Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the application of Central Florida Surgical Ambulatory Center be DENIED. DONE and ORDERED this 27th day of March, 1985, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of March, 1985.
The Issue The issue for determination is whether Respondent committed the offenses set forth in the corrected administrative complaint, and, if so, what action should be taken.
Findings Of Fact At all times material hereto, Kenneth Douglas Glaeser (Respondent) was a licensed physician in the State of Florida, having been issued license number ME 0058606. Respondent's area of specialty is Emergency Medicine. On or about May 30, 1993, at approximately 9:45 p.m., Patient L. H., a 47 year old male, presented to the emergency room (ER) at Parkway Regional Medical Center (PRMC) in Miami, Florida complaining of chest pain. Patient L. H. and his wife were visiting his mother in Miami. At first, Patient L. H. believed he had heartburn, but it would not go away. His mother convinced him to go to the hospital. Patient L. H.'s wife and mother accompanied him to the hospital. His wife parked the vehicle while Patient L. H. and his mother entered the ER. Patient L. H.'s wife completed paperwork for the ER while the ER staff attended to her husband. Patient L. H.'s mother was with him. After completing the paperwork, approximately 10 minutes later, Patient L. H.'s wife joined Patient L. H. and his mother in the examining room. At the time, Respondent was the ER physician on duty at PRMC. Respondent was the only ER physician who attended to Patient L. H. Respondent has no independent recollection of Patient L. H. or what happened during Patient L. H.'s visit to the ER at PRMC. The first goal of an ER physician is to determine if the patient has a life-threatening condition, which, often times than not, involves excluding diagnoses. The second goal of an ER physician is to determine if the patient has a condition which can receive immediate treatment and to provide that immediate treatment whether the condition is life-threatening or not. Respondent obtained Patient L. H.'s history which included the type of pain, description of the pain, location of the pain, associated symptomatology, time frame of the pain (including onset), and past history. Respondent recorded, among other things, that Patient L. H. had chest pressure which radiated bilaterally to his shoulders and a numb left shoulder; that the pain lasted for approximately 10-15 minutes, subsided, and re-occurred 30 minutes later; that Patient L. H. had no shortness of breath, diaphoresis (sweating), nausea or vomiting, or palpitations; and that Patient L. H. had no cardiac history. Respondent's history of Patient L. H. was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent performed a physical examination on Patient L. H. The physical examination included taking vital signs and examination of the cardiovascular system, lungs, and pulses of the extremities. Respondent's physical examination was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent had laboratory work performed on Patient L. H. Respondent ordered SL (sublingual) nitroglycerine for Patient L. H. But, the nitroglycerine was not administered because Patient L. H. was not complaining of chest pains at the time. The ordering of the nitroglycerine and not administering it until chest pain developed was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent ordered diagnostic tests to be performed on Patient L. H. The tests included an electrocardiogram (EKG), a chest x-ray, and cardiac enzymes. Neither Patient L. H.'s wife nor his mother were present during the tests. ER physicians are trained to read EKGs. Generally, a cardiologist is not immediately available to the ER for the reading of EKGs. An ER physician looks for an injury pattern in the EKG, which would evidence an acute cardiac event. Most times, a cardiologist will over-read the EKG a day or two after the EKG is performed on a patient. Respondent's reading of Patient L. H.'s EKG did not show an injury pattern which would evidence an acute cardiac event. Respondent determined that Patient L. H.'s EKG was within normal limits. Even though an abnormality was demonstrated in the EKG, the abnormality could have been a false/positive reading. Respondent's reading of the EKG was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. A cardiologist over-read Patient L. H.'s EKG after he left PMRC. The cardiologist found a "definite abnormality." Respondent's reading of Patient L. H.'s chest x-ray indicated that it was within normal limits. Respondent's reading of the chest x-ray was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent's interpretation of the cardiac enzymes tests (CPK and LDH) indicated that they were within normal limits. If a heart is damaged, often times the enzymes contained in the heart cells will be released, and the cardiac enzymes tests would detect the enzymes. Respondent's interpretation of the cardiac enzymes tests was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. It is undisputed that based upon Patient L. H.'s history, the physical examination, the tests results, including diagnostic and laboratory results, a recommendation to Patient L. H. by Respondent for admission to PRMC was medically warranted. Admission would allow for monitoring and further evaluation. However, a patient has a right to refuse admission. Respondent discussed his findings with the doctor who was listed as Patient L. H.'s primary physician on the ER record. The primary physician was the private physician, a cardiologist, of Patient L. H.'s mother. The primary physician authorized Respondent to contact the physician on-call. Respondent discussed his findings and his concern with Patient L. H. Respondent recommended to Patient L. H. that he be admitted to PRMC. However, Patient L. H. did not wish to be admitted; he wanted to leave the hospital. Patient L. H. rejected Respondent's recommendation for admission to PRMC. 1/ Patient L. H.'s mother attempted to convince him to agree to admission and remain in the hospital, but he refused. It is undisputed that if a patient refuses admission, the physician should advise the patient of the risks involved and recommend admission. In Patient L. H.'s circumstances, it was medically warranted that Respondent advise Patient L. H. that, if he was not admitted, he could suffer a heart attack and die and recommended admission to Patient L. H. Taking the totality of the circumstances, an inference is drawn and a finding is made that Respondent advised Patient L. H. of the risks involved if he rejected admission and recommended to Patient L. H. that he be admitted. Respondent did not record in the ER record that he advised Patient L. H. of the risks involved in rejecting admission and recommended admission. ER physicians are not medically required to spell-out in the medical record what risks are discussed with a patient and that the patient left against medical advice. It is sufficient that the ER physician explains the risks to the patient. Respondent ordered a GI cocktail (Maalox, Donnatal, and viscous Lidocaine) for Patient L. H. 2/ The GI cocktail was not administered until approximately 12:15 a.m. on May 31, 1993. 3/ The ordering or not of the GI cocktail for or the time in which the GI cocktail was given to Patient L. H. has no effect on the standard of care that Respondent provided to Patient L. H. Respondent diagnosed Patient L. H.'s condition as atypical chest pain. This diagnosis essentially indicates that a number of different things may have been causing Patient L. H. to experience chest pain. Patient L. H. left PRMC on May 31, 1993, at approximately 12:20 a.m. against medial advice even though the ER record indicates that he was discharged. 4/ Before leaving PRMC, Patient L. H. was informed by Respondent to, among other things, follow-up with the primary physician and return to the ER if needed. Neither Patient L. H. nor his wife completed any discharge papers or received discharge instructions. It is not uncommon for a patient to be discharged from a hospital without completing discharge papers or receiving discharge instructions. However, hospitals attempt to prevent such occurrences. When a patient leaves PRMC against medical advice, the patient is requested to complete certain documentation. That documentation was not completed in the case of Patient L. H. However, the absence of the documentation is not considered to evidence that Respondent failed to advise Patient L. H. of the risks involved in rejecting admission and to recommend admission. On May 31, 1993, at approximately 8:45 a.m., Patient L. H. went into cardiac arrest at his mother's home. He was transported to the ER at PRMC by emergency vehicle, where he was pronounced dead. On June 1, 1993, Respondent entered an addendum to the ER notes of May 30 and 31, 1993. The addendum provided, among other things, that Patient L. H. was opposed to admission to PRMC and that, even when Respondent explained the risks to Patient L. H., he continued to oppose admission and wanted to leave. Furthermore, the addendum provided, among other things, that Respondent instructed Patient L. H. to return to the ER if the chest pain returns and to follow-up with the primary physician. An addendum to ER notes by an ER physician is not unusual and is an accepted practice. The Dade County Medical Examiner determined that Patient L. H.'s cause of death was occlusive coronary artery disease. Respondent's medical records justified the course of treatment of Patient L. H. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent is a defendant in a pending civil suit brought by Patient L. H.'s surviving spouse.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine dismiss the corrected administrative complaint. DONE AND ENTERED in this 27th day of January 1997 in Tallahassee, Leon County, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 27th day of January 1997.
The Issue The issue is whether Florida Administrative Code Rules 64B- 9.0092(2)(f), 64B8-9.0092(4)(a), and 64B8-9.0092(4)(c) constitute invalid exercises of delegated legislative authority as defined by Section 120.52(8), Florida Statutes (2004).
