The Issue The issue in this case is whether the challenged portions of the proposed amendments set forth in the Fourth Notice of Change for Rule 64B8-9.009, Florida Administrative Code (FAC), published in the Florida Administrative Weekly on February 18, 2000, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Background Rule 64B8-9.009, Florida Administrative Code, is the Board's Rule governing the standards of care for office surgery. The Rule was first adopted on February 1, 1994 as a Rule 61F6- 27.009, Florida Administrative Code. It was transferred to Rule 59R-0.009, Florida Administrative Code, and was amended on May 17, 1994; September 8, 1994; and November 15, 1994, and then was finally transferred to Rule 64B8-9.009, Florida Administrative Code. In February of 1998, the Board directed its Surgical Care Committee to evaluate Rule 64B8-9.009 and to make recommendations for any modifications or amendments to the Rule. The 1998 Florida Legislature also addressed the issue of office- based surgery and provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings . . . " including office-surgery environments. As discussed below, hearings were conducted by the Board and its Surgical Care Committee to consider changes to the office surgery rule. The Parties R. Gregory Smith, M.D., Charles Graper, D.D.S., M.D. and Florida Academy of Cosmetic Surgery Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Smith practices cosmetic surgery, plastic surgery, and oralmaxillofacial surgery in his office. Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery and a degree in medicine. Approximately 30 percent of FACS members use general anesthesia (Level III) in their office surgery procedures. At least one representative of FACS has attended each public rulemaking hearing relating to proposed Rule 64B8-9.009, Florida Administrative Code. FACS actively participated in the rulemaking process, expressing concerns relating to transfer agreements, hospital privileges, and the requirement for an anesthesiologist in Level III surgery. FACS' purposes include addressing adverse outcomes in the field of cosmetic surgery and implementing recommended approaches to improve patient safety. Petitioner Charles E. Graper, D.D.S., M.D., is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. 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. 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. 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. Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. Graper has experience in performing Level III office surgery using general anesthesia. The Board of Medicine The Board of Medicine (Board) regulates the practice of medicine in Florida, and is the agency that adopted the rule at issue. The Florida Society of Plastic Surgeons, Inc., Florida Chapter, American College of Surgeons and Florida Society of Dermatologists The FSPS, FCACS, and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. As licensed physicians (M.D.s), members of FSPS, FCACS, and FDS are subject to the regulations promulgated by the Board of Medicine. A substantial number of physician members of the FSPS, the FCACS, and the FSD perform office surgery and are affected by the proposed amendments to Rule 64B8-9.009, Florida Administrative Code. FSPS is a Florida not-for-profit corporation whose 270 members are board-certified plastic surgeons (of the approximately 375 such physicians statewide) licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSPS was created and exists for the purposes of promoting plastic surgery as a science and profession. FSPS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members, and has participated throughout the rulemaking process with respect to Florida Administrative Code Rule 64B8-9.009. FCACS is a Florida not-for-profit corporation whose 1400 members are surgeons licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FCACS was created and exists for the purposes of promoting surgery as a science and profession. FCACS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including Petitioner Graper, routinely perform office surgery. FSD is a Florida not-for-profit corporation whose 462 members are board-certified dermatologists licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSD was created and exists for the purposes of promoting surgery as a science and profession. FSD regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including David Allyn, M.D., and Diane Calderone, M.D., routinely perform office surgery. The Florida Society of Anesthesiologists, Inc., Florida Hospital Association, Inc. and Association of Community Hospitals and Health systems 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 related to anesthesiology. The FHA and the 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. The Florida Nurses Association (FNA) The Florida Nurses Association is a professional association of approximately 7,500 nurses licensed in the state of Florida, including approximately 1,700 advanced registered nurse practitioner (ARNP) members and a substantial number of CRNAs. Among its many purposes, the FNA represents the legal, legislative, and professional practice interests of the members. The Florida Association of Nurse Anesthetists Petitioner, Florida Association of Nurse Anesthetists (FANA), is a non-profit corporation and professional organization made up of more than 1,600 certified registered nurse anesthetists practicing throughout Florida, many of whom currently provide anesthesia for surgery performed in physicians' offices. As a part of its mission, FANA advocates its members' interests in legal, legislative, and professional practice issues. Rule Challenges by FSA and the Hospitals On July 8, 1999, the FSA filed a Petition for Administrative Determination of Invalidity of Proposed Rule challenging portions of the proposed amendments to Rule 64B- 8.9009 as set forth in the Second Notice of Change. The FSA's Rule challenge was assigned DOAH Case No. 99-2974RP. Also on July 8, 1999, the Hospitals filed a petition for Administrative Determination of the Invalidity of Proposed Rules challenging portions of the proposed amendments to Rule 64B8-9.009 as set forth in the Second Notice of Change. The Hospitals' Rule challenge was assigned DOAH Case No. 99-2975RP. The Board conducted a third public hearing on the proposed Rule amendments on August 7, 1999. The Board published a Third Notice of Change to the proposed Rule amendments in the August 20, 1999, issue of the Florida Administrative Weekly. None of the changes in the Third Notice of Change related to provisions that were in litigation. On January 12, 2000, the Board, the FSA, and the FSPS filed a Joint Stipulation on provisions of Rule 64B8-9.009, Florida Administrative Code (Joint Stipulation) in DOAH Case No. 99-2974RP. The Joint Stipulation released from FSA's Rule challenge, Case No. 99-2974RP, the majority of the proposed amendments to Rule 64B8-9.009 and reserved only the proposed amendments to Subsections (1)(e) and (6)(b)1.a. of Rule 64B8- 9.009 for challenge. On January 26, 2000, the Hospitals filed a Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(b)1. and 2. and (6)(b)1.a. and b. 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)1., (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. The Board subsequently conducted an additional public meeting and published a fourth notice of change relating to the proposed amendments to Rule 64B8-9.009 still subject to challenge by the FSA and the Hospitals. These changes included the withdrawal of the proposed amendments to Subsection (4)(b)1. which would have changed "transfer agreement" to "transfer protocol." During this public meeting, the Board was informed that those parts of the Rule no longer being challenged had been filed with the Department of State. On January 28, 2000, the Board filed all of its proposed amendments to Rule 64B8-0.009, with the exception of the amendments to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)1. and 2., and (6)(b)1.a-b, for adoption with the Florida Secretary of State. The proposed amendments filed for adoption on January 28, 2000, became effective February 17, 2000. The Board voted to modify some of the proposed amendments to Rule 64B8-9.009 still subject to challenge at its public meeting on February 5, 2000. The FSA filed a Notice of Voluntary Dismissal of its Rule challenge in DOAH Case No. 99-2974RP on February 7, 2000. DOAH case No. 99-2974RP was closed on February 8, 2000. The Hospitals filed a Notice of Voluntary Dismissal of their Rule challenge in DOAH Case No. 99-2975RP on March 9, 2000, and the case was closed on March 10, 2000. The Fourth Notice of Change was published in the February 18, 2000, issue of the Florida Administrative Weekly noticing the changes to proposed amendments to Rule 64B8-9.009 voted on by the Board at its February 5, 2000, meeting. On February 25, 2000, the FACS, Graper, and Smith filed a Petition for an Administrative Determination of the Invalidity of a Proposed Rule challenging the Board's proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. This petition was assigned DOAH Case No. 00-0951RP. On March 8, 2000, the FACS, Graper, and Smith filed an Amended Petition for an Administrative Determination of the Invalidity of a Proposed Rule in DOAH Case No. 00-0951RP challenging the Board's proposed withdrawal of the proposed changes to Subsection (4)(b)1. of Rule 64B8-9.009 and the proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. The Board held a public hearing on April 8, 2000, in Orlando, Florida, and received testimony concerning the Fourth Notice of Change. At the conclusion of the hearing, the Board voted to adjourn without making any changes in the Fourth Notice of Change. On April 17, 2000, the FANA filed its petition challenging the Board's Fourth Notice of Change. The FANA's petition was assigned DOAH Case No. 00-1622RP. DOAH Case Nos. 00-0951RP and 00-1622RP were consolidated by Order of the Administrative Law Judge issued May 4, 2000. The Fourth Notice of Change states that "[t]he proposed changes to Subsection (4)(b)1., shall be withdrawn." With respect to Subsection (6)(b)1.a. of Rule 64B8- 9.009, the Fourth Notice of Change states: Proposed Subsection (6)(b)1.a. shall be changed to read, (b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia. Petitioners have challenged the Fourth Notice of Change on the following grounds: (1) the requirement that an anesthesiologist be present for all Level III surgeries in physicians' offices will increase the cost and limit surgical procedures and practice opportunities of Petitioners resulting in a substantial adverse financial impact on Petitioners and patients; (2) the Fourth Notice of Change exceeds the Board of Medicine's rulemaking authority by attempting to regulate nurse anesthetists; (3) the Fourth Notice of Change conflicts with existing statutes governing the practice of nurse anesthetists; (4) the rule is arbitrary and capricious and is not supported by competent evidence and is inconsistent with the law and policies of the federal government and of 49 states; (5) the Fourth Notice of Change is not supported by competent substantial evidence and would not have any measurable effect on patient safety; (6) the Rule was improperly adopted; and (7) that the Fourth Notice of Change conflicted with the existing requirement to provide a choice of anesthesia providers. Each of these arguments is addressed below. Final Order in DOAH Case No. 00-1058RX The Final Order in DOAH Case No. 00-1058RX invalidated certain existing Rule requirements related to transfer agreements and hospital staff privileges as a precondition for certain office surgeries. Specifically, that Final Order invalidated Subsection (4)(b) of Rule 64B8-9.009, which required a transfer agreement for any physician performing Level II office surgery who did not have staff privileges to perform the same procedure at a licensed hospital. In addition, the Final Order invalidated Subsection (6)(b) of Rule 64B8-9.009 which required a physician performing Level III office surgery to have hospital staff privileges for the procedure performed in an out-patient setting. As grounds for invalidating the staff privileges requirement, the Administrative Law Judge determined that the Board lacked specific statutory authority to mandate hospital privileges, thereby exceeding its grant of rulemaking authority. The Final Order further determined that the requirement for hospital privileges was arbitrary, deferred credentialing to individual hospitals, and was not supported by competent substantial evidence. During the prior hearing, the parties did not present specific argument related to, nor did the Final Order consider the proposed changes to the staff privileges requirement set forth in the Fourth Notice of Change due to the separate Rule challenge proceedings. The Proposed Rule Regarding Competency Demonstration Notwithstanding, Subsection 4 of the Fourth Notice of Change proposes to change Subsection (6)(b)1.a. of Rule 64B8- 9.009 to include alternatives to hospital staff privileges as a manner of demonstrating sufficient education, training and competency to perform Level III surgery in an office setting. The proposed change provides that a surgeon who seeks to provide Level III surgery in an office setting can demonstrate training as follows: The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other Board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training, and experience. (emphasis added) The proposed Rule at issue in this proceeding continues to provide for the same mechanism of hospital privileges, previously invalidated. The provision remains invalid for the reasons articulated in the previous Final Order. However, the proposed Rule also provides office surgeons with two alternative methods for objectively demonstrating sufficient training and competency through certification by a recognized medical specialty board or through direct demonstration to the Board of Medicine. That provision of the proposed Rule, provides significant flexibility and meaningful options to physicians seeking to perform office surgery. The Board demonstrated that the options are an appropriate approach for the Board to utilize in exercising its delegated regulatory authority and responsibility to adopt education and training standards for the office setting. The Petitioners adequately challenged the provisions and the Board proved the validity of the proposed alternatives by a preponderance of the evidence. Increased Costs Petitioners contend that the anesthesiologist requirement in the Fourth Notice of Change violates Section 120.52(8)(g), Florida Statutes, by imposing regulatory costs on the regulated person which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives. Petitioners offered credible evidence indicating that the hourly rates charged by anesthesiologists range from 50 to 100 percent higher than the hourly rates charged by CRNAs for similar procedures. Respondent and Intervenor, FSA, on the other hand, demonstrated that hourly rates varied from market to market within Florida and in a few cases, rates for anesthesiologists were approximately the same as for CRNAs. The evidence is clear, however, that the charges for an anesthesiologist are significantly higher than those for CRNAs for similar procedures. Anesthesiologists possess broader expertise, education, and training. As a result, requiring an anesthesiologist for Level III office surgeries will increase the total cost of a typical in-office plastic