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 The issue is whether Respondent's Florida license to practice medicine should be revoked for malpractice under section 458.331(1)(t), Florida Statutes (2006).
Findings Of Fact Respondent is licensed to practice medicine in Florida, holding license number ME 66823. He is a radiologist and is certified by the American Board of Orthopedic Radiology and Diagnostic Radiology. On June 17, 2004, the Board of Medicine (Board) disciplined Respondent's medical license by issuing a letter of concern, imposing a $15,000 fine, assessing $4,010.59 in costs, requiring eight hours of continuing medical education, and prohibiting him from treating or prescribing medication to members of his family. On or about October 4, 2006, while working at Drew Medical, Inc., Respondent performed a diagnostic procedure called an intravenous pyelogram (IVP) without tomograms for Patient G.P., who had complained of right-side pain and had a history of kidney stones. An IVP without tomograms is a series of time- lapse x-rays using a dye material to provide radiographically contrasting images to detect a stone in a kidney or ureter. The resulting x-ray images revealed a partial obstructing stone in the right-side kidney/ureter area, which Respondent detected and reported. One of the resulting x-ray images contained an anomaly having the classical appearance of an abdominal aortic aneurysm, including conspicuous tissue displacement and rim calcification. It had an elongated, water balloon-type appearance with calcifications on one of the walls. It was alarming or life- threatening in size, such that it could cause death by bleeding. Respondent did not mention the aneurysm in his report or recommend any further evaluation of the anomaly. Although he was tasked to look for kidney stones, Respondent's failure to report the aneurysm or recommend any further evaluation of the anomaly fell below the level of care, skill, and treatment that is recognized by reasonably prudent, similar physicians as being acceptable. Patient G.P. was admitted to Orlando Regional Hospital with a ruptured abdominal aortic aneurysm on October 6, 2006. Attempts were made to repair the rupture, but they were not successful. The patient died on October 12, 2006. By his conduct in disappearing without a trace, despite the diligent efforts of DOH to find him, and not participating in any manner in the hearing he requested to dispute the Administrative Complaint, Respondent effectively abandoned his license to practice medicine in Florida.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of medical malpractice, revoking his medical license, and imposing a $10,000 administrative fine. DONE AND ENTERED this 25th day of July, 2012, in Tallahassee, Leon County, Florida. S J. LAWRENCE JOHNSTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of July, 2012. COPIES FURNISHED: Greg S. Marr, Esquire Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Robert Dean Marshall, M.D. Apartment 310 400 East Colonial Drive Orlando, Florida 32803 Robert Dean Marshall, M.D. 5987 Southwest Moore Street Palm City, Florida 34990 Jennifer A. Tschetter, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Joy Tootle, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The following issues of fact were considered: Did the Respondent aid, assist, procure, or advise an unlicensed person to practice medicine? Did the Respondent delegate professional responsibilities to persons when he knew or had reason to know that said persons were not qualified by licensure to perform them? Did the Respondent presign prescription forms? Both parties submitted posthearing findings of fact, which were read and considered. Those findings not incorporated herein are found to be either subordinate, cumulative, immaterial, unnecessary, or not supported by the evidence.
