The Issue Whether Petitioner is qualified to be licensed as a medical doctor in Florida by endorsement.
Findings Of Fact Petitioner Jeffrey Jad Gaier applied for licensure by endorsement in Florida by filing a written application in November of 1983 with the Board of Medical Examiners, which is within the Department of Professional Regulation. He made a personal appearance before the Foreign Graduate Committee of the Board of Medical Examiners in April 1984. After Petitioner's appearance before the Foreign Graduate Committee, the Foreign Graduate Committee made a favorable recommendation regarding Petitioner's application for licensure to the Board of Medical Examiners. However, the full Board of Medical Examiners voted to deny Petitioner's application for licensure. On May 21, 1984, the Board of Medical Examiners rendered an Order denying Petitioner's application for licensure as a physician by endorsement, stating as the grounds: Your application and supporting documentation does not provide sufficient information to demonstrate that you can practice medicine with reasonable skill and safety. See Section 458.331(3), F.S. More specifically, the clinical training you received while attending the American University of the Caribbean as disclosed within your documentation was determined to be insufficient insofar as the clinical training was not received at a hospital affiliated with a medical school approved by the Counsel [sic] on Medical Education of the American Medical Association. The denial of Petitioner's application for licensure by endorsement was taken before the Board of Medical Examiners for reconsideration on February 3, 1985. Counsel for Petitioner was present at the hearing. At that hearing, the discussion by the Board of Medical Examiners of the request for reconsideration clarified the basis for the denial of the medical license as being the overall inadequacy of the clinical training and not specifically because the clinical training was not obtained at teaching hospitals. Except for the purposes of clarifying the issue(s) herein the collegial actions of the board are irrelevant to the instant de novo proceedings. Petitioner received a B.S. degree from Clark University, Massachusetts and a Masters degree in science education from Florida Institute of Technology, August 1978. Petitioner was granted a medical degree by the American University of the Caribbean after being enrolled at that school for less than three years. During that time, Petitioner was on the campus of the American University in Montserrat, British West Indies for only eight months. There the class used prepared slides instead of gross tissue samples. Before that, Petitioner studied at the campus in Cincinnati, Ohio, where the class used rubber cadavers instead of human cadavers. All of the clinical training received by Petitioner as part of the requirements for the completion of the medical degree consisted of preceptorships at hospitals in south Florida which included Florida Medical Center, Plantation General Hospital, University Community Hospital, and Bennett Community Hospital. Dr. Neil Katz, Petitioner's principal expert medical witness, supervised Petitioner for six weeks in a preceptorship in Family Practice. Dr. Katz is a board-certified Family Physician and a fellow of the American Academy of Family Practice. He has been Chairman of the Emergency Room Department, a member of the Credentials and Qualifications Committee, and a member of the Intensive Care Unit Committee at University Hospital, Tamarac, Florida. He has taught both foreign medical students in a clinical setting and has briefly qualified as a preceptor for the University of Florida College of Medicine. Dr. Katz actually supervised Petitioner only for the six-week period at the very beginning of Petitioner's rotations. After that six-week period of time, he only "touched base" with Petitioner, seeing him on an informal basis in the cafeteria or at meetings. During the six weeks formal observation period, Petitioner accompanied Dr. Katz in his work in his office, during hospital rounds, at the emergency room, and for most other activities that Dr. Katz participated in, including committee meetings at the hospital. Petitioner took histories and did physicals on patients under direct supervision. Petitioner displayed enthusiasm and energy in his association with Dr. Katz and the rest of the program. Dr. Katz found Petitioner "barely acceptable" in three of the nine categories for which he was to evaluate Petitioner during the preceptorship. These categories were diagnostic acumen, therapeutics and management, and medical knowledge. In explaining that evaluation, Dr. Katz testified that although Petitioner was able to take a history and a physical examination, he was not able to make a diagnosis. In fact, Dr. Katz testified that Petitioner did not have truly acceptable knowledge at the time as to the various therapeutic modalities available to a physician. He encouraged Petitioner to do more reading. During his preceptorship with the University of Florida Medical School students in their first clinical semester, Dr. Katz also saw problems similar to those exhibited by Petitioner, specifically that the University of Florida students were not "super ready," so to speak, on diagnosing and doing differential diagnoses and therapeutics at that particular stage in medical school because they were still learning. I accept Dr. Katz' opinion that Petitioner had adequate exposure to the major diseases and injuries which are common to Family Medicine, sufficient for Petitioner to go into an internship, but in light of his lack of involvement with Respondent's other preceptorships in several different hospitals after the first six weeks, and in light of his specific testimony that in his professional opinion, American-trained students were far superior to the Caribbean-trained students at the same level in terms of general knowledge (TR-65-66), Dr. Katz' opinion that Petitioner did "quite good" at the end of the year and a half period is without adequate predicate and is not persuasive. Dr. Isidoro Dunn was the primary force in the arrangements for preceptorships. Dr. Dunn talked with each preceptor to work out areas which should be covered in their respective rotations. Each preceptor had a "fair amount of latitude" in deciding how to supervise the students. Petitioner was assigned by his school to do his clinical rotations in Florida. He did 14 weeks in internal medicine, 14 weeks in surgery, 10 weeks in pediatrics, 10 weeks in obstetrics/gynecology, 4 weeks in psychiatry, and 10 weeks in electives. This totals 62 weeks, not even close to two years which is the norm in medical