The Issue Does Petitioner, The Public Health Trust of Miami-Dade County, Florida (Health Trust), have standing to challenge Department of Health (Department) proposed rules 64J-2.007, 64J-2.008, and 64J-2.009? Is proposed rule 64J-2.007 an invalid exercise of delegated legislative authority? Is proposed rule 64J-2.008 an invalid exercise of delegated legislative authority? Is proposed rule 64J-2.009 an invalid exercise of delegated legislative authority?
Findings Of Fact The Parties Health Trust is an entity of Miami-Dade County. Health Trust oversees the Jackson Health System, a health care provider functioning as a three-hospital system. One hospital is Jackson Memorial Hospital, a licensed acute care general hospital located in Trauma Service Area (TSA) 19. It operates a verified Level I trauma center, which is a part of the Miami-Dade County trauma system. Health Trust also operates Jackson South Community Hospital (Jackson South), a licensed acute care general hospital in TSA 19. There is no trauma agency in TSA 19. Health Trust is not a trauma agency. It is not attempting to form or to be a part of a coalition to form a trauma agency for Miami-Dade County. Jackson South is committed to obtaining authority to operate a Level II trauma center. In April 2015, it applied to operate a Level II trauma center. The Department denied the application. Jackson South challenged the denial and requested a formal administrative hearing. The Department referred the challenge to DOAH, where it was assigned Case No. 15-3171. Since the hearing in this case, Administrative Law Judge John Van Laningham issued an order recommending approval of Jackson South’s application.3/ As of the date of this Order, the Department has not issued a final order. In September 2015, Jackson South submitted a trauma center letter of intent to the Department expressing its intent to become a Level II trauma center in TSA 19. This was a cautionary filing in the event the Department denies Jackson South’s first application now pending in DOAH Case No. 15-3171. Kendall Healthcare is located in Miami, Florida. It is a licensed acute care general hospital located in TSA 19. Kendall Healthcare is a verified Level II trauma center. Orange Park is located in Orange Park, Florida. Orange Park is a licensed acute care general hospital located in TSA 5. There is no trauma agency in TSA 5. Orange Park submitted a Trauma Center letter of intent to the Department in September 2015, expressing its intent to file an application to become a Level II trauma center. The Department is the state agency authorized to verify and regulate trauma centers and approve the establishment of trauma agencies in the state of Florida. It published the proposed trauma agency rules challenged in this proceeding. The Florida Trauma System Chapter 395, Part II, Florida Statutes, creates a plan to establish an inclusive trauma system to meet the needs of trauma victims. § 395.40(2), Fla. Stat. The Legislature defined “inclusive trauma system” to mean “a system designed to meet the needs of all injured trauma victims who require care in an acute- care setting and into which every health care provider or facility with resources to care for the injured trauma victim is incorporated.” Id. The Legislature placed primary responsibility for the planning and establishment of this statewide inclusive trauma system with the Department. § 395.40(3), Fla. Stat. Section 395.402 establishes trauma service areas. One component of the trauma system is the option for certain local or regional organizations to form and operate trauma agencies to plan, implement, and evaluate trauma services systems in their trauma system area. § 395.401(1)(a), Fla. Stat. Section 395.4001(11) defines a “trauma agency” as “a department-approved agency established and operated by one or more counties, or a department-approved entity with which one or more counties contract, for the purpose of administering an inclusive regional trauma system.” According to Leah Colston, Bureau Chief for the Department’s Bureau of Emergency Medical Oversight, a trauma agency “is the coordinating body for all of the emergency health care systems in a regional area that is designed to evaluate the system and perform its improvement opportunities to better outputs for patients.” (Tr. 34, lines 22-25.) Section 395.401 governs establishment of trauma agencies. It provides that the Department “may approve or not approve trauma agency plans based on the conformance of the plan with [sections 395.401,] 395.4015, 395.404, and 395.4045 and the rules and definitions adopted by the department.” § 395.401(1)(c), Fla. Stat. There are four trauma agencies in Florida. One agency covers 13 rural counties. The other three are for single counties. The counties are Palm Beach, Broward, and Hillsborough. There are no trauma agencies in TSA 19, which covers Miami-Dade and Monroe Counties. The last time the Department received an application to establish a new trauma agency was in 1991. There is no dedicated funding source for trauma agencies. They must find their own funding. Absent a consistent funding source, how and where and when future trauma agencies may develop is unclear. Rulemaking Process Over the past five years, there has been a considerable amount of litigation about the Department’s rules governing the allocation of the trauma centers around the state and applications for new trauma centers. In September 2011, Administrative Law Judge David Watkins issued a Final Order invalidating Department rules governing the allocation of trauma centers throughout the state. The First District Court of Appeal affirmed the Final Order.4/ The Department proposed a new trauma allocation rule in February 2014. Health Trust and other providers challenged that rule. The rule was determined valid.5/ Afterwards, several providers applied for designation as a trauma center in TSA 19, including Jackson South. After adoption of the new rule, the Department undertook review of its trauma center rules, including the rules pertaining to trauma agencies. This was part of the Department’s compliance with its rule reduction mandate. In an effort to reduce the number of Department rules and to align the rules with the statutory requirements, the Department promulgated the proposed rules challenged in this proceeding. As Ms. Colston explained, the Department intended for the proposed rules to align the rule requirements with the statutory provisions governing the formation of a trauma agency and to delete unnecessary or redundant information. During the rulemaking process, the Department conducted several workshops. They were well-attended by representatives of health care providers, including representatives of trauma centers and emergency medical services providers. Health Trust’s representatives and legal counsel participated in the workshops. The Department heard testimony and accepted written comments from the public. The Department thoroughly reviewed the public comments and considered them in finalizing the proposed rules.
The Issue The issue is what is the correct amount of workers’ compensation reimbursement to Oak Hill Hospital for emergency services rendered to patient J.M. for a work-related injury?
Findings Of Fact Petitioner, Dollar, is a carrier within the meaning of Subsections 440.02(4) and (38), Florida Statutes, and Florida Administrative Code Rule 69L-7.602(1)(w). Respondent, the Department, is charged with the review and resolution of disputes regarding the payment of providers by carriers for medical services rendered to injured workers. The Department has exclusive jurisdiction to decide reimbursement disputes. § 440.13(7) and (11)(c), Fla. Stat. Intervenor, Oak Hill, is a health care provider within the meaning of Subsections 440.13(1)(h) and (3)(f), Florida Statutes. Oak Hill is an acute care hospital located in Spring Hill, Hernando County, Florida. On July 14, 2009, Oak Hill provided emergency services to the patient J.M., a 47-year-old male, who was injured at his place of work. J.M. was examined by Oak Hill’s emergency department physician, was administered Hydromorphone, an opiate pain medication and was given an injection of pain medication. The emergency physician also ordered a computed Tomography (CT) scan of the lower spine. The results of the CT was negative for fractures. Oak Hill's total charges for J.M.’s outpatient emergency services were $5,590.00. Oak Hill submitted its claim for reimbursement using the standard “uniform billing” form, UB- 04. The UB-04 sets out each service provided to J.M., the individual charge for each service, and the total charge. The individual services on the UB-04 submitted for patient J.M. are listed as follows: pharmacy; CT scan of the lower spine; the emergency department visit itself, and the pain medication. Oak Hill’s claim was received by MCMC, an organization described as a “third-party administrator,” and was referred in turn to Qmedtrix. Qmedtrix is a medical bill-review agent located in Portland, Oregon. Qmedtrix performs bill review by referral from carriers and third-party administrators, and performed for Dollar a bill review of the bill submitted by Oak Hill. For its compensation, Qmedtrix is paid a percentage of the difference, if any, between the amount billed by the facility and the amount paid by the carrier. Following Qmedtrix’ review, Oak Hill received a check from Dollar in the amount of $827.73, along with an “Explanation of Medical Benefits” review (EOBR), which is required to be sent along with the bill payment. The EOBR sets out the four individual components of Oak Hill’s claim. For the first component (the pharmacy charge), the EOBR indicates that “Reimbursement for the outpatient service is based on 75% [sic] the hospital’s charges.” The CT scan, with charges of $4,110.25, is paid at $247.00 with the explanation, ”Payment in accordance with the Georgia Hospital Inpatient Fee Schedule.” The emergency department visit references CPT code 99284, the same as appears on the UB-04, but is paid at $524.70 rather than at 75 percent of charges. That adjustment is explained as follows: “Reductions are due to charges exceeding amts reasonable for provider’s demographic area. Please direct questions to Qmedtrix 800/833/1993.” The last component of the claim, for the pain medication, is paid at $48.90 with the same explanation. The EOBR has one column entitled “Reason Code.” In completing an EOBR, insurers must select a code from a list of approximately 50 codes found in Florida Administrative Code Rule 69L-7.602(5)(o)2., which identifies the reason for the disallowance or adjustment. For the emergency room visit, the EOBR shows a code of 93, which is explained as follows: “Paid: No modification to the medical bill: Payment made pursuant to contractual arrangement.” As mentioned above, the EOBR indicates a “code” of 99284, the same code used on the UB-04 submitted by Oak Hill. These codes are among five codes that are used by hospitals to bill emergency department visits based on “level” of intensity rendered. These codes are taken from the American Medical Association’s Current Procedural Terminology (or CPT), a coding system developed for physician billing, not for hospitals. Over the years, these CPT codes were adopted by hospitals for billing emergency department visits. Emergency department services are billed with CPT codes 99281 through 99285. After receiving the payment and EOBR, Oak Hill timely filed a Petition for Resolution of Reimbursement Dispute, with attachments, to the Department. Oak Hill alleged in its Petition that the correct reimbursement amount owed was $4,192.50, leaving an underpayment of $3,364.77. However, subsequently, Oak Hill received a second check from Dollar, and an accompanying EOBR. The second check was for $2,835.69. The EOBR indicated that the second payment was for the CT scan of the lower spine. The sum of two payments for the CT scan is $3,082.69, which amounts to 75 percent of Oak Hill’s charges for the procedure. No further allowance was made for the other three components of Oak Hill’s claim. Qmedtrix, acting as Dollar’s representative, then filed Dollar’s Response to Petition for Resolution of Reimbursement Dispute and attachments with the Department. Attached to the Response was a letter from Mr. von Sydow dated October 19, 2009. The letter asserted that the correct payment to the hospital (Oak Hill) should be determined on an average of usual and customary charges for all providers in a given geographic area, rather than the hospital’s usual and customary charges. As authority, Mr. von Sydow cites the case of One Beacon Insurance v. Agency for Health Care Administration, 958 So. 2d 1127 (Fla. 1st DCA 2007). The letter also requested that the Department “scrutinize the bill in question in order to determine, first, whether the hospital in fact charged its usual charge for the services provided and, second, whether the billed charges are in line with the customary charges of other facilities in the same community.” The letter further alleges that the hospital “upcoded” the emergency room visit, billing using CPT code 99284, asserting that the proper billing code should have been 99282. The letter concludes that the amount paid, $524.70, for the emergency department visit exceeds the amount “usual and customary” charges that Qmedtrix asserts, on behalf of Dollar, is applicable to the claim. On October 29, 2009, the Department issued its Determination. The Determination states in pertinent part: Rule 69L-7.602(5)(q), F.A.C., stipulates the EOBR codes that must be utilized when explaining to the provider the carrier’s reasons for disallowance or adjustment. The carrier appended EOBR codes 92 or 93 to the billed items. For the line items appended with EOBR code 92, the reimbursement fails to equal the maximum reimbursement allowances (MRAs) provided in the 2006 HRM. Furthermore, the carrier failed to substantiate the existence of a reimbursement contract between Oak Hill and the carrier. Therefore, the reimbursement adjustments to line items appended with EOBR codes, 92 and 93, are unsubstantiated. Moreover, the carrier appended to the billed line items three unique codes which indicate: “Reductions are due to charges exceeding amts reasonable for provider’s demographic area”[sic], “Reimbursement for this outpatient service is based on 75% of the hospital’s charges”, and “Payment in accordance with the Georgia hospital inpatient payment fee schedule.” These explanations fail to afford the petitioner any understanding for the reimbursement adjustments documented on the EOBR. Furthermore, the Florida Statutes and Rules do not support the carrier’s reasoning for the reimbursement adjustments documented on the EOBR. Therefore, the carrier failed to substantiate its adjustment to reimbursement on the EOBR as required by Rule 69L-7.602, F.A.C. Lastly, the 2006 HRM, Section 12.A., vests specific authority in the carrier to review the hospital’s Charge Master to verify charges on the itemized statement and to disallow reimbursement for specifically itemized services that do not appear to be medically necessary. None of the submitted documentation indicates the carrier elected to exercise this option. Whereas, the carrier did not allege that any service was deemed not “medically necessary,” or that the charges on the billing form failed to match the petitioner’s Charge Master, the OMS finds the charges billed by the hospital are the hospital’s usual and customary charges. The 2006 HRM provides for reimbursement of emergency room services at seventy-five percent (75%) of the hospital’s usual and customary charges. Whereas, the carrier failed to substantiate is[sic] adjustments to reimbursement on the EOBR, the OMS determines correct and total reimbursement equals $4,192.50 ($5590.00x.75). The determination letter also informed Dollar of its right to an administrative hearing. Dollar timely filed a Request for Administrative Hearing, which gave rise to this proceeding. CODING FOR J.M.’S EMERGENCY SERVICES As mentioned above, Oak Hill reported the emergency department visit using CPT Code 99284. No one from the hospital testified, but Oak Hill’s expert, Allan W. March, M.D., reviewed Oak Hill’s hospital record for J.M. Dr. March is a graduate of Dartmouth College and Johns Hopkins University Medical School. He has extensive experience in, among other things, hospital physician practice and utilization review. Dr. March describes utilization as the oversight of medical care to affirm that it is appropriate, cost-effective, and medically necessary. Dr. March has worked as an emergency department physician and has personally treated upwards of 5,000 workers’ compensation patients. Dr. March testified on behalf of Intervenor and Respondent. Dr. March described J.M. from the hospital record as follows: “This patient is a 47-year-old man who immediately, just prior to presentation, fell off a ladder 7 feet above the ground and injured his back and presented with pain in the right lower back, with a swollen and tender area that was visible and palpable to the examining physician, with pain on movement of his lower back.” Dr. March reviewed Oak Hill’s hospital record for J.M. to analyze whether Oak Hill appropriately used CPT code 99284. Oak Hill’s coding for the emergency department visit is based on the American College of Emergency Physicians’ “ED Facility Level Coding Guidelines” (ACEP Guidelines). Oak Hill’s medical record for J.M.’s care includes an “Emergency Department Charge Sheet” corresponding precisely to the ACEP Guidelines, and in which the abbreviation “CT” is circled in the section for CPT code 99284. By using the ACEP Guidelines, Oak Hill used a nationally recognized methodology in determining the level of service to which the hospital should bill. Under the ACEP guidelines, the CPT code level assigned is always the highest level at which a minimum of one “possible intervention” is found. In this case, Dr. March determined that J.M. was given a CT scan. In Dr. March’s opinion, Oak Hill correctly assigned a 99284 code to J.M.’s emergency department visit, and that assignment is substantiated by the medical record under the ACEP Guidelines. Dr. March further explained that the coding level of a hospital does not correspond directly to the coding level assigned by the physician. The physician’s services are coded under the CPT-4 coding book. According to Dr. March, the CPT coding manual is applicable to facility coding only if the hospital chooses to use this as a basis in their methodology for coding. Further, Dr. March explained that the separate billing of the emergency department visit captures separate and distinct costs incurred by hospitals that are not included in line-items for procedures. The claim submitted by Oak Hill was sent to Qmedtrix for a bill review. Its data elements were first entered into Qmedtrix’ proprietary bill-review software known as “BillChek.” The software placed Oak Hill’s claim on hold for manual review. The claim was then manually reviewed by William von Sydow, Director of National Dispute Resolution for Qmedtrix. Although his educational background is in law, Mr. von Sydow is a certified coder certified by the American Health Information Management Association (AHIMA). Mr. von Sydow determined in his bill review that Oak Hill should have used code 99282 instead of 99284, although payment was based on code 99283 at 75 percent of what he calculated to be the average charge in the community for 99283. Mr. von Sydow described what he considers to be inconsistencies between certain diagnosis codes under the International Classification of Diseases, Ninth Edition (ICD-9) and the CPT codes used to classify the emergency department visit. He considers the ICD-9 codes on Oak Hill’s claim to be inconsistent with CPT code 99284. In his view, the ICD-9 codes correspond more closely with CPT code 99282. Moreover, Mr. von Sydow referenced a study by American Hospital Association (AHA) and AHIMA, which suggests that hospitals should count the number and kind of interventions to approximate the CPT factors, but that a hospital should not include in this count interventions or procedures, such as CTs or -rays, which the hospital bills separately. He further acknowledged that the federal Centers for Medicare and Medicaid Services (CMS) allow hospitals to use their own methodology in applying the CPT codes. David Perlman, M.D., received his undergraduate degree from Brown University and his medical degree from the University of Oregon. He has considerable experience as an emergency room physician. For the past six years, he has worked for Qmedtrix initially doing utilization review and as their medical director since 2005. Dr. Perlman testified on behalf of Dollar. Dr. Perlman is also familiar with the ACEP guidelines relied upon by Dr. March and the AHA/AHIMA study relied upon by Mr. von Sydow. He is also familiar with the CPT code handbook. Dr. Perlman suggested that the use of the ACEP guidelines could result in reimbursement essentially already provided in a separate line-item. He agrees with the methodology recommended by the AMA/AHIMA study. That is, counting the number and kind of interventions or procedures to approximate the CPT book’s factors to consider in selecting the code billed for emergency department services, but not including in this count interventions or procedures, such as CTs or X-rays, which the hospital bills separately. In Dr. Perlman’s opinion, J.M.’s injuries supported assignment of CPT code 99283 rather than 99284. The fact that J.M. underwent a CT scan did not alter this conclusion. According to Dr. Perlman, use of a CT scan in a patient’s emergency department treatment determines that the facility may assign a 99284 code under the ACEP guidelines. In his opinion, this does not necessarily reflect the severity of the illness or injury. Dr. Perlman acknowledged, however, that hospitals are free to use the ACEP guidelines and that many hospitals do so. The preponderance of the evidence establishes that there is no national, standardized methodology for the manner in which hospitals are to apply CPT codes 99281-99285 for facility billing. The preponderance also establishes that, while there is a difference of opinion as to whether ACEP guidelines are the best method, it is a nationally recognized method used by many hospitals. Oak Hill’s use of this methodology is supported by the weight of the evidence as appropriate. J.M.’s hospital record amply documents the interventions required for the assignment of CPT code 99284 under the ACEP guidelines. Therefore, coding J.M.’s emergency department visit as 99284 by Oak Hill was appropriate. There is no dispute that Oak Hill’s charges as represented on the UB-04 form conform to its internal charge master, or that the services represented were in fact provided, or that they were medically necessary.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Department of Financial Services, Division of Workers' Compensation, enter a Final Order requiring Petitioner to remit payment to Oak Hill consistent with the Determination Letter dated October 29, 2009, and Section 440.13(7), Florida Statutes. DONE AND ENTERED this 17th day of June, 2010, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of June, 2010.