Findings Of Fact The Respondent, Albert P. Oteiza, is licensed to practice medicine and surgery in the State of Florida and has been so licensed at all times relating to the charges in the Administrative Complaint. The Respondent was president and director of the Union Latina Association, Inc. (the Association), located at 1313 Southwest First Street, Miami, Florida. The Respondent was paid by the Association, which provided medical services to patients who were members of the Association. The Respondent practiced at Clinical Union Latina (the Clinic), located at 1313 Southwest First Street, Miami, Florida, and was the medical director of the Clinic. The Respondent was not an officer or director of the Clinic. The president of the Clinic was Rigoberto Garcia, and the business manager was Christian Carmona. Florencio Sanchez-Lopez was employed as a physician's assistant at the Clinic by Christian Carmona, who assigned Sanchez-Lopez's duties. Sanchez-Lopez was not a licensed physician and was not a certified physician's assistant. Sanchez-Lopez admitted seeing and treating patients at the Clinic. Sanchez- Lopez saw those patients who were in serious condition in the presence of the Respondent. Those patients who were not in serious condition, Sanchez-Lopez saw without the Respondent being present, and Sanchez-Lopez prescribed treatment and medications for these patients. Sanchez-Lopez examined and prescribed medications and treatment for Ralph Nunez, an investigator for the Board of Medical Examiners, in the manner Sanchez-Lopez had admitted to examining and prescribing for other patients. Valerio Matta was employed as a physician's assistant at the Clinic by Carmona, who assigned Matta's general duties. Matta was not a licensed physician or a certified physician's assistant. Matta saw patients at the Clinic, examining them and prescribing medications and treatment for them without the presence of a licensed physician, as he did with Georgina Jorge, an investigator with the Department of Professional Regulation. Matta also admitted that he had performed minor surgery on patients, but only when the Respondent was present in the Clinic. Carlos Manuel Rodriguez-Murgia was employed as a physician's assistant at the Clinic by Carmona, who assigned Rodriguez-Murgia his general duties. Rodriguez-Murgia was not a licensed physician or certified physician's assistant. Rodriguez- Murgia saw patients at the Clinic, examining and prescribing medications and treatment for them without the presence of a licensed physician, as he did with Georgina Jorge, an investigator with the Department of Professional Regulation. The acts performed by Sanchez-Lopez, Matta, and Rodriguez-Murgia all constituted the practice of medicine. However, these acts did not exceed the acts which could have been performed by a physician's assistant. The Respondent was aware or should have been aware that Sanchez-Lopez, Matta, and Rodriguez-Murgia were engaged in seeing patients at the Clinic and performing acts which constituted the practice of medicine. Carmona was deceased at the time of the hearing. Garcia, president of the Clinic, outlined Carmona's duties. Carmona was responsible for having Sanchez-Lopez, Matta, and Rodriguez-Murgia certified as physician's assistants. All three men confirmed that Carmona represented to them they would be licensed and they were "legal" to perform their duties. Sanchez-Lopez, Matta, and Rodriguez-Murgia could not swear that it was the Respondent's signature on the prescriptions they used or that they had seen the Respondent sign the prescriptions. There were other licensed physicians who worked at the Clinic.
Recommendation Having found the Respondent guilty of three counts of violating Section 458.331(1)(w), Florida Statutes, as alleged in the Administrative Complaint, it is recommended that the Board of Medical Examiners suspend the license of the Respondent, Albert P. Oteiza, for a period of 12 months and assess a civil penalty against him of 3,000. DONE and RECOMMENDED this 17th day of October, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, 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 17th day of October, 1983. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Blas E. Padrino, Esquire 2355 Salzedo, Suite 309 Coral Gables, Florida 33134 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION Petitioner, vs. Case No. 83-122 ALBERT P. OTEIZA, M.D., License No. 20879 Respondent. /