or cosmetic surgery procedure between five and ten percent. Furthermore, the evidence demonstrated that although some surgeons periodically use anesthesiologists during Level III office surgery for a variety of reasons, including availability, complexity of procedure, current health of patient and contractual agreements, most surgeons utilize CRNAs due to the considerable cost savings. Petitioners also claimed that the Rule would create a monopoly in the provision of in-office anesthesia for anesthesiologists and would force hundreds of CRNAs out of office practice. The Fourth Notice of Change applies to Level III surgeries, so it is reasonable to conclude that the need for CRNAs to participate in the performance of Level III surgeries under the supervision of an anesthesiologist will be obviated. Their assistance is unnecessary and cost prohibitive. And although nurse anesthetists would still be permitted to provide Level II anesthesia in the office setting under the supervision of the operating surgeon, the proposed Rule imposes a significant increase in the cost of Level III surgeries and severely decreases competition. Rulemaking Authority and Conflicting Law Petitioners mistakenly contend that the proposed anesthesiologists requirement exceeds the scope of the Board of Medicine's rulemaking authority and conflicts with existing law. The authority for the Fourth Notice of Change is contained in part in Section 458.33(1)(v), Florida Statutes, which states in pertinent part: 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 manual in order to establish grounds for disciplining doctors. Specifically, Petitioners allege that the Fourth Notice of Change constitutes an impermissible attempt by the Board of Medicine to regulate nurse anesthetists and conflicts with Chapter 464, Florida Statutes, which permits nurse anesthetists to practice under the supervision of any physician, osteopath, or dentist. The parties have stipulated that Florida-certified registered nurse anesthetists are licensed only by the Florida Board of Nursing and are subject to discipline only by the Florida Board of Nursing. In mandating that office surgeons use an anesthesiologist during in-office Level III surgery, the proposed Rule does not directly regulate any nurse or certified registered nurse anesthetist and does not subject the CRNA to any discipline by the Board of Medicine or by the Board of Nursing. Thus, the Rule on its face does not conflict with the delegated legislative authority to the Board of Medicine for rulemaking in Section 458.331(1)(v). Federal Law, Scientific Evidence, Arbitrary and Capricious, Competent Substantial Evidence Petitioners contend that the Fourth Notice of Change requiring an anesthesiologist be present during Level III surgery is inconsistent with the laws and policies of the federal government and 49 states, contrary to the overwhelming weight of scientific evidence, arbitrary and capricious, and not supported by competent substantial evidence. There is no evidence that the Fourth Notice of Change is inconsistent with the laws and policies of the federal government. There is no federal law or rule which prohibits any state from establishing its own rules governing the rights of various practitioners to administer or supervise the administration of anesthesia in any particular setting. Federal government regulations defer to state law on this subject unless a state establishes a lower standard of care. While it is insignificant whether any other state currently requires an anesthesiologist to be present for the administration or supervision of general anesthesia in an office setting, some states have considered such requirements, including Pennsylvania and New Jersey. With respect to the scientific evidence presented by the parties, it is clear that there is a lack of competent and substantial evidence to demonstrate an increased level of safety for general anesthesia patients who undergo surgery under the care of an anesthesiologist as opposed to a CRNA. CRNAs are advanced registered nurse practitioners. In addition to their nursing training, CRNAs must have at least one year of experience in a critical care setting (such as working in a hospital intensive care unit) prior to beginning their two- to-three year master's level anesthesia training. Nurse anesthetists typically are trained side by side with physician anesthesia residents, use the same textbooks, and are taught by the same instructors. Unlike physician anesthesiologists who receive a general medical-surgical license that may not require any level of training or expertise in the administration of anesthesia, CRNAs must pass a national certifying examination in anesthesia as a condition of state licensure. In addition, CRNAs must complete 40 hours of continuing anesthesia education every two years, and must be recertified every two years to retain their state license. The evidence suggests that the safety of office surgery is comparable to that of hospitals and ambulatory surgery centers. Moreover, under the existing Rule, the office surgeon and patient determine the most appropriate anesthesia provider and setting based on the individual patient's needs. The direct testimony and scientific evidence indicate no significant difference in patient outcomes based on whether anesthesia is administered by an anesthesiologist or CRNA. Hence, Florida law and the existing standard of care in Florida permits a surgeon to supervise a CRNA in the office setting. Nearly forty percent of the 1600 CRNA members of FANA provide anesthesia in physicians' offices. Furthermore, the evidence indicates that anesthesiologist supervision of CRNAs in hospitals is extremely inconsistent. "Supervision" as defined by various hospitals requires the anesthesiologists to be within five to thirty minutes of the hospital. Anesthesiologists are often absent for extended periods and typically "supervise" several operating rooms simultaneously. In fact, Federal Medicare regulations permit an anesthesiologist to receive payment for the "medical direction" of as many as four CRNAs at the same time. Moreover, several smaller and often rural hospitals and ambulatory surgical centers in Florida do not have anesthesiologists on staff. CRNAs provide the anesthesia services in those venues. Dr. David Mackey, an anesthesiologist, testified that he had reviewed information on 28 deaths related to office surgery which occurred between 1987 and 1999. Dr. Mackey concluded that there have been nine deaths resulting from office surgery in the past 12 years in which anesthesia was a cause of death. However, Dr. Mackey was able to confirm that a CRNA provided the anesthesia in only two of the nine cases. Office surgeons and related professional societies agree that an office-based surgeon may safely supervise a CRNA. Currently, there are three national accrediting organizations that may accredit office surgery facilities: Joint Commission on Accreditation for Ambulatory Healthcare Organizations; American Association for Accreditation of Ambulatory Surgery Facilities; and Accreditation Association for Ambulatory Health Care. Rule 64B8-9.0091, Florida Administrative Code. None of these accrediting organizations requires that CRNAs be supervised by an anesthesiologist. No other state currently requires anesthesiologist supervision of CRNAs in an office setting. In fact, Florida's Joint Committee of the Boards of Nursing and Medicine identify specific medical acts that may be performed by ARNPs, and the level of physician supervision required for such acts. Section 464.003(a)(c), Florida Statutes. The Joint Committee does not require anesthesiologist supervision of CRNAs in any setting. The U.S. Armed Forces do not require anesthesiologist supervision of CRNAs in any practice setting. And the American Society of Anesthesiologists' has published its own "Recommended Scope of Practice for Nurse Anesthetists" which provides for CRNAs to administer anesthesia under the supervision of the operating surgeon. Studies of Anesthesia Outcomes and Medical Error Michael B. Pine, M.D., a Board-certified cardiologist, former chief of cardiology at Cincinnati Medical school, and a former professor of medicine at Harvard Medical School and two other medical schools, testified as an expert in healthcare quality assessment and improvement. Dr. Pine has served as a healthcare quality assessment and improvement consultant to the JCAHO, the Health Care Financing Administration (HCFA), the American Medical Association (AMA), the American Osteopathic Association, the Hospital Research and Educational Trust of the American Hospital Association, the American Association of Oral and Maxillofacial Surgeons, the American Association of Nurse Anesthetists, Blue Cross/Blue Shield, and Anthem, among others. Dr. Pine characterized his career transition from clinician to consultant as moving from "dealing with diseased individuals to dealing with diseased organizations to help them assess their problems in delivering health care and help them improve and get better." Dr. Pine assisted in the development of clinical indicators for JCAHO, including indicators in anesthesia care. He has worked with the federal Health Care Financing Administration (HCFA) to measure hospital mortality and adjust for patient severity as an indicator of hospital quality. Dr. Pine's consulting experience includes evaluating outcome data for individual practitioners, groups of providers, and whole systems. Dr. Pine testified that the classic study in anesthesia mortality was a 1950's study by Beecher and Todd of 600,000 anesthetic administrations which were followed by about 8,000 deaths, 325 of which were ultimately determined to be anesthetic related. The study reflects an anesthesia mortality rate of about 1:2,500. In the Beecher and Todd study, nurse anesthetists performed twice as many cases as anesthesiologists, but the number of deaths involving nurse anesthetists was virtually the same as the number of deaths involving anesthesiologists. Beecher and Todd initially hypothesized that the greater mortality rate for anesthesiologists could be explained by the severity of illness of the patients seen by anesthesiologists rather than nurse anesthetists, but after correcting for the difference in severity of illness, they discovered the nurse anesthetists had actually treated patients who were slightly more sick. Beecher and Todd were unable to explain why physician anesthesiologists, who anesthetized only half as many patients as nurse anesthetists, were involved in an equal number of deaths. Dr. Pine testified that a later study, the Bechtoldt, measured outcomes associated with two million anesthetics in North Carolina between 1969 and 1976. The mortality rate was approximately 1:24,000; a mortality rate ten times better than the rate reflected in the Beecher and Todd study 20 years earlier. The Bechtoldt study compared the outcomes of anesthesiologists working alone, nurse anesthetists working alone, and CRNAs and anesthesiologists working together, the surgeon or dentist administering anesthesia him/herself, and deaths in which no provider could be identified. Bechtoldt concluded that: When we calculated the incidence of anesthetic related deaths for each group which administered the anesthetic, we found that the incidence among the three major groups - the CRNA, the anesthesiologist, and the combination of both - to be rather similar. Although the CRNA working alone accounted for about half the anesthesia- related deaths, the CRNA working alone also accounted for about half the anesthetics administered. A 1980 study by Forrest of 17 hospitals and about 10,0000 patents was one of the first studies to make a formal adjustment for the sickness severity of the patients. Using conservative statistical methods, Forrest concluded that "there were no significant differences in outcomes" between the hospitals that predominately used anesthesiologists and the hospitals that predominately used nurse anesthetists. Anesthesia safety continued to improve as indicated by a British study in the early 1980's, that used a procedure similar to that used by Beecher and Todd in the 1950's. The British study looked at 485,000 surgeries in which anesthesia was provided. There were 4000 deaths, only 3 of which were determined to be anesthetic related, reflecting an anesthesia mortality rate of 1:185,000. The Institute of Medicine report entitled "To Err is Human," published in 1999, reflects an even better anesthesia mortality rate of 1:200,000 to 1:300,000 cases. The Institute of Medicine report states: The gains in anesthesia are very impressive and were accomplished through a variety of mechanisms including improved monitoring techniques, the development and widespread adoption of practice guidelines and other systemic approaches to improving errors . . . . the success of anesthesia, was accomplished through a combination of technological changes, new monitoring equipment, standardization of existing equipment, information-based strategies including the development and adoption of guidelines and standards, application of human factors to improve performance such as the use of simulators for training, formation of the Anesthesia Patient Safety Foundation to bring together stakeholders form different disciplines, physicians, nurses, manufacturers, to create a focus for action and having a leader who would serve as a champion for the cause. Dr. Pine also addressed the recent study regarding anesthesia by Silber published in June 2000. This study examined 7,665 deaths following 217,000 hospital procedures for which medical bills were submitted to HCFA for Medicare reimbursement. The study attempted to characterize the type of anesthesia provider based on whether an anesthesiologist submitted a bill for providing anesthesia or supervising the anesthesia. The study assumed that a CRNA administered the anesthesia if either the CRNA billed for it, or if no bill was located. Moreover, instead of reviewing deaths that occurred within 48 hours after the surgery, the study counted all deaths which occurred within 30 days following surgery, and ignored any non-anesthesia related complications and deaths which were included in the 7,665 death toll. Conversely, the 7,665 deaths in 217,000 procedures produce a mortality rate of 1:28, nearly 100 times greater than the mortality rate in the 1950 Beecher and Todd study, and nearly 10,000 times what the 1999 Institute of Medicine study reflected as the anesthetic mortality rate. The greatly inflated and inconsistent death rate is highly questionable and provides little scientific support for the Board's proposed rule. With respect to Petitioners' argument relating to arbitrary and capricious mandate, the proposed Rule would not permit office-based surgeons to provide a choice of anesthesia provider for Level III office surgeries, since only one anesthesia provider is necessary or justified for Level III office surgery, and the proposed rule mandates the participation of an anesthesiologist. It is unreasonable and not economically feasible for the surgeon or the patient to pay for an anesthesiologist and a CRNA for the same procedure. Based on the current Rule's "choice of anesthesia provider" requirement in subsection (2)(b) of the existing Rule, the proposed anesthesiologist mandate for Level III surgery is inconsistent, confusing and illogical to the reasonable person.
The Issue Whether Respondent violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and, if so, what discipline should be imposed.