The Issue Whether the application timely filed with the Department of Health (“Department”) by Memorial Healthcare Group, Inc., d/b/a Memorial Hospital Jacksonville (“Memorial”), met the applicable standards for approval to operate as a provisional Level II trauma center; and whether the Department’s approval of the application was based upon an unadopted rule.
Findings Of Fact The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes. The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has a primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001 and 395.40(3), Fla. Stat. Shands is an acute-care hospital located in Trauma Service Area (“TSA”) 5, which lies in Baker, Nassau, Duval, Clay, and St. Johns counties. Shands has been designated by the Department as a Level I trauma center. Memorial is an acute-care hospital also located in TSA 5. Memorial operates a provisional Level II trauma center. The application that was submitted by Memorial and approved by the Department on May 1, 2017, is the subject of this proceeding. 5. Chapter 395, Part II (§§ 395.40 – 395.51), Florida Statutes (“Trauma Statute”), sets forth the statutory framework for the development of a statewide trauma system. The Department is charged with the planning and establishment of the statewide inclusive trauma system. See, § 395.40(3), Fla. Stat. The Legislature recognized the benefits of trauma care provided within an “inclusive trauma system,” that is “designed to meet the needs of all injured trauma victims.” § 395.40(2), Fla. Stat. Section 395.401(2) directs the Department to “adopt, by rule, standards for verification of trauma centers based on national guidelines, including those established by the American College of Surgeons.” The Trauma Center Standards are published in DH Pamphlet (DHP) 150-9, which is incorporated by reference in Florida Administrative Code Rule 64J-2.011 (the “Trauma Standards”). Section 395.4025 (the “Application Statute”) describes the application process for hospitals seeking to become designated as a trauma center. Section 395.4025(2)(c) requires the Department to conduct a “provisional review” of each trauma center application to determine if “the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” This “critical review” shall be based on “trauma center standards” and shall include a review of whether the hospital has: (1) equipment and physical facilities necessary to provide trauma services; (2) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (3) an effective quality assurance process. Id. Notably, the provisional review described in section 395.4025(1)(c) looks only to the application to determine whether an application “has [met] the critical elements required for a trauma center.” Id. Section 395.4025(13) authorizes the Department to “adopt, by rule, the procedures and processes by which it will select trauma centers.” Pursuant to this authorization, the Department issued rule 64J-2.012, which provides detailed regulations governing the application process. Rule 64J-2.012(1)(d) includes a detailed list of elements that a provisional trauma center applicant must satisfy (the “critical elements”) to receive provisional approval from the Department. The Trauma Standards contain other elements that were not designated by the Department as “critical” (the “non-critical elements”). These standards pertain primarily to ensuring the programmatic integrity of a trauma center. Provisional trauma center applications must eventually establish compliance with the non-critical elements, but the non-critical elements are not examined by the Department until after a provisional trauma center application is granted. See Fla. Admin. Code R. 64J-2.012(1)(h). The process for obtaining designation as a provisional trauma center begins on October 1 each year. By that date, hospitals must submit to the Department a letter of intent to file a provisional trauma center application. See § 395.4025(2)(a), Fla. Stat.; Fla. Admin. Code R. 64J- 2.012(1)(a). If a hospital timely submits a letter of intent, the Department must provide the hospital with a provisional trauma center application and instructions for submitting it to the Department. § 395.4025(2)(b), Fla. Stat. April 1 of the following year is the deadline for the hospital to submit a provisional trauma center application. See Fla. Admin. Code R. 64J-2.012(1)(a). The Department conducts a review of the application to determine whether it is complete and has established compliance with the critical elements. See Fla. Admin. Code R. 64J-2.012(1)(d). The Department does not conduct a site visit until a provisional trauma center application is approved and the trauma center is operational. § 395.4025(2)(d) and (5), Fla. Stat. By April 15, the Department must provide the applicant with written notice of any deficiencies in the critical elements and gives the hospital the opportunity to submit additional clarifying or correcting information. See Fla. Admin. Code R. 64J-2.012(1)(e). Applicants then have five working days to address the identified deficiencies and submit additional information. See Fla. Admin. Code R. 64J-2.012(1)(f). On or before May 1, the Department must send written notification to each applicant hospital advising whether its application was approved or denied. See Fla. Admin. Code R. 64J-2.012(1)(g)1.-2. If a hospital is granted provisional approval, it is required to begin operation as a provisional trauma center on May 1 and becomes a full member of Florida’s integrated trauma system on that day. § 395.4025(3), Fla. Stat.; Fla. Admin. Code R. 64J-2.012(1)(g)1. The Department also immediately notifies EMS providers of the newly operational provisional trauma center. Providers are required immediately to begin transporting “trauma alert” victims, as identified pursuant to field triage criteria, to the newly designated provisional trauma center for trauma care when it is the nearest trauma center to the location of the incident. See Fla. Admin. Code R. 64J-2.002(3)(g). In the summer of 2016, Memorial received a letter from the Department notifying Memorial of the opportunity to submit a letter of intent to become a trauma center. Memorial timely submitted a letter of intent to the Department in September 2016. This letter indicated that Memorial would seek approval from the Department to operate as a Level II trauma center. After Memorial submitted its letter of intent, the Department responded by sending Memorial a notice accepting its letter of intent and providing information on the application process. The notice directed Memorial to the Department’s trauma center application and contained instructions for the completion and submission of the application. Once Memorial received the Department’s notice confirming acceptance of its letter of intent, it began making significant investments of resources and capital to develop its trauma program. It did so to ensure that its application would be compliant with the Trauma Standards. In order to implement its trauma program and meet the required Trauma Standards, Memorial made investments in a number of areas, including the renovation of its emergency department (“ED”) to accommodate two dedicated trauma resuscitation bays; the hiring and recruitment of new physicians and staff; conducting significant staff education; and beginning work towards the construction of a new helipad. By May 1, 2017, Memorial had invested over $4 million to develop its trauma program. This capital investment included approximately $2.5 million in construction and equipment. Memorial also invested $1.7 million in recruiting physicians and staff, as well as trauma-related training and education. Memorial was well positioned to develop its trauma program, since many of the needed surgical specialties were already offered at the hospital. The hospital recruited additional physicians to fill the more than 20 non-surgical specialties required by the Trauma Standards. In addition to new physicians, Memorial recruited many new specialized nurses needed to serve trauma patients. Memorial ultimately provided over 6,000 hours of trauma training before May 1, 2017, and continues to train new nurses. The hospital ensured that over 200 nurses received training in Trauma Nurse Core Competencies, which ensures that nursing staff can provide high quality care for severely injured patients. Memorial made all of the above investments prior to March 31, 2017, the date on which Memorial submitted its application to the Department. Memorial’s Application was prepared by a core team, headed by Eleanor Lynch, senior vice president of operations at Memorial. The key members of the team included Memorial’s trauma medical director, trauma program director, as well as representatives from the intensive care unit (“ICU”) and operating room. In order to ensure Memorial’s Application met the Trauma Standards, the team preparing the application met at least three times each week. Those meetings sometimes consisted of 30 different individuals from a variety of disciplines, including the trauma program director, trauma medical director, registration, respiratory, ICU, and the ED. The process was comprehensive and inclusive to ensure the hospital was fully prepared to address each Trauma Standard in its application. This team reviewed the application before it was submitted to the Department to ensure that it complied with the Trauma Standards. Memorial also received assistance from K.C. Pidgeon, vice president of trauma for HCA South Atlantic Division--which includes Memorial. Mr. Pidgeon, who has significant experience in developing trauma programs in Florida, participated in each of the team meetings. He provided guidance into making sure the hospital and its application met the Trauma Standards, including updating policies and procedures, purchasing equipment, recruiting staff, and development of nurse leaders. The final application submitted to the Department consisted of 32 separate binders encompassing thousands of pages of information. In order to be ready to operate by May 1, 2017, Memorial set an internal deadline of February 27, 2017, for the hospital to meet each of the Trauma Standards. Memorial met this internal deadline and included a letter in its application from Memorial’s CEO confirming this milestone. Memorial timely submitted its trauma center application to the Department on March 31, 2017. In developing its trauma program and preparing its application, Memorial ensured that it met all of the Trauma Standards that are required for provisional approval. After receiving Memorial’s Application, the Department arranged for it to be reviewed by two outside experts, Dr. Marco Bonta and Nurse Marla Vanore. Both Dr. Bonta and Nurse Vanore have reviewed numerous trauma applications on behalf of the Department, and are very familiar with the Trauma Standards. Following their review, Dr. Bonta and Nurse Vanore sent the Department a checklist identifying alleged deficiencies in Memorial’s Application. Both reviewers concluded that the quality of the application on initial review was excellent, and reflected a serious effort to meet the Trauma Standards before beginning operations. On April 14, 2017, the Department sent Memorial a letter notifying it of the deficiencies that Dr. Bonta and Nurse Vanore had identified. The few deficiencies identified by the Department were mainly clerical in nature or required simple clarifications. For instance, one of the noted deficiencies included updating the curriculum vitae of Memorial’s trauma program director. Memorial timely responded to each deficiency identified by the Department on April 22, 2017. Memorial’s deficiency response was also reviewed by Dr. Bonta and Nurse Vanore. Following their review of Memorial’s deficiency response, the expert reviewers concluded that Memorial properly addressed each deficiency identified during the Department’s initial review. On May 1, 2017, the Department informed Memorial that its application was in compliance with the applicable Trauma Standards and directed it to begin trauma operations on that same day. As indicated by the parties’ stipulation, Shands takes issue with only a few of the hundreds of requirements that comprise the Trauma Standards. The only aspects of Memorial’s Application which Shands disputes are the standards related to trauma surgeon call coverage (Standards II.A.4-5, II.B.2, and III.A) and the helipad (Standard V.A.5). Shands does not dispute that the application meets the remaining Trauma Standards. Standard III of the Trauma Standards details the surgical staffing requirements that each trauma center must meet. Standard III.A specifically addresses the requirements for general trauma surgeons. Standard III.A.1 requires that “[t]here shall be a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary and backup trauma coverage 24 hours a day at a trauma center when summoned.” Standard III.A.2 requires each trauma surgeon to sign the General Surgeons Commitment Statement, which confirms that each surgeon on primary and backup call will comply with certain conditions, including arriving promptly when summoned. Standard III.A.3 lists the minimum qualifications for each trauma surgeon taking call, such as certifications and hospital privileges. Memorial submitted substantial documentation which demonstrated its compliance with the requirements in Standard III.A. Although the Trauma Standards only require five trauma surgeons, Memorial secured nine trauma surgeons for its program. For each of these surgeons, Memorial provided proof of hospital privileges, board certification, state licensure, Advanced Trauma Life Support (“ATLS”) certification, proof of participation in past trauma cases, completion of continuing medical education courses, attestation by the Chief of Neurosurgery, and the commitment statement, among other documentation. Memorial’s documentation for this section totaled more than 500 pages. Memorial also submitted primary and backup call schedules for February, March, April, and May 2017, indicating when each trauma surgeon was scheduled to take trauma call. In addition, Memorial submitted a number of policies and procedures, including Memorial’s credentialing criteria, which is more stringent than what the Department requires. In order to be credentialed at Memorial, a trauma surgeon must agree to the following requirements for primary trauma call: be physically present in-house to meet all trauma patients in the trauma resuscitation areas at the time of the trauma patient’s arrival; perform no elective surgery or procedures during the on- call period that would render the trauma surgeon unavailable to arrive promptly to a trauma alert patient; and refrain from taking general surgery emergency call at any other facility or trauma call at any other facilities while on trauma call at the primary facility. Similar requirements exist for trauma backup call. Standard II of the Trauma Standards sets forth the trauma call coverage requirements that each trauma center must meet. Specifically, Standards II.A.4 and II.A.5 require “[a]t least one qualified trauma surgeon (as described in Standard III.A) to be on primary trauma call at all times to provide trauma service care” and “[a]t least one qualified trauma surgeon (as described in Standard III.A) to be on backup trauma call at all times to provide trauma service care.” Simply put, there must be one trauma surgeon on primary call and one trauma surgeon on backup call at all times. As part of its application, Memorial submitted detailed information about each of the nine trauma surgeons on its monthly call schedules, including the call schedules themselves. The call schedules detail each of the trauma surgeons scheduled to take primary and backup trauma call for February through May 2017. Memorial secured and submitted commitment statements (DH Form 2043E) from each of the trauma surgeons on its call schedule. These signed commitment letters indicate that each trauma surgeon agreed to commit to the call schedules submitted to the Department and be available as indicated. These letters also indicate that each surgeon pledged not to take trauma call at any other facility while on trauma call at Memorial. Trauma Standard II also includes a requirement that the hospital ensure any new trauma surgeons are appropriately qualified and sign the commitment statement. Specifically, “[a]s surgeons change, the trauma medical director must ensure that the new surgeons have the qualifications delineated in Standard III.A.3 and that they sign the General Surgeons Commitment Statement. The trauma service shall keep a current and up-to- date commitment statement on file in the hospital’s trauma center application at all times for