The Issue The issue in this case is whether Respondent, Andrew Logan, M.D., committed a violation of Section 458.331(1)(t), Florida Statutes, as alleged in an Administrative Complaint filed by Petitioner, the Department of Health, on April 30, 2003, and, if so, what disciplinary action should be taken against him.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. Respondent, Andrew Logan, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 0058658. Dr. Logan's last known business address is 8551 West Sunrise Boulevard, Suite 105, Plantation, Florida 33322. At the times material to this matter, Dr. Logan was certified in ophthalmology. He specializes in medical and surgical ophthalmology. Dr. Logan received a bachelor of arts degree in biology in 1982 from Brown University. He received his medical degree in 1986 from the University of California, San Francisco.2 Dr. Logan completed a residency in ophthalmology. Dr. Logan has practiced medicine in Florida since 1990. At the times relevant to this matter, Dr. Logan worked in a group practice in Plantation, Florida. Most of his practice consisted of an office practice, seeing patients. He also performed some laser and minor surgeries in the office. Approximately once a week, for half a day, he performed surgery out of the office at "three hospitals and surgical centers." Dr. Logan's license to practice medicine has not been previously disciplined. The Department's Administrative Complaint and Dr. Logan's Request for Hearing. On April 30, 2003, the Department filed an Administrative Complaint against Dr. Logan before the Board of Medicine (hereinafter referred to as the "Board"), alleging that his treatment of one patient, identified in the Administrative Complaint as C. S., constituted gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances (the recognized acceptable treatment will hereinafter be referred to as the "Standard of Care"), a violation of Section 458.331(1)(t), Florida Statutes. In particular, it is alleged in the Administrative Complaint that Dr. Logan violated the Standard of Care in "one or more of the following ways": Respondent failed to identify the correct patient for the implantation of the 23 diopter lens; Respondent failed to verify that the lens he implanted into Patient C.S. was the power of lens that he had previously ordered; Respondent implanted the wrong lens into the left eye of Patient C.S. The factual allegations of the Administrative Complaint, although stated differently, essentially allege that Dr. Logan operated on the wrong patient. Dr. Logan filed a request for a formal administrative hearing with the Department, which was filed by the Department with the Division of Administrative hearings. Treatment of Patient C.S. C.S., who was 70 years of age at the time of the incident involved in this matter, began seeing Dr. Logan for eye care in approximately February 1997. C.S. developed cataracts in both eyes, for which Dr. Logan diagnosed and suggested surgical treatment.3 Dr. Logan explained the procedure he believed necessary to remove C.S.'s cataracts to her and obtained her approval thereof. The procedure to be performed on C.S., known as phacoemulisification, consisted of making an very small incision in her eye, breaking up her natural, or intraocular, lens with ultrasound, irrigating the eye, and then suctioning out the destroyed lens and irrigation material. Once the intraocular lens is removed, it is replaced with an artificial lens, the power and model of which is selected by the physician. Dr. Logan determined that the lens needed to restore C.S.'s vision in her left eye after removal of her intraocular lens was a 15-diopter lens. The "diopter" of a lens relates to the corrective power of the lens. C.S. was scheduled for the planned cataract surgery on her left eye at the Surgery Center of Coral Springs (hereinafter referred to as the "Surgery Center") for the morning of September 5, 2000.4 C.S. was one of at least two patients scheduled for surgery by Dr. Logan that morning. The Surgery Center is a free-standing center where various types of surgery are performed. Dr. Logan was not an owner or employee of the Surgery Center. He did not hire, nor could her fire, any employee of the Surgery Center, and none of the equipment utilized in the Surgery Center was owned by him.5 Consistent with established procedures, the Surgery Center was faxed information concerning C.S.'s scheduled surgery. In particular, the facsimile identified C.S. by name, which eye was to be operated on (her left eye), and the power (15-diopter) and model number of the replacement lens Dr. Logan had determined was necessary to restore C.S.'s vision after the surgery. The day before C.S.'s scheduled surgery, Dr. Logan was provided with C.S.'s patient records and the records of the other patient scheduled for surgery on September 5, 2000. He reviewed those records either that afternoon or that night. He also took the records with him to the Surgery Center where he reviewed them again. On or around the morning of September 5, 2000, the Surgery Center's nurse manager took the facsimiles that had previously been sent to the Surgery Center by Dr. Logan's office and retrieved the lens for each patient scheduled for surgery that day. When the nurse manager retrieved the lens, she was expected to ensure that the ordered lens, both as to power and model, were available, and that they were within their expiration date. She then bundled the lens and the facsimile. Three lens per patient were routinely retrieved. The bundles were then placed on a table in the operating room in the order they were supposed to be used. The order of surgery for September 5, 2000, had been prearranged and that information was available on a list prepared by the Surgery Center to all of those involved in the surgery that morning, including Dr. Logan and his surgery team. C.S. had been scheduled to be the second patient seen that morning. When C.S. arrived at the