schools in the United States. Petitioner was required to follow patients from admission to discharge in each specialty within each of these clinical rotations. Petitioner had didactic teaching on a daily basis, weekdays. Petitioner represents that he had specific didactic courses in hematology, EKG readings, pathology, orthopedics, cardiology, radiology, and gastrointestinal invasive procedures. In each subspecialty, he had a written examination after completion of the rotation, didactic teachings in each rotation, and was required to read medical journals. On Saturdays, Petitioner was required to participate in case conferences, make case presentations, and complete assigned reading from current medical journals. The case presentations necessitated review of patient records, laboratory tests, x-rays, and pathology slides. On "patient management reviews," the Petitioner was "exposed to" or "spent time in" the dialysis unit, pathology laboratory, intensive care unit, emergency room, gastrointestinal unit, blood lab, catherization department, radiology department, EKG unit, and cardiac surgery unit. Petitioner testified, and Dr. Katz confirmed, that there was an entity called the "Doctors' Club," which had a considerable amount of audiovisual equipment available for use 7 days a week, 24 hours each day. Practicing physicians used this media to obtain continuing medical education approved for credit by the American Medical Association. Petitioner represented that "on several days" he signed out equipment or reading material. There is no precise language in his testimony that he used the equipment or that he read the reading material, but drawing any other inference is straining the clear meaning of Petitioner's unrebutted testimony. Petitioner and the other students were required to use various materials from this service, but there is no evidence that Petitioner or other students were objectively checked by Dr. Dunn or their preceptors to verify that they had actually read or viewed the material assigned. Petitioner specifically testified that there was not necessarily any follow-up by the preceptors. Dr. Katz did talk with Petitioner about the reading assignments he gave. Petitioner was required to pass a competency examination for each rotation. Petitioner's clinical studies evaluation forms in his school records indicate no overall evaluation grades below "Good." Petitioner was required to attend and pass both a written and practical examination for a two-day Advanced Cardiac Life Support Course. This course is required even of board certified emergency room (ER) physicians. In Petitioner's opinion, this course was imperative for medical doctors who might work in an emergency room because they need to be very familiar with how to handle a patient presenting with a cardiac arrest, including the administration of drugs, "cardioversion" and "intubation." To the best of Petitioner's knowledge, Dr. Dunn was to report the students' progress to the dean of the American University of the Caribbean. However, the predicate for that testimony is hearsay, uncorroborated by any direct, credible evidence. As for the relationship with the university, Dr. Katz had no knowledge as to any arrangement between Dr. Dunn and the American University of the Caribbean or any counterpart-sponsoring organization in the United States. He did not know if there was any arrangement whatsoever. Dr. Katims was accepted as an expert physician witness, as an expert teaching fellow witness, and as an expert witness in medical applications and licensure. He testified that in the normal course of medical education in the United States, part of a student's medical education is clinical training, and that experience consists of bedside outpatient treatment and supervised training under the supervision of a faculty selected particularly for their knowledge, background, and interest in education and teaching. Dr. Katz testified unequivocally that a preceptorship is very different from a clinical rotation or a clerkship. A clerkship takes place in a teaching hospital, which is a very structured environment, wherein students make rounds in a very large hospital and are given instruction in an approved clinical structure. In contrast, a preceptorship gives students more knowledge about what private practice is like and it gives students a view of direct patient care, but does not replace a formal teaching setting in clinical medicine. As recognized above, in Dr. Katz' opinion, American-trained students were far superior to the Caribbean-trained students at the same level in terms of general knowledge. In Dr. Katims' opinion, Petitioner's clinical studies consisting of only four semesters were not sufficient for him to practice medicine with reasonable skill and safety. Dr. Katims testified concerning the importance of clinical training in medical education, commenting that clinical training is the sine qua non of the practice of medicine. In the usual clinical rotation, medical students are assigned to a particular area of a hospital and perform under the full-time supervision of attending physicians. In teaching hospitals, faculties are selected for their ability, interest, and dedication to education, as well as to the practice of medicine. The attending staff at a teaching hospital include house physicians, interns, and residents. Dr. Katims himself has served as a preceptor and testified that a preceptorship is one method of obtaining a minor portion of clinical training, but is very unstructured and unsupervised. Dr. Katims testified that preceptorship training is an inferior method of training because the quality of training depends totally on the quality of the physician to whom the student is assigned and the program is unstructured. There was no testimony that any of the preceptors that supervised, or purportedly supervised, Petitioner were faculty members of any medical school, let alone the American University of the Caribbean. Upon the Requests for Admissions and the Joint Pre-Trial Stipulation of the parties, it is found that: the State of Florida Board of Medical Examiners has granted a medical license to a Dr. Flugsrud-Breckenridge and a Dr. Cobb, both having non-teaching clerkships. Three doctors, Adela Fernandez, Andrew Gonzalez, and Manuel E Garcia, did their clerkships principally at the International Hospital (Miami), a non-teaching/non-medical school-associated hospital, and obtained Florida medical licenses. At least 25 foreign graduates received Florida medical licenses within the years 1981-1984 and did their clerkships principally in non-teaching/non-medical school associated hospitals. No further information appears of record by which