Department of Health review.” In response to this subpart, Memorial appropriately submitted the commitment statements for its initial nine trauma surgeons. Because this was Memorial’s provisional application, none of the new trauma surgeons who have subsequently joined its program after May 1, 2017, were included with this submission. After completing their initial review of Memorial’s Application, the Department’s expert reviewers identified only one issue to be addressed in the above sections. For one of the trauma surgeons, Dr. Alton Parker, there was a question as to whether he had met all the required continuing medical education (“CME”) requirements. As requested, Memorial submitted additional documentation with its Deficiency Response confirming that Dr. Parker had in fact completed the required CME courses. With this concern resolved, the expert reviewers ultimately concluded that Memorial’s Application met every requirement. At hearing, Shands alleged that because some of the trauma surgeons listed in Memorial’s Application do not live in Jacksonville year round, the application did not meet the Trauma Standards detailed above. However, there is no requirement in the Trauma Standards that trauma surgeons must live full time in the same community as the hospital at which they take trauma call. Rather, the Trauma Standards require that trauma surgeons on primary and backup trauma call in Level II trauma centers be available within 30 minutes once summoned. In actuality, Shands’ criticisms appear to be a matter of preference or imagining the ideal situation, rather than substantive questions about compliance with the legal requirements for trauma surgeon call. Memorial has not had any gap in trauma call coverage or similar issues since it began operations on May 1, 2017; every shift has been covered and each trauma surgeon available as required. Memorial’s trauma surgeons are committed members of the trauma team, including active participants in the quality improvement process, regardless of where their permanent residence may be. As part of its mission to ensure high-quality care, Memorial requires its trauma surgeons on primary trauma call to be physically present at the hospital during the entire shift, which is beyond what the Trauma Standards require for Level II trauma centers. Memorial established this requirement in part to ensure that there would be no issues with response time for trauma surgeons. Any trauma surgeons on backup call that do not have permanent residences within 30 minutes response time of the hospital, typically stay at a hotel close to the hospital in order to comply with the Trauma Standards and Memorial’s own requirements. For any trauma surgeons who do not live full time in the Jacksonville area, Memorial requires that they report well in advance of beginning the call coverage to ensure there are no issues, e.g., a trauma surgeon beginning call at 9:00 a.m. Monday morning must report to the hospital by 9:00 p.m. the night before. Memorial’s trauma surgeons have positive working relationships with other team members, like the ED physicians, and have collaborated well with local EMS. Memorial has worked to build a full-time trauma surgeon roster, with the hope that recruited physicians will ultimately decide to make the Jacksonville area their home. Memorial currently has three trauma surgeons, including the trauma medical director, Dr. Michael Samotowka, who live full time in Jacksonville and plans to continue recruiting until all six current spots are filled by full-time residents. Both Dr. Bonta and Nurse Vanore determined that Memorial’s trauma call coverage met the applicable Trauma Standards, including Standards II.A.4-5, II.B.2, and III.A. Both expert reviewers confirmed at hearing that the Trauma Standards only require trauma surgeons on primary and backup call to be readily available--they do not dictate where surgeons must reside full time. Nurse Vanore also testified that many trauma centers across the country utilize physicians who do not live in the immediate vicinity of the hospital. These physicians either stay at the hospital or make arrangements to stay nearby when on call. This reflects a common trend in trauma centers nationwide, which often use the rotation of trauma surgeon (both on- and off-call) shifts to enhance patient care. Most trauma centers do not use trauma surgeons to provide longitudinal care (one surgeon with the patient throughout the care process). Instead, there is a comprehensive patient handoff to the next trauma surgeon. There was no indication in Memorial’s Application that its trauma surgeons would not fulfill their call obligations. The general trauma surgeon call schedules submitted by Memorial adequately demonstrated that Memorial would be able to fulfill its trauma call coverage requirements. Since beginning trauma operations, Memorial has not had any gaps in coverage or other issues related to trauma call. Therefore, Memorial satisfied Standards II.A.4-5, II.B.2, and III.A. The helipad became a central issue at hearing. Standard V addresses the facility requirements relating to the ED, including the helipad. Standard V.A.5 requires that each hospital must have a “helicopter-landing site in close proximity to the resuscitation area.” “Close proximity” is defined to mean that “the interval of time between the landing of the helicopter and the transfer of the patient into the resuscitation area will be such that no harmful effect on the patient’s outcome results.” In addition to this requirement, the helipad must be properly licensed by state and federal authorities, and have appropriate policies and procedures for helipad operations. Memorial has used the helipad in its current location since 1993. Before it began operations as a trauma center, Memorial effectively used its helipad to transport trauma patients out of its ED to Shands and other trauma centers without incident for the entirety of that time period. The helipad is located approximately 1900 feet from Memorial’s ED. To meet this Trauma Standard, Memorial hired Liberty Ambulance Service, a private ambulance service, to staff the helipad 24/7, so that at all times there is an advanced life support ambulance with two paramedics ready to transport patients from the helipad to the ED. In addition, the ambulance driver has received emergency vehicle operations course training. Memorial also provided training to the ambulance crew members to ensure they were proficient in helicopter safety. This training included in-depth interaction with air crew of TraumaOne, which is one of the region’s air transport providers. Memorial hires deputies from the Jacksonville Sheriff’s Office to be present at all times for helicopter arrivals. These deputies can be used to block any pedestrian or vehicle access to the transport route or otherwise provide transport assistance, although this has not been needed. Memorial conducted numerous time studies, almost daily since February 27, 2017, to ensure it could quickly move patients from the helipad to the ED without delaying treatment. The time trials entailed actually loading a stretcher onto an ambulance at the helipad, driving the ambulance to the ED, and unloading the stretcher at the ED. These time trials, which were conducted beginning in December 2016 and continue today, showed an average transport time of two to three minutes. Each time trial was attended by Memorial’s EMS Coordinator, Greg Miller, and signed off by each ambulance crew that participated. These time trials helped familiarize the ambulance crew with the short route from the helipad to the ED, as well as to identify an alternate route that can be used if needed. Admittedly, the trials were performed using hospital personnel posing as patients, rather than actual trauma patients, but the methodology, while presenting a best case scenario, was nonetheless reasonable. In addition to the time trials, actual air transports of non-trauma patients confirm the close proximity of the helipad. It only took five minutes to transport a recent non- trauma patient from the helipad to the ED, as documented by the LifeFlight air crew which transported the patient. Since beginning trauma operations, there have not been any issues with trauma patients arriving by helipad. At the time of hearing, Memorial had only had one trauma patient delivered by helicopter since May 1, 2017. Memorial has only had 24 total non-trauma patients delivered by helipad in 2017. In fact, very few patients are transported by air in TSA 5, generally. As part of ongoing renovations, Memorial is currently constructing a new helipad, which will be situated one floor directly above the ED. The new helipad is scheduled to be completed in July 2018. Shands alleged at hearing that Memorial’s helipad was not optimally located and voiced general concerns about its potential impact on patient care. While 1900 feet from the ED cannot be considered the “optimal location” for the helipad, the claims of adverse impact on patient care were not supported by evidence produced at hearing. None of Shands’ witnesses suggested that the patient transport times reflected in Memorial’s Application would adversely impact patient care, or that any adverse incidents had occurred on Memorial’s helipad. Actually, none of Shands’ witnesses had even reviewed any of the time trials or actual patient transport information included in Memorial’s Application. The time it takes to transport patients from Memorial’s helipad to the ED is not substantially different from other trauma centers in the region. Shands’ own witnesses confirmed that Shands’ helipad sits atop a six-story parking garage across the street from its ED, which requires patients to be transported down an elevator and wheeled on a stretcher across a road while security blocks traffic access. Despite their criticisms, none of Shands’ witnesses knew how long it took to transport patients from Shands’ helipad to the ED. Moreover, with the construction of its new helipad atop the ED, any concerns about the current transport times will be eliminated. Both Dr. Bonta and Nurse Vanore determined that Memorial’s helipad met the applicable Trauma Standard, namely Standard V.A.5. Based on the time studies provided by Memorial which showed the average transport time from the helipad to the ED was only two to three minutes, the expert reviewers determined that the helipad was in “close proximity” to the resuscitation area. Based on their experience, the expert reviewers concluded that two to three minutes was typical of other trauma centers, including hospitals with rooftop helipads. This duration of transport time is actually quite good and would not adversely affect patient care. Memorial’s helipad is in close proximity to the trauma resuscitation area, as the Department properly concluded based on the information provided in Memorial’s Application. The two-to- three minute transport time for trauma patients is well within the acceptable range and demonstrates that Memorial met Standard V.A.5. Memorial elicited testimony from a longtime expert in health care planning, Gene Nelson of Health Strategies, Inc. Mr. Nelson spoke at length in an effort to establish need for an additional trauma center in TSA 5 through a feasibility study employing well recognized health planning concepts. He focused primarily on access to trauma care for patients needing the comprehensive specialized care offered by trauma centers. Mr. Nelson noted that many trauma patients were being treated in general acute care hospitals without trauma centers which fell short of the care provided in centers like Shands and the proposed Memorial trauma center. He concluded that a substantial need exists for another trauma center in TSA 5 and that Memorial would fulfill that need. Shands objected to this discussion of need by Mr. Nelson on behalf of Memorial, and argues that the letter of intent and application filed by Memorial should not have been accepted in the first place, since there was not a documented need for another trauma center in TSA 5. As will be discussed in the Conclusions of Law below, the need for an additional trauma center is not a determination to be made at the time of a hospital’s filing for authority to begin operating a provisional trauma center. Shands testified that Memorial’s operation of a trauma center in TSA 5 has already resulted in injury to its operations and profitability. This injury will only continue in the future as Memorial gains a stronger foothold in the TSA. The negative impacts include fewer trauma patients at Shands resulting in a longer period for trauma nurses to acquire and maintain the specialized skills necessary for operating in a trauma center versus a general acute care hospital. The opening of Memorial’s provisional trauma center has caused the number of severely injured trauma patients at Shands to decrease. Shands predicts an annual loss of 324 trauma cases due to Memorial’s opening, translating to a $2.25 to $2.7 million annual loss of revenues. If outpatient cases are included in this analysis, Shands projects an annual loss in revenues of $12,422 per case over the 324 lost cases, resulting in an annual total loss of approximately $4 million. Memorial argues that sufficient trauma volume exists in TSA 5 for both facilities to operate their trauma centers. Memorial projects that it will treat 1,556 trauma patients per year, well above the American College of Surgeons’ (“ACS”) recommendation of at least 1,200 patients per year as a minimum volume level. Mr. Nelson estimates that, annually, only between 300 and 500 trauma patients will be treated at Memorial that otherwise would have been treated at Shands. The rest likely would have received treatment at an acute care hospital, not a trauma center. Mr. Nelson believes that Memorial’s trauma program has had, at most, a minimal impact on Shands. An analysis produced by Shands demonstrates that Shands’ own projections estimate a loss of only 154 trauma patient admissions, well below the numbers projected by Memorial. Even with Memorial’s trauma program being fully operational, Shands will continue to receive in excess of 2,000 trauma patients admitted annually. That volume is well above the ACS’s recommended minimum patient volume of 1,200 for Level I trauma centers. Shands’ own data shows that it will continue to see over 4,600 total trauma patients annually, including inpatient and outpatient cases. Estimates prepared by Shands’ associate vice president of finance, Dean Cocchi, demonstrate that even with a potential impact from Memorial, Shands will still have a contribution margin of well over $30 million. Mr. Cocchi also testified that Shands’ projected financial impact from Memorial operations will not endanger the continued operation of its trauma program. While the presence of Memorial in the TSA 5 market will have a small negative financial impact on Shands, it is not projected to be substantially adverse. The quality of care provided at Shands has not been impacted by the opening of Memorial’s trauma center. Shands remains a high-quality provider of trauma care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Memorial met its burden of establishing that its trauma center application met the applicable standards; awarding provisional Level II status to Memorial; and dismissing Shands’ petition. DONE AND ENTERED this 13th day of June, 2018, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of June, 2018. COPIES FURNISHED: Stephen A. Ecenia, Esquire Gabriel F.V. Warren, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32302-0551 (eServed) Seann M. Frazier, Esquire Marc Ito, Esquire Parker, Hudson, Rainer & Dobbs, LLP 215 South Monroe Street, Suite 750 Tallahassee, Florida 32301 (eServed) Daniel Ryan Russell, Esquire Jones Walker, LLP 215 South Monroe Street, Suite 130 Tallahassee, Florida 32302 (eServed) Michael Jovane Williams, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399 (eServed) Martin B. Goldberg, Esquire Lash & Goldberg, LLP 100 Southeast Second Street, Suite 1200 Miami, Florida 33131 (eServed) Jeffrey L. Frehn, Esquire Radey Law Firm, P.A. 301 South Bronough Street, Suite 200 Tallahassee, Florida 32301 (eServed) J. Stephen Menton, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32302-0551 (eServed) Nichole Chere Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed) Shannon Revels, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1703 (eServed) Celeste M. Philip, M.D., M.P.H. State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 (eServed)
The Issue The issue in this case is whether an application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital (“Wolfson”), to operate a pediatric trauma center should be approved.