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," establishes requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is the only organization that the Board has ever approved as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. FLACS began operating as an approved office surgery accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the Board's next scheduled meeting agenda. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Rule 64B8-9.0092(2)(f)--Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accreditation organization to include copies of all incident reports filed with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes. FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS filed two such adverse incident reports with its new application. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record searches even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited practices. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organizations (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain time frame. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain time frame. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents from occurring in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rule 64B8-9.0092(4)(a)--Quality Assurance Program Florida Administrative Code Rule 64B8-9.0092(4)(a) requires an accrediting organization to "have a mandatory quality assurance program approved by the Board of Medicine." Though it is not apparent on the face of the rule, this provision relates to an "internal" quality assurance program used by the accrediting organization, not a quality assurance program implemented at a physician's office. The rule does not define a quality assurance program or describe the required contents of a quality assurance program necessary to achieve the Board's approval. There are no forms or instructions to provide guidance in designing an such a program. Mr. McPherson testified that FLACS could have used the quality assurance programs of national accrediting agencies as a reference when designing its own program. The greater weight of the evidence indicates that the "internal" quality assurance programs of national agencies are proprietary and not available to the public. Public information from JACHO and AAAASF relates to the ways that they monitor the quality assurance programs of the offices they inspect. For example, JACHO's manual discusses quality management issues for accredited practices, including standards, elements of participation, and the rationale that supports each. There is no evidence to show what internal steps the national agencies take to assure the quality of their programs apart from monitoring the programs of the accredited practices. Therefore, the Board could not have compared FLACS's "internal" quality assurance program and processes with the "internal" quality assurance programs and processes of the national accrediting agencies. During the hearing, the Board presented expert testimony about quality assurance programs in general. The expert testified that a generic quality assurance program for healthcare providers requires the following: (a) identification of positive outcomes that one desires; (b) identification of undesired negative outcomes based on the service and risk profile of the facility; (c) evaluation of accrued adverse incidents to identify trends; and (d) identification of ways to prevent future problems. The Board's quality assurance expert based his testimony on the standards published by the Center for Medicare and Medicaid Services (CMS). The description of a quality assurance program in the CMS document forms a skeleton for national accreditation programs such as the AAAASF, JACHO, and the Accreditation Association for Ambulatory Health Care (AAAHC). The rule does not reference CMS, JACHO, AAAASF, or AAAHC as having established models for an "internal" mandatory quality assurance program that the Board would approve. FLACS's office quality improvement plan compares favorably to the one established by AAAASF in some respects. For instance FLACS requires its accredited physicians and offices to perform a random chart screen of five cases on a quarterly basis. AAAASF requires a minimum of six cases per surgeon utilizing a facility or two percent of all cases in a group practice every six months. AAAASF requires its clients to engage in a peer review process at least every six months. The review is done by a recognized peer review organization or a medical doctor other than the operating room surgeon. FLACS does not require peer review evaluations due to concerns that peer review documents would be subject to discovery in legal proceedings in Florida. Rule 64B8-9.0092(4)(c)--Ongoing Anesthesia-related Accreditation and Quality Assurance Processes Involving the Active Participation of Anesthesiologists Florida Administrative Code Rule 64B8-9.0092(4)(c) requires an accrediting organization to have "ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists." The Board did not base its denial on FLACS's anesthesia-related accreditation standards and quality assurance processes required by Florida Administrative Code Rule 64B8-9.0092(4)(b). Instead, the denial is based upon the requirement for "active participation of anesthesiologists." The Board has no standards that describe or define the "active participation of anesthesiologists." There is no evidence that shows how the Board applied this requirement to FLACS's application. There are no forms or instructions to provide guidance for an applicant attempting to show the ongoing active participation of anesthesiologists. There is no evidence regarding the participation of anesthesiologists in ongoing anesthesia-related accreditation and quality assurance processes of national accreditation agencies. FLACS has an Anesthesia Review Committee, which is made up of three participating anesthesiologists, FLACS's inspectors, and FLACS's Executive Director. The committee meets quarterly to discuss current issues involving office surgery anesthesia, any anesthesia incidents involving FLACS's accreditees, new pharmacological agents available for outpatient anesthesia and, when available, additional information such as incident reports involving anesthesia mishaps of physicians who are not FLACS's accreditees. The Anesthesia Review Committee keeps written minutes. FLACS's Board of Directors reviews the minutes during regularly scheduled meeting. The Anesthesia Review Committee is responsible for updating FLACS's Anesthesis Parameters of Care on an annual basis. They also attend FLACS's educational meeting to update members on current practice in outpatient/office surgery anesthesia. The Board's quality assurance expert testified that he could not determine exactly how FLACS's anesthesiologists participated, i.e. what they did and how they came to conclusions. The expert could not say whether the participation of FLACS's anesthesiologists resembled the participation of anesthesiologists in the programs of national accreditation agencies. The expert acknowledged that for a relatively small number of physician's offices with a small number of anesthesia- related problems occurring within those offices, an evaluation of such problems on a quarterly basis might be quite adequate.
The Issue The issues to be determined are whether Respondent violated section 478.52(1)(m), Florida Statutes (2017),1/ by accepting and performing professional responsibilities that she knew or had reason to know she was not competent to perform; and, if so, what penalty should be imposed for the violations proven.
Findings Of Fact The Department is the state agency charged with the licensing and regulation of electrolysis pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Respondent has been licensed as an electrologist in the State of Florida, having been issued license number EO2650. Respondent is also licensed by the State of Florida as an acupuncturist, license number AP 1378. Respondent is a certified surgical assistant, having obtained certification through the American Board of Surgical Assistants. Documents in the record indicate that in 1998, Respondent completed medical school at Universidad Libre in Barranquilla, Columbia. However, Respondent is not a licensed medical doctor in the State of Florida. Respondent’s address of record is 8210 West Waters Avenue, Tampa, Florida 33615. At all times material to the Administrative Complaint, Respondent owned and operated Orozco Medical Center (“OMC”), located at 8210 West Waters Avenue, Tampa, Florida 33615. Patient N.M. Patient N.M. is a female born in 1964. She testified that she was familiar with OMC because she had therapy there following a car accident in 2000. N.M. presented to OMC in early 2015 for consultation regarding a liposuction with fat transfer procedure, commonly called a “Brazilian Butt Lift” (“BBL”). Fat is taken from one part of the body and reinjected into the buttocks. N.M. testified that Blanca Cabrera, who performs massages at OMC, recommended a “doctor” at OMC named Marlon Barcelo to perform her BBL. Marlon Barcelo worked at OMC as a surgical assistant but was not a medical doctor. N.M. testified that she believed Mr. Barcelo would perform her BBL procedure and that she never knew that he was not a physician. Ms. Cabrera told her that Mr. Barcelo had been a very good doctor in Columbia. N.M. testified that at her initial consultation at OMC regarding the BBL, she met exclusively with Respondent, who showed her where the fat would be removed and where it would be injected. N.M. testified that she met with Respondent three times before her surgery. N.M. testified that, at the conclusion of the initial consultation, she was given an appointment card directing her to return to OMC on January 13, 2015, for an electrocardiogram, lab work, and the medication she would be expected to take before the procedure. The medical records indicate that N.M. was confused as to the dates. It appears from the records that her initial consultation was on January 13, 2015, that her EKG and lab work were performed on March 2, 2015, and the date of her surgery was March 13, 2015. N.M. testified that each time she visited OMC prior to the surgery, she met only with Respondent, who examined her and explained the procedure to her with no other persons present. N.M. testified that on the date of the surgery, her daughter drove her to OMC. After she checked in at the front desk, N.M. was taken to an exam room and told to change into a hospital gown. Respondent then marked her body to identify the locations where fat was to be removed. Respondent gave N.M. a medication to calm her prior to the procedure. The medical record indicates that N.M.’s pre- operative medications included Keflex (cephalexin, an antibiotic), lorazepam (a sedative and anti-anxiety medication), and Benadryl (diphenhydramine, an antihistamine with sedative properties). N.M. described the medication’s effect as “like a Xanax.” N.M. testified that the medication relaxed her but did not affect her recollection of the procedure. She testified that she was awake throughout the surgery and was allowed to use her cell phone during the procedure. N.M. did not recall meeting Dr. Mark Kantzler and denied ever meeting Dr. Amina Edathodu. She believed that Mr. Barcelo was going to perform the surgery, though up until the morning of the procedure she had not met him. N.M. was taken to the surgical room and placed on a table. She stated that there was a drape that blocked her view of the surgical area, but that it was low enough to allow her to see everyone in the room. She could see two men, Mr. Barcelo and someone identified as “Abel,” and Ms. Cabrera, the massage therapist, who appeared to be assisting. N.M. testified that Mr. Barcelo performed the liposuction. She testified that everyone in the room was wearing surgical gowns and gloves but no surgical masks. N.M. testified that during the liposuction procedure, Respondent told her that she would be performing the fat injections because she was very good at that procedure. N.M. testified that after the liposuction was completed, Mr. Barcelo called on Respondent to perform the fat injections into her buttocks. N.M. stated that she saw Respondent walk into the room carrying a syringe. During this portion of the procedure N.M was positioned on her stomach but stated that she knew from the conversation in the room that it was Respondent who was placing the injections into her buttocks. Upon conclusion of the procedure, Respondent gave N.M. pain medication for post-surgical pain. N.M. returned to OMC for a follow-up visit regarding the lack of drainage from her incision. During this visit, Respondent examined N.M. and gave her medication to reduce the swelling she was experiencing. Dr. Edathodu testified that she has been a licensed physician in the State of Florida for over 25 years. From 2015 through 2017, she worked as a contract physician at