the undersigned may determine any other similarities or dissimilarities of these licensees to each other and/or to Petitioner. Nor does the record divulge what, if any, other facts may have been considered in these cases. Petitioner is licensed to practice medicine in Georgia and is a resident of Florida. Petitioner passed the first time his Educational Commission for Foreign Medical Graduates' (ECFMG) examination was given in June, 1981. The examination is a prerequisite to acceptance in a medical residency program. The Federation of State Medical Boards of the United States, Inc.'s (FLEX) examination is recognized by all 50 states, including Florida. Petitioner took this examination after completing his rotations in Florida. Petitioner passed the June 1982 FLEX examination with an 84 percentile ranking. Fifty percent of this test is on patient management. This clinical competence examination was taken before Petitioner started his first year of residency. Petitioner had passed the FLEX examination, completed one year of residency, and obtained a medical license in another state, Georgia, by the time of the April 1984 application hearing. In Dr. Katims' opinion, Petitioner's successful passage of the FLEX examination in the 84 percentile does not show Petitioner to have had good clinical rotations, even though the FLEX test consisted of 50 percent on patient management. Dr. Katims did not feel that by the time Petitioner was in his fourth year of residency, this would be curative of deficiencies in the clinical semesters at a non-teaching hospital, but expressed the opinion that if Petitioner passes his internal medicine board examination and becomes board certified, his clinical deficiencies would be cured and Petitioner should then be granted a Florida medical license by endorsement. Dr. Katz opined that Petitioner presently possesses the medical knowledge, judgment and competency to act with reasonable skill and safety in the practice of medicine in Florida. Affidavits of Ira Spiler, M.D. and John R. Middleton, M.D. support similar opinions of these New Jersey medical physicians. Petitioner has completed three years (July 1, 1982 to June 30, 1985) of Internal Medicine residency at Raritan Bay Medical Center, Perth Amboy General Hospital, New Jersey. Petitioner is presently enrolled in a Nephrology Fellowship program, Medical College of Georgia, a teaching hospital located at, and affiliated with, the University of Georgia Medical School. Petitioner is currently eligible for board certification in internal medicine and will be certified in the event he passes the board examination taken September 10-11, 1985. Petitioner has submitted letters of Ira Spiler, M.D. and Salvatore Chiaramida, M.D., both of New Jersey attesting to Petitioner's good moral character, and no contrary evidence was turned up by the Board's investigation. The parties have stipulated that Rule 21M-22.18, Florida Administrative Code, is not applicable to Petitioner's situation.
Recommendation That the Florida Board of Medical Examiners enter a final order denying Petitioner a medical license by endorsement. DONE and ORDERED this 16th day of January, 1986, in Tallahassee Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of January, 1986.
Findings Of Fact At all times material to this proceeding, Respondent was licensed to practice medicine in the State of Florida, with license number 0017339. On October 25, 1979 the Commission on Medical Discipline of Maryland, licensing authority for the State of Maryland, revoked Stanley Radvan- Ziemnowicz's (Ziemnowicz) license to practice medicine in the State of Maryland. On August 18, 1981 the commission on Medical Discipline of Maryland denied Ziemnowicz's petition for reinstatement from its order of revocation dated October 25, 1979. On January 3, 1984, the Commission on Medical Discipline of Maryland granted Ziemnowicz a stay of its order dated October 25, 1979 revoking his license to practice medicine in the State of Maryland and placed him on probation. On April 29, 1986 the Commission on Medical Discipline of Maryland entered an order withdrawing the stay of its order dated October 25, 1979 entered on January 3, 1984 and again revoked Ziemnowicz's license to practice medicine in the State of Maryland. Stanley Radvan-Ziemnowicz whose license to practice medicine in Maryland was revoked on April 29, 1986 is the same Stanley Radvan-Ziemnowicz who is the Respondent in this Respondent's license to practice medicine in the State of Maryland has not been reinstated since the entry of the Order by the Commission on Medical Discipline of Maryland, dated April 29, 1986, and Respondent's license to practice medicine in the State of Maryland is currently revoked.
Recommendation Based upon the Findings of Fact and Conclusions of Law recited herein, and there being no mitigating circumstances presented by the Respondent, it is RECOMMENDED that the Board enter a Final Order revoking Respondent's license to practice medicine in the State of Florida. Case No. 87-3183 Respectfully submitted and entered this 4th day of December, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 4th day of December, 1987. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-3183 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the Petitioner in this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Finding or Fact 1. Adopted in Finding of Fact 2. Rejected as not supported by the evidence in the record in that the order of the Commission of August 18, 1981 denied Respondent's reinstatements to practice medicine. Rejected as not supported by the evidence in the record in that it was the Order of January 3, 1984, that entered the stay and placed the Respondent on probation. Adopted in Findings of Fact 5 and 6. 6.-7 Adopted in Finding of Fact 7. Rulings on Proposed Findings of Fact Submitted by the Respondent The Respondent did not submit any Proposed Findings of Fact or Conclusions of Law. COPIES FURNISHED: Susan Branson, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Stanley Radvan-Ziemnowicz, M.D. 9400 Old Georgetown Road Bethesda, Maryland 20014 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Executive Director Department of Professional Regulation Board of Medicine 130 N. Monroe St. Tallahassee, Florida 32399-0750
The Issue The issue in these two consolidated cases is whether disciplinary action should be taken against Luis J. Marti, M. D., hereinafter referred to as "Respondent Marti," and/or Jesus Escar, M.D., hereinafter referred to as "Respondent Escar," based upon the alleged violations of Chapter 458, Florida Statutes, contained in the separate Administrative Complaints filed against each of the Respondents.