Findings Of Fact The following findings of fact are derived from the stipulation of the parties, the admitted exhibits, and the testimony at final hearing. DOH is the state agency responsible for, inter alia, the review and approval (or denial) of applications to operate trauma centers, including pediatric trauma centers. DOH denied the trauma center application filed by Wolfson, not due to an absence of need in the area, but due to Wolfson’s failure to comply with some requirements set forth in the application. Wolfson is a 216-bed not-for-profit children’s hospital located in Jacksonville, Duval County, Florida. It is part of the Baptist Health organization and is one of three hospitals operated under that entity’s license. Wolfson is located on the same campus as Baptist Medical Center – Jacksonville. The two hospitals share a pharmacy which is located in the children’s hospital and a laboratory located in the adult hospital, but no other services or staff. Interestingly, Wolfson was developed by the sons of Morris Wolfson, a Jewish immigrant to the United States. One of Mr. Wolfson’s children had died at an early age due to lack of access to health care services. Later in his life, after acquiring a small fortune from his business, Mr. Wolfson asked his five remaining sons to develop a children’s hospital accessible to every child, regardless of race, creed, or religious affiliation. By 1951 the sons had raised over half a million dollars and were prepared to construct a hospital. They approached the Baptists, who agreed to build the children’s hospital as part of their development of Baptist Hospital. In 1955, Mr. Wolfson’s dream became a reality. Wolfson provides a wide range of services to children, including but not limited to: two neonatal intensive care units; cardiac catheterization; open heart surgery; bone marrow transplants; and extracorporeal membrane oxygenation, a less complex bypass procedure. There is an emergency department at Wolfson. It receives approximately 60,000 patients per year. Wolfson also operates three satellite emergency departments and has three mobile ICUs (known as “Kids Kare” mobile units). Wolfson’s service area is quite large, comprised of a triangle identified by the vertices of Savannah, Georgia – Dothan, Alabama – and Daytona Beach, Florida. About ninety percent of Wolfson’s patients come from within that area. There is not currently a pediatric trauma center in Jacksonville, which is located in Trauma Service Area (“TSA”) 5. There are five counties in TSA 5: Duval, Baker, Clay, Nassau, and St. Johns. The closest pediatric trauma center to Jacksonville is located in Gainesville, Alachua County, Florida, some 60 miles away. There is a Level II trauma center located at UF Health Jacksonville, but it is not specifically for pediatrics. There are differences in the provision of care to pediatric patients versus adult trauma patients, including specialized equipment, age-appropriate drugs, and modified procedures. Pediatric trauma patients from TSA 5 must be transported to UF Health Jacksonville or Shands in Gainesville. Some of those patients are designated as “trauma alert patients.” Those are individuals identified by emergency medical services as requiring immediate, high-level treatment by skilled professionals. Not all trauma patients are trauma alert patients. Once a pediatric trauma patient has been stabilized at UF Health Jacksonville or Shands, the patient can be transferred to Wolfson for further treatment. Wolfson then undertakes the care needed by the patient. UF Health Jacksonville transfers about 20 to 30 pediatric trauma patients per month to Wolfson. Not all of those patients have previously been deemed trauma alert patients, but Wolfson has extensive experience treating patients with significant needs. It is Wolfson’s desire to operate its own pediatric trauma center, thereby obviating the need for a trauma patient to first go to UF Health Jacksonville or Shands before being transferred. There are times when a delay in transfer can have negative consequences for the patient. The number of such occurrences was not quantified by Wolfson, but Wolfson considers it a significant problem. There is, by rule, a very precise process for a hospital to obtain verification as a trauma center. There are three stages to the process: provisional review, in-depth review, and site visit. Hospitals are given only one opportunity each year to apply for verification. In order to apply, a hospital must file a letter of intent (“LOI”) between September 1 and October 1. On or before October 15, the Department sends an application package to each hospital which had timely submitted an LOI. After receiving the application package, a hospital has until April 1 of the following year to complete and submit the application. DOH must complete its provisional review of the application and notify the applicant, by April 15, of any deficiencies which should be addressed. The hospital then has five business days to submit clarifying or corrective information. In accordance with this process, Wolfson timely filed its application to operate a pediatric trauma center. By rule, the application must contain responses and support relating to nineteen “critical elements” related to trauma care. The Department then reviews the application to make sure that all minimum standards for approval have been met. An applicant is not required to necessarily satisfy each element or subpart of a standard in order for it to be approved by the Department. However, failure to comply with a critical element overall can result in denial of the application. The initial review of an application by the Department is extremely important because, if provisionally approved, the applicant can immediately commence operating as a trauma center. In the present case, Wolfson’s application was reviewed by two persons under contract with the Department: Dr. Robert Reed and Susan Cox, RN. The Department deems each of those persons to be an expert in the field of trauma care based on their background and training. The provisional review by the reviewers was for the purpose of determining whether the application was complete and whether the hospital satisfied the critical elements required for a trauma center. After completion of their initial review, the reviewers sent a letter to Wolfson identifying certain deficiencies they had found in the application. There were a number of deficiencies identified by Dr. Reed and Nurse Cox in Wolfson’s application. However, the most important of those (and the ones at issue in this proceeding) were as follows: Standard II.B.1.b relates to trauma-related continuing medical education (“CME”) requirements for emergency physicians; Standard XVII relates to required multidisciplinary conferences which must be held throughout the year; and Standard XVIII addresses Quality Management a/k/a Quality Improvement (“QI”), also referred to as Performance Improvement. Wolfson was given an opportunity to address each of the stated deficiencies and did, in fact, submit some additional information. Despite the additional information, Wolfson’s application was still deemed insufficient and was denied. The Department now concedes that the CME standard was satisfied in Wolfson’s application. The same is true for the standard relating to multidisciplinary conferences. The QI standard (Standard XVIII), however, remains in dispute. DOH contends that the information submitted by Wolfson in its initial application and deficiency response falls short of proving compliance with this critical element. The QI standard requires a system of procedures and protocols that will promote performance improvement while maintaining patient safety. The goal is to establish processes to ensure a hospital is continually improving the quality of care provided. The subparts of the QI standard require detailed demonstrations of various processes, including: A.2 – A clearly defined performance improvement program for the trauma population; – Review of all trauma patient records from five specified categories; – Monitoring of six indicators relevant to the respective facility (which are in addition to four state-mandated indicators); – Review of cases relevant to the six indicators by the trauma medical director (“TMD”) and trauma program director (“TPD”), to decide whether the cases should be referred to the quality management committee (“QMC”). B.5 – Evaluation by QMC of the effectiveness of action taken to ensure problem resolution; – Preparation and submittal of a quarterly report showing which cases have been selected for corrective action; and – Maintenance of an in-hospital trauma registry with information on patients being treated. The gist of Wolfson’s QI program is set forth on a flow chart contained in the application. That chart is entitled, “Trauma PI Process: Levels of Review.” Though not explained at final hearing, the “PI” in the chart is presumably “Performance Improvement.” The flow chart indicates there to be a primary (daily) review, a secondary (weekly) review, and a tertiary (monthly) review involving certain designated persons. In each of the “boxes” for the respective reviews, there is a stated purpose for the review. For the primary review, the purpose is stated as: Identification of opportunities for Improvement/Validation. The secondary review’s purpose is: Adverse Event/Audit Filter Review. And the purpose of the tertiary review is: Peer Review/Accountability Determination, Loop Closure Plan, Trended Data Review. Phases of care identified in the flow chart are: Pre- hospital, Resuscitation, Inpatient Care Review, and Readmission Review. There is a list of “actions” in the flow chart: Education; Counseling; Trend Report; Guidance/Policy/Protocol Development; and Hospital PI Project. From that list, there is an arrow pointing back toward the primary review box. There is no narrative in the flow chart to explain how the various boxes interconnect or how the information therein ties to the requirements as outlined in the application form. Wolfson asserts that all relevant information is contained in the flow chart, whether in narrative form or not. There is also additional information in the application, attached as a “Scope of Services” addendum, which further elucidates what is found in the flow chart. The Department deems the flow chart and scope of services information insufficient for determining whether the proposal satisfies the critical elements. Wolfson says the flow chart is a “clearly defined performance improvement program.” It is, in fact, only an outline of a clearly defined program. The testimony provided at final hearing by Wolfson’s TPM explained how that outline would work to improve performance. With that explanation, the flow chart/scope of service information minimally satisfies this critical element of the application. Wolfson maintains that the information provided supports the requirement for review of all records from five specified categories, i.e., all trauma alert cases, critical or ICU admissions, operating room admissions for traumatic injury, critical trauma transfers, and in-hospital deaths. Upon review of the flow chart there is insufficient evidence concerning those five areas. However, the scope of information addendum at least minimally refers to those areas as part of the review process. The flow chart/scope of service information addresses the four state-required indicators. The other six indicators required in the application are listed as “to be determined by the [Quality Management] committee.” Wolfson points out that in the minutes from a QMC meeting in February (which was included in the application), nine additional indicators are listed. So, although not easily found, the application does provide sufficient response to the required element. The application is also supposed to identify cases relevant to the six selected indicators in order to determine whether any of those cases should be referred to the QMC. The determination to refer cases is followed up by an evaluation of the effectiveness of actions taken by the committee. The flow chart can be interpreted to address this requirement, but it is fairly nebulous. The scope of services information provides some additional support, but only in general terms. The required quarterly reports are supposed to show which cases have been selected for corrective action by the committee. Wolfson asserts that it cannot submit any such reports until it is operating as a pediatric trauma center, i.e., until it actually has patient cases to report. That position is plausible. The Department did not provide any evidence as to how other applicants satisfied this requirement, so Wolfson’s position cannot be measured against other providers.1/ The same is true as to the requirement for an in- hospital registry of information concerning patients who are being treated. Wolfson has purchased the software needed to commence its registry once patients are being admitted, but it cannot do so at this time, again because it has no such patients. All things considered, Wolfson’s application was not a superlative response to the question of its abilities, but it at least minimally met the requirements for approval of a provisional license. Considering, de novo, all of the evidence concerning Wolfson’s proposed trauma center operations, the application is complete. Wolfson provided extensive testimony and evidence as to the need for a pediatric trauma center in the service area and its willingness and ability to meet that need. There is no doubt that, if approved, the pediatric trauma center would be beneficial to the area. However, need was not an issue in the proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent, Department of Health, enter a Final Order approving the pediatric trauma center application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital. DONE AND ENTERED this 14th day of November, 2017, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of November, 2017.
The Issue The issue in this case is whether Respondent should be sanctioned for an alleged violation of Chapters 395 and 401, Florida Statutes (1989).
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made. HCA Raulerson is the only hospital in Okeechobee County, Florida. As such, it serves all of Okeechobee County and parts of the surrounding counties. It is a small community hospital that is best characterized as a primary care receiving facility as opposed to a secondary hospital or a tertiary care or trauma center hospital. The Hospital does not provide heart-bypass surgery, cardiac catherization, neuro-surgery services or even obstetrical services (other than the emergency delivery of babies.) The Hospital provided approximately three million dollars in uncompensated care to indigent residents of Okeechobee County in the year preceding the incident involved in this case. Under existing Florida law, a hospital is not required to provide either orthopedic surgery services or peripheral vascular services and there is no requirement for a hospital to have on its medical staff any orthopedic surgeons or peripheral vascular surgeons. The Hospital does not have the angiography equipment necessary for peripheral vascular surgery. As a result, the Hospital does not provide peripheral vascular surgery and there are no vascular surgeons on staff. Such services were not offered at the Hospital for at least several months prior to the incident in question. The Hospital has a single orthopedic surgeon on staff, Dr. Zafar Kureshi. Dr. Kureshi is board certified in orthopedic surgery. He has been engaged in the private practice of medicine in Okeechobee, Florida since October of 1986. While many of Dr. Kureshi's patients are treated at the Hospital, Dr. Kureshi is not employed by or under contract with the Hospital. This arrangement is not unusual since surgeons, including orthopedic and vascular surgeons, do not typically become employees of hospitals or enter into contracts with hospitals. The Hospital has tried to recruit additional orthopedic surgeons and other specialists for its medical staff, but has been unsuccessful. There is a shortage of orthopedic surgeons in Florida, especially in rural areas, and recruiting orthopedic surgeons to such areas is extremely difficult. It is unrealistic to expect that the Hospital would be able to recruit or retain any orthopedic surgeons if it required them to be "on call" at all times. For a short time after he first obtained staff privileges, Dr. Kureshi provided "on call" services for the Hospital's emergency room several nights per month. On those occasions, he treated patients irrespective of their financial status. At the time of the incident in question, however, Dr. Kureshi had ceased providing "on call" services. His decision was consistent with the Hospital medical staff by-laws. The by-laws of the Hospital medical staff state that, if there is only one physician on staff in a specialty, then that specialty does not have to make emergency department call rosters available to the emergency room. Since he was the only specialist on staff in his area of practice, Dr. Kureshi was not required to provide "on call" coverage. Subsequent to the incident involved in this case, Dr. Kureshi, at the request of the Hospital, has voluntarily agreed to be "on-call" several nights per month. Even when Dr. Kureshi is not formally "on call," the emergency room staff often contacts him when a patient presents at the emergency room in need of orthopedic care. On some such occasions, Dr. Kureshi will treat the patient if he was capable of doing so. When an orthopedic patient or a peripheral vascular patient presents at the Hospital and Dr. Kureshi can not or will not treat the patient, the Hospital (1) provides such care as can be rendered by the emergency room physician or others on HCA Raulerson's medical staff, (2) stabilizes the patient for transfer, (3) calls hospitals and their on-call physicians to arrange transfer, and (4) arranges suitable transportation and transfers the patient. In the months preceding the incident in question, the Hospital arranged the transfer to other hospitals of approximately eleven patients who presented at the Hospital's emergency room in need of orthopedic care. Four of those patients were "paying" patients covered by third party insurers, four were covered by Medicare or Medicaid and the remaining three were self-pay patients. There is no indication that financial status and/or the ability to pay in any way influenced the Hospital's actions with respect to these patients. HRS contends that Sections 395.0142, 395.0143 and 401.45, Florida Statutes, require a hospital that provides any given specialty service (e.g., orthopedic surgery services) to arrange 24-hour a day, seven day a week coverage for that service, either by providing coverage through physicians on staff or entering into advance transfer agreements with other hospitals to cover any such patients who may present in need of such services. The Hospital has attempted, but has been unsuccessful in its attempts, to obtain advance transfer agreements from other hospitals regarding the transfer of patients presenting themselves at the Hospital's emergency room in need of orthopedic surgery services or in need of peripheral vascular surgery services. The Hospital has limited bargaining power in attempting to induce other hospitals to enter into an advance transfer agreement. Because the Hospital is a small rural hospital, virtually all the services it offers are already available at the neighboring hospitals which are potential transfer partners. The only advance transfer agreements that the Hospital has been offered would require the Hospital to assume full responsibility for payment for services rendered to transferred patients by the transferee hospital. Those proposals have been rejected because the financial burden of such an arrangement would probably cause the Hospital to close. As of August 24, 1989, the date of the incident which is the subject of the Administrative Complaint in this case, HRS had not notified the Hospital of any rule or policy interpreting Sections 395.0142, 395.0143, and 401.45, Florida Statutes. As of August 24, 1989, HRS had not adopted any rule which stated a specific requirement that hospitals which provide orthopedic surgery must staff or provide on-call orthopedic surgery services on a continuous basis, i.e. twenty-four (24) hours per day, 365 days per year or have in place an agreement with another hospital(s) to provide such coverage. HRS contends that this requirement is imposed by the clear language of the statutes. On the evening of August 24, 1989 at approximately 7:45 p.m., K.H., a 28 year old male, presented himself at the Hospital's emergency room for treatment of a shotgun wound to his lower left leg. Dr. Charles Vasser, the emergency room physician on duty when K.H. arrived, stabilized the Patient and provided all the treatment that could be provided by an emergency room physician not trained in orthopedic surgery or vascular surgery. The radiology report prepared at the Hospital diagnosed the Patient's condition as follows: "focal soft tissue injury, with multiple metallic fragments of variable size, super imposed over soft tissues of distal right leg are noted. Comminuted compound fracture of distal tibial shaft, as well as linear fracture through distal fibula at same site, are observed. Findings are due to gun shot injury with residual bullet fragments within soft tissues. Correlation with patient's clinical findings is recommended." Because of the nature of the injury and the extent of the damage to the soft tissue of the Patient's lower leg, Dr. Vasser and the attending staff were concerned about the possibility of vascular damage. They frequently checked and charted