Findings Of Fact The Department is charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2003). Dr. Dangl, whose address of record is 3900 Clark Road, Suite F-1, Sarasota, Florida 34233, was issued Florida license number ME 71286. On or before September 25, 2003, Dr. Dangl's office was approved to perform Level II Office surgical procedures by the Department. In a Level II Office surgery, "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." Fla. Admin. Code R. 648-9.009(4). Patient J.R., a 38-year-old female, presented to Dr. Dangl on September 25, 2003, for the removal of existing breast implants and the placement of larger saline implants. The surgery was scheduled to take place in Dr. Dangl's office. The surgical team consisted of Dr. Dangl; Amanda Fortner, R.N.; and Bruce Crow. Ms. Fortner assisted Dr. Dangl in administering anesthetic agents and other controlled substances, and monitored J.R. during the procedure. Her duties included documenting J.R.'s vital signs and the types and quantities of medications that were administered. A cardiac respiratory monitor, a pulse oximeter, and a blood pressure monitor were devices used to monitor J.R. during the surgery. A cardiac respiratory monitor records the heart rate, respirations, and the sinus rhythm of the heart. The oxygen saturation in the blood is measured by the pulse oximeter, which is placed on one of the patient's fingers. Blood pressure is monitored by the blood pressure machine. Bruce Crow was the surgical technician. During the surgical procedure, he made sure supplies and surgical instruments were ready, maintained the sterile field, and assisted Dr. Dangl with the procedure. At approximately 9:15 a.m. on September 25, 2003, Dr. Dangl started an IV in J.R.'s left hand and administered the following medications: one gram of Rocephin, 20 milligrams of Reglan, 50 milligrams of Demerol, ten milligrams of Valium, 25 milligrams of Ketamine and Versed. Dr. Dangl gave the initial medications, and Ms. Fortner administered additional drugs pursuant to Dr. Dangl's orders. J.R. was given an additional 200 milligrams of Demerol. The last dose of Demerol was administered by Ms. Fortner at 9:50 a.m. J.R. was a small person, and, for her weight and size, it took an unusual amount of Demerol to get J.R. sedated. Versed and Valium are sedative hypnotics, which sedate patients and cause them to become sleepy. Demerol is an analgesic, a pain medication. These medications can decrease respiration. Ketamine is a dissociate anesthetic, which does not cause respiratory depression. J.R. was also given a Propofol drip IV to help keep J.R. asleep. Propofol is a general anesthetic which depresses brain cells. The Propofol was mixed with a saline solution at a rate of one 55 cc vial per 100 cc's of saline. Ms. Fortner prepared the solution, which was initially administered by Dr. Dangl until he got it to the rate that he wanted. Once the surgery started, he would tell Ms. Fortner to speed-up or slow- down the drip as necessary. Three bottles of Propofol were used during the surgical procedure. J.R. was also given two liters of oxygen during the procedure. An oral airway was inserted into J.R.'s mouth during the early stages of the procedure. An oral airway is a long device that is inserted behind the tongue and goes deep into the patient's throat. In order to tolerate an oral airway, the patient would have to be in a deep level of sedation. J.R. was awake when the medications were started. She continued to talk through at least half of the time the medications were being administered. At one point during the surgery, J.R. "moaned a little bit, but then went right back to sleep." During the surgical procedure, Dr. Dangl sat J.R. up approximately three times to check the symmetry of the implants. J.R. continued to sleep through these checks. During the last time that J.R. was brought to a sitting position at approximately 11:55 a.m., the pulse oximeter alarmed. Thinking that the device may have fallen off J.R.'s finger, Ms. Fortner checked the device and also checked to make sure that the oximeter was not on the arm on which the blood pressure machine was placed. The pulse oximeter was on the correct finger. Ms. Fortner advised Dr. Dangl that something was wrong. She turned up the oxygen and placed an Ambu bag1 over the oral airway which had been placed in J.R.'s mouth at the beginning of the case. Ms. Fortner started Ambu bagging J.R. At Dr. Dangl's direction, Ms. Fortner turned off the Propofol drip. However, J.R.'s pulse oximeter reading did not improve. Not wanting to break the sterile field, Dr. Dangl yelled at Ms. Fortner, "Don't make me come back there and help your ass." When J.R. still did not improve, Dr. Dangl broke the sterile field, pushed Ms. Fortner aside, and began to Ambu bag J.R. Dr. Dangl checked J.R. for a pulse, but was unable to find one. Ms. Fortner checked for a pulse and thought that she may have found a faint pulse. Dr. Dangl, hearing the receptionist in the hallway, called to her to get Michelle Purdy, another employee of Dr. Dangl. The receptionist went to get Ms. Purdy and came back saying that Ms. Purdy was on the telephone. Dr. Dangl told the receptionist to get Ms. Purdy. Ms. Purdy, who is not a nurse, came into the operating area and tried to find a pulse for J.R. Unfortunately, Ms. Purdy tried to find a pulse using her thumbs. After being corrected by the surgical team, Ms. Purdy attempted to locate a pulse in the brachial, then the femoral, and then the pedal pulses, but she was unable to find a pulse. After being unable to locate a pulse, Dr. Dangl instructed one of his staff to call for emergency medical services (EMS). While Dr. Dangl and his employees were searching for a pulse, the surgical technician asked for leave to begin chest compressions. Mr. Crow told Dr. Dangl that the heart rate monitor was flat lining, meaning that it showed no basic heart rhythm for J.R. J.R.'s skin was gray and her fingers were turning blue. Dr. Dangl told Mr. Crow to wait. Dr. Dangl instructed Ms. Fortner to give J.R. three milligrams of Atropine two times. Ms. Fortner complied with his orders, but J.R. still had not started to breathe again. Mr. Crow continued to request Dr. Dangl to allow him to start chest compressions. After the administration of the Atropine failed to revive J.R., Dr. Dangl allowed Mr. Crow to begin chest compressions. From a minimum of two minutes to a maximum six minutes2 elapsed between the time Mr. Crow first asked to do chest compressions and when he began to do chest compressions. While chest compressions were being administered, Dr. Dangl ordered Ms. Fortner to administer Epinephrine to J.R. While Dr. Dangl continued to Ambu bag J.R., Mr. Crow administered three cycles of chest compressions. A cycle is 15 chest compressions to two Ambu breaths. J.R.'s heart rate returned and J.R. developed tachycardia, which means a high heart rate. About the time that J.R. revived and became stable, the paramedics arrived. J.R. was breathing, had a heart rate, and had a pulse oximeter reading of approximately 98. Neither the paramedics nor Dr. Dangl or any of his staff checked J.R.'s pupils. When the paramedics arrived, the surgery was not completed. The paramedics informed Dr. Dangl that another EMS team was on the way. Dr. Dangl and the paramedics agreed that Dr. Dangl could finish closing and suturing the wound, while waiting for the other EMS team to come and transport J.R. to the hospital. The paramedics stayed for a short time in the operating area monitoring J.R.'s vital signs and then left to make copies of J.R.'s chart, leaving Ms. Fortner to continue the monitoring of the vital signs. While Dr. Dangl was completing the procedure, J.R.'s vital signs were within normal range. Ms. Fortner periodically checked J.R.'s breathing by placing her hand over J.R.'s mouth. After Dr. Dangl completed suturing the wound, the second team of paramedics came into the operating area to transport J.R. The paramedics examined J.R.'s eyes, which were fixed and dilated. The paramedics immediately intubated J.R. and took her to the hospital. While at the hospital, Dr. Dangl admitted to J.R.'s fiancée that he had given J.R. "a lot of medication for her body size and weight," but that he thought J.R. was metabolizing the anesthetic very quickly. J.R. never regained consciousness after she was transported to the hospital. She died several months later from hypoxic encephalopathy, which means low oxygen brain damage. On September 26, 2003, Dr. Dangl dictated a report of operation. His documentation of J.R.'s "cardiorespiratory event" is as follows: Immediately prior to closure, the patient experienced a cardiorespiratory event that required CPR and resuscitative efforts. The EMS was activated and assumed care of the patient upon arrival. At this time the patient had responded to the resuscitative effort, vital signs were stable and permission was given by EMS to complete closure of the incisions prior to transport. The incisions were closed in a layered fashion with 3-0 PDS II and 5-0 nylon. A sterile dressing was placed over the incision sites. The patient was entubated [sic] by EMS prior to transport and left the O.R. via ambulance for Doctor's Hospital Emergency Room. Dr. Dangl signed a document entitled, "Operating Room Record." The record contained a section in which the medications that were administered should have been listed along with the time administered, the dosage, and the method of administration. That section of the record contained the following, "see anesthesia record," in lieu of listing the medications. The anesthesia record which was prepared by Ms. Fortner did not list all the medications that were administered to J.R. such as the Atropine and Epinephrine. She did not list the amount of Lidocaine or Propofol that was administered. It should have been obvious to Dr. Dangl when he reviewed the anesthesia report, that it was not correct. When Dr. Dangl prepared the Report of Operation and signed the Operating Room Record, he should have included the medications which he ordered and which were not included in the anesthesia report. Both Dr. Dangl and Ms. Fortner were certified in Advanced Cardiac Life Support at the time of the surgery. Ms. Fortner is not an anesthesiologist, a certified registered nurse anesthetist, or a physician assistant. Based on the testimony of Ms. Fortner that three 50 cc bottles of Propofol were used during the surgery, Dr. Joan Christie calculated that the dosage of Propofol that was administered was between 160 and 170 micrograms per kilo per minute. In a normal patient, who has received no other drugs, 100 micrograms per kilo per minute would be a lot of medication. J.R. received between 160 and 170 micrograms per kilo per minute on top of the other drugs that had been administered to her at the beginning of the procedure. The Propofol was administered in excessive amounts. Based on the evidence presented, it is clear that J.R. went from a Level II to a Level III office surgery during the surgical procedure. She tolerated an oral airway, which she could not do under a Level II or Level I. She was not responding purposefully to verbal commands or tactile stimulation. When J.R. was sat up to check the symmetry of her implants, she did not wake up or otherwise respond. Although she did moan at one time during the surgical procedure, that did not mean that she was either at Level I or Level II. Dr. Dangl has had no prior disciplinary actions taken against him by the Department.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and revoking his license to practice medicine. DONE AND ENTERED this 23rd day of February, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 23rd day of February, 2005.
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 The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, 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 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
The Issue This case arises out of Orlando Regional Medical Center's objection to the issuance of a Certificate of Need to Surgical Services of Orlando, Inc., for the construction and operation of an ambulatory surgical center in Orlando, Florida. At the formal hearing, Orlando Regional Medical Center called as witnesses, Herbert E. Straughn, Norton Baker, Terry Weibley, Marlene Mariani, Michael L. Schwartz, Janice Smith, Richard Douglas Signer, Cathy Canniff Gillam, Jack Bradley, Barbara W. Miner, John Bozard and Stephen Haar. The Intervenor, Surgical Services of Orlando, Inc., called as witnesses, Steven Haar, Janice Smith, John Bozard, Michael Means, Jerry Senne, James Leveretee, Stephen Foreman, John S. Lord, Robert C. Klettner, Albert S. Bustamante, Pedro Diaz- Borden, Alberto J. Herran, Marianna Johnson, Richard Toole, Don Newton, Hank Gerken, Gordon Kiester, Leonard J. Levine, Rufus Holloway, Brenda Brinkman, Betty Barker, Wayne Deschambeau, Mark Richardson and Rick Knapp. Department of Health and Rehabilitative Services called as its only witness, Mr. Thomas Porter. Surgical Services of Orlando, Inc., offered and had admitted into evidence 33 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, Orlando Regional Medical Center was given permission to file a late-filed exhibit with Surgical Services of Orlando, Inc., and the Department having the opportunity to object to said exhibit. That exhibit has been filed as Orlando Regional Medical Center Exhibit No. 9 and consists of excerpts from the Department of Health and Rehabilitative Services file relating to this application. That exhibit is admitted. The Department of Health and Rehabilitative Services offered and had admitted into evidence one exhibit. A map of Orlando reflecting the location of the various hospitals in Orange County was admitted as joint exhibit 1. Subsequent to the formal hearing, each of the parties submitted proposed findings of fact and conclusions of law for consideration by the Hearing Officer. To the extent that those proposed findings of fact and conclusions of law are inconsistent with this order, they were considered by the Hearing Officer and rejected as being unsupported by the evidence or as unnecessary to the resolution of this cause.