Surgery Center she was eventually taken to a pre-operation room (hereinafter referred to as "pre-op") to be readied for surgery. The patient who had been scheduled for the first surgery of the morning (hereinafter referred to as the "First Scheduled Patient"), had been late arriving on September 5, 2000. C.S. had come early. Therefore, C.S. was taken to pre-op in place of the First Scheduled Patient. What exactly transpired after C.S. was taken to pre-op was not explained. The nurse manager, who had overall responsibility for getting patients ready for surgery did not testify during this proceeding and the circulating nurse, Ann Tuza, was unable to recall what took place in any detail. What was proved is that Dr. Logan was not informed of the switch and the records and lens, which had been placed in the order of the scheduled surgeries for that day, were not changed to reflect that C.S. would be taken to surgery in place of the First Scheduled Patient. Therefore, although C.S. was the first patient into surgery, the records and lenses of the First Scheduled Patient were not replaced with C.S.'s records or lens. As was his practice, before going into the operating room, Dr. Logan went to pre-op to administer a local anesthesia. Dr. Logan, who had not been informed that the second scheduled patient, C.S., had been substituted for the First Scheduled Patient, administered the anesthesia to C.S. Dr. Logan found C.S. asleep. Dr. Logan did not recognize C.S. and he did not speak to her, as would have been his practice had she been awake, or otherwise identify her. Dr. Logan injected a local anesthesia by needle under and behind C.S.'s left eye,6 a procedure referred to as a "block" or "retrobulbar block."7 After the block had time to take effect, which normally took approximately five to ten minutes, Nurse Tuza went to retrieve C.S. from pre-op and bring her to the operating room. C.S. was brought into the operating room by Nurse Tuza and prepared for surgery. She was covered completely except for her feet and her left eye, which had an "X" placed over it to identify the eye to be operated on. Nurse Tuza remained in the operating room, along with a scrub technician, who assisted Dr. Logan, and a nurse anesthetist. None of these individuals apparently checked to ensure that they were correct in their assumption that the patient was the First Scheduled Patient. Dr. Logan, who did not recall what he did between seeing C.S. in pre-op and arriving at the operating room, completed scrubbing and entered the operating room where C.S. awaited. He had placed his charts in the operating room. His routine after arriving in the operating room was to go to the head of the patient and adjust a microscope used during the surgery. It is inferred that he did so on the morning of September 5, 2000. Although C.S. was awake when she was taken into the operating room and during the surgery, no one, including Dr. Logan, asked her her name. Nor did anyone, including Dr. Logan, check to see if she was wearing a wrist-band which identified her. Instead everyone, including Dr. Logan, assumed that they were operating on the First Scheduled Patient. Not actually knowing who he was operating on,8 Dr. Logan performed the surgery scheduled for the First Scheduled Patient on C.S. Although the procedure her performed on C.S., fortunately, was the same one scheduled for C.S., the diopter of the replacement lens was not.9 The First Scheduled Patient was to receive a 23-diopter lens, rather than C.S.'s 15- diopter lens. Dr. Logan placed the 23-diopter lens in C.S.'s eye, completed the procedure, and C.S. was taken to recovery. When Nurse Tuza went to get the next patient for surgery, who she expected to be C.S., she discovered for the first time that C.S. had been substituted for the First Scheduled Patient. She immediately informed Dr. Logan of the error. Dr. Logan went to the recovery room and, after ensuring that C.S. was alert enough to comprehend what he was saying, informed C.S. of the error. She consented to Dr. Logan's suggestion the he take her back into the operating room, remove the 23-diopter lens, and replace it with the correct, 15-diopter lens, which he immediately did. The replacement procedure required no additional trip to the Surgery Center, anesthesia, or incisions. C.S. recovered from the procedures without problem or direct harm. She continued to see Dr. Logan as her eye care until a change in insurance prevented her from doing so. Standard of Care. There was little dispute that Dr. Logan "failed to identify the correct patient for the implantation of the 23 diopter lens"; "failed to verify that the lens he implanted into Patient C.S. was the power of lens that he had previously ordered [for her]"; and "implanted the wrong lens into the left eye of Patient C.S." These facts, which form the factual basis for the Department's allegation that Dr. Logan violated the Standard of Care, have been proved. Including Dr. Logan, five physicians gave opinions in this proceeding as to whether Dr. Logan's actions violated the Standard of Care: Drs. William Cobb, Harry Hamburger, Joel Kramer, and Lowell Sherris. The testimony of Drs. Cobb and Kramer, primarily, and, to a lesser