the Patient's distal pulses. While the distal pulses appeared normal, the presence of distal pulses does not rule out vascular injury. A vascular injury is possible with a comminuted fracture even when the distal pedal pulses appear normal. A vascular problem is especially likely when the wound was inflicted by a shotgun blast and numerous metallic fragments are involved. After providing initial emergency room services to the Patient, Dr. Vasser felt that the assistance of appropriate specialists, i.e., an orthopedic surgeon and at least a consult with a vascular surgeon, would be required for further treatment. Dr. Vasser called the only orthopedic surgeon on the Hospital's medical staff, Dr. Zafar Kureshi, at 8:50 p.m. Dr. Kureshi was not on call that evening. Based on Dr. Vasser's description of K.H.'s condition, Dr. Kureshi stated that he was not capable of treating K.H. without the backup availability of a vascular surgeon and advised that K.H. should be transferred. This recommendation was made not only because Dr. Kureshi was not on call, but also because Dr. Kureshi was not capable of treating the Patient at an acceptable level of medical care without the availability of a vascular surgeon. As indicated in Findings of Fact 3 above, there are no vascular surgeons on staff at the Hospital and the Hospital does not offer vascular surgery services. In determining whether a patient needs the services of a physician in a particular specialty, the Hospital relies upon the medical judgment of the attending physician and any consulting physician. The Hospital did not and should not have ignored the medical determination made by the emergency room physician, in consultation with Dr. Kureshi, that the Patient, K.H., needed vascular backup in order to be properly treated. With the assistance of emergency technician Wendy Johns, Dr. Vasser began placing calls to other hospitals and their on-call physicians at 9:15 p.m. in an effort to arrange a transfer of the Patient. The first physician contacted through another hospital, Dr. Floyd, indicated that he would be unable to treat the Patient because of the extent of the soft-tissue injuries and the corresponding likelihood of vascular involvement. A number of additional hospitals and physicians were contacted and they also refused to accept the transfer of the Patient. All told, nineteen different physicians and/or hospitals were contacted between 9:00 p.m. and 12:00 a.m. A variety of reasons were cited by those who refused to accept the transfer. Many of the reasons given for refusing the transfer were arguably a pretext and/or contravened the language and intent of Sections 395.0142, 395.0143 and 395.0144, Florida Statutes. Several of the doctors who were contacted confirmed that the treatment of the Patient would require the availability of a vascular surgeon as well as an orthopedist. After numerous unsuccessful attempts to transfer the Patient, Dr. Vasser contacted a general surgeon on the Hospital's medical staff, Dr. Husain, at approximately 12:10 a.m. Dr. Vasser and Dr. Husain again contacted Dr. Kureshi. The three physicians concurred that they were unable to treat the Patient because of the need for a vascular backup and the Hospital's inability to provide the necessary vascular backup. After he talked to Dr. Kureshi the second time, Dr. Vasser resumed calling other hospitals and their on-call physicians. The next call was to a vascular surgeon, Dr. Viamentes. Dr. Viamentes was reached through his beeper, but was unable to accept the transfer because he was out of town. At approximately 12:30 a.m., a social worker for the Hospital, Terry Cooper, contacted St. Mary's Hospital in West Palm Beach. After some discussion and deliberation, St. Mary's agreed to accept the transfer of K.H. The Patient was transferred in stable condition via ambulance to St. Mary's Hospital where he arrived at approximately 3:00 a.m. Surgery was initiated at approximately 4:30 a.m. After the Patient was admitted to St. Mary's Hospital, the administration of that hospital filed a complaint with HRS pursuant to Section 395.0142, Florida Statutes. That complaint recites the facts surrounding the transfer of the Patient and the refusal of several other hospitals to accept the transfer. It is not clear whether St. Mary's was questioning the medical necessity of the transfer or simply the refusal of the other hospitals to accept the transfer. HRS initiated an investigation of the transfer of the Patient and submitted the Patient's medical records from both HCA Raulerson and St. Mary's to its expert, Dr. Slevenski, for review. Dr. Slevenski is an emergency room physician who has no specialized training in orthopedic surgery or vascular surgery. Dr. Slevenski testified that he saw no evidence in the Hospital's medical records that a vascular evaluation or consultation was necessary to treat this Patient and that the Hospital inappropriately transferred the Patient to another hospital. Dr. Slevenski's opinions are rejected. Dr. Slevenski erroneously assumed that the Hospital had not attempted to contact an orthopedic surgeon regarding the Patient. In fact, the Hospital contacted Dr. Kureshi, the only orthopedic surgeon on its staff, who indicated he was not qualified to treat the Patient's injury. The evidence established that both the emergency room physician and the orthopedic surgeon who was contacted at home felt that a vascular consult was necessary. These opinions were reasonable under the circumstances. The testimony of Dr. Henderson, the Respondent's expert, is accepted and confirms that the opinions of the emergency room physician and the orthopedic surgeon were reasonable under the circumstances and given the nature of the Patient's injury. There is no evidence that the Patient's care was deficient in any respect at either St. Mary's or the Hospital. The Patient progressed normally and a good result was achieved. In sum, the evidence established that the Hospital secured appropriate treatment for K.H. by providing an on-site emergency room physician and supporting staff who (1) provided immediate emergency care and stabilized the patient for transfer, (2) confirmed with the orthopedic surgeon on the Hospital's medical staff that a transfer was medically necessary, (3) called hospitals and their on-call physicians to arrange the transfer, and (4) arranged suitable transportation and transfer of the patient. The Hospital provided all the care that it could within its service capability. In view of his injury, the Patient's best interests were served by transferring him rather than treating him at the Hospital. The evidence did not establish whether K.H. was a paying or nonpaying patient. The evidence did establish that the decision to transfer K.H. was not based on his financial status.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered which dismisses the Administrative Complaint filed against HCA Raulerson Hospital. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 17th day of January, 1991. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of January, 1991.
The Issue The issue in this case is whether the application filed with the Department of Health (“Department”) on March 31, 2017, by Galencare Inc., d/b/a Northside Hospital (“Northside”), to operate as a provisional Level II trauma center met the applicable criteria and standards under Part II, Chapter 395, Florida Statutes (2017),1/ and Florida Administrative Code Chapter 64J-2.
Findings Of Fact Parties The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes. The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has a primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001 and 395.40(3), Fla. Stat. Northside is a 288-bed acute-care hospital located in TSA 9, Pinellas County, Florida. Northside provides a wide range of services, including inpatient cardiovascular and neuroscience services. Northside has developed a trauma program and submitted an application to operate as a provisional Level II trauma center in March 2017. The Department’s preliminary determination to deny Northside’s application on May 1, 2017, is the subject of this proceeding. Bayfront is an acute-care hospital located in TSA 9, Pinellas County, Florida. Bayfront has been designated by the Department as a Level II trauma center. Northside’s Trauma Center Application Northside Submitted a Timely Letter of Intent In the summer of 2016, Northside received a letter from the Department notifying Northside of the opportunity to submit a letter of intent to become a trauma center. Northside timely submitted a letter of intent with the Department in September 2016. This letter indicated that Northside would seek approval from the Department to operate as a Level II trauma center. Northside was well-situated for a trauma center because of the resources and services already in place at the hospital. Moreover, Northside was prepared to open a trauma program because it already had extensive experience treating critically ill patients. After Northside submitted its letter of intent, the Department responded by sending Northside a notice accepting its letter of intent and providing information on the application process. The notice directed Northside to the Department’s trauma center application and contained instructions for the completion and submission of the application. Northside Established a Full Trauma Program after the Department Accepted its Letter of Intent Once Northside received the Department’s notice confirming acceptance of its letter of intent, it began making significant investments of resources and capital to develop its trauma program. It did so to ensure that its forthcoming application was compliant with the requirements set forth in DOH Pamphlet (DHP) 150-9 (the “Trauma Standards” or “DHP”), which is incorporated by reference in rule 64J-2.011. As part of the development of its trauma program, Northside hired Doreen Gilligan in October 2016 to serve as director of Trauma Services. The hospital also worked with Angie Chisolm to draw on resources from other approved trauma centers, such as trauma-related policies and procedures and best practices for trauma center operations. Northside’s expertise in advanced, life-saving care, including cardiovascular and neuroscience programs and its intensive care unit (“ICU”), made it a well-qualified candidate to open a new trauma center. Between October 1, 2016, and April 1, 2017, Northside invested over $4 million to develop its trauma program. Northside invested $2.5 million in physical plant improvements and equipment. These improvements included: A helipad, which is properly licensed by the Department of Transportation and FAA. The helipad is operational and Northside is already receiving patients from helicopters on a daily basis in its capacity as an acute- care hospital. Two state-of-the-art trauma resuscitation bays in the emergency department (“ED”) that are in immediate proximity to the helipad. These new trauma bays can accommodate up to four trauma patients at the same time. The expansion of the ICU to include 12 beds that are specifically designated for trauma patients. The expansion of one of the operating rooms because trauma patients often require care from multiple doctors simultaneously. The purchase of new equipment, including new ICU monitors, operating room equipment, and equipment to support physician subspecialists. The purchase of a blood track machine for the emergency department. This machine dramatically reduces the amount of time it takes for patients to receive blood transfusions. The purchase of a platelet function testing machine and a thromboelastography machine. These machines help identify where a trauma patient is bleeding. These machines also play a critical role in quickly stopping bleeding – one of the key functions that every trauma center must perform. The purchase of a second computed tomography (“CT”) machine dedicated solely to the provision of radiology services needed by trauma patients. Northside invested approximately $1.7 million in physician and staff employment and recruitment. This investment has enabled Northside to do the following: Provide continuous, around-the-clock trauma surgeon coverage, 7 days a week (beginning February 16, 2017). Provide continuous, around-the-clock anesthesiology coverage. Provide hospital coverage for the required 19 physician sub-specialty groups. These physicians are able to arrive at the hospital within 30 minutes or less. Hire more than 30 additional full-time nurses to meet the staffing requirements in the Trauma Standards. These hires have allowed Northside to provide a continuous, in-house presence of operating room nurses and technicians. Hire specialized administrative staff for the trauma program, including Doreen Gilligan (Director of Trauma Services), a trauma registrar, and a performance improvement coordinator dedicated solely to ensuring Northside’s trauma patients receive high quality care. Once Northside’s trauma program becomes operational, Northside plans to hire a second trauma performance improvement coordinator. Between January and March 2017, Northside provided over 5,000 hours of trauma training to its staff, including the CEO and CFO of the hospital. The major focus of this training was the Trauma Nursing Core Course (“TNCC”) for nursing staff, which is the foundation of emergency nursing education and ensures that the nursing staff can provide high-quality care for the most severely injured patients. The hospital implemented nursing education requirements which exceeded the Trauma Standards. Some of this training included actual operational practice using simulations and mock trauma drills. Northside implemented over 200 new facility policies related to trauma during this period. Northside subsequently trained its staff on these new programs. Northside made all of these investments prior to March 31, 2017, the date on which Northside submitted its application to the Department. Northside Timely Assembled and Submitted Its Trauma Center Application and Deficiency Response to the Department Northside’s application was prepared by a core team whose mission was to ensure that the application fully complied with the Trauma Standards. The key members of that team were Peter Kennedy, chief operating officer; Doreen Gilligan, director of Trauma Services; Dr. Erik Barquist, interim trauma medical director; and Angie Chisolm, assistant vice president of Trauma Services for HCA East and West Florida Divisions. The final application submitted to the Department encompassed over 10,000 pages of information. Because the application was too voluminous for any one person to prepare alone, each of the team members played an important role in ensuring the application addressed each Trauma Standard. Preparation of the application involved thousands of staff hours and required close cooperation with the physicians, staff, and community members. Northside timely submitted its trauma center application (“Northside Application”) to the Department on March 31, 2017. After receiving the Northside Application, the Department arranged for it to be reviewed by two outside experts, Dr. Lawrence Reed and Nurse Susan Cox. Both Dr. Reed and Nurse Cox have reviewed trauma applications on behalf of the Department in the past. On April 14, 2017, the Department sent Northside a letter notifying it of the deficiencies that Dr. Reed and Nurse Cox had identified (the “Deficiency Notice”). The Department provided a checklist (Department of Health Initial Provisional Review Checklist for Northside, April 5, 2017, hereafter referred to as the “Initial Checklist”) based on the Trauma Standards with boxes marked “Yes” or “No” to indicate whether the reviewers found evidence to demonstrate that each particular Trauma Standard and subpart was met. The checklist also contained written comments from the reviewers for subparts which were checked “No.” Of the more than 350 subparts that make up the Trauma Standards, the reviewers only identified 35 about which they had concerns or additional questions. Most of the comments from the reviewers consisted of simple requests for clarification. In some cases, the reviewers asked for information that Northside had already submitted with the initial application on March 31, 2017. Northside timely responded to each deficiency identified by the Department on April 21, 2017 (the “Deficiency Response”), five business days after receipt of the Deficiency Notice. The Deficiency Response was prepared by the same team that prepared the initial application. Much like the initial application, the team’s role was to ensure that each concern was addressed and that the application demonstrated that the hospital met the Trauma Standards. The Deficiency Response included 78 supporting exhibits consisting of hundreds of pages. The Deficiency Response was divided in two sections: (1) a narrative table; and (2) supporting exhibits to the narrative table. In the narrative table, Northside addressed each Trauma Standard subpart identified in the Initial Checklist as an area not met or an area of concern. The table was organized into three columns: the first reciting the subpart language; the second copying the reviewer concern from the Initial Checklist; and the third detailing Northside’s narrative response or explanation to each comment. The Deficiency Response was also reviewed by Dr. Reed and Nurse Cox. These reviewers determined that Northside addressed and corrected the vast majority of deficiencies identified in the initial review. Only three Trauma Standard subparts were identified as remaining areas of concern: Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G). Each of these issues was identified by Dr. Reed. Neither Dr. Reed nor Nurse Cox recommended to the Department that Northside’s application be denied. On May 1, 2017, the Department informed Northside that its application was not in compliance with the applicable Trauma Standards and would be denied (“Denial Letter”). The Denial Letter did not identify which (if any) of the Standards that the Department believed that Northside had not met. Instead, the Denial Letter attached a checklist indicating concerns with only three subparts. The Department now takes the position that Northside’s application is deficient because it did not satisfy Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G), although the Department has not stated whether each one of these Standards, standing alone, would have (in its view) warranted denial of the application. The Denial Letter did not afford Northside any opportunity to address the potential issues identified with respect to the three Standards. Instead, it informed Northside that its only options were to seek an administrative hearing challenging the Department’s denial or to submit a trauma center application the following year. Northside therefore did not submit any additional documentation to the Department. Northside’s Evidence Establishes That It Satisfied Each of the Three Standards the Department Claimed Were Deficient Standard V(B)(3)(a)(1) Standard V addresses the facility requirements relating to the emergency department. It includes requirements for a trauma resuscitation area, helipad, emergency physicians, support staff, and trauma flow sheet, among other criteria. This Standard also details the required qualifications for emergency room physicians who may provide care to trauma patients. Emergency room physicians must be board certified in emergency medicine or meet stringent alternate criteria demonstrating their qualifications. There are two ways to meet the alternate criteria. The first includes attestation from the trauma medical director that there is a critical need for the physician, completion of an accredited residency training program, documentation that the physician participated in the Advanced Trauma Life Support (“ATLS”) program, 48 hours of trauma-related continuing medical education in the past three years, evidence that the physician attends at least 50 percent of the trauma performance improvement meetings, evidence of membership or attendance at regional or national trauma meetings during the past three years, and attestation by the trauma medical director and emergency department director that the physician compares favorably with other physicians on the trauma call schedule. The second way for a physician to meet the alternate criteria is by providing evidence of board certification in a primary care specialty and attestation by the emergency department director that the physician has worked as a full-time emergency physician for three of the last five years. As part of its initial application, Northside provided the Department with staffing schedules for March, April, and May 2017, which documented the physicians on staff in the emergency room during those months and the shift times they would cover. Northside also submitted substantial evidence regarding the qualifications of each of these emergency room physicians. One of these emergency room physicians was Dr. Abraham Wilks. At the time it submitted its initial application, Northside believed Dr. Wilks met both paths of the alternate criteria. In preparation for the initial application, Dr. Wilks, working with Northside, went to extraordinary lengths to secure the seven required components under the first alternate criteria path. Northside also provided evidence that Dr. Wilks qualified under the second alternate criteria path since he was board eligible for family medicine and had been working as an emergency physician for the past five years. The staffing schedules submitted with Northside’s application on March 31, 2017, showed that Dr. Wilks was scheduled to be the sole physician provider for short periods of time on a limited number of days. During his review of the initial application, Dr. Reed