Findings Of Fact Surgical Services of Orlando, Inc., (hereafter referred to as SSO), is a Florida corporation based in Orlando, Florida. The stock of the corporation is owned in equal shares by Steven Foreman, Dr. Rufus Holloway and Randall Phillips. Mr. Steven Foreman is a life underwriter and financial consultant, and real estate investor in the Orlando area. He is secretary and director of SSO. Dr. Rufus Holloway is an otolaryngologist in the Orlando area and is treasurer and a director of SSO. Randall Phillips is a hospital administrator presently employed by American Medical International, Inc. Orlando Regional Medical Center, Inc. (hereinafter referred to as ORMC) is an existing hospital located in Orlando, Florida. It is a not-for-profit regional tertiary care center with 1035 beds and 24 operating rooms. ORMC has two main divisions, the Orange Division and the Holiday Division and is presently constructing a new facility, Sand Lake Division, which will open sometime in mid 1985. The Sand Lake Division will have 4 operating rooms and 150 beds. Dr. Rufus Holloway and Steven Foreman have committed their personal resources to provide financial support for the complete development and operation of the applicant's proposed ambulatory surgical center. The facility will be constructed by a partnership, the Kaley Avenue Medical Partnership of Dr. Holloway, Mr. Foreman and Richard Toole, a citrus owner in the Orlando area, and will be leased to SSO. Two banks in the Orlando area have given commitments to provide the necessary financing for the proposed facility and start-up expenses. Pan American Bank has committed to provide a $2.5 million loan for the construction and equipping of the building and $750,000 line of credit. Dr. Holloway and Mr. Foreman, and the parties of the Kaley Avenue Partnership have sufficient financial resources to fulfill their commitments to the proposed project. The proposed building will be a one floor building containing 15,000 square feet. The total cost for the project will be $2,737,636. The building is to be constructed and equipped by the Kaley Avenue Medical Partnership and leased to SSO at $16 per square foot. The proposed site of the facility is on Kaley Avenue within two or three blocks of ORMC. Its service area will include all of Orange County. The facility will contain five operating rooms with only three of the rooms being completely equipped initially. These rooms will be used for general and local anesthesia. The remaining two rooms will be equipped as demand requires. The applicant has budgeted $743,000 for initially equipping the facility with an additional $160,000 required to equip the two remaining operating rooms. The equipment proposed by the applicant is adequate to perform those procedures which the applicant proposed to perform at its facility. In addition to the five operating rooms, the center will include laboratory, x-ray, administrative areas, as well as holding and recovery areas for the patients. The applicant projects a total number of procedures in the first year of 1,800 and 2,760 in the second year of operation. Based upon a Medicare utilization rate of 15 percent SSO projects an operating loss in the first year of $223,000 with the facility making a profit in the second quarter of the second year and generating a total profit of $766,000 in the second year. The projected break-even point is 2,448 procedures within a year. Projected revenues are based upon an average charge per case of $575. SSO also intends to accept Medicaid patients. Presently, Medicaid does not reimburse freestanding ambulatory surgical centers. Medicaid charges would be included as charity cases in the projected bad debt of 6 percent of gross revenues. Based upon an inflation rate of 8 percent per annum when SSO begins operation in January, 1986, its average charge per case will be competitive with other facilities in the area providing ambulatory surgical services. Medicare now reimburses 100 percent of the facility charges in a freestanding ambulatory facility and 80 percent for outpatient surgery in a hospital setting. Prior to opening, SSO will implement a marketing program directed to four different target groups: physicians, consumers (patients), employers and insurance carriers. SSO has retained a marketing expert who has prior experience in marketing ambulatory surgical care in Florida. Similar marketing has proven successful for other freestanding ambulatory surgical centers in Florida. SSO has budgeted $20,000 for pre-opening marketing expenses and $35,000 for the first year of operation. It is difficult upon this record to make a truly accurate comparison of outpatient surgical rates in existing facilities to the proposed average charge of SSO. ORMC presented evidence that the present average charge in ORMC and three other hospitals per outpatient case is as follows: ORMC $417.19 Florida Hospital $469.86 Winter Park $512.21 Orlando General $560.81 No average charges were presented into evidence for West Orange Hospital, Lucerne Hospital, or Brookwood Hospital. The evidence established that 8 percent is a reasonable inflation or increase rate for health care charges over the next two years. Applying an 8 percent inflation rate to the above average charges these charges for 1986, SSO's first year of operation would be: ORMC $486.61 Florida Hospital 548.04 Winter Park 597.44 Orlando General 654.13 In calculating its present average charge of $417.19, ORMC did not include those outpatient surgeries performed at the Orange Division which are charged at inpatient rates. A memo dated January 19, 1984, to John Bozard, ORMC Vice President for Finance, from Steve Horr, ORMC Assistant Controller/Reimbursement, reflects that Holiday Division had 484 outpatient surgical cases which are estimated to generate gross revenues of $228,547. This results in an average charge per case for the month of December 1983 of $472.20. It is concluded that in 1986 the SSO projected average charge of $575 will be competitive with those existing facilities in the Orange County area. There is presently no rule which contains a specific methodology for determining need for ambulatory surgery centers. HRS uses a methodology which is based upon policy but has not been proposed or promulgated as a formal rule. The present methodology utilizes the total surgery cases for the most recent 12 month period to determine a surgical utilization rate per 1,000 population. By separating inpatient and outpatient surgeries for the same 12-month period, a percentage ratio of outpatient surgery cases to total surgeries is established. Applying the utilization rate to future projected population, HRS then determines the total projected surgeries for future years and from this number calculates the projected outpatient surgeries which will be performed in existing facilities. Literature relating to ambulatory surgeries projects that 18 to 40 percent of all surgical procedures performed could be performed in an outpatient setting. In calculating total potential surgeries HRS utilizes 29 percent as the potential surgeries that can be performed in an outpatient setting. The 29 percent factor is the mean of 18 percent to 40 percent and appears reasonable in light of the fact ORMC, Holiday Division, Winter Park Memorial and Orlando General had outpatient surgery of 29.4 percent, 30.1 percent and 30.6 percent respectively for 1983. Applying the 29 percent factor to projected total surgeries, HRS calculates the projected potential ambulatory surgery for a given year in the future. Subtracting those outpatient surgeries which will be performed in existing facilities from the total potential outpatient surgeries provides the unmet need for outpatient surgical care. This need is reflected in total cases. In evaluating ambulatory surgical applications, HRS utilizes a two year planning horizon. It is projected that SSO would begin operation January 1, 1986, and therefore under the HRS methodology, 1986 and 1987 become the relevant years for the HRS methodology, 1986 and 1987 became the relevant years for looking at projected need. Using the methodology described above, HRS projects the potential number of outpatient surgical cases which could be performed in other than a hospital setting to be 7,203 and 7,347 for 1986 and 1987, respectively. HRS projects the break-even level of the SSO facility at 2,693 surgical cases per year. Subtracting the SSO break-even factor from 7,203 and 7,347 results in an unmet need even after the SSO facility is in operation of 4,510 and 4,654 surgical cases in 1986 and 1987. HRS calculated the outpatient utilization rate in existing hospitals in 1983 to be 15.3 percent. If the unmet need of 4,510 and 4,654 in 1986 and 1987 was met by these existing facilities, that utilization rate would increase to 24 percent or approximately 1 1/2 times the 1983 rate. The projected utilization for the SSO facility for 1986 and 1987 will constitute only about 20 percent and 30 percent respectively of the unmet need for outpatient surgery in those years. The applicant in projecting need used a five year planning horizon to project need for ambulatory surgical services in Orange County for the year 1989. Under SSO's methodology, an outpatient utilization rate of 30 percent, 35 percent and 40 percent was used to project the total potential outpatient or ambulatory surgeries for the year assuming a total surgical utilization rate of 101.45 cases per thousand. Using these assumptions, the applicant projected unmet need for ambulatory surgeries in Orange County in 1989 as: Percentage of Ambulatory Surgery Unmet Need 30% 6,357 35% 9,246 40% 12,136 Although the projected unmet need is somewhat lower than that projected by HRS, it does reflect a need for the SSO facility. The methodology used by ORMC utilizes what ORMC's experts described as the "excess capacity theory." This methodology is based upon the assumption that no need exists for an ambulatory surgical center until such time as all excess capacity in the existing operating suites in Orange County is utilized. Using this approach, ORMC contends that of the 79 total operating suites in Orange County, there are presently 39 excess operating suites available to perform outpatient surgery. By multiplying total number of hours per day per operating room times 260 days, ORMC calculates the total available hours of operation of an operating suite and by multiplying this number times the total number of suites, the total available hours or operating room time for a facility is determined. The total available hours is then divided by the average operating room time for all procedures performed to determine the total number of potential procedures. Using this approach, ORMC's expert opined that there is potential for 95,513 - 98,980 total surgical cases in the existing 79 operating rooms in Orange County These 79 rooms include the 4 new operating suites in ORMC's Sand Lake facility as well as the 4 suite in Florida Hospital's new freestanding ambulatory surgical center. Subtracting the total procedures of 47,712 from the potential capacity, ORMC projects an available excess capacity for growth of 47,801 to 51,268 surgical cases in Orange County. Also using total available hours, hours per average procedure and total hours required for procedure presently being performed, ORMC's expert calculated the number of operating suites presently required. By subtracting this number from the number of existing suites, the ORMC expert concluded that there are presently 39 excess operating suites in Orange County. Once the ORMC Sand Lake facility and the Florida Hospital Freestanding Ambulatory Center (FAC) open, there will be a total or 79 operating suites in Orange County. These are divided as follows: ORMC, Orange Division 14 ORMC, Holiday Division 10 Winter Park Memorial 10 Orlando General 4 West Orange 3 Lucerne 8 Brookewood 5 Florida Hospital 17 Florida Hospital, FAC 4 ORMC, Sand Lake 4 79 At present, ORMC, Holiday Division, is the only facility operating dedicated ambulatory surgical suites. There are no applications pending for dedicated outpatient facilities within hospitals or for a freestanding ambulatory surgical facility. No such applications have been filed for these types of facilities since the SSO application was filed. Each of the existing facilities listed above performs outpatient surgery to some degree. On August 16, 1982, Florida Hospital was issued a Certificate of Need to construct a freestanding ambulatory surgical center. That facility will contain four operating suites and is expected to begin operation in mid 1984. Once this facility is complete, Florida Hospital will not perform outpatient surgery in its 17 other suites, except when special equipment which is available only in those suites is required. Outpatient surgery at Winter Park Memorial and Orlando General now comprises approximately 30 percent of the total surgeries performed at those facilities. Lucerne Hospital operates no separate ambulatory surgery unit and favors SSO's application. ORMC has been performing outpatient surgery for over 20 years. However, the specific facilities in which outpatient surgery has been performed have changed during this period of time. Prior to August 1979, outpatient surgery was performed at the Five North unit in the Orange Division as well as at the Holiday Division. At that time, Orange Five North was closed for renovation and outpatient surgery was concentrated in Holiday One East. In October 1981, an outpatient surgery review committee was established by ORMC to examine more efficient ways to conduct outpatient surgery and to improve utilization of certain departments at the Holiday Division. The end result was a decision to concentrate outpatient surgery at ORMC in one designated unit to be known as Outpatient Day Surgery ("ODS"), and to provide a financial incentive for physicians and patients to utilize the unit. One of the primary reasons for concentrating outpatient surgery in Holiday One East was the inefficiency and increased cost of staffing the units. Outpatient census counts were resulting in overstaffing the 3 to 11 shift. To encourage doctors and patients to utilize Holiday One East, ORMC reduced the rates for outpatient surgery in the ODS unit by approximately 40 percent. Although some outpatient surgery continues to be performed at the Orange Division the charge for such surgeries is at the inpatient rates rather than the reduced rates utilized by the ODS. The ORMC Board of Directors approved the capital expenditure to renovate the Holiday One East area into the ODS unit on September 20, 1982. The ODS unit was renovated at a cost of approximately $600,000, which was below the Certificate of Need threshold requirement. The ODS unit opened on November 28, 1983. The ODS unit is open Monday through Friday, and utilizes a ten hour day with general anesthesia administered to outpatients from 7:30 a.m. to 1:00 p.m. ODS patients use a separate and distinct entrance to the Holiday Division and have a designated parking area east of the hospital. There are sixteen semi- private holding beds and four recliner chairs located within the ODS unit. The average case load and length of stay are such that holding beds may be used for more than one outpatient per day. As a result of instances where there have been shortages of holding beds for outpatients, ORMC beginning April 2, 1984, established an overflow area of ten beds on the third floor of the Holiday Division. As of May 29, 1984, this overflow area had been utilized on three occasions. The ODS unit contains two dedicated operating rooms where only local anesthesia can be administered. Outpatient procedures requiring general anesthesia are performed in the eight general operating suites of the Holiday Division. These eight operating suites are also used for inpatient surgery. Outpatients are placed in the same holding and recovery areas where inpatients are held. The staff in these areas serve inpatients and outpatients. The ODS unit averages 15 to 16 outpatients per day. In 1983, outpatient surgery comprised 29.4 percent of the total surgeries performed at the Holiday Division. This was a slight increase over the 27.7 percent outpatient percentage for that same division for the previous year. Presently, the two dedicated local anesthesia rooms are being utilized approximately 40 percent of the time. The present utilization rate of the entire Holiday Division is approximately 50 to 55 percent to as much as 80 percent depending upon the particular day of the week. The 80 percent rate is attained on a regular basis at least once per week. ORMC has been issued a Certificate of Need for a children's hospital. As presently designed and approved, the construction of the children's hospital will require the demolition of Holiday One East where the ODS unit is located. It is uncertain where the ODS unit would be relocated. The master facility plan approved by the ORMC Board of Directors includes the construction of a freestanding ambulatory diagnostic center which will include ambulatory surgery. Depending upon the staff and its efficiency and the quality of care provided, a freestanding ambulatory center offers several advantages over outpatient units within hospitals. In such a freestanding facility, only outpatient surgery is performed and the staff and physicians, including anesthesiologists, can be specialized in outpatient surgery. In the freestanding facility, outpatients are not mixed with inpatients. A substantial portion of those patients utilizing outpatient surgery are well patients having elective surgery performed. By specializing in outpatient surgery only, overall operating costs are likely to be less and should result in reduced patient costs. In a hospital setting, there is on occasion a problem with "bumping" elective surgery for emergencies. This would not occur in a freestanding ambulatory surgery facility. Patients will have shorter waits in the facility and Medicare patients will be reimbursed 100 percent rather than the 80 percent reimbursed in a hospital setting. The 550 application is consistent with the applicable criteria enumerated in Section 381.494(6)(c), Florida Statutes and need for its facility exists in Orange County. Of the thirteen governing criteria, the parties have stipulated that the criteria contained in Subsections 6, 7, 10 and 11 of Section 381.494(6)(c), Florida Statutes, are not applicable to this proceeding. In addition, the parties stipulated that Subsection 1 of Section 381.494(6)(c), Florida Statutes, is not applicable to this proceeding to the extent that there is no applicable district health plan or state health plan pertaining to ambulatory or outpatient surgery.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is, RECOMMENDED That HRS issue a Certificate of Need to Surgical Services of Orlando, Inc., to construct and operate a freestanding, five operating room ambulatory surgery center in Orange County. DONE AND ENTERED this 2nd day of July, 1984, in Tallahassee, Florida. MARVIN E. CHAVIS 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 3rd day of July, 1984. COPIES FURNISHED: Douglas L. Mannheimer, Esq. CULPEPPER, TURNER & MANNERED 318 North Call on Street Tallahassee, Florida 32302-3300 Fred W. Baggett, Esq. ROBERTS, BAGGETT, LaFACE, RICHARD, & WISER P.O. Drawer 1838 Tallahassee, Florida 32302 E. G. Boone, Esq. P.O. Box 1596 Venice, Florida 34284 Steven R. Bechtel, Esq. MATEER, HARBERT, FREY BECHTEL AND PHALIN, PA P.O. Box 2854 Orlando, Florida 32802 P. Joseph Wright, Esq. MURRAH AND DOYLE, P.A. P.O. Box 1328 Winter Park, Florida 32790 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue Whether Proposed Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006, constitute an invalid exercise of delegated legislative authority?
