the three patients under her care. The time period covered by the investigation was March 12 through March 17, 2001. Of the six days included in the investigation period, Simmons determined that all the discrepancies had occurred on one day, March 13, 2001. Nurses are required to record the kind and amount of medication that they administer to patients. This information should be recorded at or near the time the medication is administered. It is the policy of Lee Memorial that should a nurse not administer the medication or the entire amount of the medication dispensed under his or her password, that nurse should have another nurse witness the disposal of the medication. The nurse who serves as a witness to the disposal of medication would then enter his or her identification number in the Pyxis. As a result of that entry, the nurse who observed the disposal of the medication would be listed on the Pyxis report as a witness to the disposal of the medication not administered to patients. Such excess medication is termed waste or wastage. The physician's order for Patient F.R. indicated that the patient could have 1 to 2 Percocet tablets, to be administered by mouth, as needed every 3 to 4 hours. On March 13, 2001, at 14:06 Respondent withdrew 2 Percocet tablets for Patient F.R. However, there was no documentation in the patient's MAR, focus notes, and other records which indicated that Respondent administered the Percocet tablets to Patient F.R. The physician's order for Patient G.D. indicated that 1 to 2 Percocet tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, at 11:18 Respondent withdrew 2 Percocet tablets and on that same day at 17:16, Respondent withdrew another 2 Percocet tablets for Patient G.D. However, there was no documentation in the patient's MAR, focus notes, or any other records which indicated that Respondent administered the Percocet tablets to Patient G.D. The physician's order for Patient T.G. indicated that 1 to 1.5 Lortab/Vicodin tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, Respondent withdrew 2 Lortab/Vicodin tablets for Patient T.G. However, Respondent failed to document on the patient's MAR, focus notes, or other records that the medication had been administered to Patient T.G. With regard to the above-referenced medications withdrawn by Respondent on March 13, 2001, there is no documentation that any of the medications were wasted. All the medications listed in paragraphs 13, 14, and 15 are narcotics or controlled substances. Because Respondent did not document the patients' MARs or focus notes after she withdrew the medications, there was no way to determine whether the medications were actually administered to the patients. Proper documentation is very important because the notations made on patient records inform nurses on subsequent shifts if and when medications have been administered to the patients as well as the kind and amount of medications that have been administered. Without such documentation, the nurses taking over the subsequent shifts have no way of knowing whether medication has been administered, making it possible for affected patients to be overmedicated. Respondent has been a registered nurse since 1994 and knows or should have known the importance of documenting the administration of medications to patients. Respondent does not dispute that she did not document the administration and/or wastage of the narcotics or controlled substance she withdrew from the Pyxis system on March 13, 2001, for the patients identified in paragraphs 13, 14, and 15. Moreover, Respondent provided no definitive explanation as to why she did not properly document the records. According to Respondent, she "could have been busy, called away, [or] got distracted." Following Simmons' investigation of Respondent relating to the withdrawal and/or administration of medications, Respondent agreed to submit to a drug test. The results of the drug test were negative. Prior to being employed by Lee Memorial, all of Respondent's previous experience as an R.N. had been in long- term care. Except for the complaint which is the subject of this proceeding, there have been no complaints against Respondent's registered nurse's license.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order (1) imposing an administrative fine of $250; (2) requiring Respondent to remit the Agency's costs in prosecuting this case; (3) requiring Respondent to complete a continuing education course, approved by the Board of Nursing, in the area administration and documentation of medications; and (4) suspending Respondent's nursing license for two years. DONE AND ENTERED this 1st day of April, 2002, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of April, 2002. COPIES FURNISHED: Reginald D. Dixon, Esquire Agency for Health Care Administration General Counsel's Office-Practitioner Regulation Post Office Box 14229 2727 Mahan Drive Tallahassee, Florida 32317-4229 Marla Gunderson 1807 Northeast 26 Terrace Cape Coral, Florida 33909 Ruth R. Stiehl, Ph.D., R.N. Executive Director Board of Nursing Department of Health 4080 Woodcock Drive, Suite 202 Jacksonville, Florida 32207-2714 Mr. R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