OMC and acted as medical director for the facility. Dr. Edathodu developed the protocols for OMC’s tumescent liposuction procedures and ensured they were followed. Dr. Edathodu remembered N.M. as a patient who had undergone previous surgeries and presented for further liposuction and fat transfer. Dr. Edathodu testified that she performed the liposuction procedure on N.M. Dr. Edathodu’s signature is on the cosmetic surgery consent form that was also signed by N.M. on March 3, 2015. The “Liposuction and Autologous Fat Transfer” consent form signed by N.M. on March 3, 2015, specifically names Dr. Edathodu as the surgeon who will perform the procedure and was signed by Dr. Edathodu. Dr. Edathodu testified that she reviewed the procedure with N.M., discussing the risks and benefits. Dr. Edathodu does not speak Spanish and uses Respondent to translate with Spanish speakers such as N.M. She identified herself to N.M. as a surgeon through Respondent’s translation. Dr. Edathodu spoke to N.M. about having realistic expectations and cautioned her that she may not obtain an optimal result because of her previous procedures. Dr. Edathodu testified that, aside from her, the persons in the surgical theater were three surgical assistants: Respondent, Mr. Barcelo, and Pavel Cabanes. It is found that Mr. Cabanes must have been the “Abel” referred to by N.M. Dr. Edathodu testified that during the surgery, there is a drape between the surgical field and the patient’s face and head, to prevent the patient from being disturbed by the sight of the procedure. The drape is made of disposable paper and is about five feet high. When performing the surgery, Dr. Edathodu is unable to see the patient’s face and the patient is unable to see past the drape. Dr. Edathodu testified that she performed the entire surgical procedure on N.M. Dr. Edathodu made the site markings on N.M. while Respondent took photographs. Respondent did not perform any part of the surgical procedure. Respondent performed none of the fat transfer on N.M. Respondent did nothing other than what Dr. Edathodu specifically directed her to do. Dr. Edathodu testified that she met with N.M. on four or five occasions after the surgery. Dr. Edathodu’s testimony, as supported by the medical records, is credited. Perhaps because of her inability to speak English, N.M. appeared confused and inconsistent in her testimony, at least as it appeared in the Transcript. N.M.’s credibility was strained by her uncertainty as to dates and medications. She offered improbable details, such as the lack of coverage by the surgical drape and the failure of the surgical team to wear masks. N.M. was certain that Respondent was performing the fat injection, even though N.M. could not see what was happening. Though N.M. testified that she was awake and alert during the procedure, the undersigned cannot disregard that she had been given a medication that she likened to Xanax, most likely the lorazepam. The undersigned hesitates to rely upon N.M.’s disjointed testimony where it conflicts with the straightforward and credible testimony of Dr. Edathodu.3/ Based on the foregoing findings of fact, it is found that the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient N.M. Patient R.C. Patient R.C. is a female born in 1988. At the time of the hearing, she worked as a claims specialist. She testified that a friend from her previous job at HealthPlan Services referred her to OMC for a consultation. She first went to OMC on or about June 6, 2016. R.C. testified that this initial consultation was with Respondent. She told Respondent that she wanted liposuction on her back and waist and wanted the fat transferred to her buttocks. They discussed the procedure and pricing. From that point until the day of the surgery, R.C. went to OMC only to drop off periodic payments for the surgery. Her only contact was with the person at the front desk. She testified that she did not see Respondent again until the day of her surgery. R.C.’s surgery was scheduled for August 5, 2016. R.C. testified that she was dropped off at OMC by her children’s father. She went in and met Respondent and a few workers in the front of the facility. When she went to the back to prepare for the procedure, she met a man wearing scrubs whom she had never seen before. Two other staff persons were present, but R.C. stated she only talked with the one staff person who spoke English. R.C. testified that Respondent and the man in scrubs marked her body for the surgery. She believed that Respondent was going to perform the surgery. R.C. stated that she was not familiar with Dr. Edathodu. R.C. stated that she filled out the consent forms on August 5, 2016. An assistant gave her medication, saying it would calm her down. R.C. was not told the name of the medication, but testified that she took a blue pill and half of a white pill. The medical records indicate she was given Ativan (a brand name for lorazepam) and Benadryl. R.C. testified that the medications made her drowsy. R.C. was assisted to the room where the surgery would be performed. R.C. testified that she was placed on her stomach, face down. Everyone in the room was wearing a surgical mask. In the room were Respondent, the man in the scrubs, and two assistants. R.C. stated that she was awake during the procedure, but was drowsy and did not recall much about it. She could hear Respondent’s voice and the noise of the liposuction machine. She could not see who actually performed the procedure. After it was over, one of the assistants phoned R.C.’s driver and helped R.C. get up and walk. Respondent handed her a bag containing pills that R.C. believed were antibiotics. She received post-operative instructions. R.C. testified that she returned to OMC for a follow- up visit about a month after the surgery and met with Respondent. Dr. Edathodu testified that she performed the surgical procedure, called “tumescent liposuction,” on R.C. on August 5, 2016. On August 2, 2016, R.C. signed a “liposuction & autologous fat transfer consent” form that specifically named Dr. Edathodu as the surgeon who would perform the surgery. Dr. Edathodu ordered, reviewed, and signed R.C.’s lab results. Dr. Edathodu met with R.C. prior to the procedure and completed a “pre-operative clearance” form to document R.C.’s fitness and willingness to go through the surgery. Both R.C. and Dr. Edathodu signed the pre-operative clearance form. Dr. Edathodu testified that she met with R.C. three or four times post-surgery. As in the case of N.M., all of the medical records support the version of events described by Dr. Edathodu.4/ Dr. Edathodu’s testimony, as supported by the medical records, is credited. R.C. frankly conceded that she did not remember much about the surgery and could not see who performed it. Dr. Edathodu clearly and credibly recalled performing the procedure. The greater weight of evidence supports the finding that Dr. Edathodu performed the surgery, assisted by Respondent and Mr. Barcelo. The evidence could not sustain a finding that Respondent performed a surgical procedure on R.C. R.C. was a more credible witness than N.M., and her testimony on some of the details regarding her consultations and pre-operative events was persuasive. However, it must be kept in mind that the only relevant factual question is whether Respondent performed an “invasive/surgical medical procedure” on R.C. The evidence on this question is not persuasive. Based on the foregoing findings of fact, it is found that the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient R.C. Patient K.H. Patient K.H. is a female born in 1989. She learned of OMC from a friend at work. She first came into OMC for a consultation regarding a liposuction and fat transfer on November 29, 2016. K.H. testified that she met only with Respondent at this initial consultation. On November 29, 2016, K.H. signed an “information certification” form accepting Dr. Mark Kantzler as the physician who would be in charge of her liposuction procedure. K.H. came back to OMC on January 9, 2017, to make a $500 deposit and to schedule the surgery. The procedure was scheduled for February 11, 2017. Again, K.H. testified that she met alone with Respondent, who told her that she would need to come in a couple of days before the surgery to get medication and a list of things she would need for post-operative care. K.H. testified that she believed that Respondent was a physician and that she would be performing the liposuction procedure. The “liposuction and autologous fat transfer consent” form that K.H. signed on February 9, 2017, authorized Dr. Kantzler to perform the liposuction and fat transfer procedure. The “surgery certification” form that K.H. signed on February 9, 2017, indicated that Dr. Kantzler reviewed the entire medical file with her before performing the procedure. On February 11, 2017, K.H. was driven to OMC by her mother. Shortly after arriving, K.H. noted the presence of a tall man with white hair and blue eyes. An OMC assistant escorted K.H. to a room with a bed and a chair. Respondent came in to the room and marked K.H. for surgery. Respondent then called in the tall man with white hair and blue eyes, who looked at the surgical markings and then asked K.H. some questions about her stretch marks. During her direct examination, K.H. testified that she was not given the man’s name. During cross-examination, K.H. was forced to concede that during an August 2017 interview, she told Department investigators that she had been introduced to the tall man with white hair and blue eyes and that his name was Dr. Mark Kantzler. K.H. testified that Respondent gave her a pill to take before surgery. She was taken to the surgical suite and was placed on the table. K.H. testified that the surgical drape prevented her from seeing the surgical area. The only people she had noted in the room were Respondent and “Claudia,” a woman K.H. recognized as a massage therapist at OMC. She could not be certain whether or not Dr. Kantzler was in the room. K.H. testified that she was awake during the surgery. She stated that she was in pain during the surgery and complained, in Spanish, to Respondent. K.H. stated that Respondent told her she had “a little stubborn fat” and continued the procedure without doing anything to alleviate her pain. K.H. testified that all conversation during the procedure was in Spanish. She heard no English being spoken. K.H. confirmed that Dr. Kantzler was the physician who signed the letter requesting that she be excused from work immediately after her surgery. Dr. Kantzler testified that he had no specific recollection of K.H. or of her procedure. He stated that he worked on a contract basis with OMC for about three years. He came in about once a week to perform liposuction procedures, conforming to the protocols established by Dr. Edathodu. He saw the patients only briefly before their procedures, relying on Respondent to perform the patient consultations and Dr. Edathodu to prescribe the pre-operative tests in her role as medical director. He was paid by the procedure. Dr. Kantzler testified that he does not speak Spanish, but that his surgical assistants, Respondent and Mr. Barcelo, would often converse in Spanish during surgery. Dr. Kantzler reviewed the medical records and confirmed that he signed the documents and performed the surgery on K.H.: Q. Is there any doubt in your mind about whether or not you performed these procedures? A. Not when I’m looking at the files, no. Q. And if you had not done the procedures, would you have signed off on the documentation? A. I wouldn’t have had them to sign. No. Dr. Kantzler’s lack of a clear recollection distinguishes this procedure from those involving Dr. Edathodu. However, an offsetting distinguishing factor is that K.H. had a clear recollection of seeing and speaking with Dr. Kantzler at OMC on the morning of her surgery. She did not see him enter the surgical suite or hear him speak during the procedure, but she was unable to say that he was not in the room. The medical record is replete with indications that Dr. Kantzler performed the liposuction and fat transfer procedure on K.H. Dr. Kantzler testified that he voluntarily relinquished his Florida medical license in 2017 “for my own reasons not relevant to this [case].” The Department’s Proposed Recommended Order suggests that this relinquishment was “in response to or in anticipation of disciplinary proceedings.” There is no record evidence to support the Department’s suggestion, and it is disregarded here. Based on the foregoing findings of fact, the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient K.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order dismissing Count I of the Administrative Complaint against Respondent, Claudia Patricia Orozco-Fandino, E.O. DONE AND ENTERED this 18th day of April, 2019, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON 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 18th day of April, 2019.