Findings Of Fact Standing. The Petitioners, Medivision, Inc., and Tampa Surgi-Center, d/b/a Ambulatory Surgery Center, have standing to challenge the proposed rules at issue in these cases. See the affidavits of Larry Cyment and Donna McMillan. Intervenor, Florida Hospital Association, Inc., has standing to participate in these cases. See the affidavit of Pat Haines. The following Intervenors have established their standing to participate as intervenors in these cases through testimony or affidavit: Cataract Surgery Center, Cortez Foot Surgery Center, Ambulatory Surgery Center of Bradenton, Tampa Outpatient Surgical Facility, Naples Day Surgery, Ambulatory Surgical Center, Specialty Surgical Center and Tallahassee Single Day Surgery. Eye Surgery Center, The Eye Associates, FW Associates and Cordova Ambulatory Surgical Center have failed to prove their standing to participate in these cases. The Proposed Rules; Purpose and Adoption. The Health Care Cost Containment Board (hereinafter referred to as the "Board"), published Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006 (hereinafter referred to as the "Proposed Rules"), in Volume 16, Number 12, of the Florida Administrative Weekly (March 23, 1990). The purpose of the Proposed Rules is to collect data concerning the provision of ambulatory surgery services in the State of Florida. Data collected by the Board will allow a comparison of patient charges and will create an additional bases for the analysis of trends in the health care field. In particular, data collection will promote the analysis of shifts in the provision of health care from inpatient to outpatient settings. Data concerning patient identity, geographic location, diagnosis, procedures performed and charges for services is required to be collected and submitted to the Board pursuant to the Proposed Rules. In June of 1989, the staff of the Board presented a study to the Board concerning the growth of ambulatory health care services. Staff recommended that the Board direct that steps be taken to explore the possibility of collecting ambulatory surgery data. The Board accepted the recommendation and appointed a Technical Advisory Panel. The Technical Advisory Panel appointed by the Board consisted of nine representatives of various interested groups. Two members were from freestanding ambulatory surgery centers and two members were from hospitals providing ambulatory surgery services. At meetings of the Technical Advisory Panel in July, August, September and October, 1989, the collection of ambulatory surgery services data was considered. The Technical Advisory Panel discussed collection costs, the type of data to be collected, implementation dates, legislative authority, methods of submitting data and the scope of data collection. The Board was made aware of the Technical Advisory Panel's efforts through minutes of the Panel's meetings and other materials provided to the Board. The collection of ambulatory surgery services data was considered by the Board at its October, November and December, 1989, meetings. The Proposed Rules were approved by the Board at its December, 1989, meeting. There is no statutory authority which specifically provides that data may be collected by the Board from "freestanding ambulatory surgical centers." The Board cited Section 407.03, Florida Statutes (1989), as the specific authority for the Proposed Rules. The Board cited Sections 407.003, 407.03 and 407.08, Florida Statutes (1989), as the laws implemented by the Proposed Rules. Scope of the Proposed Rules. Ambulatory surgery services are provided in a variety of settings: hospitals (e.g., acute care, psychiatric and rehabilitation), licensed freestanding ambulatory surgery centers, physician offices and other unlicensed health care facilities. The Proposed Rules provide that all licensed hospitals included in Groups 1 through 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual which provide outpatient surgery services and all licensed ambulatory surgery centers in Florida are required to collect and submit 45 data elements to the Board. Psychiatric hospitals and rehabilitation hospitals are not subject to the Proposed Rules. Physicians' offices and other unlicensed health care providers are also not subject to the Proposed Rules. The Proposed Rules are limited to licensed providers of ambulatory surgery services so that the Board's staff can insure that all members of the groups selected data actually collect and report data. The Board cannot insure that all unlicensed providers of ambulatory surgery services, such as physicians' offices, comply with the Proposed Rules. Therefore, if data was required to be collected and submitted by unlicensed providers, the data would be less reliable. The weight of the evidence failed to prove that the requirement of the Proposed Rules that only hospitals included in Groups 1 and 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual and licensed freestanding ambulatory surgery centers collect and submit data constitutes an invalid exercise of delegated legislative authority. Specific Data vs. Aggregate Data. The Proposed Rules require the collection and reporting of 45 specific data elements. Aggregate data concerning ambulatory surgery services could be obtained from insurance companies and used by the Board as an alternative to the more specific data required to be collected pursuant to the Proposed Rules. Aggregate data is a compilation of specific data. Aggregate data can be used to comply with the Board's statutorily required functions. If aggregate data is used, however, it is likely that reporting will be incomplete. Not all information is reported to insurance companies concerning outpatient activity. Therefore, aggregate data obtained from insurance companies would not cover 100% of ambulatory surgery services provided by reporting entities, resulting in the potential for presenting an incomplete or inaccurate picture of ambulatory surgery services. The recommendations and conclusions which can be reached from aggregate data are limited. Specific data allows more flexibility for research purposes. Specific data will assure greater accuracy and comparability of data. Recommendations and conclusions reached from specific data should be more accurate. In order to insure comparability of data, specific data concerning patients, geographic location, diagnoses, procedures and charges must be collected. The Board collected aggregate data concerning ambulatory surgery services through a special study. The Board collected the data from hospitals and, on a voluntary basis, from licensed ambulatory surgery centers. "Typical" charges for specified ambulatory surgery procedures was collected. This collection effort was flawed by the lack of specific data. The accuracy of the reports based upon the aggregate data was criticized publicly. The reports were even criticized by one of the witnesses called to testify by Intervenors, Cataract Surgery Center, et. al. The weight of the evidence failed to prove that the requirement of the Proposed Rules that specific data be collected and submitted instead of aggregate data constitutes an invalid exercise of delegated authority. Confidential Patient Data. Some of the data elements to be reported pursuant to the Proposed Rules constitute confidential patient information. Disclosure of confidential patient information is prohibited by Florida law. The Proposed Rules do not require or authorize disclosure of confidential patient information. The manner in which the data collected will be distributed has not yet been decided upon by the Board. The evidence failed to prove that the Board will not comply with prohibitions against disclosure of confidential patient information. The weight of the evidence failed to prove that the requirement of the Proposed Rules that confidential patient information be reported to the Board constitutes an invalid exercise of delegated authority. Computer Use. The Proposed Rules require that data be submitted by computer tape or computer diskette. Therefore, data will have to be input into a computer system. The Proposed Rules specify the format data must be in when submitted. Most of the language of the Proposed Rules is computer terminology. The terminology of the Proposed Rules will require some knowledge of computers to carry out the requirements of the Proposed Rules. The language of the Proposed Rules is intentionally designed to convey technical information. The general purpose and requirements of the Proposed Rules does not take any special knowledge to understand. Requiring the submission of data by electronic means is designed to assure the accuracy and confidentiality of the data. The requirement of the Proposed Rules that data be reported in computer form and the use of computer terminology does not constitute an invalid exercise of delegated legislative authority. Errors in the Proposed Rules. Proposed Rule 10N-6.002(2) defines "Ambulatory Surgery Services" as procedures "provided in a hospital in its dedicated ASC ..." [Emphasis added]. Instead of "ASC" the Board intended to use the terms "operating room." Proposed Rule 10N-6.005 contains a list of the data elements to be collected and reported to the Board. This Proposed Rule contains the following errors or unclear language: Item 20 is "Facility Fee - Pri. Proc." "Pri. Proc." is an abbreviation for primary procedure. Items 21-24, similar to Item 20, contains the abbreviation "Sec. Proc." instead of secondary procedure. Items 25-27 contain a reference to "Page 3". As published in the Florida Administrative Weekly, there is no page 3. Item 35, which deals with expected methods of payment, refers to "Comm. Ins. (incl. BCBS)." This reference is an abbreviation for commercial insurance (Blue Cross Blue Shield). Item 44, patient birth date, uses the abbreviation "MMYYYY." This abbreviation should be "MMDDYY." Proposed Rule 10N-6.006 refers to "Primary Diagnosis Code" and "Secondary Diagnosis Code." The Rule should refer to Primary and Secondary "Procedure" Code. The mistakes identified in findings of fact 38-40 are not significant enough to characterize the rule as vague. Nor are these mistakes sufficient enough to otherwise conclude that the Proposed Rules constitute an invalid exercise of delegated legislative authority. Economic Impact. The Economic Impact Statement (hereinafter referred to as the "EIS"), issued with the Proposed Rules provided the following concerning the economic impact of the Proposed Rules on the Board: ESTIMATE OF THE COST OF IMPLEMENTATION: The agency will be affected by the costs of rule promulgation and by the demands placed upon staff time to assure compliance with the rules and to analyze the data collected. Costs for these activities are estimated to be approximately $85,000 per year. The weight of the evidence failed to prove that this portion of the Board's EIS is unreasonable. The EIS provided the following concerning the economic impact of the Proposed Rules on persons affected by the Proposed Rules: ESTIMATE OF THE COST OF IMPLEMENTATION: Implementation by affected facilities will cost approximately $2.9 to $3.1 million. These funds will be used to develop the programs necessary to collect and submit the data required. On-going compliance will have a much less significant impact. . . . . ESTIMATE OF COST TO ALL PERSONS DIRECTLY AFFECTED BY THE RULE: The initial cost to Florida hospitals and freestanding ambulatory surgery centers (ASC) would be from approximately $2.9 to $3.1 million to develop the reporting system necessary to generate the necessary data elements. On-going annual cost to the hospitals and free standing ASCs would be substantially less after the first year's start-up procedures are adopted. . . . . The EIS is insufficient because it does not adequately discuss the costs (implementation and ongoing costs) to affected persons or the impact of the Proposed Rules on small business. The weight of the evidence proved that the Proposed Rules will have an economic impact on affected persons. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the implementation cost affected persons can be expected to incur as a result of the Proposed Rules. As indicated in the EIS, the Board's determination of the estimate of the economic impact on affected persons was based upon surveys the Board distributed to licensed ambulatory surgery centers, an estimate of costs that hospitals incurred in implementing the Board's detailed patient data collection rule, the Board staff's experience with computer costs (including the collection and entry of data) and consultation with a computer expert familiar with the Proposed Rules. The surveys relied upon by the Board were distributed to all licensed freestanding ambulatory surgery centers. A total of 91 surveys were distributed. The Board requested that the surveys be returned within one week. Forty-one responses to the surveys were received by the Board from licensed freestanding ambulatory surgery centers. The responses constitute hearsay. Findings of fact concerning whether the information contained in the responses is correct, therefore, have not been made. The responses to the surveys have, however, been relied upon to make findings of fact concerning what information the Board based its EIS on. The Board received the following pertinent responses to the surveys from licensed freestanding ambulatory surgery centers: (1) 26 of the responders use computers, 12 have no computer capacity and 3 have some computer capacity; 17 or 18 different software programs are in use; and, (3) the costs to implement the proposed collection of data ranged from $0 to $50,000.00. Twenty- six responders indicated that they did not know how long it would take for them to implement the proposed collection of data. The Board determined that the average implementation cost for licensed freestanding ambulatory surgery centers reported in the responses to its survey was $18,975.00 and that the average implementation time was 13 weeks. The Board rounded up the average cost reported to it in the surveys and estimated that the cost of implementing the Proposed Rules at licensed freestanding ambulatory surgery centers would be $20,000.00. Based upon the existence of 85 licensed facilities, the Board estimated the total implementation cost for licensed freestanding ambulatory surgery centers to be $1,700,000.00 ($20,000.00 x 85). The Board estimated that the maximum cost of implementing the Proposed Rules at affected hospitals would be $2.00 per patient record. This estimate was based upon the Board's estimate of the cost of hospital compliance with the Board's detailed patient discharge data rule. Based upon an estimate of 600,000 patient records a year which will have to processed as a result of the Proposed Rules, the Board estimated the total cost of implementation in affected hospitals to be $1,200,000.00. The Board concluded that the total minimum cost of implementing the Proposed Rules will be $2,900,000.00 ($1,700,000.00 cost for freestanding ambulatory surgery centers plus $1,200,000.00 cost for affected hospitals). The Board discussed the cost of implementing the Proposed Rules with J. Thomas Solano, an expert in computers. Mr. Solano estimated that the cost of modifying an existing computer system (small to mid-range computer) to comply with the Proposed Rules would be $4,000.00 to $10,000.00. The Board used the highest estimate, $10,000.00, and multiplied this cost by the number of affected persons (85 freestanding ambulatory surgery centers and 220 hospitals x $10,000.00). This resulted in a rounded-up estimated implementation cost of $3,100,000.00. The Board concluded that the total maximum cost of implementing the Proposed Rules will be $3,100,000.00. Some of the data to be collected and reported pursuant to the Proposed Rules is already being collected by affected persons. Therefore, the primary cost of complying with the Proposed Rules will be associated with modifying existing computer software and/or hardware. The cost of modifying an existing computer system can fluctuate widely. As a general rule, computer users with existing software must rely upon their existing software provider to make modifications. The cost of modifying software can, therefore, be much higher than Mr. Solano estimated. As an alternative to modifying existing systems, affected persons can acquire a freestanding personal computer and software which can be used to comply with the Proposed Rules. The cost of such an acquisition should be approximately $2,500.00 to $5,600.00. Intervenor, T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it will have to spend approximately $14,000.00 to $20,000.00 to implement the Proposed Rules. This estimate is based upon a letter purportedly from the Intervenor's computer company. The information contained in the letter is hearsay. The estimated implementation costs are, therefore, not supported by admissible evidence. The estimate, even if supported by competent