Findings Of Fact Based on the stipulations of the parties; on the testimony of the witnesses, and on the exhibits received in evidence at the hearing; I make the following findings of fact. Respondent Escar is, and has been at all times material hereto, a licensed physician in the state of Florida, having been issued license number ME 0034247. Respondent Escar's last known address is 935 West 49th Street, Suite #107, Hialeah; Florida 33012. Respondent Marti is, and has been at all times material hereto, a licensed physician in the state of Florida, having been issued license number ME 0034842. Respondent Marti's last known address is 24355 West Flagler Street, Miami, Florida 33125. Respondent Marti went to medical school in Madrid, Spain. In approximately 1970, while Respondent Marti was in medical school in Madrid, Spain, Respondent Marti met Jose A. Tudela for the first time. At the time, Tudela had come to Madrid, Spain, for the purposes of starting medical school. In approximately 1975, while Respondent Marti was working as a resident at Cedars of Lebanon Hospital, Respondent Marti again saw Jose A. Tudela. At about the same time, Respondent Escar met Tudela for the first time. Tudela's father, Francisco Tudela, a physician, was an attending physician at Cedars of Lebanon Hospital. Respondents Marti and Escar saw Jose and Francisco Tudela in 1975 while on rounds at the hospital. In 1979, while Respondents Marti and Escar were working at Palm Springs General Hospital, Jose A. Tudela came to the hospital to apply for a position as a house physician and saw Respondents Escar and Marti. When Tudela applied for the position of house physician at Palm Springs General Hospital, Respondents Marti and Escar were both residents at the hospital. On the day that Jose A. Tudela came to apply for the position of house physician at Palm Springs General Hospital, Tudela came to the doctors' lounge at the hospital where he spoke with Respondents Escar and Marti. Tudela had with him a diploma which appeared to Respondents Escar and Marti to be authentic and which appeared to have been issued by the Universidad Central del Este. The diploma had on the back what appeared to be official stamps and seals and the signature of the Vice Consul of the United States. Additionally, a translation of the diploma was attached to the diploma. On the date that Tudela came to apply for the position of house physician at Palm Springs General Hospital, Tudela also showed Respondents Escar and Marti what appeared to be a transcript of his grades from the Universidad Central del Este and a letter purportedly from one Victoria Marcial de Gomez. The transcript and letter appeared to Respondents Escar and Marti to be original and authentic. The letter from Gomez, who purportedly was the medical director for the health center of Trujillo Alto Health Department, in the associated Free State of Puerto Rico, appeared to verify the fact that Dr. Jose A. Tudela had worked in the Health Center of Trujillo Alto for seven months. When Respondent Marti reviewed Tudela's documents, he knew it was important that foreign papers be certified because he had had the experience of having to leave Cuba and re-establish himself. Respondent Marti's own diplomas from Spain bear attestations of notarization of a foreign government. Respondent Escar believed that Tudela's documents were originals because of his experience in having seen similar original documents of other residents in the past. On or about August 1, 1979, Jose A. Tudela completed an application for employment as a house physician at Palm Springs General Hospital. The application contained basic personal information about Tudela and listed some of Tudela's education and work experience. According to the application, Tudela went to Belle Glade High School, in Belle Glade; Florida; Warwick High School, in Newport News, Virginia, where he graduated in 1965; and the University of Miami; in Coral Gables, Florida where he graduated in 1970. According to the application, Tudela worked in an unspecified capacity in the Centro de Salud, in Trujillo Alto, Puerto Rico, from 1978 to 1979. The application form does not contain any information about Tudela's medical education. Specifically, it does not contain any mention of University of Santo Domingo, Universidad Central del Este, or U.C.E. On or about August 8, 1979, Jose A. Tudela was employed by Palm Springs General Hospital as a house physician. Jose A. Tudela remained at Palm Springs General Hospital as a house physician until October 29, 1979. Tudela left Palm Springs General Hospital on that date to become a surgical assistant at Miami Children's Hospital. While employed a Miami Children's Hospital, Tudela received the highest score on every item on his employee evaluation form. That hospital never knew of any problem with Tudela's performance or credentials until this case occurred. Between approximately 1979 and 1983, Respondents Escar and Marti practiced medicine together as partners. In 1980, Jose A. Tudela approached Respondent Marti and asked Respondent Marti to sign an affidavit on behalf of Tudela. Therefore, on or about March 13, 1980, Respondent Marti signed a Form B-1 which was addressed to Rafael A. Penalver, M.D., Director, Office of International Medical Education, University of Miami School of Medicine; Miami; Florida. The form B-1 contained the following sworn statement: This is to certify that Jose A. Tudela born in Cuba and a graduate from the University Santo Domingo on 1978 was legally engaged in the practice of medicine from ---- to in Puerto Rico. I have known the applicant since 1975 and was acquainted with him/her during the time he practiced medicine. I was algo (sic) engaged in the practice of medicine in Miami U.S.A. during the years of 1975 and up. At some time after Respondent Marti signed the Form B-1, the abbreviation "(U.C.E.)" was added to the above-referenced sworn statement after the school name, "University Santo Domingo." Respondent Marti did not place the quoted abbreviation on the Form B-1. Prior to signing the subject Form B-1, Respondent Marti reviewed, for verification purposes, the employment application of Jose A. Tudela for Tudela's employment as a house physician at Palm Springs General Hospital. However, the employment