Findings Of Fact I. Proposed findings of Medivision and DHRS Included in HO # 1. Accepted insofar as included in HO # 13. Included in HO # 2. Included in HO #6. Included in HO #5. Accepted insofar as included in HO #11. Included in HO 8 and 9. Included in HO 3 and 10 and 12, 13, and 14. Rejected insofar as inconsistent with HO #16. Accepted insofar as included in HO #2. Accepted. Not deemed relevant to results reached. Accepted insofar as included in HO #18. Included in HO #2. Accepted. Not deemed relevant to results reached.- Included in HO #2. Rejected as inconsistent with HO #14 and 15. Rejected as inconsistent with HO #15,16, and 17. Rejected as inconsistent with HO #15,16, and 17. Accepted. Not relevant to results reached. Accepted only insofar as included in HO #19. Included in HO #13, 14. Included in HO #18. Accepted. Not relevant to results reached. Rejected insofar as inconsistent with HO #l3. Included in HO #21. Included in HO #15. Included in HO #15, 16, 19, and 20. PROPOSED FINDINGS WFRMC Included in preliminary portion of RO. Accepted insofar as included in HO 42. Rejected as irrelevant. Rejected as irrelevant. Rejected as irrelevant. Included in preliminary portion of RO. Included in HO #6. Included in HO #6. Accepted insofar as not in conflict with HO #8. Rejected as irrelevant. Rejected as stating a negative. Accepted insofar as in agreement with HO #8. Accepted. Included in HO #20. Included in HO #21. Included in HO $17. Accepted. Included in HO #8. Accepted. Accepted insofar as included in HO #13. Included in Ho #21. Included in HO #16. Included in HO #16. Included in HO #16. APPENDIX JOINT PROPOSED FINDINGS OF BAPTIST HOSPITAL AND SACRED HEART HOSPITAL Accepted. Relevant portions are included in HO #1. Included in HO #4. Included in HO #3. Included in HO #3. Included in HO #3. Included in HO #6. Included in HO #8. Included in HO #7. Included in HO #8. Included in HO #10. Included in HO #10. Accepted insofar as included in HO #15. Accepted insofar as included in HO #12 and 16. Accepted insofar as included in HO #16. Rejected as conclusion of law Included in HO #18. Included in HO #18. Included in HO # 2. Rejected as not relevant. Included in HO #2. Included in HO #18. Accepted insofar as included in HO #8,9, and 15. Accepted insofar as included in HO #17. Included in HO #18. Accepted insofar as included in HO #16. Accepted. Not included because irrelevant and immaterial. Figures rejected as speculative. Accepted insofar as included in HO #17. Accepted insofar as included in HO #17. Rejected as inconsistent with HO #18. Rejected as conclusion of law. Rejected. Non-rule policy not applicable to specialty ambulatory surgery centers. ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES MEDIVISION OF ESCAMBIA COUNTY, INC., Petitioner, vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, CASE NO. 85-2443 Respondent, and WEST FLORIDA REGIONAL MEDICAL CENTER, SACRED HEART HOSPITAL OF PENSACOLA and BAPTIST HOSPITAL, INC. /
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of February, 2000.
Findings Of Fact MCH was constructed circa 1973 as an acute care hospital and before 1980 had 126 medical-surgical beds authorized including eight intensive care beds. MCH is a for-profit hospital owned by Hospital Corporation of America. It is financially able to fund the proposed addition. In 1980 it received a certificate of need (CON) to add 64 medical-surgical beds for a total bed capacity of 190 medical-surgical beds. These beds came on line in January 1982. MCH here proposes to add a 54-bed unit for oncology patients; to add six operating rooms to use primarily for eye, ear, nose and throat surgical procedures on an outpatient basis; and a new eight-bed surgical intensive care unit located on the first floor adjacent to the existing surgery department. Currently, the hospital has two oncologists on staff who use a 16-bed unit dedicated to the treatment of cancer. Space exists for the additional operating room so the net result is an application for an additional 62 beds. The application also included expansion of general stores and maintenance and the addition of a parking structure, which were granted, leaving only the issue of need for the 62 additional beds requested at a cost of $7 million. When constructed MCH had an eight-bed ICU primarily for coronary care patients located on the second floor of the hospital in the opposite wing from the surgery department on the first floor. It has added a four-bed ICU on the fourth floor by converting two semiprivate medical-surgical rooms. The ratio of ICU beds to total beds in 1973 was 8:126 which is nearly identical to the current ratio of 12:190. The evidence was unrebutted that the ICU at MCH is usually full, that on occasion patients have to wait in the emergency room until a less ill patient can be moved from a bed in ICU, and that the more ICU beds are available the more they will be used. This use was attributed to the doctors desiring their patients to be in an ICU and to testimony that current surgical procedures are more sophisticated than formerly and a greater need exists today for a surgery patient to go to an ICU than existed 15 years ago. In its application for a CON (Exhibit 18) MCH's estimated charge for a medical-surgical bed is $100-150 per day and its estimated charge for ICU beds and SICU beds is $350 per day. The primary service area for MCH is Marion County. Petitioner submitted evidence that nearly 20 percent of the cancer patients diagnosed in Marion County in 1981 came from the surrounding counties of Citrus, Lake, Sumter, and Levy. Accordingly, MCH contends that its primary service area for oncology patients should include these counties. Evidence was also submitted that MCH has been certified by medical associations as an approved cancer treatment hospital; that oncology service is a service generally provided in regional hospitals which provide Level III medical treatment; and, therefore, MCH should be considered on a different scale than Level II services. No evidence was presented that any health systems plan ever considered MCH as a regional cancer hospital or established any bed need for cancer patients at MCH. The evidence was also unrebutted that cancer patients at MCH are primarily treated by chemotherapy; that the drugs used in the treatment are extremely toxic, some have a short life span after being mixed and must be used almost immediately; that having a mini-pharmacy in the cancer ward is highly desirable; that special training of nurses is required to safely administer these drugs to patients; that patients develop nausea, ulcers in the mouth and throat, and present special feeding problems, and because of these special feeding problems it is advantageous to have some facilities in the cancer ward to prepare food at odd hours for patients; that cancer is a "personal" disease, patients desire more privacy, and should have private rooms; that an area away from the patient's room where the patient can visit with his or her family and the family can consult with the doctor in some privacy is desirable; that some newer drugs require hospitalization of the patient for treatment with these drugs, but the hospital stay is shorter and the drugs may be used over longer periods of time; and that the patient needs the security that comes from developing a feeling of trust by the patient of the nurses and doctors who are administering to his needs. MCH has no radiation treatment facilities in the hospital. However, the hospital staff has access to a Linear Accelerator which is located in a private physician's office on MCH's campus. Several witnesses testified to the need for additional beds for cancer patients at MCH; that patients have had to wait several days for a vacant bed; some oncology patients have had to be placed in other wards at MCH; and that special treatment and special training for nurses are required for oncology patients. Marion Regional Medical Center (MRMC) is a nonprofit hospital owned by the Marion County Hospital District, a public body established by statutes with taxing powers in Marion County. MRMC is currently expanding its facilities by 80 beds to the authorized 314-bed hospital pursuant to a CON approved in 1981. The $23 million for that project was financed by revenue bonds issued by Marion County Hospital District. Preliminary bids indicate the original project will be under the estimated cost resulting in a $2-3 million savings. If the additional beds here requested are approved and the construction associated therewith can be accomplished concurrently with the present construction, a saving of nearly $1 million can be obtained. MRMC is the only full service hospital in Marion County and provides medical, surgical, obstetrical, pediatric, psychiatric, intensive care, coronary care, and neurological/neurosurgical services. It has the third most active Emergency Room in the state and receives approximately 45 percent of its admissions through this service. MRMC's proposed project calls for the construction of a sixth floor on the hospital, construction of 66 inpatient beds, and the conversion of a 20-bed pediatric unit for use as a labor and delivery suite, a net gain of 46 beds. As initially proposed, this would provide for eight additional pediatric beds, four pediatric intensive care beds, and 34 medical-surgical beds to be used as a pulmonary medicine unit. Before the hearing the request for additional pediatric beds was withdrawn, leaving a request for 34 additional hospital beds and four pediatric intensive care beds, a total of 38 medical-surgical beds, at a cost of $2.8 million. It was stipulated that both MCH and MRMC provide an acceptable quality of care and operate efficiently. The application satisfied the criteria in Section 381.494(6)(c) with the possible exception of need, and need is the only issue in dispute in these proceedings. Both applicants submitted evidence that they accept all patients regardless of their ability to pay; however, MCH is a private for-profit hospital whose bad debt and charity care amounts to two percent of its gross revenues. MRMC's patient load is four percent indigent and bad debts, and charity care amounts to 12 percent of its gross revenues. Exhibit 18 shows MCH patient utilization to be 61 percent Medicare and one percent Medicaid, and MRMC patient utilization to be 51 percent Medicare and five percent Medicaid, in 1981. There is currently "applicable district plan" or "annual implementation" as provided for in Section 381.494(6)(c)1, Florida Statutes (1982). The implementation of this statute has been stayed by rule challenges. The North Central Florida Health Planning Council, Inc. (NCFHPC), was the Health Systems Agency (HSA) for what was formerly known as Health Service Region II which included only Marion County as a district sub-area. Prior to the July 1, 1982, amendment of Florida's CON law, the HSA reviewed applications and made recommendations with written findings of fact to DHRS. The 1982 CON law eliminated HSA, accordingly the NCFHPC no longer exists. The former HSA recommended approval of the applications of both MCH and MRMC; however, the staff of the HSA recommended disapproval of both applications. For the determination of need in these proceedings, a planning horizon of five years is acceptable and was used by all parties. Thus, the need