concluded that Dr. Wilks did not meet either of the alternative criteria because he did not complete an emergency medicine residency and was no longer board-certified in family medicine. Because Dr. Wilks did not meet these qualification requirements in Standard V(B)(3) as an emergency department physician, he could not be the sole physician provider in the emergency department. After receiving the Deficiency Notice and Initial Checklist, Northside immediately took steps to address Dr. Reed’s comments. Northside’s leadership worked with the director of the emergency department to ensure that Dr. Wilks would not be the sole physician provider in the emergency room. After April 18, 2017, Dr. Wilks never served as the sole physician provider in the emergency room. The emergency department physician staffing schedule for April and May 2017, was updated to reflect these changes (“Updated Staffing Schedule”). The other physicians listed on the staffing schedule were appropriately qualified, and the staffing schedule provided for appropriate physician coverage. In its Deficiency Response, Northside noted these operational changes regarding Dr. Wilks and specifically addressed Dr. Reed’s concerns. Northside informed the Department that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately.” Dr. Reed agreed at his deposition that if Dr. Wilks were removed from the staffing schedule, Northside would be in compliance with Standard V(B)(3)(a)(1). The Deficiency Response also referenced a related exhibit, which Northside intended to be the amended staffing schedule. However, due to a clerical error, Northside’s Deficiency Response included the old staffing schedule from the initial application, which incorrectly showed Dr. Wilks as the sole provider for limited periods. The old staffing schedule contradicted the narrative explanation of Northside’s operational changes included in the Deficiency Response and was clearly submitted in error. Dr. Reed himself noted this contradiction: The response document also states that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately. However, it appears that Dr. Wilks is the only ED physician on site from 6a-8a on May 4, May 7, May 20, and May 21. Please clarify this contradiction.” The Department did not follow Dr. Reed’s recommendation. It never contacted Northside to ask why the staffing schedule listed Dr. Wilks as the sole provider for limited periods of time when Northside’s submission expressly stated that Dr. Wilks would no longer be the sole provider. Had the Department contacted Northside, it would have learned that the “old” staffing schedule had been submitted rather than the current and correct staffing schedule, i.e., the one that did not include Dr. Wilks as the sole provider. Thus, there can be no dispute that, as of April 18, 2017, (1) Northside’s operative emergency department staffing schedule was updated to reflect that Dr. Wilks would never be the sole provider; and (2) at all times, Northside’s emergency department was fully staffed by properly qualified emergency department physicians. Under these circumstances, the Department erred in taking the position that Northside did not satisfy Standard V(B)(3)(a)(1) simply because it mistakenly submitted an outdated staffing schedule to the Department in conjunction with its clear narrative explanation. Standard V(B)(3)(d) The physician qualifications included in Standard V also require that each physician maintain a current ATLS provider certification. The ATLS certification is required only of emergency department physicians and trauma surgeons because these are the physicians who treat trauma patients when they first arrive at the trauma center. One of the emergency department physicians included in Northside’s application is Dr. Joseph Nelson. Dr. Nelson also serves as the emergency department’s pre-hospital trauma care expert for the Committee of Emergency Preparedness and Readiness, meaning that he is the state’s expert on issues relating to the emergency care provided on-site before patients are brought to the hospital. Northside’s application included an extensive set of documents that established Dr. Nelson’s credentials, including the following: a compilation of Dr. Nelson’s certifications, proof of his osteopathic board certification, his Florida Department of Health medical license, his physician profile with the American Medical Association, proof of his continuing medical education hours, his letter of privileges at Northside, and his most recent ATLS certificate. Dr. Nelson’s ATLS certificate included a letter from ATLS that recognized Dr. Nelson for high scores on his written and practical tests and recommended that he apply to be an ATLS course instructor, an honor that is accorded only to doctors who attain the best performances at the training course. At the time Northside submitted its initial application, Dr. Nelson’s ATLS certification had recently expired and he was planning to take a course to renew his certification. Dr. Nelson was aware of the expiration before the submission and made a concerted effort to complete the course in advance by registering for a course in February 2017. However, the course Dr. Nelson was originally scheduled to take in February 2017 was cancelled due to a snowstorm. Because ATLS courses are in high demand and often full, Dr. Nelson was not able to immediately reschedule for a course in his region. After working with Northside and Angie Chisolm, he registered for another course to be held in Tallahassee on April 23, 2017. Northside included proof of his course registration with its initial application. In the Deficiency Notice and Initial Checklist provided by the Department, Dr. Reed noted that Dr. Nelson’s ATLS certificate had expired and acknowledged that he was scheduled to take his ATLS course on April 23, 2017. Dr. Reed asked the hospital to “provide evidence of successful completion of the ATLS course he is scheduled to take on 4/23/2017.” Dr. Reed did not ask the hospital to submit any further documentation before the certificate arrived. On multiple occasions, Northside sought clarification from the Department regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). Before Northside submitted its initial application to the Department, it informed the Department that Dr. Nelson was registered for and planned to take the ATLS course on April 23, 2017, and asked for guidance regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). The Department advised Northside to provide proof of registration with its initial application, and Northside did just that. Northside returned to the Department for guidance after receiving the Deficiency Notice and reminded the Department that Dr. Nelson planned to complete the ATLS course on April 23, 2017. Once again, the Department directed Northside to submit documentation of course registration and to later submit Dr. Nelson’s updated ATLS certificate when available. In its Deficiency Response, Northside reiterated that Dr. Nelson was registered for and scheduled to complete the ATLS certification course on April 23, 2017, just two days later. Based on the Department’s guidance, Northside also included Dr. Nelson’s ATLS course registration, which demonstrated that he was scheduled to take the course in Tallahassee on April 23, 2017, as well as email communication from the course host confirming that Dr. Nelson paid for and secured a seat at that course. Northside further indicated that it would provide evidence to the Department of Dr. Nelson’s ATLS recertification following successful completion of the course. Northside also informed the Department that if Dr. Nelson did not attend and pass the course on April 23, 2017, he would be removed from the call schedule effective May 1, 2017. Dr. Nelson successfully completed the course on April 23, 2017, and thus satisfied his ATLS requirement that day. Northside immediately confirmed with the ATLS coordinator that Dr. Nelson had passed the course and concluded that he was in compliance with Standard V(B)(3)(d). Dr. Reed’s review of Northside’s Deficiency Response stated: “Upon receipt of a copy of Dr. Nelson’s updated ATLS certification, compliance with this standard will have been met.” Northside subsequently received Dr. Nelson’s updated ATLS certification. It did not arrive at Northside until after May 1, 2017, due to normal delays in processing by the American College of Surgeons. At hearing, Northside presented Dr. Nelson’s updated ATLS certification reflecting his successful completion on April 23, 2017. In sum, Dr. Nelson was ATLS-certified as of April 23, 2017, which is before the Department’s May 1, 2017, deadline. Northside also provided a litany of information to the Department with its initial application and Deficiency Response detailing Dr. Nelson’s efforts to secure his ATLS certification. Northside therefore satisfied Standard V(B)(3)(d). Standard XVIII(G) Standard XVIII addresses quality management, which is one of the core requirements of a trauma program. Since the time that Northside began building its trauma program, it has prioritized quality management. Northside began developing its trauma quality management program in early December 2016. As part of this effort, Northside developed a trauma quality management plan, which is essential for any quality management program. Following the beginning of limited trauma-related operations on February 16, 2017, Northside held its first peer review meeting on February 22, 2017, to discuss patient treatment issues. Dr. Barquist attended these meetings and minutes were kept. Northside also began to hold nursing and ancillary staff meetings, known as trauma quality management (“TQM”) meetings, during this time. The directors of each department at the hospital attended these meetings, as well as the chief operating officer and chief financial officer. The objective of these meetings was to operationalize the more than 200 trauma-specific policies and procedures put in place during the trauma program development. Any issues identified in these meetings were addressed immediately with the whole trauma staff to ensure program-wide compliance. To demonstrate compliance with this Standard, Northside submitted nearly 400 pages of documents with its initial application. These included Northside’s Trauma Performance Improvement and Patient Safety Plan, policies and procedures, and peer review minutes. As part of its application, Northside submitted the minutes of its peer review meetings at which quality management issues were discussed. Even though Northside was not receiving trauma alert patients from local emergency medical services (something it could not do prior to becoming a provisionally approved trauma center), it routinely conducted quality management activities with regard to patients in the hospital with trauma injuries. With this patient population, Northside employed its trauma improvement processes to identify areas in which there was room for improvement in care, and to determine how education, training, and equipment could be enhanced to improve care for similar patients in the future. In his review of Standard XVIII(F), Dr. Reed affirmed that Northside held quality management meetings at which the following issues were discussed: The subject matter discussed, including an analysis of all issues related to each case referred by the trauma service medical director to the trauma program manager, cases involving morbidity or mortality determining whether they were disease related or provider related and the preventability, and cases with other quality of care concerns. A summary of cases with variations not referred to the committee. A description of committee discussion of cases not requiring action, with an explanation or each decision. Any action taken to resolve problems or improve patient care and outcomes. Evidence that the committee evaluated the effectiveness of any action taken to resolve programs or improve patient care and outcomes. Northside also submitted documents addressing Standard XVIII(G). This subpart addresses a quarterly report prepared by the trauma quality management committee which must be submitted to the Department by approved trauma centers 15 days after the end of each quarter. If approved as a provisional trauma center, Northside would have submitted its first quality report to the Department on August 15, 2017. The report, which is only submitted by provisionally approved and verified trauma centers, must include information related to patient case reviews, select clinical indicators, and patient complications. The report is only made available by the Department to approved trauma centers; it is not provided to applicants. The report form is not referenced in any Department rule, the Trauma Standards, or the Department’s website. However, to establish that Northside was prepared to provide the required report once it received provisional approval, Northside obtained a copy of the template from an affiliated operating trauma center and included that template in its application. Because it was not an approved trauma center, Northside ultimately submitted a detailed template of the quality report to be submitted following approval as required. The detailed template included blank fields with the quality indicators selected by the Department and the hospital, benchmarking data points, patient complications, and case review information. The fields in the report regarding patient complications and case review information can be taken directly from the peer review minutes, which Northside submitted with its initial application and were located directly in front of its detailed template. In his review of Northside’s initial application, Dr. Reed concluded that Northside provided much of the required evidence, demonstrating “an active and effective trauma quality improvement program” and met the vast majority of subparts in this Standard. However, regarding Standard XVIII(G), Dr. Reed identified deficiencies on the basis that “[a] template of a report was submitted, but there were no cases recorded.” Dr. Reed confirmed that he reviewed the peer review minutes Northside submitted with its application. In response to Dr. Reed’s comment, Northside submitted updated templates with additional information. The quality indicator and benchmarking templates were populated with data from its trauma registry regarding the patients with traumatic injuries that the hospital had treated since February 16, 2017. In addition to these documents, which specifically addressed Standard XVIII(G), Northside also submitted more peer review minutes from subsequent meetings since the initial application, which were included directly in front of Exhibit 75. Dr. Reed ultimately concluded that Northside had not demonstrated compliance with Standard XVIII(G)(1)-(3). That conclusion, however, is unsupportable by the evidence at hearing. Dr. Reed acknowledged that Northside’s Deficiency Response provided the “quarterly data regarding the state required indicators and the additional institution-specific indicators.” The only reason he believed that Northside’s application remained deficient was that it did not “address the individual case quality review issues required in Standard XVIII.G.1-3.” This conclusion is undermined by Dr. Reed’s recognition-–as reflected in his review of Standard XVIII(F)-–that Northside was conducting case quality reviews. In his deposition, Dr. Reed agreed that Northside’s Deficiency Response “did include information regarding the number of cases and indicators and that sort of thing.” Indeed, Dr. Reed’s true concern appears to have been that Northside’s “numbers,” i.e., the number of patient cases reviewed by Northside, were “still kind of thin.” But Dr. Reed himself recognized that prior to the time that a trauma center application is provisionally approved and the trauma program begins treating trauma alert patients, a trauma program is unlikely to have a large number of patient cases to review. The Department’s view that Northside did not satisfy Standard XVIII(G) is not supported by the evidence. The section of the quality report addressing individual case reviews is simply a summary of the information contained in the hospital’s peer review minutes-–and Northside conducted the required peer review meetings. Northside demonstrated at hearing that it was capable of preparing a table summarizing its peer review cases and the corrective action taken for each case. All the information contained in the completed table was taken verbatim from the peer review minutes that Northside submitted with its initial application and Deficiency Response. If approved, Northside was prepared to submit the quarterly report as required on August 15, 2017. Thus, at worst, Northside did not copy and paste information from one place to another. To the extent possible, Northside complied with this Standard. The Department’s review of an earlier trauma center application confirms that the Department should not have determined that Northside did not satisfy Standard XVIII(G). In April 2016, the Department approved an application to operate as a provisional Level II trauma center submitted by Jackson South Community Hospital. As part of its approval, the Department-- based on a review by Dr. Reed--determined that Jackson South met each of the requirements in Standard XVIII(G). However, Jackson South only submitted hospital policies, promising to prepare and submit the required quality report if approved. Jackson South did not submit any quality report or even a template of such a report. Despite submitting far less evidence demonstrating compliance, Dr. Reed did not note any deficiencies for this Standard with regard to Jackson South’s application. The Department ultimately approved the application. Dr. Reed confirmed that Northside’s quality management program was significantly more developed than the one for Jackson South Community Hospital that Dr. Reed himself had recommended be approved only two years earlier. At hearing, Chief Dick could not explain the inconsistency. In sum, the Department erred in concluding that Northside had not satisfied Standard XVIII(G) because Northside had an active and effective quality management program that involved thorough case reviews and Northside demonstrated that it was capable of submitting the required forms once its program was approved and its fully operational. Contemporaneous Emails Demonstrate That the Department Denied Northside’s Application for Reasons Having Nothing to Do with the Merits of Northside’s Program The Department’s decision to deny Northside’s application was not made in a vacuum. On April 28, 2017-–only two days before the Department sent Northside the Denial Letter-– a circuit judge in Leon County entered an order (“Injunction Order”) temporarily enjoining Northside from operating as a trauma center and enjoining the Department from permitting Northside to operate as a provisional trauma center. This injunction was based exclusively on issues of administrative law and did not in any manner address the merits of Northside’s application. In fact, the Department strongly opposed the injunction. The injunction did not prevent the Department from approving Northside’s application. The Department’s internal correspondence demonstrates that the injunction led the Department to deny Northside’s application, presumably because it was concerned about the ramifications of provisionally approving Northside’s application while the injunction was pending and Northside could not begin trauma center operations. On April 28, 2017, just hours before the Injunction Order was issued, Kate Kocevar, head of the Department’s Trauma Section, emailed Dr. Reed’s final conclusions to Chief Dick and informed her that in her opinion “Northside Hospital appears to have passed the reviewers [sic] survey and will be granted Provisional status.” Chief Dick confirmed at hearing that her initial impression based on Ms. Kocevar’s email was that Northside passed the survey. Later that day, Chief Dick received the injunction order and immediately emailed other Department personnel, “[l]ooks like the letter to Northside will not be going out on Monday as originally written.” Three days later, on May 1, 2017, the Department sent Northside the Denial Letter, notifying the hospital that its application had not met the Trauma Standards and would be denied. Given the looming injunction order, the Department’s internal correspondence, and the fact that the three alleged deficiencies are minor, at the very most, the Department’s decision to deny the application was apparently motivated by an administrative decision that it should not approve an application while the injunction was in place-–not by any genuine concerns regarding the merits of Northside’s program. Northside Has Expended, and Continues to Expend, Millions of Dollars to Maintain an Operational Trauma Program Northside has continued to maintain its trauma service capability, including retaining physicians and staff, while proceeding with its challenge of the Department’s preliminary denial. As part of its readiness efforts, Northside’s quality management program remains in place, meaning that Northside is still holding peer review and quality improvement meetings. Maintaining a continued state of readiness to initiate operations as a provisional Level II trauma center will cost Northside approximately $13 million this year.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department enter a final order finding that Northside met its burden of establishing that its trauma center application met the applicable standards, and awarding provisional Level II status to the applicant. DONE AND ENTERED this 20th day of December, 2017, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2017.