degree, the testimony of the Dr. Logan and the other two physicians, support a finding that Dr. Logan's actions, as alleged in the Administrative Complaint, constitute a violation of the Standard of Care. The testimony of Drs. Cobb, Kramer, and Sherris, which was credible and persuasive, have been summarized in the Department's proposed recommended order, and will not, in light of recent changes in Section 456.073(5), Florida Statutes, be summarized in any detail here. All of the physicians who testified, including Dr. Logan, agreed that a physician must know on whom he or she is operating and that operating on the wrong patient or inserting the wrong lens in a patient's eye is inappropriate. Dr. Logan, with Dr. Hamburger's support, attempted to prove that Dr. Logan did not violate the Standard of Care, despite the fact that he "failed to identify the correct patient for the implantation of the 23 diopter lens"; "failed to verify that the lens he implanted into Patient C.S. was the power of lens that he had previously ordered [for her]"; and "implanted the wrong lens into the left eye of Patient C.S.," by suggesting the following: It is reasonable and common practice in the South Florida community for a physician to rely on the staff of a surgical center to identify a patient prior to surgery and bring the patients [sic] back in the order originally anticipated. Dr. Logan had several safeguards in place to avoid the error that occurred in this case. The standard of care does not require that physician act as a supervisor who is responsible for every act of the healthcare provided team. This incident occurred due to an error of the staff at the Surgical Center at Coral Springs. . . . . Respondent's Proposed Final [sic] Order, paragraph 78. The proposed findings quoted in paragraph 37 are based primarily on Dr. Hamburger's, and to a lesser extent, Dr. Logan's, assertion that the surgery was a team effort, that the team had established procedures to identify the patient, and that the team failed in this instance to properly identify the patient. This testimony, and the proposed findings quoted in paragraph 37 are rejected. Nothing in the procedures followed in this instance alleviated Dr. Logan's responsibility to ensure that he actually established for himself who he was about to perform surgery on, a task which would have taken little effort.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Andrew Logan, M.D., has violated Section 458.331(1)(t), Florida Statutes (2000), as alleged in the Administrative Complaint, requiring the payment of an administrative fine of $5,000.00, completion of four hours of continuing medical education in risk management, and attendance at a one hour lecture on wrong patient surgery and how to avoid it, and issuing Dr. Logan a letter of concern from the Board of Medicine. DONE AND ENTERED this 19th day of February, 2004, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 19th day of February, 2004.
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS 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 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue Should the certificate of registration of Petitioner, Professional Pain Management, Inc., License No. PMC 296, as a privately-owned pain management clinic, be revoked?
Findings Of Fact Petitioner, Professional Pain Management, Inc., License No. 296, is a pain management clinic (PMC) subject to the requirements of sections 458.3265 and 459.0137, Florida Statutes (2010).1/ PMC 296 is not wholly-owned by medical doctors (M.D.s), osteopathic physicians (D.O.s), or a combination of M.D.s and D.O.s. PMC 296 is not a health care clinic licensed under chapter 400, part X, Florida Statutes. PMC 296 has three equity shareholders. Their names and percentages of ownership interests are: Robert Ciceles (20 percent); Terra Hom (40 percent), and Erez Cohen (40 percent). None of the three equity shareholders is a physician, M.D. or D.O. Erez Cohen is, and at all pertinent times, has been president of PMC 296. He is not an M.D. or a D.O. Since at least August 2010, the owners and officers of PMC 296 were aware of the requirement that it be wholly physician-owned, effective October 1, 2010. PMC 296 was, at all times pertinent to this proceeding, not wholly-owned by physicians, M.D.s, D.O.s, or a combination of M.D.s and D.O.s. A dispute among the shareholders arising out of a dissolution of marriage proceeding has prevented PMC 296 from establishing ownership by a M.D., a D.O. or a combination of M.D.s and D.O.s. Management of PMC 296 plans to transfer ownership to physicians at an unspecified future date once the shareholder dispute is resolved. There was no evidence of any exemption from the operation of sections 458.3265 and 459.0137 presented at the hearing.
Recommendation Based on the foregoing Findings of Fact and Conclusion of Law, it is RECOMMENDED that the Department of Health issue a final order revoking the certificate of registration of Professional Pain Management, Inc., License No. PMC 296. DONE AND ENTERED this 30th day of September, 2011, in Tallahassee, Leon County, Florida. S JOHN D. C. NEWTON, II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 2011.