for the requested CON is assessed for the year 1988. At this time the population of Marion County is forecast to be 165,880. The percentage of persons 65 and older in Marion County is increasing in proportion to the remainder of Marion County's population, and this increase will continue through 1988. This "aging" of the population is occurring throughout the United States as people live longer and demographics change with differing birth rates at differing periods. No evidence was submitted that the percentage of people over 65 is greater in Marion County than in other parts of Florida. MCH has 190 authorized medical-surgical beds and MRMC has 244 authorized medical-surgical beds, for a total of 434 such beds authorized in Marion County in two hospitals across the street from each other in Ocala, Florida. With the 1982 amendment to the CON statute the HSA in Marion County ceased to exist and has been replaced by a local health council. Rule challenges have stayed the promulgation of a comprehensive state health plan and the only Health Systems Plan in being for Marion County is the revised 1983 Health Systems Plan (HSP). This plan was approved by the HSA for Marion County in June of 1982 and contains goals, objectives and standards for planning for the health services required in Marion County. Standard 1-1 provides the need for medical-surgical beds within each Level II planning area (Marion County) should be based on the actual 1980 medical-surgical bed need per 1,000 population in this area. Standard 2-1 provides no additional beds should be added to a community's total bed supply until the occupancy rate of medical- surgical beds in the community exceeds 85 percent if more than 200 such beds are available in the community. The generally accepted standard for occupancy rate above which more beds may be needed is 80 percent. However, where beds are concentrated in one area, which is the case in Marion County where 434 medical- surgical beds are authorized, 85 percent occupancy leaves a reasonable surplus of beds to cover most emergencies or unusual situations that would cause the bed availability to be exceeded. The need for medical-surgical beds per 1,000 population (use rate) in Marion County in 1980 was 2.41. The HSP has a goal of 3.5 beds per 1,000 population and an objective of 4.0 beds per 1,000 population by 1987 in Region II. Applying the 1980 use rate to the 1988 forecast population of Marion County results in a need for 400 medical-surgical beds. The Health Systems Plan update for Marion County defines medical- surgical beds as all hospital beds which are not reserved solely for the use of pediatric, obstetrics, or psychiatric patients. At the time the revised Health Systems Plan for Marion County was promulgated, the two hospitals, MRMC and MCH, had been authorized an additional 80 and 65 beds, respectively, and these beds were being placed in service. By prescribing a use rate for 1980 as the standard to be used in considering applications for additional medical-surgical beds in 1983 and for a year or two thereafter, it would be reasonable to conclude the HSA expected the use rate for the years 1981 and 1982 to be influenced by the addition of the recently authorized 144 beds and to not accurately reflect a reliable use rate for planning purposes. MRMC and MCH presented expert witnesses who, by using different modalities, containing different assumptions, arrived at a need for additional beds in Marion County in 1988 ranging from 97 to 200. Most of these modalities used an occupancy rate of 3.5 beds per 1,000 population and 80 percent utilization of beds. All assume increasing usage of medical-surgical beds by the increasing and aging population. In their application MRMC and MCH planned to finance these projects with rate increases of 11 percent per year (to keep even with inflation) and a continuing increase in the number of patients handled at these higher rates. While inflation may again be up to 11 percent or higher, it is generally accepted today that the current inflation rate is five percent or less. More than 50 percent of both MRMC and MCH patients are presently covered by Medicare, which pays 80 percent of the charges generated by these patients. To assume that this situation will not only continue in the face of current federal deficits, but grow to cover the increased use of these facilities predicted in the assumptions used to show increased bed need for 1988, is not necessarily a valid assumption. Evidence was presented that the number of doctors in Marion County has doubled in the last five years. The ratio of doctors to the population of Marion County for 1977-78 and 1982-83 was not presented nor was the percent increase in the number of doctors in the United States over the past five years. Without some basis for comparison, the fact that the number of doctors in a particular community doubled over a five-year period has no relevancy.
Findings Of Fact At all times relevant hereto Respondent was licensed as a physician in the State of Florida having been issued license number ME0040318. Respondent completed a residency in internal medicine and later was a nephrology fellow at Mayo Clinic. He was recruited to Florida in 1952 by Humana. In 1984 he became associated with a Health Maintenance Organization (HMO) in an administrative position but took over treating patients when the owner became ill. This HMO was affiliated with IMC who assimilated it when the HMO had financial difficulties. At all times relevant hereto Respondent was a salaried employee of IMC and served as Assistant Medical DIRECTOR in charge of the South Pasadena Clinic. On October 17, 1985, Alexander Stroganow, an 84 year old Russian immigrant and former cossack, who spoke and understood only what English he wanted to, suffered a fall and was taken to the emergency Room at a nearby hospital. He was examined and released without being admitted for inpatient treatment. Later that evening his landlady thought Stroganow needed medical attention and again called the Emergency Medical Service. When the ambulance with EMS personnel arrived they examined Stroganow, and concluded Stroganow was no worse than earlier when he was transported to the emergency Room, and refused to again take Stroganow to the emergency Room. The landlady then called the HRS hotline to report abuse of the elderly. The following morning, October 18, 1985, an HRS case worker was dispatched to check on Stroganow. Upon arrival, she was admitted by the landlady and found an 84 year old man who was incontinent, incoherent, and apparently paralyzed from the waist down, with whom she could not engage in conversation to determine his condition. She called for a Cares Unit team to come and evaluate Stroganow. An HRS Cares Unit is a two person team consisting of a social worker and nurse whose primary function is to screen clients for admission to nursing homes and adult congregate living facilities (ACLF). The nurse on the team carries no medical equipment such as stethoscope, blood pressure cuff, or thermometer, but makes her evaluation on visual examination. Upon arrival of the Cares Unit, and, after examining Stroganow, both members of the team agreed he needed to be placed where he could be attended. A review of his personal effects produced by his landlady revealed his income to be above that for which he could qualify for medicaid placement in a nursing home; that he was a member of IMC's Gold-Plus HMO; his social security card; and several medications, some of which had been prescribed by Dr. Dayton, Respondent, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement because Stroganow was not ambulatory, but felt he needed to be placed in a hospital or nursing home and not left alone with the weekend approaching. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, who was in charge of the South Pasadena Clinic, and, they thought, was Stroganow's doctor. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic as well as by EMS personnel. There were always two, and occasionally three, doctors on duty at South Pasadena Clinic between 8:00 and 5:00 daily and, unless the patient requested a specific doctor he was treated by the first available doctor. Stroganow had not specifically requested to be treated by Respondent. When the Cares unit met with Respondent they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the previous evening but did not advise Respondent that the EMS squad had refused to return Stroganow to the emergency Room when they were recalled for Stroganow the same evening. Respondent telephoned the Metropolitan General Emergency Room and had the emergency Room medical report on Stroganow read to him. With the information provided by the Cares unit and the hospital report, Respondent concluded that Stroganow needed emergency medical treatment and the quickest way to obtain such treatment would be to call the EMS and have Stroganow taken to an emergency Room for evaluation. When the Cares unit arrived, Respondent was treating patients at the clinic. A clinic, or doctors office, is not a desirable or practical place to have an incontinent, incoherent, and non-ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to perform certain procedures that may be required for emergency evaluation of an ill patient. At a hospital emergency Room such equipment is available. EMS squads usually arrive within minutes of a call being placed to 911 for emergency medical treatment and it was necessary that someone be with Stroganow when the EMS squad arrived. Accordingly, Respondent suggested that the Cares team return to Stroganow and call 911 to transport Stroganow to an emergency Room for an evaluation. Upon leaving the South Pasadena clinic the Cares team returned to Stroganow. Enroute they stopped to call a supervisor at HRS to report that the HMO had not solved their problem with Stroganow. The supervisor then called the Administrator at IMC Tampa Office to tell them that one of their Gold-Plus HMO patients had an emergency situation which was not being property handled. Respondent left the South Pasadena Clinic around noon and went to IMC's Tampa Office where he was available for the balance of the afternoon. There he spoke with Dr. Sanchez, the INC Regional Medical Director, but Stroganow was not deemed to be a continuing problem. By 2:00 p.m. when no ambulance had arrived the Cares Unit called 911 for EMS to take Stroganow to an emergency Room. Upon arrival shortly thereafter the EMS squad again refused to transport Stroganow. The Cares team communicated this to their supervisor who contacted IMC Regional Office to so advise. At this time Dr. Sanchez authorized the transportation of Stroganow to Lake Seminole Hospital for admission. Although neither Respondent nor Sanchez had privileges at Lake Seminole Hospital, IMC had contracted with Lake Seminole Hospital to have IMC patients admitted by a staff doctor at Lake Seminole Hospital. Subsequent to his meeting with the Cares team Respondent received no further information regarding Stroganow until well after Stroganow was admitted to Lake Seminole Hospital. No entry was made on Stroganow's medical record at IMC of the meeting between Respondent and the Cares Unit. Respondent was a salaried employee whose compensation was not affected by whether or not he admitted an IMC Gold-Plus patient to a hospital.