The Issue This hearing dealt with the consideration of the adequacy of the proposals by the Petitioner and Intervenor which were offered in response to the Respondent agency's RFP inquiry about a contract for the delivery of health services. Consideration of the dispute was as envisioned by Section 120.53(5), Florida Statutes. Respondent had determined that the Petitioner's proposal was unresponsive, and the proposal of the Intervenor was found to be acceptable. Petitioner challenged this opinion, leading to an assessment through the hearing process of the responsiveness of the proposals submitted by the Petitioner and Intervenor.
Findings Of Fact On September 12, 1985, the State of Florida, Department of Corrections, the Respondent in this action, issued request for proposals number 85-CO-2336-R. (A request for proposals is commonly referred to as an "RFP.") The purpose of this RFP was to obtain the assistance of a vendor or contractor in the provision and management of medical services at a newly constructed reception/medical facility located in southern Florida. Following the review of four responses to the RFP a decision was made on October 15, 1985, to award the project to Emergency Medical Services Associates, Inc., the Intervenor. In the face of this intended agency action, the Petitioner, Correctional Medical Systems, Inc., filed a Notice of Intent to Protest on October 18, 1985. This was followed by a Formal Written Protest dated October 23, 1985, which was amended on November 7, 1985. These pleadings raise the issues which are described in this Recommended Order. In particular Respondent, through the RFP, sought the ideas of the contractors necessary for the provision of comprehensive health care services in the new facility which is known as the South Florida Reception Center. Among the specific requirements of the RFP were the supply of medical and psychological personnel physical and psychological examinations, x-ray and laboratory facilities, the provision of an infirmary and an intensive care mental health unit. The RFP called for the provision of the services for three years with an option to renew for a second three-year term upon agreement of the provider and Respondent. In addition to the Petitioner and Intervenor, two other firms submitted responses to the RFP. Those companies were Correctional Health Services, Ltd., and Prison Health Services, Inc. The price quotations given by the four responding vendors were as follows: Correctional Medical Systems, Inc. $11,084,805.00 Correctional Health Services, Ltd. 11,560,000.00 Emergency Medical Services Associates Inc. 13,687,419.00 Prison Health Services, Inc. 15,720,387.00 In issuing the RFP the Respondent had as its goal the ability to select from competitive proposals that proposal which best met the needs of the agency. This method of selection was utilized, notwithstanding the fact that health services are not required to undergo the rigors associated with the bid laws of Florida. The RFP, in its terms, had allowed the unsuccessful bidders to protest the Respondent's decision of the matter of a contract award based upon authority set forth in Section 120.53(5), Florida Statutes. Three of the four proposals submitted by the four companies were rejected by the Respondent as being nonresponsive or irregular. Petitioner's proposal was rejected in view of the Respondent's belief that the proposal failed to contain a firm fixed price. Prison Health Services' bid was depicted as being inadequate, in that it failed to offer a fixed price and to include a legally binding proposal. Correctional Health Services' proposal was deemed nonresponsive for the failure to include resumes of key personnel within that organization. These determinations of irregularity or of lack of responsiveness were based upon a facial review of the submissions by the contractors and no further steps were taken by the Respondent to make an in- depth analysis of those proposals or to compare them to other proposals prior to deciding the ultimate question of which contractor it preferred to engage in this undertaking. The proposals from the four contractors were received and opened on October 7, 1985. William Stancill, the General Services Administrator to the Respondent had reviewed the submissions by the four vendors with an eye for any failings in those documents pertaining to what he perceived to be mandatory requirements of the PEP. This assessment lead Stancill to recommend the rejection of the three vendors for lack of compliance with mandatory requirements. Having reached this conclusion, the vendors other than the Intervenor were told that their proposals were unacceptable. Again, upon the facial examination of the proposals, only that proposal of Emergency Medical Services Associates was found to be responsive. 1/ Before the proposals were received from the various contractors, Respondent held what is known as a responders' conference to discuss the terms of the RFP. In the course of this conference, an indication was given to the potential responding parties on the topic of the Respondent's desires as to a price quotation. In the RFP, paragraph 5.2 [page 28] indicates "The cost proposal will be stated in terms of a fixed price for each year of the contract and option " In the course of the proposal submitted by the Petitioner, it offered the following comments about its price: CMS' price for each year of the contract is shown based on a 5 percent yearly increase. If the Medical Care Component of the Consumer Price Index deviates more than 2 percent from the projected 5 percent increase in a given year, CMS reserves the right to renegotiate its price with the Florida Department of Corrections for that year. This price is not fixed as contemplated by the terms of PEP, and this submission by the Petitioner fails to comply with the PEP on this subject. This failing is not cured by the testimony of Richard Turpenoff, Vice President of Financial Services for the Petitioner, when he describes personal involvement with the submission of seventy-five to a hundred health care proposals for correctional facilities and the fact that this language set forth in the present response to PEP had been used on those occasions. Nor is it beneficial to the Petitioner when it indicates that this type of language set forth in the response to the price demands of the PEP is that which has been used by health care providers throughout the industry. Petitioner's idea of reserving to itself the ability to discuss with the Respondent an equitable adjustment in the price of its services, in what the Petitioner foresees as an unlikely event that the Medical Care Component of the Consumer Price Index were to rise drastically over the period of the contract, is in itself a departure from the terms of the PEP. The PEP does not allow for this interference with the orderly process of the contract terms through any suggested negotiations, and it does not suffice to say that those negotiations are not unilateral in nature. Further, it is insufficient rehabilitation of the response to the PEP to indicate that the Petitioner has not abandoned any of its contracts before the expiration of the terms of those agreements. In this connection, the testimony of Joseph Rowan, Executive Director of Juvenile and Criminal Justice International, an expert in health care, states that he has reviewed a large number of proposals and has seen numerous proposals with provisions similar to that set forth in the Respondent's statement on price and concludes that the provision in the proposal is a firm fixed price. That statement is rejected. It is rejected because the interpretation given to this provision on the part of the Respondent in the person of Mr. Stancill is more compelling. Stancill believes that the Petitioner's quotation is not binding and is therefore not a fixed price, and that understanding is accepted. The Petitioner's deviation from the requirement for fixed price is one which may not be considered a minor irregularity, in that it is not an item which does not have an adverse effect on the cost or performance as described in paragraph 4.7 [page 25] of the PEP. The terms of the PEP as paragraph 4.7 and Rule 13A-1.02, Florida Administrative Code, contemplate the waiver of minor irregularities in the proposals submitted by the contractors. By not submitting a fixed price, Petitioner has failed to comply with a mandatory requirement of the PEP, and its offer is unresponsive. Finally, in the last four years, the Medical Care Component of the Consumer Price Index has exceeded 5% in each of those years and has reached as high as 8.7% in one of those years. As with the Petitioner's submittal, in examining the propriety of the submission by the Intervenor, it is the question of mandatory compliance with the RFP that is critical to the qualification of the latter proposal. To this end, the Petitioner has attempted to identify in the course of the final hearing those items within the proposal by the Intervenor which Petitioner argues constitute noncompliance in categories in which compliance is mandated. The first area of concern by the Petitioner pertains to subparagraph 5.1.2 of the RFP [page 27]. This provision relates to job descriptions and resumes of employees included within the FTE count. It says: A job description for all employees to be employed by the Contractor in the institu- tion, must be included. (Format samples are attached.) Resumes of any designated senior administrative/management or professional personnel should be included. As a minimum, the positions equivalent to senior adminis- trator, the chief health officer, and the nursing Director must be designated and a resume provided. Having considered the language of this provision, and the explanation concerning the provision as provided by Stancill, this provision is found to require the submission of job descriptions for all employees that the contractor intends to utilize in the institution. Further, it is necessary that the contractor designate by name and provide resumes for those persons holding the positions within the organization which are equivalent to the senior administrator, chief health officer and nursing director. This provision cannot be construed, as urged by the Respondent and Intervenor, to countenance the idea that only the job descriptions pertaining to positions equivalent to senior administrator, chief health officer and nursing director must be provided. In its submission, the Intervenor failed to submit job descriptions for employees in the classifications clerical assistant, medical records librarian, rehabilitative therapist ward clerk, clerk typist, pharmacy assistant and, arguably, clinical psychologist. Those job descriptions identified were provided at a later date. An additional conference was held between the Respondent and Intervenor following the Respondent's stated intention to select the Intervenor as the contractor, and in the course of this meeting, the Respondent established what it would accept in the way of the provision of services under the term medical assistant. That indication was to the effect that this job title must pertain to licensed nurses and medical technicians. In Florida, there is a specific category of licensed professional referred to as "medical assistant," found at Section 458.34, Florida Statutes, (Ch. 84-543, Laws of Florida) as it deals with assistants to physicians. The job description related to medical assistants as provided by the Intervenor more closely corresponds to the duties of licensed nurses or persons who assist those nurse practitioners, not persons who work under the direct supervision of a physician as described in Chapter 458, Florida Statutes. This job description also refers to the possibility of filling positions with persons who have worked as emergency medical technicians, EMTs. While the Intervenor failed to submit the job descriptions which have been identified in the previous paragraph, and as such violated subparagraph 5.1.2 of the RFP, this noncompliance is not a failure to comport with mandatory terms of the RFP. The mandatory terms as generally described in paragraph 3.1, and as defined by the following paragraphs and subparagraphs, do not point to the idea that the failure to provide the job descriptions is mandatory and a fatal defect in the proposal. While paragraph 3.1 and its ensuing provisions do regard the provision of resumes and background information related to key personnel as being mandatory the provision of job descriptions for the personnel at issue is not a mandatory item. Finally, the omission of those job descriptions in this instance has not been found to have a bearing on cost or performance. In a related vein, the inability, in theory, to compare the job descriptions of one contractor with those of another would impair the purchaser's efforts at selecting between the proposals. However, this comparison is not needed if the other contractors have been excluded based upon noncompliance with mandatory requirements of the RFP. Indeed, the other three proposals were properly discarded for noncompliance, and no comparison has been made. In the absence of the necessity of comparing job descriptions, it was not inappropriate for the Respondent to allow for the provision of the missing job descriptions subsequent to the submission of the basic proposal or to engage in discussion about the needs under the category medical assistant following the submission of the proposal. The Petitioner next challenges the accuracy of the claims which have been made by the Intervenor reference James A. Brigham, a key person in the plans of the Intervenor in its attempts at honoring the terms of a contract with the Respondent. Brigham is the Intervenor's Director of Marketing. On page 3 of the proposal of the Intervenor, in the introductory remarks, it is stated: Mr. Brigham was formerly an executive with and helped to found and manage Correctional Medical Systems, Inc. He has worked directly with the Department of Corrections in the states of Illinois, Alabama, Georgia and Missouri. In fact, Brigham neither founded nor managed Correctional Medical Systems, Inc. Although he has offered advice in the formative years of that corporation through his affiliation with another corporate entity which was associated with Correctional Medical Systems, Inc., that experience cannot be elevated, even under the most liberal construction, to a level of founding and managing. Brigham has never been employed by Correctional Medical Systems per se and has not served in any executive capacity with that organization. The resume of Brigham, which is a part of the proposal by the Intervenor, also sets forth that Brigham served as the Executive Vice President of Spectrum Emergency Care, Inc., in the years 1977-1983. (Spectrum is the other corporation previously mentioned which Brigham was associated with when advising Correctional Medical Systems.) His service as Executive Vice President lasted from 1977 through October 1, 1982. He did serve as an employee of Spectrum Emergency Care between the years 1977 and 1983. In the course of that employment, he prepared proposals and consulted with various states in the area of provision of medical care within correctional facilities. In that regard he had some contact with the states of Illinois, Georgia, Missouri, Arkansas and Alabama. Correctional Medical Systems was organized in 1979 to promote comprehensive medical services within correctional facilities throughout the United States. The focus of Spectrum in this regard had been primarily the provision of physician staffing in correctional facilities. It is not evident from what has been presented in the course of this hearing why these inaccurate statements were set forth in the RFP in describing Brigham's association with Correctional Medical Systems and Spectrum. On balance, having considered those statements and having reviewed the deposition of the witness Brigham on the subject of his experience, these inaccuracies within the RFP response are not found to be sufficient to recommend the rejection of this proposal. Paragraph 2.7 [page 1O] of the RFP states: The proposal shall indicate the contractor's plans to secure and maintain standards of the Commission on Corrections accreditation of the health services program, regardless of whether the entire institution may be accredited. This refers to standards established by the American Correctional Association. Petitioner claims that the Intervenor did not describe in its proposal how it intends to provide access information to the incoming prisoners pertaining to health care. As argued by the Petitioner, this is a requirement by the American Correctional Association in its standards dealing with the provision of medical care access information to prisoners. However, the RFP cannot be construed as requiring a contractor to identify how it would comply with that provision as a feature of its response to the RFP. The RFP is read to stand for the proposition that the contractor, in cooperation with the Respondent, shall make efforts to gain accreditation by the American Correctional Association and does not extend to the idea of a separate statement in its proposal of how it will provide access information to incoming prisoners. Moreover, it was established in the course of the hearing that at the point of intake of inmates into the Florida system of corrections, those inmates are routinely made aware of their right to receive medical services. At paragraph 2.1, lettered section C, [page 7] of the RFP, there is a discussion of the length of stay contemplated in the mental health unit of the facility. In particular it states: The patients in this mental health unit are expected to be successfully treated or stabi- lized within 30 to 60 days so as to permit assignment to another institution. This obligates the contractor to the establishment of a program varying in length from thirty to sixty days which will meet those requirements of successful treatment or stabilization. In preparing a budget to address this requirement, it leaves to the contractor the decision on whether the program needs to be thirty or more days. The latitude is afforded to use as few as thirty days in preparing the budget, which the intervenor did. By its terms, the RFP calls for the processing of eighty adult offenders and twenty youthful offenders per week for a total of a hundred inmates a week to be seen at reception for routine physical exams. This requirement of the RFP has been addressed in the budget statement of the Intervenor in Attachment D [page 2], described as a hundred physicals times 52 weeks or fifty-two hundred examinations. This item is separate from another item set forth on that page dealing with physical examinations which are on an annualized basis with a calculation being made that approximately five persons will be examined per day in the category of annual examinations. It has not been shown that the Intervenor budgeted for five examinations a day related to the intake function of receiving and processing inmates, when twenty per day was called for by the RFP. None of the other claims of the Petitioner set forth in the formal protest and its amendments on the subject of alleged infirmities within the Intervenor's response to proposal have been proven. The Emergency Medical Services Associates proposal had been reviewed by the evaluation committee of the Respondent which had the responsibility to make decisions on the sufficiency of such proposals and was found to be satisfactory. This determination has not been shown to be in error through proof in this hearing.