application in question does not reflect any attendance by Tudela at any educational institution in the Dominican Republic or Santo Domingo. Furthermore, the employment application does not indicate the capacity in which Tudela worked in the Centro Salud in Trujillo Alto, Puerto Rico, and does not specifically indicate that Tudela practiced medicine in Puerto Rico. In 1980, Jose A. Tudela also approached Respondent Escar and asked Respondent Escar to sign an affidavit for him. Therefore, on or about March 13, 1980, Respondent Escar signed a Form B-1 which contained the following sworn statement: This is to certify that Jose A. Tudela born in Cuba and a graduate from the University of Santo Domingo on 1978 was legally engaged in the practice of medicine from ---- to in Puerto Rico. I have known the applicant since 1970 and was acquainted with him/her during the time he practiced medicine. I was algo (sic) engaged in the practice of medicine in Miami, Fla during the years of 1977 and up. The Form B-1 was addressed to Rafael A. Penalver, M.D., Director; Office of International Medical Education, University of Miami School of Medicine, Miami, Florida. At some time after Respondent Escar signed the Form B-1, the abbreviation "(U.C.E.)" was added to the above-referenced sworn statement after the school name, "University of Santo Domingo." Respondent Escar did not place the quoted abbreviation on the Form B-1. Respondent Escar relied upon Respondent Marti's verification of Tudela's background information in signing the Form B-1 described in the immediately preceding paragraph. Respondent Escar did not personally review Tudela's application for employment at Palm Springs General Hospital but discussed the information contained in the employment application with Respondent Marti. At the time Respondents Marti and Escar signed the Forms B-1, they did not know Tudela very well and did not know very much about his background. Although they both thought Tudela was probably a graduate of a medical school, they did not remember what school he had supposedly graduated from, as evidenced by the fact that they put the wrong school name on the Forms B- 1. Both Respondent Escar and Respondent Marti lacked personal knowledge of the information contained in the Forms B-1 which they signed for Jose A. Tudela. Neither of the Respondents saw or taught Tudela at medical school in the Dominican Republic. Furthermore, neither Respondent Escar nor Respondent Marti was in Puerto Rico at the time Jose A. Tudela allegedly practiced medicine at the Centro Salud in Trujillo Alto, Puerto Rico. Neither of the Respondents had any source of information about Tudela's alleged medical education in the Dominican Republic or his alleged practice of medicine in Puerto Rico other than statements Tudela may have made to them, statements Tudela wrote on the application form at Palm Springs General Hospital, and whatever information could be gleaned from a casual review of Tudela's forged credentials. Jose A. Tudela has never graduated from the Universidad Central del Este, which is located in the Dominican Republic, nor from any other medical school. Tudela enrolled in the Universidad Central del Este (U.C.E.) medical school in August, 1977. There is no evidence in the school records for U.C.E. that Tudela passed any of his courses. In May of 1978 Tudela was no longer at the university. Tudela was given a special concession at U.C.E. so that upon presentation of a pre-medical certificate which Tudela claimed to possess, Tudela could receive credit for the pre-medical program training. However, Tudela never presented the required proof of his pre-medical program. Tudela did not complete any of the twelve semesters at U.C.E. which make up the medical degree program including pre-medical training. Although Respondent Marti first met Tudela in 1970 and Respondent Escar met him in 1975, the Form B-1 signed by Respondent Marti states that he met Tudela in 1975, and the one signed by Respondent Escar states that he met Tudela in 1970. The reason for this error is that both of the forms were prepared by Respondent Marti and the forms were inadvertently switched at the time they were signed. The Forms B-1 signed by Respondents Marti and Escar were submitted to the Board of Medical Examiners by Jose A. Tudela as attachments to an Application for Continuing Medical Education Program, which was submitted as part of Tudela's application for licensure as a physician in Florida. Tudela applied for licensure in Florida under the provisions of a special law which provided that the Board of Medical Examiners would establish continuing education courses designed to qualify for licensure those individuals who were resident nationals of the Republic of Cuba and were residents of Florida on July 1, 1977. In order to qualify for the continuing education program set up by the Board of Medical Examiners for Cuban nationals, an applicant had to demonstrate that he was a graduate from a medical school with a medical degree and that he was a resident national of the Republic of Cuba and a resident of Florida on July 1, 1977. Upon approval of the applicant to participate in the continuing education program set up by the Board of Medical Examiners, the applicant would have to complete the continuing education program. Upon completion of the continuing education program, the applicant would be qualified to take the licensing examination. In or about March of 1980, Tudela submitted an Application for Examination, an Application for Florida State Board of Medical Examiners Continuing Education Program, and the necessary attachments, which included the Forms B-1 signed by Respondents Escar and Marti and copies of what purported to be his diploma and transcript of grades. After successfully completing the continuing medical education program and the licensure examination, Tudela became certified to practice medicine and surgery by the Board of Medical Examiners on August 23, 1982. At the time of Tudela's application for medical license, the staff of the Board of Medical Examiners conducted the initial review and made the initial determination as to whether an individual was qualified to take the continuing education course and to take the licensure examination for certification to practice medicine and surgery