The Issue The issue in this case is whether the challenged portions of Rule 64B8-9.009, Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact In 1994, Respondent, Florida Board of Medicine promulgated Rule 61F6-27.16, Florida Administrative Code. The Rule was later renumbered twice before being referenced as 64B8- 9.009, Florida Administrative Code. In 1998, the Florida Legislature provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings, including, but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manuals in order to establish grounds for disciplining doctors." Section 458.331(1)(v), Florida Statutes. On March 13, 1998, Respondent published in the Florida Administrative Weekly (FAW) a Notice of Proposed Rule-making concerning the Rule, followed by the first meeting of Respondent's Surgical Care Committee with respect to potential amendments to the Rule. After additional meetings, all of which were properly noticed in the FAW, the Surgical Care Committee presented its recommended amendments to the Rule to the full Board of Medicine from December 4-6, 1998. The full Board did not accept the Surgical Care Committee's recommendation completely, but rather voted to alter the proposed amendments. These latter amendments were approved by the Board at its January 6, 1999, conference call. On April 11, 1999 and June 3, 1999, the Board held additional public hearings, leading the Board to publish two Notices of Change, the second of which was published on June 18, 1999. Among the amendments contained in Rule 64B8-9.009 as proposed on June 18, 1999, was a deletion of Section (4)(b) which required those physicians not having staff privileges to perform the same procedure as that being performed in the office to have a "transfer agreement" with a licensed hospital within reasonable proximity. The Board considered replacing this mandate with a "transfer protocol." The June 18, 1999, version also considered a change to Section (6)(b)1., thereby permitting certain physicians to perform Level III surgery without hospital staff privileges and eliminating the mandated presence of a physician anesthesiologist. On July 8, 1999, the Florida Society of Anesthesiologists (FSA) and the Florida Hospital Association, et al. (FHA) filed separate rule challenges seeking to invalidate the proposed Rule (DOAH Case Nos. 99-2974RP and 99-2975RP, respectively). On August 7, 1999, the Board of Medicine held an additional public hearing, where further amendments were made to the Rule, none of which materially affected the above sections. A third Notice of Change was published on August 20, 1999, reflecting these amendments approved on August 7, 1999, by the Board. During the Fall of 1999, the incoming Chairman of the Board of Medicine, Dr. George El-Bahri, held several private settlement negotiations with the parties to the various rule challenges. Nevertheless, as of the Board's December 4, 1999, meeting, no settlement had been reached in either challenge, and the Board voted unanimously to proceed with the rule challenge litigation and make no further changes to the proposed amendments. This course of action was confirmed by the Board during its January 2000 conference call. Following the Board's January conference call, the parties to the pending litigation agreed to "submit to the Department of State for codification" those sections of the proposed amendments which were not at issue in the litigation. As a result, the Board, FSA, and FSPS entered into a joint stipulation on January 26, 2000. The FHA filed a Partial Voluntary Dismissal on January 28, 2000, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(g)1. and 2.; and (6)(b)1a. and 6., which are not at issue in this case. On January 28, 2000, the Board properly filed with the Department of State, portions of the proposed amendments which were no longer subject to the pending litigation, with the rule in its current form becoming effective on February 17, 2000. Because any proposed amendments relating to transfer protocols and Level III staff privileges were withdrawn and no longer being considered, they were not filed for adoption on January 28, 2000. Those existing sections remained unchanged in the rule and were renumbered by the Department of State. Petitioners challenge each of the approved amendments to Rule 64B8-9.009 which became effective on February 17, 2000, alleging that the provisions of the existing rule are an invalid exercise of delegated Legislative authority under Section 120.52(8), Florida Statutes. Specifically, Petitioners challenge the following Subsections of Rule 64B8-9.009. Subsection (1)(a) which provides that the rule covers "any elective procedures for aesthetic, reconstructive, or cosmetic purposes;" Subsection (2) which Petitioners allege imposes costly record-keeping requirements; c. Subsections (2)(d), (3), (4), (5), and (6) which Petitioners allege limit the types and durations of aesthetic reconstructive and cosmetic procedures which may be performed in Petitioners' office surgical suites; Subsections (4)(e) and (6)(e) which Petitioners allege impose costly equipment requirements; Subsections (4)(f), (5)(b)2., and (6)(f) which Petitioners allege impose costly personnel requirements; Subsections (3), (4), (5), and (6) which Petitioners allege establish levels of surgery unrelated to any rational classification scheme. Petitioners further challenge Subsection (3)(b) and (4)(b) of Rule 64B8-9.009 relating to transfer agreements and staff privileges as they existed prior to February 17, 2000, which contain the exact same language in Subsections (4)(b) and (6)(b) of the current version of the Rule. PARTIES Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Petitioner Smith practices cosmetic surgery, plastic surgery, and oral-maxillofacial surgery in his office. Petitioner Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery, a degree in medicine from the University of Florida College of Medicine, residency at the University of Florida with an internship in general surgery, and served as a faculty member at the University of Florida College of Dentistry in the Department of Oral and Maxillofacial Surgery at Shands Hospital Jacksonville. After specialty training in cosmetic surgery, Petitioner Smith opened his private practice in 1991. Petitioner Smith performs various surgical procedures in his office, including hair transplantation, cosmetic eyelid surgery, functional eyelid surgery, cosmetic and functional nasal surgery, face, neck, and forehead lifts, tumor reconstruction, liposuction, abdominoplasties, breast implants, and breast reductions. Petitioner Smith is also President of the Florida Academy of Cosmetic Surgery, Inc. (Academy). Petitioner Academy is an organization of multispecialty physicians who perform both cosmetic and functional surgery in their offices. Functional surgery means surgery being performed as part of a disease process or correcting some deformity and is generally not done for purely cosmetic reasons. Petitioner Charles E. Graper, D.D.S., M.D., FACS, is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Petitioner Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Petitioner Graper is Board- certified by the American Board of Oral and Maxillofacial Surgery, Board-certified in general cosmetic surgery, Board- eligible in general plastic surgery, and is a Fellow of the American College of Surgeons (FACS). Petitioner Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Petitioner Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. The Board The Board regulates the practice of medicine in Florida, and is the agency that adopted the Rule at issue. It is comprised of 15 members appointed by Florida's Governor and confirmed by the Florida Senate. The FSPS and the FSD The FSPS and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. The FSA The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues particular to anesthesiology. The Hospitals The Florida Hospital Association, Inc. (FHA) and the Association of Community Hospitals and Health Systems (ACHHS) are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members. Rule Adoption Procedures In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for adoption. Liz Cloud is the bureau chief for the Department of State's Bureau of Administrative Code (BAC). Ms. Cloud serves as the filing officer for rules and regulations filed by agencies, all laws passed by the legislature and any advertisements for publication in the Florida Administrative Weekly. She oversees the publishing of the Florida Administrative Weekly and the Florida Administrative Code and has served in that position since 1977. The BAC has rule-making requirements which agencies must follow in order to file a rule for adoption. When the BAC receives a rule that is filed for adoption, specific documents must be included, or the agency is required to resubmit a corrected rule packet. The BAC verifies that the certification from the Joint Administration Procedures Commission has been received and that all the required time frames have been met. BAC checks to ensure the rule is filed within the 90-day limit in Section 120.54(3)(e), Florida Statutes, and determines if there is a challenge to the rule. The BAC receives a weekly computer printout from JAPC on which Cloud's staff relies to determine if there are outstanding rule challenges to a rule being filed for adoption. The BAC's role in the rule-making process is not merely ministerial. If, for example, an agency files a rule on which the 90-day time limit has run, the BAC rejects the rule and does not file it for adoption. Nancy Murphy is a research associate at the Office of the Attorney General. With regard to rules and rule promulgation, Ms. Murphy drafts the documents necessary for rule- making, including notices of rule development, notices of rule- making, supporting documents that have to be supplied to JAPC and any documents that have to be prepared for adoption of rule. Prior to filing a rule for adoption, Ms. Murphy verifies that the time frames are correct and she has all the documents that are required for adoption, including the certificate, the additional statement, and the correct copy of the rule text and coded copy, which is the underlined and struck- through version of the rule. Ms. Murphy also determines whether the