substantial evidence, is within the Board's estimated implementation costs and, therefore, fail to prove that the Board's EIS is unreasonable or that the Board failed to fully consider the economic factors or impact. Intervenor, Cataract Surgery Center, estimated implementation costs of $1,900.00. This amount is limited to additional maintenance fees, supplies and personnel costs. Cataract Surgery Center believes there will no charge from its computer vendor to modify its software. Cataract's estimated costs are reasonable and within the Board's estimates. Ambulatory Surgical Center of Lake County (hereinafter referred to as "Lake"), does not own a computer. It uses the computer system of its physician owners. Lake considered more than one method of complying with the Proposed Rules. It considered buying a personal computer and estimated it would cost $5,000.00. This cost is consistent with the estimates of the Board. Lake also considered purchasing an integrated hardware and software package. It estimated that such a system would cost $40,000.00 to $50,000.00. The estimate is based upon hearsay. Even if the evidence concerning the cost of an integrated system is accepted as correct, the evidence fails to prove that such costs are necessary to comply with the Proposed Rules. The estimate for this system is based upon Lake's decision that it would perform other functions with the computer system, including storing management information and performing billing functions. These functions are not required in order to comply with the Proposed Rules. Lake currently treats approximately only 300 patients annually. The weight of the evidence failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the implementation cost which will be incurred by affected persons. The weight of the evidence also failed to prove that the inadequate treatment of implementation costs in the EIS was fully considered by the Board. Therefore, the treatment of implementation costs in the EIS constitutes harmless error. Although the primary costs to affected persons caused by the Proposed Rules will be associated with implementation of the Proposed Rules, there will also be certain costs associated with ongoing compliance with the Proposed Rules. There will be ongoing costs for the collection of data, entry of the data into a computer and reporting data to the Board. Ongoing costs caused by the Proposed Rules will be greater if an affected person with an existing computer system acquires a freestanding computer system instead of using the existing system. The Board's statement in the EIS concerning ongoing costs was not based upon information from affected persons. The statement concerning ongoing costs does not indicate what the ongoing costs of compliance with the Proposed Rules will be. It only indicates that it will be less than the initial implementation costs associated with the Proposed Rules. Although the weight of the evidence did not prove the estimated total amount of ongoing costs to affected persons from the Proposed Rules, the weight of the evidence failed to prove that ongoing costs will be greater than the estimated total amount of implementation costs. T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it would incur ongoing costs of approximately $6,000.00. This estimate is reasonable. Cataract Surgery Center estimated that it would incur ongoing costs of $41,600.00, or $20.00 per case, to comply with the Proposed Rules. Cataract Surgery Center's estimated costs include the following costs: reel purchase; handling; reel preparation; collection of billing data; process of sending information to the Board; clarification of errors; additional record production; and response to public inquiries. Cataract Surgery Center's estimated costs are not reasonable. The estimated time to comply with the Proposed Rules is excessive and some of the tasks, i.e., collection of billing data, are not required by the Proposed Rules. Cataract Surgery Center's conclusion that it may have an increase in maintenance fees is reasonable. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the ongoing costs affected persons can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of ongoing costs in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the ongoing cost which will be incurred by affected persons. The EIS contains a statement that the Proposed Rules should have no economic impact on small business. In reaching this conclusion the Board failed to take into account the legal definition of "small business" contained in Florida Statutes. The Board did, however, actually consider the impact the Proposed Rules would likely have on small ambulatory surgery centers subject to the Proposed Rules. The Board attempted to reduce the economic impact on small ambulatory surgery centers by allowing affected persons to file data on computer tape or on diskette. By allowing the use of diskettes for reporting data, the Board made it possible for affected persons to use personal computers to comply with the Proposed Rules. Delayed submission of some data elements was also allowed in order to reduce the impact on small facilities. It is unlikely that the Board would have made further modifications of the Proposed Rules had the legal definition of "small business" been considered. The weight of the evidence failed to prove what, if any, reasonable modifications should have been taken by the Board to accommodate any economic impact on small business. The weight of the evidence failed to prove whether any of the entities that participated in the proceeding were small businesses. Those entities, although meeting the definition of small business with regard to the number of employees they have and their net worth, failed to prove whether they are "independently owned and operated." See Section 288.703(1), Florida Statutes (1989). The weight of the evidence failed to prove if any person affected by the Proposed Rules is a small business. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of small business which can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of the impact on small business in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated legislative authority because of the impact on small business. The Petitioners and Intervenors presented evidence concerning a number of actions which the Board did not take during its consideration of the economic impact and factors of the Proposed Rules and its preparation of the EIS. This evidence proved only that there were other steps which the Board could have taken during its preparation of the EIS. The Petitioners and Intervenors failed to prove, however, that the steps which the Board did take were not sufficient. The Petitioners and Intervenors therefore failed to prove that the steps which the Board did not take were required or necessary.
Findings Of Fact Petitioner filed an application for certification as a physician assistant pursuant to Section 458.347(7)(b), Florida Statutes, a special avenue of certification as a physician assistant for graduates of foreign medical schools. In furtherance of that application, he appeared before the Physician Assistant Committee of the Board of Medicine. Subsequent to his appearance before that Committee, on August 13, 1992, Respondent sent Petitioner a letter which provides, in pertinent part, as follows: This is to advise that your application for issuance of a temporary certification with the requirement that prior to issuance of temporary certificate you submit within 30 days of date of appearance, a new corrected and complete application to be reviewed by the Board staff. Please complete the enclosed application. You will be required, as a condition to take the examination, 2 new personalized letters of recommendation, specifically recommending you as a physician assistant. The letter did not enclose an application form for Petitioner to complete. Respondent admits that the information in the letter was incorrect because it confused temporary certification with the requirements for examination. It is apparent that the letter is also incorrect because it fails to advise Petitioner if his application was being granted or denied; moreover, the wording of the letter makes no sense. By Order dated August 26, 1992, the Board of Medicine notified Petitioner that his application for temporary certification as a physician assistant was denied pursuant to the Committee's August 1 determination and the Board's August 9 determination that the length of time since Petitioner had last worked in the field of medicine or received significant medical education or training precluded him from being able to establish that he could practice as a physician assistant with reasonable skill and safety to the public. That Order further advised Petitioner, however, that the Board had granted Petitioner's application to sit for the certification examination pursuant to Section 458.347(7)(b), Florida Statutes, because Petitioner was eligible to take the examination to become certified as a physician assistant and that passage of the examination would serve to establish Petitioner's qualifications for practice. The Order specifically provided that the Board's permission for Petitioner to sit for the certification examination was "contingent upon and subsequent to receipt within 30 days" of Petitioner's appearance before the Physician Assistant Committee of (1) a complete and correct application and (2) two more letters of recommendation which specifically recommend Petitioner as a physician assistant. It would have been difficult for Petitioner to timely comply with the Order entered August 26 requiring him to file documents within 30 days of his August 1 appearance before the Committee. By letter dated August 31, 1992, Petitioner requested an extension of one week by which to obtain the second letter of recommendation due to the devastation produced by Hurricane Andrew and Petitioner's inability to communicate with the doctor who would sign it. Petitioner did, however, submit another application which was postmarked August 31, 1992, and received by Respondent early in September. At hearing, Respondent advised that it was waiving the 30-day deadline contained in the August 26, 1992, Order due to the intervention of Hurricane Andrew and because Respondent had not strictly enforced such deadlines as to other applicants. Rather, Respondent simply required that Petitioner comply with its Order within a reasonable period of time. By letter dated December 21, 1992, Respondent advised Petitioner that his application was incomplete because the Board had only received Petitioner's new application, one letter of recommendation, and Petitioner's request for an extension of time for submittal of the second letter. The letter further advised that the Board's staff's review of Petitioner's recent application had revealed some discrepancies requiring an explanation by Petitioner. The letter, therefore, advised Petitioner to submit one more recommendation letter, provide an explanation for six specified areas, and submit pages 8 and 9 of the application regarding Petitioner's clerkships. The letter further advised Petitioner that all information must be received by the Board no later than December 31, 1992. On January 20, 1993, Respondent received an undated letter from Petitioner referencing Respondent's December 21, 1992, letter which was received by Petitioner on December 30. Petitioner's letter enclosed the additional letter of recommendation requested by the Board, responded specifically to the six areas of inquiry, and enclosed pages 8 and 9 of the Board's application form. On January 20, 1993, the Board received a letter from Dr. Jose M. Bermudez, recommending Petitioner as a physician assistant. On January 28, 1993, the Board sent Petitioner a letter advising him that the Board had received the letter of recommendation from Dr. Bermudez and pages 8 and 9 of the application. That letter further provided as follows: However, the Physician Assistant Committee required you to submit a new complete and accurate application, and two (2) additional letters of recommendation which specifically recommend you as a physician assistant. Enclosed you will find a complete physician assistant application. Please fill the application out in its entirety and submit it to the Board of Medicine as soon as possible. In compliance with that request, Petitioner submitted yet another application for certification as a physician assistant, which was received by the Board on February 8, 1993. On February 24, 1993, the Board of Medicine entered its Order denying Petitioner's application for certification as a physician assistant. The Order recited that the denial was based upon the determination made by the Physician Assistant Committee on January 8 and by the Board on January 13 because Petitioner "failed to submit a new and complete and accurate application and one new personalized letter of recommendation within the time frame allotted by the Board." That Order does not mention Petitioner's application to sit for the certification examination, the issue pending before the Board, since the Board had already denied Petitioner's application for certification by Order entered August 26, 1992. That February Order also advised Petitioner of his right to request an administrative hearing regarding the Board's determination. On February 26, 1993, the Board's staff sent Petitioner a letter advising him that he had been certified by the Board to take the examination for licensure as a physician assistant to be administered in September, 1993. On March 10, 1993, the staff sent Petitioner a letter acknowledging Petitioner's "request for a hearing on the denial of your application for certification as a physician assistant," and advising Petitioner that the February letter advising him that he had been certified to take the examination for licensure as a physician assistant had been sent to Petitioner in error. A "corrected" letter was enclosed. That "corrected" letter dated March 10 advised Petitioner that the Board had preliminarily denied him certification to take the examination for licensure as a physician assistant. By letter dated March 18, 1993, the Board's staff sent an additional letter to Petitioner advising Petitioner as to the correct dates for the examination. In applying for temporary certification as a physician assistant and/or to sit for the certification examination, Petitioner has filed an additional application each time he has been instructed to do so by the Board or by the Board's staff and has submitted a letter explaining the information given in his applications each time that the Board's staff has requested that he do so. Petitioner has filed at least three such applications and has responded by letter to inquiries regarding the contents of his applications at least three times. Additionally, Petitioner has personally appeared before the Physician Assistant Committee on August 1, 1992, to be questioned regarding his qualifications. The Board has discovered some "discrepancies" or omissions in analyzing those various documents. Petitioner's August application states that the ending date for medical school, assumedly the date he received his degree, was February 25, 1965. That date appears in three places. Further, the copy of his diploma submitted to the Board reflects that date. Yet, the December 21, 1992, form from the Board to Petitioner advises him that he must explain his ending date for medical school. In response to that indication that he must provide different information, Petitioner's letter received by the Board on January 20, 1993, states that the ending date for medical school was February 29, 1962. At hearing, Petitioner explained that he attempted to differentiate between the date he completed classes and the date he completed all requirements, including internships, in order to receive his diploma. The information contained in Petitioner's application is correct. The August application contains an answer in the negative to question numbered 9 asking Petitioner if he is or has ever been emotionally or mentally ill. Although Petitioner's subsequent February 1993 application contains no answer to that question, the Board did not have before it the February application when it decided in January to deny Petitioner's application. Even so, Petitioner had no intention to be incomplete or inaccurate when he failed to answer that question on the February application. In his August application Petitioner does not list the completion of any social service work in either section inquiring about post-graduate training or practice employment. In an application that Petitioner filed in 1985 requesting licensure as a physician, Petitioner had specifically detailed the social service work performed by him as part of his medical school training. In that application he listed the dates as January 1, 1963 to December 31, 1963. The letter Petitioner wrote to the Board in response to its December 1992 