The Issue Whether certain forms incorporated by reference into the administrative rules of the Respondent constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Tampa General Hospital ("TGH" or "Petitioner") is a general acute care hospital in Tampa, Florida and is a verified Level I state-approved trauma center. By definition, a Level I trauma center is required to include an adult trauma center and a pediatric trauma referral center. The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with responsibility for certification of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") has filed an application for state approval as a pediatric trauma referral center which is the subject of a separate administrative challenge by TGH. In the instant case, TGH challenges three DHRS forms incorporated by reference into the Florida Administrative Code and which are utilized by applicants seeking certification as state-approved trauma centers. Tampa General has standing to challenge the forms in this proceeding. The three forms challenged by TGH in this case are HRS Form 1840, ("State-Approved Trauma Center Letter of Intent"), HRS Form 1721, ("Application for State-Approved Pediatric Trauma Referral Center"), and the portions of HRSP 150-9, which identify the "critical standards" which must be met by an applicant seeking to obtain approval as a provisional state approved pediatric trauma referral center. The three forms include reference dates of October 1991. The forms were adopted as part of a rule promulgation effort prior to the 1992 Legislative session. Obviously the DHRS did not address the 1992 legislation in the 1991 rules. In relevant part, the 1992 legislation added a requirement that, under conditions set forth in the statute, proposed trauma centers must be certified as consistent with local or regional trauma plans. The forms challenged by TGH fail to reference the requirement. Section 395.4025(2)(a), Florida Statutes, requires submissions of letters of intent from hospitals seeking to become certified as state-approved trauma centers. Section 395.4025(2)(a), Florida Statutes, further requires that "[i]n 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 state-approved 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." The statute states that the requirement is not applicable to hospitals which were provisional or verified trauma centers on January 1, 1992. There are five local or regional trauma agencies in Florida which have been approved by the DHRS. Hillsborough County, where both the Petitioner and the Intervenor operate hospitals, has one of the five local trauma agencies. Rule 10D-66.109(a), Florida Administrative Code provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department. " The form letter of intent provided to applicants by the DHRS fails to reference the local plan consistency requirement or the conditions under which the requirement is applicable. Section 395.4025(2)(a), Florida Statutes, relates only to letters of intent. It clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider. The form letter of intent does not provide notice to the applicant that such certification may be required, either as part of the completed letter of intent or otherwise. The omission of the certification requirement from the letter of intent form is misleading. It fails to indicate that a hospital should address the issue in its letter of intent. The form contravenes the statute. TGH also challenges HRS Form 1721, October 91, ("Application for State-Approved Pediatric Trauma Referral Center",) and the portions of HRSP 150- 9, October 91, which identify the "critical standards" which must be met by an applicant. Section 395.4025(2)(c), Florida Statutes, (1994 Supplement) provides as follows: In order to be considered by the department, applications from those hospitals seeking selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of deter- mining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center. The form is incorporated by reference in the rule. HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center, fails to reference the local plan consistency issue or the conditions under which the requirement is applicable. However, the instructions to the form provide as follows: INSTRUCTIONS: To be eligible for approval as a SAPTRC, a hospital must complete this application and submit all requested information to the HRS, Office of EMS, for review. The following must be used to complete this application: HRS Pamphlet (HRSP) 150-9 entitled "State Approved Trauma Centers and State-Approved Pediatric Trauma Referral Center Approval Standards", Oct 91 (standards document), and the application requirements of Chapter 395, Florida Statutes (F.S.), and Chapter 10D-66, Florida Administrative Code (F.A.C.). Following discussion of a three phase review process, the HRS Form 1721 instructions again state that "HRS Pamphlet (HRSP) 150-9, Oct 91, the application requirements of Chapter 395, F.S., and Chapter 10D-66, F.A.C., will be used as criteria for application review." By reference to the statute and rules, the instructions to the application notify an applicant as to the requirements for certification. The failure of the actual application to specifically restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement. As to the standards document in which the critical standards for provisional approval are set forth, rule 10D-66.109(d)2, Florida Administrative Code, provides as follows: The minimum standards for review for Provisional SAPTRCs are the following portions of HRSP 150-9, October 91; STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E It is unnecessary to address each critical standard in this order. Essentially, they relate to the first three "critical elements" set forth as Section 395.4025(2)(c)1-3, Florida Statutes. However, review of the cited portions indicates that there is no reference within the cited sections of HRSP 150-9, October 91, which addresses the possible requirement of local trauma plan consistency certification. The application processing framework set forth by the administrative rules indicates that local plan consistency is to be considered prior to the DHRS's commencement of provisional review. Rule 10D-66.109(d), Florida Administrative Code, provides that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards." If, as the rule suggests, certification of local plan consistency is considered prior to commencement of provisional review, it would be duplicative to include the requirement in the technical critical standards set forth in the standards document. The failure of the standards document to restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since June 16, 1980, a physician licensed to practice medicine in the State of Florida. She holds license number ME 0036758. Since the completion of her residency at Engelwood Hospital in New Jersey in 1974, Respondent has specialized in internal medicine, although she is not board-certified. Until December of 1987, when she relocated to Florida, she had her own practice in New Jersey. Following her arrival in Florida, she initially went into private practice. In June of 1990, Respondent went to work part-time at Humana's Urgent Care Center (hereinafter referred to as the "UCC") in Plantation, Florida, a walk-in clinic servicing Humana members who needed to see a physician but, because of the unexpected nature of their illness, did not have a scheduled appointment with their primary care physician. 7/ In February of 1991, Respondent was hired as the full-time Director of the UCC. She remained in that position until her resignation in February of 1994. She presently has her own practice in Fort Lauderdale, Florida. On or about April 22, 1992, patient L.K., an 80-year old female, slipped and fell. Later that same day, at around noon, L.K., accompanied by two companions, presented to the UCC with complaints of right groin pain and difficulty walking after the fall. L.K. did not have any of her medical records with her, nor did her primary care physician provide the UCC with these records in advance of her visit. L.K. was greeted by the receptionist at the UCC. The receptionist asked L.K. for her name, address, telephone number and social security number. L.K. provided the information requested, which the receptionist recorded on a "priority care record" form (hereinafter referred to as the "PCR Form"). Thereafter, a nurse escorted L.K. from the reception area to an examining room. Once in the examining room, the nurse questioned L.K. as to the reason for L.K.'s visit to the UCC and also inquired about any medications L.K. might be taking and allergies she might have. In response to these inquiries, L.K. told the nurse that: she was 80 years old; she had fallen that morning and, as a result, was experiencing pain in her right groin and had "great difficulty walking;" she was taking insulin 8/ and Ecotrin, among other medications; and she was allergic to sulfur. The nurse documented these responses on the PCR Form. By now, it was approximately 12:30 p.m. The nurse then took and recorded on the PCR Form L.K.'s vital signs, which were within normal limits. L.K.'s temperature was 98.6 degrees Fahrenheit, her pulse rate was 68, her respiratory rate was 20 and her blood pressure was 110 over 60. The nurse and L.K. were soon joined in the examining room by Respondent. Upon entering the examining room, Respondent asked L.K. "what had happened." L.K. told Respondent that she had slipped and fallen and that she had pain in her right groin. Respondent recorded this information on the PCR Form. Respondent also noted on the PCR Form that L.K. was "dragging [her] leg." Although Respondent's records do not so reflect, L.K. also complained to Respondent that she had pain in her lower back and that before falling, she had been feeling fine and had not been experiencing any chest pains or dizziness. It was apparent to Respondent, based upon her conversation with L.K., that L.K. was oriented as to person, place and time. Respondent then conducted a thorough physical examination of L.K., but failed to document that she did so or to note the results of the examination on the PCR Form or elsewhere in her records. In not recording any of the findings of her physical examination of L.K., Respondent was following her practice of "charting by exception," that is noting only positive findings or abnormalities in her records. "Charting by exception" is not uncommon in hospital emergency room and walk-in clinic settings. As part of her examination of L.K., Respondent rechecked L.K.'s blood pressure. It was still 110 over 60. She listened to L.K.'s heart and lungs and discovered no abnormalities. She inspected L.K.'s skin. There were no scratches, bruises or abrasions. L.K.'s skin color was "good." She palpated L.K.'s abdominal, pelvic and groin areas. No masses or hernias were found. The abdomen was soft and not tender. The spleen and liver were normal to the touch. She tested the range of motion of L.K.'s hip. The test revealed that it was unlikely that L.K. had suffered a hip fracture. She performed a rectal examination of L.K., which included a guaiac test of L.K.'s stool. The test did not reveal the presence of any blood in the stool. She observed L.K.'s eye movements and found them to be normal. There was no indication from the physical examination Respondent conducted that L.K. had any respiratory, metabolic, hemodynamic or other problem requiring immediate hospitalization. Respondent did not order or perform any tests be done on L.K.'s blood, such as a complete blood count or prothrombin time. In failing to do so, Respondent did not act in a manner that was inconsistent with what a reasonably prudent internist, in view of L.K.'s clinical presentation, would have recognized as being acceptable and appropriate. Notwithstanding that her physical examination of L.K. revealed no signs of any fracture, Respondent, as she noted on the PCR Form, ordered that x- rays be taken of L.K.'s right hip and pelvic area. Humana's x-ray facilities were in a building adjacent to the UCC. L.K. was brought to the building in a wheelchair and the x-rays Respondent had ordered were taken. The radiologist on contract with Humana to read x-rays taken at this site, David Francis, M.D., was not at his station. L.K. returned to the UCC with the x-rays. She told Respondent that the radiologist was unavailable. Respondent telephoned Dr. Francis' office and was told that he had left for the day. Respondent then looked at the x-rays. The x-rays were difficult to read because of the presence of bowel gasses, feces and a pessary and the osteopenic condition 9/ of the x-rayed bone structures. Respondent had obtained L.K.'s medical records from L.K.'s primary care physician and, upon a review of those records, learned, among other things, that L.K. had a "history of osteoporosis," which made her more susceptible to bone fractures. 10/ Nonetheless, as she noted on the PCR Form, Respondent did not see any fractures when she looked at the x-rays. Respondent so informed L.K. and her companions, but added that she was not a radiologist and therefore was not certain that L.K. had not sustained a fracture. She told them that she would have a radiologist look at the x-rays "first thing in the morning" and that she would make arrangements to have L.K. seen by an orthopedic specialist thereafter. Under the circumstances, it was appropriate for Respondent, who was, and did not hold herself out to be anything other than, an internist without any specialized skills or training in either radiology or orthopedics, to seek the input of a radiologist and an orthopedist. Moreover, there was no reason for Respondent to believe that there was any need to have a radiologist or an orthopedist involved in the matter any sooner than the following day. Based upon her reading of the x-rays and the other information she had gathered, Respondent preliminarily determined that L.K. had a lumbosacral sprain, which she noted on the PCR Form by writing, under "assessment," "L/S Sprain." Respondent reasonably believed that there was no present need to hospitalize L.K., particularly inasmuch as she had been assured by L.K.'s companions that there would be someone available at home to watch L.K. at all times. Respondent therefore instructed L.K. to go home and rest. She ordered a walker or a wheelchair for L.K. to use at home when she needed to get out of bed. Respondent told L.K. and her two companions that if there was any increase in L.K.'s pain or discomfort, or if any new problems developed, L.K. should go directly to the Humana/Bennett Hospital emergency room. 11/ That Respondent sent L.K. home is reflected on the PCR Form, however, the form does not indicate what, if any, instructions Respondent gave L.K. Before L.K. left the UCC, she was given injections of Toradol, an anti-inflammatory drug, and Norflex, a muscle relaxant. The injections appeared to make L.K. feel considerably more comfortable. L.K. was also given prescriptions for Indocin and Soma. Respondent listed these medications (Toradol, Norflex, Indocin and Soma) on the PCR Form under "plan." No other entries were made under this heading on the form. Following L.K.'s departure from the UCC, Respondent took L.K.'s x-rays to Dr. Francis' office and laid them on his desk, along with a note requesting that, upon his return to the office, he read the x-rays and call Respondent to tell her of his findings. Respondent also telephoned an orthopedic specialist to schedule an appointment for L.K. for the next day. On the morning of April 23, 1992, Dr. Francis read the x-rays that Respondent had left on his desk the day before. His reading of the x-rays revealed that L.K. had multiple pelvic fractures. Because the anatomy of the pelvis is atypical, it is not uncommon for internists and other primary care physicians who do not have the specialized skills and training of a radiologist or an orthopedist to miss pelvic fractures on x-rays, as did Respondent in the instant case. Respondent's failure to identify the pelvic fractures on L.K.'s x-rays, however, did not result in Respondent rendering care and treatment to L.K. that was inadequate or otherwise inappropriate. Given L.K.'s clinical presentation, whether she had a fractured pelvis or not, sending her home with instructions to rest (as opposed to hospitalizing her) was not inappropriate. Reasonably prudent physicians do not routinely hospitalize patients simply because they have pelvic fractures. After reading L.K.'s x-rays, Dr. Francis telephoned Respondent and advised her that the x-rays revealed that L.K. had fractured her pelvis. Respondent thereupon placed a telephone call to L.K.'s residence. The person who answered the telephone informed Respondent that L.K. had been taken to the Humana/Bennett Hospital emergency room because she was in a great deal of pain. L.K. arrived at the emergency room at approximately 10:30 a.m. complaining of weakness and dizziness. She had a temperature of 95 degrees Fahrenheit (taken orally). Her blood pressure was 98 over 60 and her pulse was 96. Laboratory testing done at the hospital indicated that L.K.'s blood sugar was very high (750 milligrams, which was twice as high as normal), that her hemoglobin 12/ and blood pH were low, 13/ and that she had an enzyme profile indicative of a myocardial infarction. An electrocardiogram administered at the hospital also lent support to the conclusion that L.K. had a myocardial infarction. It appears likely, particularly in light of L.K.'s very high blood sugar, that the myocardial infarction was the product of a diabetic acidosis. X-rays taken at the hospital revealed that L.K. had sustained multiple fractures of her pelvis, but that there was no significant bone displacement. The fracture sites were not near any major arteries or blood vessels. L.K.'s condition quickly deteriorated after her arrival at the hospital. At 2:15 p.m. she was pronounced dead. Thereafter, an autopsy was performed by Stephen Nelson, M.D., of the Broward County Medical Examiner's Office. The following are the "Autopsy Findings" set forth in in Dr. Nelson's Autopsy Report: Atheroscerotic vascular disease, multifocal 14/ Calcific aortic valve Pulmonary congestion, with calcific vessels Ateriolonephrosclerosis Pelvic fracture Cystic encephalomalacia, left putamen, remote Status post resuscitation Edentulous mouth In his report, Dr. Nelson listed the following as the "CAUSE OF DEATH," "CONTRIBUTORY CAUSE OF DEATH" and "MANNER OF DEATH": CAUSE OF DEATH: Pelvic fracture CONTRIBUTORY CAUSE OF DEATH: Coronary atherosclerosis MANNER OF DEATH: Accident Although Dr. Nelson listed "pelvic fracture" as L.K.'s cause of death, in his Autopsy Report, he did not state that he found evidence of tears or lacerations of any major arteries or blood vessels, nor did he indicate that he discovered the loss of an amount of blood sufficient to have caused or contributed to L.K.'s death. He did note, however, the following: Hemorrhage is noted dissecting within the planes of the rectus abdominis muscle extending from umbilicus to pubic symphysis. Hemorrhage is subsequently traced to a 1 inch wide ragged displaced fracture at the pubic symphysis par- ticularly prominent on the left side. There is tearing of the peritoneum, though, no free or clotted peritoneal fluid is noted. There is hemorrhage along the anterior surfaces of the urinary bladder and the serosa of the urinary bladder.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board of Medicine enter a final order dismissing Count One of the Administrative Complaint, finding Respondent guilty of the violation of subsection (1)(m) of Section 458.331, Florida Statutes, alleged in Count Two of the Administrative Complaint, and disciplining her for having committed this violation by issuing her a reprimand. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 14th day of March, 1995. STUART M. LERNER 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 14th day of March, 1995.