in Florida. In making such determinations, consideration is given to all of the information contained in an applicant's file, which includes such things as the applicant's degree or diploma, transcript of grades, and the Forms B-1. At the time Tudela applied for licensure, the staff of the Board of Medical Examiners did not verify the medical education of applicants and conducted no investigation into the school or the graduation of applicants for licensure. Prior to approving Tudela's application, neither the Board members nor the staff independently contacted the Universidad Central del Este to verify whether Tudela actually graduated from medical school. The Board members did not personally review Tudela's application. The staff reviewed the papers and presented the Board with a list of applicants who appeared to be eligible for the continuing education course and the licensure examination. The diploma and the transcript of grades which Tudela showed to the Respondents and filed with the Board of Medical Examiners are forgeries. They are very good forgeries and bear a remarkable resemblance to genuine diplomas and transcripts issued by the Universidad Central del Este. The false documents provided by Tudela to the Board as part of his application, along with the Forms B-1 signed by Respondents Marti and Escar, deceived the staff into recommending Tudela for the continuing education course, the licensure exam, and ultimately for certification to practice medicine. Tudela's application to the Board also contains several letters of recommendation from other physicians who were convinced of Tudela's competence. The Educational Commission for Foreign Medical Graduates granted Tudela a certificate despite his forged documents. In November 1984, an Administrative Complaint was filed against Jose A. Tudela which alleged that Tudela did not graduate from or obtain a degree of Doctor of Medicine from U.C.E., contrary to what Tudela had indicated in his application for licensure examination described above. In March 1985, the Board of Medical Examiners entered an order accepting the surrender for revocation of Jose A. Tudela's license to practice medicine in lieu of further prosecution of the charges contained in the Administrative Complaint which had been filed in November 1984. Tudela is not currently licensed as a physician in the state of Florida. No further action was taken against him for his having fraudulently obtained a medical license in Florida. Respondents Escar and Marti were both aware of the fact that the Forms B-1 which they signed were to be submitted as part of the application for the continuing medical education program which had been established by the Board of Medical Examiners for Cuban nationals as a prerequisite to take the licensure examination. In fact; Respondent Marti became eligible to take the medical licensure examination in Florida by completing the same continuing medical education program. When the Respondents Escar and Marti signed the subject Forms B-1, neither of them had any personal knowledge as to the truth or falsity of the statements therein regarding Tudela's medical education and experience; yet they deliberately certified, under oath, to the truthfulness of matters about which they were distinctly uninformed. When the Respondents Escar and Marti signed the subject Forms B-1, both of them knew the purpose of the forms and both knew that the Board of Medical Examiners would rely on the information in the forms.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, the following relevant facts are found. Pursuant to a sworn application for a limited license filed by Petitioner on approximately March 5, 1982, and received by the Respondent on March 12, 1982, the Respondent, Board of Medical Examiners (herein sometimes referred to as the "Board") on April 17, 1982, considered Petitioner's application for limited licensure. By a Final Order of the Board dated May 11, 1982, Petitioner was advised that he did not meet the statutory requirements for limited licensure pursuant to Section 458.137, Florida Statutes, and therefore his application for limited licensure was being denied. Petitioner was further advised of his rights pursuant to Sections 120.57 and 120.60, Florida Statutes, to petition for a hearing and otherwise seek review of the Board's decision. Petitioner timely filed a request for a Section 120.57(1), Florida Statutes, hearing concerning whether or not he is in fact entitled to a limited license. The Petitioner, on June 1, 1981, retired from the position of Corporate Medical Director for Abbott Laboratories in North Chicago, Illinois. The Petitioner has been a licensed medical doctor since approximately 1945. Since his admission to practice medicine, Petitioner has enjoyed an illustrious career. His professional qualifications are not at issue herein. Petitioner wants a retired physician's license to "lend dignity to his status as a retired physician." The Petitioner does not desire to practice medicine and, in fact, represented that pursuant to his retirement plan with Abbott Laboratories, he would be forced to return to Abbott Laboratories all monies earned from any medical practice. During the hearing herein, when Petitioner was advised that Florida has no procedure to obtain a limited license such as that which he now seeks, Petitioner requested (1) that a refund of his $100 application fee be returned or (2) that the $100 fee be applied to his application to sit for the next medical licensing examination. During a brief period since he retired in June, 1981, the Petitioner was employed on a part-time basis at the Veterans Administration Hospital in Broward County, Florida. As stated, Petitioner does not now seek to practice medicine at that center or any other public or private institution.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: 1. That the Respondent enter a Final Order denying Petitioner's application for a limited license to practice medicine in this State. 3/ RECOMMENDED this 28th day of January 1983, in Tallahassee, Florida. R. T. CARPENTER, 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 28th day of January 1983.
The Issue Whether Respondent’s Rule 59R-11.001, Florida Administrative Code, is an invalid exercise of delegated legislative authority.