rule is subject to challenge before it is filed, and if JAPC has received a written response to all correspondence. Ms. Murphy was responsible for filing the amendments to Rule 64B8-0.009 for adoption. In determining which portions of the rule could be filed and which remained under challenge, she reviewed the Joint Stipulation and the Hospitals' Notice of Partial Voluntary Dismissal in DOAH Case Nos. 99-2974 and 99- 2975. Ms. Murphy redrafted and renumbered the proposed amendments to Rule 64B8-9.009 to be filed for adoption, excluding the sections that were still under challenge, after consultation from Ms. Cloud's office. Ms. Murphy also met with Vicky Macintosh at the BAC to review the Rule section-by-section before filing. Ms. Murphy provided a copy of the Joint Stipulation and Notice of Partial Voluntary Dismissal to establish the provisions of the Rule still under challenge. Murphy also consulted with JAPC prior to filing the amendments to Rule 64B8-9.009 for adoption. The BAC's standard operating procedure with regard to a rule challenge that challenges only a portion of a proposed rule is to accept for filing the unchallenged portions of the rule. This procedure has been strictly followed in the past, and approved by the BAC's counsel. Pursuant to that policy, the BAC permitted the Board to file for adoption those portions of Rule 64B8-9.009 not subject to challenge on January 28, 2000. The BAC received a certification from JAPC that permitted the filing of Rule 64B8-9.009 pursuant to Section 120.54(3), Florida Statutes. Based upon the evidence presented, it is concluded that, although the Board had considered amendments to Sections (3)(b) and (4)(b) involving transfer agreements and Level III staff privilege requirements, they were withdrawn and no longer subject to the pending litigation in DOAH Case Nos 99-2974 and 99-2975 after the Board agreed to make no change. Petitioners have not met their burden of proving that the Board materially failed to follow the rule-making procedures and requirements of Chapter 120, Florida Statutes. Record-Keeping Requirements: Subsection (2) Petitioners presented no evidence with regard to the record-keeping requirements or the cost of the record-keeping requirements imposed by Rule 64B8-9.009(2). Accordingly, Petitioners have not met their burden of proof in challenging this subsection of the rule. Limitation on Types and Duration of Procedures: Subsections (2)(d), (3), (4), (5), and (6) Subsection (2)(d) of Rule 64B8-9.009 states: In any liposuction procedure, the surgeon is responsible for determining the appropriate amount of supernatant fat to be removed from a particular patient. A maximum of 4000 cc supernatant fat may be removed by liposuction in the office setting. A maximum of 50 mg/kg of Lidocaine can be injected in the office setting. Petitioners claim that a limitation of 4000 cc on liposuction is arbitrary and unreasonable since a physician cannot accurately estimate the amount of fat to be taken out. Notwithstanding, Petitioners' witnesses acknowledged that the risk of a liposuction procedure is heightened as the volume of fat removed and the level of anesthesia increase. Petitioners' Exhibit 8, a journal article entitled "Does the Location of the Surgery of the Specialty of the Physician Affect Malpractice Claims in Liposuction?" supports this view. It states: "Large-volume liposuction (over 4000 cc) is inherently risky, but it also involves more aggressive anesthesia, adding to its danger. Risk management for liposuction should stress smaller liposuction procedures using local anesthesia, with minimal sedation." Petitioners' Exhibit 8 also includes the "2000 Guidelines for Liposuction Surgery" of the American Academy of Cosmetic Surgery. Those guidelines recommend volumes of up to 4000 cc of supernatant fat removal in the routine liposuction process. The Board received extensive testimony and information regarding the limitation of removal of tissue in office-based surgery as part of its rule-making process. In setting the volume limit for liposuction, the Board considered the amount of material removed, the Lidocane dosage required, and fluid replaced. The Board considered testimony supporting no limit on liposuction volume, and testimony supporting limitations on volumes as low as 2000 cc. The Board determined that the consensus among experts around the country is that 4000 cc is the appropriate ceiling to ensure the safety of patients undergoing liposuction procedures in the office environment. This conclusion is reasonable and amply supported by the rule-making record. Petitioners presented no evidence at hearing regarding other limitations on types or duration of procedures relating to Subsections (3), (4), (5), or (6) of Rule 64B8-9.009. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions. Equipment Requirements: Subsections (4)(e) and (6)(e) Petitioners presented no evidence at hearing regarding the equipment requirements of subsection (4)(e) of Rule 64B8- 9.009, or the cost thereof. Accordingly, they have not met their burden of proof with respect to these provisions. With regard to Subsection (6)(e) of Rule 64B8-9.009, the only evidence presented by Petitioners at hearing related to the requirement that at least 36 ampules of Dantrolene be available on-site at a physician's office where Level III Office Surgery is being performed. Petitioners claim that the requirement in subsection (6)(e) for 36 ampules of Dantrolene is unreasonable. The cost of 36 ampules of Dantrolene can be as much as $2,000.00 and the shelf-life of Dantrolene is approximately one to two years. The evidence presented at hearing indicated that the manufacturer of Dantrolene will replace it for free if the shelf- life expires, and therefore, shelf-life of Dantrolene is not an economic consideration. The manufacturer of Dantrolene advises that 36 ampules of Dantrolene are necessary to ensure that a patient suffering from malignant hypothermia can be saved. The more persuasive evidence supports the Board's decision to impose a requirement consistent with this recommendation. Personnel Requirements: Subsections (4)(f), (5)(b)2., and (6)(f) Petitioners presented insufficient evidence regarding the cost of additional personnel required by Subsections (4)(f), (5)(b)2, or (6)(f) of the existing Rule. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions. Petitioners did, however, present some general testimony with regard to Subsection (4)(f) of Rule 64B8-9.009. The evidence was insufficient, however, to prove that Subsection (4)(f) is invalid. That Subsection states: Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in Rule 64B8-30.012(b)(6), Florida Administrative Code, or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed in Advance Cardiac Life Support or, in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia. Petitioners have not presented any persuasive evidence that this requirement is vague, arbitrary, or unreasonable. Evidence was presented that during meetings of the FACS, Dr. Anthony Rogers has held courses in conscious sedation to train non-anesthesiologist physicians to be providers of anesthesia for Level II Office Surgery. Dr. Rogers testified that he does not instruct surgeons on administering anesthesia to patients upon which the surgeons are performing surgery. Rather, he trains the surgeons to serve as anesthesia providers for other surgeons as well as providing them with a better understanding of "what's happening on the other side of the table." The training given by Dr. Rogers consists of approximately six to eight hours of staged administration of anesthesia and discussion of hypothetical scenarios. The training does not involve the actual administration of anesthesia by the physicians-in-training. Physicians attending Dr. Rogers' training course are not required to be certified in Advance Cardiac Life Support. No examination is administered as part of Dr. Rogers' training course, and no certification is issued for completion. Even assuming that some FACS members have completed Dr. Rogers' course, the requirement in Subsection (4)(f) for assistance by a qualified anesthesia provider has not been shown to be unreasonable. Levels of Surgery: Subsections (4), (5), and (6) Petitioners contend that the definitions of the various levels of surgeries provided in the Rule are impermissibly vague. Subsection (4) of Rule 64B8-9.009 defines Level I Office Surgery to include: Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in Level I Office Surgery. Subsection (5) of Rule 64B8-9.009 defines Level II Office Surgery as follows: Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post- operative monitoring necessary. Such procedures shall include, but not be limited to, hemmorroidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000 cc supernatant fat. Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflect withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Subsection (6) of Rule 64B8-9.009 defines Level III office surgery as follows: Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II office surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or Major Conduction anesthesia. The definitions of the three levels of office surgery are based on definitions developed by the American Society of Anesthesiologists and have been adopted in substantially similar form in other states. The American Society of Anesthesiologists is recognized as a group of specialists in anesthesia. Petitioners acknowledged the expertise of the American Society of Anesthesiologists in developing definitions of levels of office surgery. Petitioners argued that the classifications of levels of surgery in the Rule are irrational and vague because it is virtually impossible to differentiate between the various levels of surgery as defined in the Rule. However, the more persuasive evidence establishes that classifications were reasonably based on accepted medical standards. In discussing the potential for a particular patient to drift between what has been defined as Level II anesthesia and Level III, Petitioners' witness, Dr. Rogers testified that medicine itself is vague in this area because there is no machine to tell you if a patient is unconscious. He suggested that anesthesia is a continuum and there is no clear way to define levels of surgery. Dr. Carl Lentz, Board-certified plastic surgeon, supported the Rule's classification scheme. In his opinion, the differences between Levels II and III are clearly understood. When preparing for surgery, a surgeon develops an anesthesia plan. The procedures are distinctly different for each level. If, during surgery, a patient temporarily crosses the line of consciousness, which is apparent if the patient is appropriately monitored, actions to reverse the level can be taken quickly. According to Lentz, if a surgeon does not determine, prior to surgery, the level of anesthesia to be provided, the surgeon should not be performing the surgery. Petitioners complain that the terms "appropriate," "adequate," and "unpleasant" are vague. Although the Petition identifies no other specific terms that are vague, during the hearing, Dr. Graper suggested that numerous other terms contained in Rule 64B8-9.009 are vague, including, "preoperative," "medication," "minimal," "tranquilization,," "anesthesia," "local," "drug-induced," "consciousness," "sedation," "intravenously," "intra-operative," "monitoring," "necessary," "procedures," "hernia repair"," "reduction of simple fractures," "large joint dislocation," "colonoscopy," "tolerate," "cardiorespiratory function," and "ability to respond purposefully." His testimony related to vagueness was unpersuasive and not supported by the evidence. After reviewing the rule and considering the evidence, it is concluded that the Rule requirements are not unacceptably vague. The terms "adequate," "appropriate" and "purposeful" have standard meanings in the field of medicine. Likewise, the remaining medical terms in the rule are not unacceptably vague. Transfer Agreements and Staff Privileges: Subsections (4)(b) and (6)(b) Petitioners contend that the transfer agreement and staff privilege requirements found in the rule are vague, fail to establish adequate standards for agency decisions, vest unbridled discretion in the agency, enlarge modify and contravene the law, are arbitrary and capricious and not supported by competent substantial evidence. According to Subsection 455.517(4)(a), Florida Statutes, neither the Department of Health, nor the Board of Medicine may take any action: . . . that tends to create or maintain an economic condition that unreasonably restricts competition, except as provided by law. However, Subsection 458.331(1)(v), Florida Statutes, provides that the Board of Medicine may establish rule standards of practice for office surgery settings, including transfer agreements, in order for the Board to determine whether a licensed doctor, subject to discipline, has practiced beyond the scope of the law or beyond his competency level. Subsection (4)(b) of Rule 64B8-9.009, relating to Level II Office Surgery, states: Transfer Agreement Required. The physician must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. Subsection (6)(b) of Rule 64B8-9.009, relating to Level III Office Surgery, states; Hospital Staff Privileges Required. The physician must have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. There is no transfer agreement or hospital privileges requirement for Level I Office Surgery. Historically, surgeries were typically performed in hospitals, and a large body of regulation has developed to ensure patient safety. As many types of surgeries moved into ambulatory surgical centers, a new body of regulation was developed to ensure health and safety in that setting. Over the past few years, surgeons have increasingly been performing many types of surgeries in office settings with varying degrees of regulation. Among the regulations ensuring safety in hospitals are requirements for an organized medical staff, and staff-developed rules to set criteria for appointment to the staff and delineation of staff privileges. These rules promote quality of care by providing a review of the qualifications of staff physicians. Decisions regarding medical staff privileges are a function of the medical staff of a hospital with support and final approval by the Board of Trustees. Often, national standards and demonstrated competence provide a guide in making medical staff privilege decisions. The medical staff credentialing process is a well-established, but at times, subjective mechanism for evaluating the qualifications of a physician. A transfer agreement is a contract between a hospital and an office surgeon, providing for the transfer and acceptance of a patient in an emergency situation. There is no law or regulation which requires a hospital to enter into a transfer agreement with any physician. In addition, there is neither specific nor consistent criteria for the contents of a transfer agreement. Some agreements are very detailed contracts and others are general. During the rule-making process, the Board received testimony regarding surgeons performing Level II as well as Level III Office Surgeries and the requirement of staff privileges and transfer agreements. The Board's stated purpose for the Rule requiring a physician to enter into a transfer agreement is to ensure that steps are taken in advance to care for a patient who experiences a complication during surgery which exceeds the level of care that can be provided in a given facility. However, there is no reliable evidence that transfer agreements improve the quality of patient care. In the rare event an emergency occurs in the office surgery setting, the emergency 911 is called and the patient is delivered to the hospital. The absence of a transfer agreement between the hospital and office surgeon does not delay or impede the patient's admission to the hospital and access to appropriate medical care. Under Florida law, a hospital is required to accept and care for a patient who requires emergency medical attention. At the hearing, Petitioners provided significant testimony demonstrating they have been unable to obtain staff privileges and transfer agreements from certain hospitals. The determination of whether to grant staff privileges and/or a transfer agreement is solely the hospital's decision. And the evidence demonstrated that the determination doesn't always depend on the qualifications and reputation of the physician and the resources and circumstances of the hospital. It is undisputed that hospital privileges and transfer agreements may be denied (or revoked) for reasons other than physician competence. The standards for obtaining privileges vary from hospital to hospital. In fact, during the rule-making proceeding, the Board initially approved a change in Level III office surgery to remove the requirement that the surgeon have staff privileges, and recognized that: Hospital staff privileges may be denied for reasons other than competency, and that other documented training is comparable demonstration of competency. Factors other than physician competence enter into the decision of whether hospital privileges or transfer agreements may be approved. For example, turf battles at hospitals and personality conflicts among physicians at hospitals have been considered. Moreover, some physicians have refused to proctor other physicians as a part of the credentialling process. In fact, in some hospitals, competing physicians vote upon the approval or denial of the application of an office surgeon's request for hospital privileges. The evidence further showed that a physician's staff privileges can be approved by the medical staff but denied by the board of the competing hospital. Physician competence to perform Level II office surgery procedures is determined by Subsection (4)(d) of the Rule, "Training Required." Under this provision, in order to perform Level II surgery, the surgeon must either have staff privileges for the same procedure, or must be able to document satisfactory completion of training, or must document comparable background training or experience. Nevertheless, a competent office physician who possesses the "training required" to perform an office surgery procedure is precluded unless the physician has received either a transfer agreement or hospital privileges for that procedure. The inability of a qualified office surgeon to secure a transfer agreement or hospital privileges will have a drastic impact on the physician's ability to perform office surgery. The physician's office surgery will be limited to Level I office surgery. The Rule's requirements for either a transfer agreement or hospital privileges for Level II surgeries and hospital privileges for Level III surgeries unreasonably enable a competing hospital to unilaterally refuse a transfer agreement and privileges to a qualified office surgeon for reasons unrelated to physician competence. It has the direct effect of terminating a physician's Level II and Level III office surgery practice, without regard to the fact that the physician otherwise meets the "training required" elements of the Rule. It is inconsistent, provides no objective, non-competitive based criteria evaluation and tends to create and maintain an economic condition that unreasonably restricts competition which is inconsistent with and contravenes Section 455.507, Florida Statutes. Barbara Dame (Dame), who is a risk management consultant provided further support. She testified that over the last two years, many of her very qualified physician clients have had applications for transfer agreements summarily denied. Ms. Dame does not get involved in obtaining hospital staff privileges for her clients. Conversely, Bill Bell, General Counsel for the FHA, testified that the Rule requirement for physicians performing office-based surgery to have transfer agreements has existed for a few years and he is not aware of any problems physicians have had obtaining such agreements. The evidence to the contrary is more compelling. Transfer agreements can be a tool for some hospitals to control competition for surgery sites. Office surgery sites compete with hospitals for patients. Dr. Brent Amey is the Vice President of St. Joseph's Baptist Health Care, and has been an emergency room physician since 1974. He is aware of instances involving "economic credentialing", and the denial of transfer agreements and staff privileges unrelated to competence, although not at hospitals with which he has been associated.
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