request for a better explanation states that his social service work was done between March 1, 1963 and September 30, 1963. There is no dispute regarding whether Petitioner did in fact complete his social service work requirement as part of his education in order to receive his diploma, and it is clear that such work was done in 1963. Although there is a discrepancy regarding which months during 1963 he did his social work, the discrepancy as to the months during which Petitioner did something 30 years ago does not make his application inaccurate. In fact, the August application may be more accurate than the 1985 application form. The August application required Petitioner to list in chronological order from the date of graduation to the present all practice experience and/or employment. Petitioner advised that from February 28, 1970, to April 30, 1976, he was in private practice in Nicaragua. The Board's December 1992 letter asked for clarification because a prior application indicated additional activity. Petitioner's response letter advised that he was also in pediatric practice at the General Hospital of Managua from 1970 to 1972. His 1985 application did not mention the pediatric practice at General Hospital. At final hearing, Petitioner explained that he was in private practice at the same time that he practiced at the clinic in the hospital. Petitioner's 1985 and February 1993 applications, although not the subject of this proceeding, also contained some minor discrepancies regarding Petitioner's employment experience. For example, one shows Petitioner beginning his employment with the Nicaraguan Red Cross on May 1, 1976, and the other shows Petitioner's employment beginning on May 31, 1976. The parties do not dispute that Petitioner in fact practiced with the Nicaraguan Red Cross during that time period. In further response to the question requiring Petitioner to list all of his practice experience or employment, Petitioner did not list his activities from September 10, 1984, and thereafter. The Board's December 21, 1992, letter to him requested that he account for all his activities for the time period of January 1, 1984, and thereafter. In his response he did not identify those activities except to say that during that time period he was living in Miami. The detailed information had been provided to the Board in response to a letter to Petitioner from the Board dated March 8, 1992, in conjunction with his original application for certification as a physician assistant, although he did not again provide that information when he was ordered by the Board to file a new application. In Petitioner's August application, he listed no ending date regarding his private practice begun on January 1, 1984 in Managua, Nicaragua. Petitioner's 1985 physician license application showed that that employment ended September 10, 1984, whereas his February application showed that practice to have ended on September 15, 1984. Such a discrepancy is not material to Petitioner's application or eligibility. The application form contains a section regarding clerkships and requests that each clerkship be specified. In the August application Petitioner did not specify his four individual clerkships. After being asked pursuant to the Board's staff's December 1992 letter to resubmit pages 8 and 9 as to his clerkships, Petitioner did so by referring to them as a group rather than breaking them down individually. He did the same in the February 1993 application. The parties do not dispute that Petitioner performed the required clerkships. It is unclear how many letters recommending him as a physician assistant Petitioner has submitted to the Board. Petitioner referenced his submittal of photocopies of the "last two" letters of recommendation, the originals of which had previously been submitted to the Board, in a letter that Petitioner sent the Board in March of 1992. In correspondence from the Board to Petitioner in May of 1992 reference is made to the requirement that Petitioner submit another letter of recommendation because the Board did not have the original of that letter in its file. When the Board's staff instructed Petitioner to appear before the Physician Assistant Committee on August 1, 1992, the absence of necessary letters of recommendation was not one of the reasons given. The Board's August 26, 1992, Order requests "two more letters", which indicates that letters had been previously submitted. The staff's December 21, 1992, communication to Petitioner acknowledges receipt of one additional letter but requests another, which request was complied with at least by the submittal of the letter from Dr. Bermudez received by the Board on January 20, 1993. Petitioner applied to be certified as a physician assistant and the Board determined that he was eligible to take the examination. Thereafter, through a series of mistakes and correct acts, the Board's staff requested Petitioner on a number of occasions to file additional applications which he did. When the Board's staff asked for clarification he responded in writing and by telephone call, and the Board agrees that it has telephone slips in Petitioner's file. Each time the Board's staff asked for different information than had been given in Petitioner's previous application(s), Petitioner provided more and/or different information. There is no suggestion that Petitioner attempted to provide inaccurate or false information, and it is found that Petitioner provided correct and complete information to the best of his ability. Petitioner's mistakes are certainly no greater than the mistakes made by the Board's staff in sending Petitioner conflicting instructions, conflicting correspondence, and one letter that did not make any sense.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered permitting Petitioner to sit for the physician assistant examination to be administered during September of 1993. DONE and ENTERED this 12th day of July, 1993, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1993. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 93-1550 Respondent's proposed findings of fact numbered 1-10 have been adopted in substance in this Recommended Order. Respondent's proposed finding of fact numbered 11 has been rejected as not being supported by the weight of the evidence in this cause. COPIES FURNISHED: Catherine Lannon, Esquire Department of Legal Affairs The Capitol PL-01 Tallahassee, Florida 32399-1050 Enrique Rueda Arguello 9409 Fountainbleau Boulevard, Apt. #101 Miami, Florida 33172 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint filed July 7, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2006). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2006). Dr. Edison is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 44240. Dr. Edison received his medical degree from the University of Massachusetts; did his residency in general surgery at the Kaiser Foundation in Los Angeles, California; and did a residency in plastic surgery, with specialties in reconstructive surgery and cosmetic surgery. Dr. Edison is certified in plastic surgery by the American Board of Plastic Surgery and is a lifetime diplomate of that Board. Dr. Edison was also certified in Advanced Cardiac Life Support ("ACLS") at the times material to this proceeding. Dr. Edison has been practicing plastic surgery in Florida for 22 years. Prior to the time material to this proceeding, Dr. Edison performed approximately 150-to-200 breast augmentation surgeries each year and approximately 100-to-150 liposuction procedures each year. Dr. Edison practices at the Cosmetic Surgery Center, which is an office that contains two operating rooms, a recovery room, and an overnight recovery facility that is staffed by an ACLS-certified nurse for patients who undergo procedures such as stomach tucks or facelifts. Dr. Edison's surgical practice is limited to Level II office surgery, which is defined in Florida Administrative Code Rule 64B8-9.009, Standard of Care for Office Surgery, in pertinent part as follows: Level II Office Surgery. Scope Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, this making intra and post- operative monitoring necessary. . . . 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 reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Standards for Level II Office Surgery. * * * 4. 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 subparagraph 64B8- 30.012(2)(b)6., F.A.C., 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. . . . The level of pain and anxiety management achieved under Level II sedation is determined by the type of drugs administered and the dosages in which they are administered. Dr. Edison was ACLS certified and was, therefore, authorized to use the services of a registered nurse to administer the drugs that bring patients to Level II sedation. He does not use the services of an anesthesiologist or of a Certified Registered Nurse Anesthetist in his surgical facility. Patient P.L. P.L. first consulted with Dr. Edison on July 5, 2005. P.L. filled out a portion of a Patient Information form, and Dr. Edison took a general medical history from P.L., but he did not weigh P.L. during this initial visit, and the Patient Information form does not include her blood pressure, height, or weight. Dr. Edison found P.L. to be a healthy 29-year-old female, the mother of three children, who had no known allergy or adverse reaction to any medication. P.L. wanted breast implants, and, upon examination, Dr. Edison found that P.L. would be a good candidate, anatomically, for the surgery. Dr. Edison spent the majority of time during this initial consultation talking with P.L. and her husband, A.A., about the various breast implant options. He also discussed with them the risks and possible complications of the surgery. After her visit to Dr. Edison's office on July 5, 2005, P.L. notified Dr. Edison's office that she had decided to have the surgery. Dr. Edison had a cancellation on July 7, 2005, and P.L. was scheduled for surgery for 8:00 a.m. on that date. P.L. returned to Dr. Edison's office on July 6, 2005, for a pre-operative examination. At that time, Dr. Edison did an examination during which he checked P.L.'s heart, lungs, blood pressure, and pulse rate, and he noted the results in his examination notes dated July 6, 2005. He found nothing abnormal and concluded that P.L. was a 29-year-old patient in perfect health, with no known allergy or adverse reaction to any medication. Dr. Edison also had blood drawn during the July 6, 2005, office visit, which was sent to a laboratory for testing. The laboratory report was completed at 8:21 a.m. on July 7, 2005, and showed nothing abnormal. P.L. presented herself at Dr. Edison's office on July 7, 2005, at approximately 8:00 a.m. She was examined by Dr. Edison at 8:10 a.m., and he stated in his office notes that she had decided on the 300 cubic centimeter implant. There were no notations of her vital signs in his office notes. Dr. Edison intended for P.L.'s breast augmentation surgery to be Level II office surgery, and he noted this on P.L.'s Immediate Pre-Op Evaluation, which he completed on July 7, 2005. He also decided to use the transaxillary technique, making incisions under the arms through which to insert the implants under the muscle in P.L.'s chest. Dr. Edison was assisted during surgery by Michelle Hoff, an Advanced Registered Nurse Practitioner, who administered the sedatives and other drugs to P.L. under Dr. Edison's direction. Dr. Edison was also assisted by Liliana Gabor, a surgical technician. Ms. Hoff is not a Certified Registered Nurse Anesthetist, nor has she received any formal training in administering sedative drugs or anesthesia. She has a significant amount of experience administering drugs for pain and anxiety management. Her experience administering drugs to achieve Level II sedation consists of an externship with Dr. Edison while working on her master's degree in nursing and extensive on-the-job training while working in the operating room with Dr. Edison, which she has done every day since beginning to work with Dr. Edison full-time in November 2003. At some point immediately prior to surgery, Dr. Edison asked P.L. her weight, which she reported as 95 pounds, or 43 kilograms, on the morning of surgery. Dr. Edison needed to know P.L.'s weight in order to calculate the correct dosage of the drugs she would be given, and he wrote "95 lbs" on the outside of P.L.'s folder. Dr. Edison noted P.L.'s weight on the outside of the folder so it would be plainly visible to Ms. Hoff when she had the chart on the anesthesia stand.4 Dr. Edison did not enter P.L.'s weight in his examination notes, and the only other mention of P.L.'s weight in the medical records maintained by Dr. Edison is the notation "<100 lbs" on a sheet containing the contact numbers for P.L. and for her husband, who would be picking her up after surgery. At approximately 8:20 a.m. on July 7, 2005, P.L. walked to the operating room. Working under Dr. Edison's direction, Ms. Hoff hooked P.L. up to various monitoring devices, so that her heart, blood pressure, and oxygen saturation level could be monitored during surgery. Her vital signs were noted on the anesthesia chart by Ms. Hoff; at 8:20 a.m., P.L.'s heart rate was approximately 104. At 8:20 a.m., Ms. Hoff began to administer drugs to P.L. to achieve Level II sedation in accordance with directions from Dr. Edison; she documented the name of the drugs she administered, together with the time and dosage administered; she monitored and documented P.L.'s vital signs, including heart rate, blood pressure, and oxygen saturation level; and she maintained anesthesia notes. At 8:20 a.m., Ms. Hoff administered two milligrams of Valium; one gram of Ancef, and 0.2 milligrams of Robinol at Dr. Edison's direction. At 8:25 a.m., she administered 10 milligrams of Ketamine and 10 milligrams of Talwin and started the administration of Diprivan by microdrip at the rate of approximately 25 micrograms per kilogram of weight per minute. Ms. Hoff's notes do not indicate the manner in which she administered the Diprivan, nor the dosage or rate of administration. Ms. Hoff also administered nitrous oxide and oxygen at 8:25 a.m., and she noted that Dr. Edison also began administering local anesthetic by injection at 8:25 a.m. Ms. Hoff noted that P.L. was responding to verbal stimuli. Ms. Hoff was not involved with the preparation or administration of local anesthetic to P.L. Dr. Edison prepared a dilute solution of 70 cubic centimeters of 1% Lidocaine with epinephrine with 350 cubic centimeters of saline solution and 10 cubic centimeters of 1/2% marcaine. At approximately 8:25 a.m., Dr. Edison began injecting the Lidocaine solution, which totaled approximately 700 milligrams or approximately 14 milligrams of Lidocaine per kilogram of P.L.'s body weight and 50 milligrams of marcaine, into the tissue surrounding P.L.'s breasts. At 8:30 a.m., Ms. Hoff, at Dr. Edison's direction, administered another 10 milligrams of Talwin. At 8:35 a.m., P.L.'s heart rate was 112 beats per minute and her blood pressure was 142/102. At Dr. Edison's direction, Ms. Hoff administered 1/4 cubic centimeter of Labetalol to help control P.L.'s blood pressure. Ms. Hoff noted that P.L. tolerated the Labetalol well and was responsive to verbal stimuli. At 8:45 a.m., Ms. Hoff noticed a brief facial twitch on P.L.'s face, which is an indication of a possible seizure. At Dr. Edison's direction, she immediately stopped administering all sedatives, and the surgery was cancelled. At Dr. Edison's direction, Ms. Hoff administered 2.5 milligrams of Valium to keep P.L. sedated and to help control the seizure, together with three liters of oxygen by mask. At 8:55 a.m., Ms. Hoff administered another 2.5 milligrams of Valium at Dr. Edison's direction,5 and she noted that P.L.'s status was unchanged, by which Ms. Hoff meant that P.L.'s airway, breathing, and circulation were maintained, that her vital signs were stable, and that she remained responsive to verbal stimuli. Between 8:55 a.m. and 9:15 a.m., P.L.'s status was unchanged. According to Ms. Hoff's notes, P.L.'s airway, breathing, circulation, and vital signs were maintained at normal levels, and she responded well to the Valium and oxygen. Ms. Hoff observed during this time that P.L. was lethargic and appeared to be a little more deeply sedated than typical Level II sedation. P.L. continued breathing on her own and responding to verbal stimuli. During this interval, Dr. Edison was waiting for P.L. to come out of sedation, and he intended to send her home and recommend that she see her doctor about the twitch. Ms. Hoff noticed a second facial twitch between 9:15 a.m. and 9:20 a.m., and Dr. Edison directed Ms. Hoff to call Emergency Medical Services to transport P.L. to the hospital. Ms. Hoff continued to monitor P.L.'s airway, breathing, circulation and vital signs until the Emergency Medical Services team arrived at 9:30 a.m. During this time, Ms. Hoff noted that P.L. responded