Findings Of Fact Chelation therapy is the introduction of a man-made amino acid into a patient’s vein. It has been approved by the U.S. Food and Drug Administration and is used for the treatment of heavy medal toxicity and the removal of lead. American Board of Chelation Therapy (ABCT) is an autonomous organization that provides education and certification to any physician who wishes to become knowledgeable in Chelation therapy. ABCT was established in 1982 for the purpose of establishing the criteria necessary for certification in the area of Chelation therapy. The Board of Medicine is a statutory entity, established by Chapter 458, Florida Statutes, as the primary regulatory authority for the practice of allopathic medicine in the State of Florida. Pursuant to section 458.301, Florida Statutes, the legislature recognizes that the practice of medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The section further provides that the primary legislative purpose in enacting the medical practices act is to “ensure that every physician practicing in this state meets minimum requirements for safe practice.” In keeping with the legislative mandate to ensure that purpose of the medical practices act, the legislature created the Board of Medicine and authorized the Board to create administrative rules for the purpose of implementing chapter 458. Rule 59R-11.001, Florida Administrative Code, is the advertising rule of the Board of Medicine.3 The rule codifies provisions of section 458.331(1)(d), Florida Statutes, and provides criteria for identifying false, deceptive, or misleading advertising. In particular, the rule governs advertising on physician letterhead and limits the use of the term “specialist” unless the specialty is recognized by (1) a specialty board of the American Board of Medical Specialties (ABMS) or (2) a board that meets the requirements of Rule 59R-11.001, Florida Administrative Code. For those specialties recognized by organizations that do not meet the requirements of the rule, the physicians may still advertise their specialty so long as they provide a disclaimer. By rule the disclaimer must state the following “The Specialty recognition identified herein has been received from a private organization not affiliated with or recognized by the Florida Board of Medicine.” ABMS is generally recognized in the United States as the agency that approves allopathic medical specialty boards and the Board of Medicine has historically relied upon ABMS and its standards and, as reflected in the current rule, continues to rely on ABMS and its standards for approving recognizing agencies. On July 17, 1995, the Petitioner, ABCT submitted an application to Florida Board of Medicine for the purpose of being certified as a “recognizing agency” pursuant to rule 59R-11.001. ABCT is not a specialty board of the ABMS. Because ABCT is not a member board of the ABMS, the Board of Medicine looked to the requirements of rule 59R- 11.001(2)(f) to determine whether ABCT met the criteria enunciated in the rule and whether it is therefore a “recognizing agency” capable of bestowing specialty status on a physician. Rule 59R-11.001(2)(f), Florida Administrative Code, provides that non-ABMS Boards may seek recognition as “recognizing agencies” if they meet the following criteria: The recognizing agency must be an independent body that certifies members as having advanced qualifications in a particular allopathic medical specialty through peer review demonstrations of competence in the specialty being recognized. Specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada that includes substantial and identifiable training in the allopathic specialty being recognized. Specialty recognition must require successful completion of a comprehensive examination administered by the recognizing agency pursuant to written procedures that ensure adequate security and appropriate grading standards. The recognizing agency, if it is not an ABMS board, must require as part of its certification requirement that each member receiving certification be currently certified by a specialty board of the ABMS. The recognizing agency must have been determined by the Internal Revenue Service of the United States to be a legitimate not for profit entity pursuant to Section 501 (c) of the Internal Revenue Code. The recognizing agency must have full time administrative staff, housed in dedicated office space which is appropriate for the agency’s program and sufficient for responding to consumer or regulatory inquiries. The recognizing agency must have written by-laws, and a code of ethics to guide the practice of its members and an internal review and control process including budgetary practices, to ensure effective utilization of resources. However, a physician may indicate the service offered and may state that practice is limited to one or more types of services when this is in fact the case; On April 15, 1996, the Board of Medicine issued an order denying the ABCT’s application for specialty status. As basis for the denial, the order stated that the application of the ABCT failed to establish compliance with the requirements for approval as set forth in Rule 59R-11.001(2)(f), Florida Administrative Code. Specifically, the order stated: The requirements for diplomat status in ABCT do not require advanced qualifications in a particular allopathic medicine specialty; specialty recognition given by ABCT does not require completion of an allopathic medical residency program approved by the ACGME or the Royal College of Physicians and Surgeons of Canada that include substantial and identifiable training in the allopathic specialty being recognized; specialty recognition provided by the ABCT does not require successful completion of a comprehensive examination pursuant to written procedures that ensure adequate security and appropriate grading standards in that ABCT requires only a score of 60% to pass the examination, the examination consists of true false questions and answers, and the examination is not a medically comprehensive examination; ABCT is not an ABMS board and does not require that each member it certifies be currently certified by an ABMS board; and ABCT has not provided evidence that it is a legitimate not-for-profit entity pursuant to Section 501(c) of the Internal Revenue Code as determined by the Internal Revenue Service. Each of the requirements of rule 59R-11.001(2)(f) were addressed at the administrative hearing. With regard to criteria (1) of rule 59R-11.001(2)(f), advanced qualifications in a particular allopathic medical specialty through peer review, the ABCT does not require an advanced qualification in a particular allopathic medical specialty. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(1). Criteria (2) of rule 59R-11.001(2)(f) provides that the specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada. The ACGME is generally recognized as the organization that sets criteria for graduate medical education in the United States. The Board of Medicine has incorporated that recognition in the rule by requiring that the advanced education component of the rule be ACGME approved. The Royal College of Physicians and Surgeons of Canada is ACGME’s counterpart in Canada. With regard to criteria (2) of rule 59R-11.001(2)(f), ABCT does not require completion of an allopathic residency program approved by either the ACGME or the Royal College of Physicians and Surgeons of Canada. In fact, ABCT has no requirement for a residency program. ABCT reasoned that a there is no need for a residency program for Chelation therapists because Chelation therapy does not require overnight hospital stay. The only requirement remotely relating to residency is an ABCT requirement that applicants for diplomat status administer a minimum of 1000 Chelation treatments. There is no requirement that these treatments be supervised and no requirement for verification that the minimum number of treatments were administered. With regard to criteria (3) of rule 59R-11.001(2)(f), requiring successful completion of a comprehensive examination, ABCT does not require all applicants for diplomat status to complete a written examination in order to obtain certification. Specifically, some candidates are grandfathered in without being required to complete the written examination. For those applicants that are required to submit to an examination, Dr. Arthur L. Koch testified that the examination is composed of approximately sixty percent true/false questions. In addition, Dr. Koch testified that another ten percent of the test is not medically oriented but rather addresses the history and politics of Chelation therapy in the United States. At the hearing, ABCT submitted its Spring 1994 examination as an exhibit. That examination contained a majority true/false questions and a few multiple choice questions. To pass the ABCT diplomat examination, the candidate is required to achieve a score of 62.5 percent. In contrast, the Board of Medicine generally requires a passing score of at least 75%. The Board of Medicine expressed concern about the low passing score accepted by ABCT on its certification examination. The Board of Medicine also expressed concern over the large number of true/false questions used in the example examination submitted by ABCT. Uncontroverted testimony was presented at the hearing to support a finding that an examination consisting of a majority of true/false questions is not a viable method of testing knowledge. With regard to criteria (4) of rule 59R-11.001(2)(f), requiring members of non-ABMS boards to also be certified by a specialty board of the ABMS, the ABCT does not require that each physician seeking diplomat status be currently certified by an ABMS specialty board. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(4). With regard to criteria (5) of rule 59R-11.001(2)(f), that the recognizing agency must be a legitimate not for profit entity under the Internal Revenue Code, evidence was presented to verify that ABCT is a non-profit, tax-exempt organization. With regard to criteria (6) of rule 59R-11.001(2)(f), requiring the recognizing agency to have full-time administrative staff sufficient to respond to consumer or regulatory inquiries, no evidence was presented at the hearing relating to this criteria. With regard to criteria (7) of rule 59R-11.001(2)(f), requiring the recognizing agency to have written by-laws and a code of ethics to guide the practice of its members, ABCT submitted its Constitution and Bylaws as adopted in March of 1982 and subsequently amended. The Constitution and bylaws, however, did not include a written code of ethics and therefore did not fully comply with the requirements of the rule.
The Issue The issue for determination is whether Respondent, a licensed physician, committed violations of Chapter 458, Florida Statutes, as alleged in the Administrative Complaint, sufficient to justify the imposition of disciplinary sanctions against his license.
Findings Of Fact Respondent is Ernesto C. Jaranilla, M.D., a licensed physician at all times pertinent to these proceedings, holding medical license number ME 0065787. Respondent's last known address is 633 Baker Street, Rochester Hills, Michigan 48307. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Chapter 458, Florida Statutes. The State of Michigan Department of Commerce, Board of Medicine, is the licensing authority for the State of Michigan. On or about May 9, 1994, the State of Michigan Board of Medicine issued a final order requiring Respondent to pay a fine of $1,000.00 within 60 days, placed Respondent's license on probation and required him to complete 100 hours of approved continuing education credits. As a result of the action of the Michigan Board of Medicine, Respondent is guilty of having action taken against his license to practice medicine by the licensing authority of the State of Michigan. Respondent did not notify the Florida Board of Medicine within 30 days of the action taken by the State of Michigan against his license to practice medicine. Instead, Petitioner's personnel learned of Respondent's transgression by way of a report from the Federation of State Medical Boards dated April 19, 1996. The report indicated that the Michigan disciplinary action had been terminated by order dated January 26, 1996.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered imposing discipline upon Respondent's license in this cases as follows: An administrative fine of $750 for each Count of the Administrative Complaint for a total of $1500. Suspension of Respondent's license to practice medicine in the State of Florida with such suspension to be terminated upon Respondent's payment of the administrative fine, and successful compliance with such other terms and conditions as may be prescribed by the Florida Board of Medicine, inclusive of Respondent's personal appearance before the Florida Board of medicine for presentment of proof of his reinstatement to practice medicine in the State of Michigan and to certify his completion of any Board prescribed course for practitioners who have failed to comply with reporting or other obligations to the Board. DONE AND ENTERED this 8th day of January, 1997, in Tallahassee, Leon County, Florida. DON W. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 8th day of January, 1997. COPIES FURNISHED: Kevin w. Crews, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, FL 32317-4229 E. Jaranillia, M.D. 301 State Street Harbor Beach, MI 48441 Marm Harris, Executive Director Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
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.