to verbal stimuli by moving her head a little bit and attempting to open her eyes. P.L.'s oxygen saturation rate was consistently maintained at 99% to 100% between 8:20 a.m. and 9:30 a.m., when Emergency Medical Services arrived. During this time, P.L. was breathing independently and did not need any assistance with her airway. Emergency Medical Services received the call from Dr. Edison's office at 9:21 a.m. and arrived at 9:26 a.m. At that time, P.L. was receiving oxygen, her airway was normal, and her perfusion was good. Her blood pressure was 102/68, her pulse was strong and regular at 120 beats per minute, her respiratory rate was 20, her respiratory effort was normal, and her breath sounds were clear. She was, however, non-responsive: She was not able to open her eyes, she had no motor response, and she was not able to give a verbal response. She appeared to be having seizure activity in the form of twitching on both sides of the jaw line. P.L. was transported to Memorial Regional Hospital at 9:31 a.m., and she arrived at the hospital at 9:36 a.m. A notation on the EMS Report for the incident states that a "[l]ist of sedation medication [was] given to ER staff." Dr. Todd Gardner was the emergency room physician who treated P.L. on her arrival at Memorial Regional Hospital. His diagnosis on admission was status epilepticus and hypoxia. Status epilepticus is seizures that are unrelenting to normal therapeutic intervention, and hypoxia is low oxygen level. Dr. Gardner did not attribute a cause to the status epilepticus. Dr. Gardner's intake notes reflect that, prior to presenting at the emergency room, P.L. had received Ketamine, Labetalol to lower her blood pressure, and Valium to relieve the seizures. Nothing on the intake sheet indicates that P.L. had received Lidocaine, and there is no list of the medications given by Dr. Edison in the hospital file. Dr. Gardner intubated P.L. at 10:02 a.m. and placed her on a ventilator in the emergency room because she was unable to breathe on her own. He also treated her with Valium, Dilantin, and Diprivan, which is used to sedate patients in the intensive care unit. Dr. Robert Alterbaum, an internist specializing in pulmonary medicine and critical care, provided care to P.L. in the intensive care unit of Memorial Regional Hospital. P.L.'s chest X-ray was abnormal and showed pneumonitis, or an inflammation of the lungs, caused by fluid being aspirated into the lungs. Based on the emergency room chart, Dr. Alterbaum diagnosed P.L. with status epilepticus, or seizures, related to the administration of Ketamine during the pre-operative procedure for breast augmentation surgery. There was no objective medical evidence to support Dr. Alterbaum's conclusion that Ketamine was the cause of the seizures; he reached this conclusion because Ketamine was the only medication noted on the chart as having been administered to P.L. Dr. Alterbaum was not aware that P.L. had also received Lidocaine; had he been aware of this, it might have been information he would have considered in reaching his conclusion regarding the cause of P.L.'s seizures.6 P.L. was discharged from Memorial Regional Hospital on July 12, 2005. She had difficulty walking at first, but has fully recovered except that she sometimes experiences a little memory loss. Drugs administered to P.L. Valium Valium is a benzodiazopene used to control anxiety, and the standard dosage ranges from two to 20 milligrams for conscious sedation. Valium is a controlled substance. Ancef Ancef is an antibiotic. Ketamine Ketamine is a disassociative non-barbiturate analgesic used for sedation and general anesthesia; the maximum dosage is 4.5 milligrams per kilogram of body weight. Ketamine causes a large amount of secretions, and its effects last only five to 10 minutes. Ketamine is a controlled substance. Robinol Robinol is an anticholinergic medication used to prevent bradycardia, a heart rate of less than 60 beats per minute, and to help dry out secretions in mucous membranes. Robinol is contraindicated for a patient with tachycardia, or a heart rate of more than 100 beats per minute, however, because it could make the patient's heart rate increase. In a healthy 29 year-old patient such as P.L., however, it was not a violation of the standard of care to administer 0.2 milligrams of Robinol to P.L. even though her heart rate was 104 beats per minute at the time it was administered; a healthy 29-year-old patient could easily sustain a heart rate of 140 beats per minute without ill effects. Dr. Edison administered Robinol to P.L. as a drying agent, to control secretions brought on by the use of Ketamine. Although other drugs can be used to control these secretions, Robinol is the best drug for this purpose and the one most commonly used. Dr. Edison had ample justification for using Robinol under the circumstances, and he did not violate the standard of care by ordering Ms. Hoff to administer the drug even though P.L.'s heart rate slightly exceeded 100 beats per minute. Talwin Talwin is an opiate analgesic that is used to control pain, and the standard dosage is 30 milligrams. Talwin is a controlled substance. Nitrous oxide Nitrous oxide is an anesthetic gas that is used for analgesia and sedation; it was administered to P.L. by nasal cannula, which delivers a relatively small amount of gas. Diprivan Diprivan is a sedative hypnotic medication used both for intravenous sedation and for general anesthesia; the package insert recommends a dosage from 100 to 150 micrograms per kilogram of body weight per minute. Diprivan's clinical effects wear off approximately three minutes after its administration is discontinued. The total dose of Diprivan administered to P.L., 25 milligrams, was included in Dr. Edison's medical records, but the manner of administering the Diprivan and the rate of infusion are not recorded. Diprivan, together with other sedative drugs, may be administered in Florida by a registered nurse at the direction and under the supervision of a surgeon during Level II office surgery.7 Dr. Edison did not deviate from the standard of care in Florida by delegating responsibility to Ms. Hoff, an Advanced Registered Nurse Practitioner, for administering the various drugs to P.L., under his direction and supervision. Based on her training and experience, Ms. Hoff was qualified to administer these drugs to P.L. to achieve Level II sedation under Dr. Edison's direction and supervision. The combination of sedative drugs Dr. Edison ordered administered to P.L., specifically Diprivan, Ketamine, Talwin, Valium, and nitrous oxide, was appropriate to induce Level II sedation in P.L., and the dosage of each of the drugs administered to P.L. was well below the maximum dosage recommended for each of the drugs. These drugs work synergistically, however, and, depending on the patient and the circumstances, the same combination of sedative drugs could induce Level III sedation. Florida Administrative Code Rule 64B8-9.009 defines Level III office surgery and sets forth the standards that must be met, in pertinent part, as follows: Level III Office Surgery. Scope. Level III Office Surgery is that surgery which involves, or reasonable 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. * * * Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: * * * 4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. . . . One difference between Level II and Level III sedation is the degree of alertness of the patient. At Level II sedation, the patient must be able to respond to verbal and/or tactile stimuli. If a patient's only response is a reflexive withdrawal from a pain stimulus, the patient is sedated beyond Level II. A primary indication that a patient has slipped from Level II to Level III sedation is the loss of the ability to breathe without assistance, and the patient's airway must be partially or totally managed. In Level II sedation, the need for management of the airway is minimal compared to that required at Level III sedation. P.L.'s blood pressure, pulse rate, oxygenation, and mental state were consistent with Level II sedation until P.L. had her first seizure and all medications, except for the one- half therapeutic dose of Valium, were discontinued. She remained responsive to verbal stimuli after the second 2.5 milligram dose of Valium was given to control the seizure activity, even though she was more lethargic than normal under Level II sedation. P.L. was non-responsive when examined by Emergency Medical Services personnel, but she was breathing independently and was not at Level III sedation. Her lack of response was more likely than not the result of the seizures, after which a patient can go into a postictal state, or a trance of sleepiness.8 Dr. Edison did not violate the standard of care for office surgery in ordering the amounts and combination of drugs used to sedate P.L. because P.L. did not reach Level III sedation. In accordance with the standard of care for Level II office surgery, Ms. Hoff, as a registered nurse, was qualified to administer anesthesia to P.L., including Diprivan, Ketamine, and the other sedative drugs used in P.L.'s surgery, at the direction and under the supervision of Dr. Edison. Dosage of Lidocaine As stated above, Dr. Edison injected a dilute solution of Lidocaine with epinephrine and marcaine into the tissue around P.L.'s breasts between 8:25 a.m. and 8:45 a.m., before P.L. had her first seizure at 8:45 a.m. Lidocaine is a local anesthetic used to numb nerves and tissue. In breast augmentation surgery Dr. Edison always uses Lidocaine with epinephrine because epinephrine is a vasoconstrictor that causes intense vasoconstriction, or closing of the small blood vessels, which slows the rate of absorption of the Lidocaine and virtually eliminates bleeding at the site of surgery. Marcaine is also a local anesthetic similar to Lidocaine, but it is slow to take effect and lasts four to six hours and helps control pain after surgery is completed. Marcaine is commonly used with Lidocaine. It is Dr. Edison's practice to perform breast augmentation surgery using the tumescent infiltration technique to infuse a relatively large volume of dilute Lidocaine solution into the breast area as a local anesthetic. Dr. Edison uses this tumescent infiltration technique in breast augmentation surgery because he can deliver a large volume of Lidocaine that is evenly distributed throughout the breast area, which results in more effective pain reduction. The injection technique Dr. Edison uses for tumescent infiltration in the breast area is very specific, and it takes between 20 and 30 minutes to complete the injections. The needle cannot penetrate close to the pectoral muscle, especially in a woman as small as P.L., because of the danger of puncturing a lung. Dr. Edison injects the solution under pressure into the subcutaneous tissue between the breast and the pectoral muscle. Lidocaine is absorbed faster in areas that are highly vascular. The tissue in the aerolar space between the breast and the pectoral muscle does not contain many blood vessels, so Lidocaine injected in this tissue is absorbed more slowly than it would be if injected into highly vascular tissue. In Dr. Edison's experience, because the epinephrine in the Lidocaine solution causes intense vasoconstriction in the tissue surrounding the injection sites, the Lidocaine stays in place and numbs the area in which the surgery is to be performed. The Lidocaine solution is absorbed slowly over approximately 24 hours, and the peak serum concentration of Lidocaine occurs approximately 10 to 12 hours after it is administered. In this case, Dr. Edison prepared approximately 400 cubic centimeters of solution, which contained 700 milligrams of Lidocaine and 50 milligrams of marcaine, together with a small, non-therapeutic dose of epinephrine. According to his surgical notes, Dr. Edison began the injections of Lidocaine at 8:25 a.m. and had completed the injections by the time P.L. had the first seizure at 8:45 a.m., although it is his recollection that he had not used all of the Lidocaine solution he had prepared. Dr. Edison did not, however, record in the medical records the amount of Lidocaine solution he injected, and any remaining solution was discarded without being measured, so he does not know the dosage of Lidocaine P.L. actually received. Had he injected all of the solution, P.L. would have received approximately 14 milligrams of Lidocaine per kilogram of body weight. According to the package insert that accompanies a bottle of Lidocaine, the maximum dosage of Lidocaine without epinephrine is five milligrams per kilogram of body weight, and the maximum dosage of Lidocaine with epinephrine is seven milligrams per kilogram of body weight. There is nothing in Dr. Edison's medical records to indicate that the Lidocaine he used in P.L.'s surgery included epinephrine or that he calculated the amount of Lidocaine to administer to P.L. based on her body weight Using the maximum dosage specified on the package insert, the maximum dosage of Lidocaine without epinephrine for P.L. would have been 215 milligrams, and the maximum dosage of Lidocaine with epinephrine would have been 301 milligrams, using the traditional method of administering the drug. Based on the standard established by the package insert, Dr. Edison exceeded the maximum dosage of Lidocaine with epinephrine injected into P.L. by approximately 400 milligrams, which constituted a toxic dose of Lidocaine when measured by the maximum dosage stated on the package insert. The maximum dosage of Lidocaine with epinephrine stated on the package insert is routinely exceeded by surgeons performing liposuction, which involves suctioning fatty tissue. The tumescent infiltration technique using Lidocaine with epinephrine in a dilute solution is commonly used with liposuction, and Florida Administrative Code Rule 64B8- 9.009(2)(d), which sets out the standards of care for office surgery, specifically provides that a "maximum of fifty (50) mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting." Large dosages of Lidocaine can be safely used in liposuction because Lidocaine is metabolized more slowly by fatty tissue than by muscle or skin, and approximately 20% of the Lidocaine solution is suctioned out of the body with the fat that is aspirated during liposuction. As a result, it is possible to administer what would otherwise be toxic doses of Lidocaine under the maximum dosages specified in the package insert. Dr. Edison has used the tumescent infiltration technique many times in performing breast augmentations without his patients' suffering any ill effects. There is, however, no rule in Florida equivalent to that relating to liposuction that permits the use of high dosages of Lidocaine as local anesthetic in breast augmentation surgery. Furthermore, Dr. Edison has failed to submit persuasive evidence of a standard of care in Florida among plastic surgeons that would permit the use of dosages of Lidocaine with epinephrine in excess of the seven milligrams per kilogram specified on the package insert for breast augmentation surgery.9 Dr. Edison violated the standard of care by injecting approximately of 700 milligrams of Lidocaine with epinephrine into the tissue surrounding P.L.'s breasts when the maximum allowable dosage, according to the insert packaged with the drug and based on P.L.'s weight, was approximately 300 milligrams. Dr. Edison's previous discipline10 Dr. Edison was charged in an Administrative Complaint dated February 21, 1995, with having committed medical malpractice in violation of Section 458.331(1)(t), Florida Statutes. He executed a Consent Agreement in which he neither admitted nor denied the factual allegations in the complaint but agreed that, if proven, the facts would constitute a violation of Section 458.331(1)(t), Florida Statutes. The Agency for Health Care Administration entered a Final Order dated August 20, 1995, adopting the Consent Agreement in relevant part. This Final Order does not establish that Dr. Edison committed a violation of Section 458.331(1)(t), Florida Statutes. In a Final Order entered January 4, 2007, the Board adopted the recommended disposition in the Recommended Order in Department of Health, Board of Medicine v. Richard B. Edison, M.D., DOAH Case No. 06-0598PL (Recommended Order August 25, 2006), that Dr. Edison be found guilty of a single violation of Section 458.331(1)(m), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order Dismissing Counts Three and Four of the Administrative Complaint; Finding Dr. Edison guilty of a single violation of Section 458.331(1)(m), Florida Statutes, and of two violations of Section 458.331(1)(t)1., Florida Statutes; Suspending Dr. Edison's license for a period of 90 days, followed by four years' probation under such terms as shall be imposed by the Board; and Imposing an administrative fine in the amount of $15,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2007.
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.
