Findings Of Fact The application of Petitioner, John David Young, M.D., for licensure by endorsement initially was filed on March 13, 1991. The initial application was not completed within one year and, under F.A.C. Rule 61F6-22.016, was not acted upon by the Board of Medicine. The Petitioner reapplied on September 1, 1992, and his application was denied by Respondent's Order rendered on November 4, 1993. The basis of denial stated in the November 4, 1993, Order is: You failed to show a medical education as that term is used in Chapter 458 in Sections 458.313(1)(a) and 458.311(1)(f) and have failed to show medical practice as required by Section 458.313(1)(c). Additionally, you have misrepresented your education. Sections 458.313(1)(a) and (7); 458.311(1)(c) and (d); 458.331(1)(a) and (gg), F.S. Medical Education Dr. Young received his Doctorate of Medicine Degree from Grace University School of Medicine, St. Kitts, Nevis, West Indies, June 4, 1986. Grace University is registered with the World Health Organization. Dr. Young began his medical education on May 5, 1981, at the Universidad de Mundial, Dominican Republic, where he completed one year as reflected by the transcripts found at Joint Exhibit 1, page 195. Dr. Young transferred to CETEC, Dominican Republic, because of his concerns that Universidad de Mundial would close within a few years. The transfer to CETEC occurred in late December, 1981. CETEC allowed Dr. Young to take pathology and physiology at the University of Southern California on the condition that CETEC would administer exams on those subjects before they would give him credit. The University of Southern California did not give credit for the courses, which was not a concern to Dr. Young because he was seeking credit from CETEC upon taking the CETEC examination. CETEC attempted to establish a liaison with Orange State University School of Medicine in Southern California whereby students could take courses at Orange State and receive credit by CETEC. Dr. Young completed his basic science course work at Orange State as reflected by the transcript at Joint Exhibit 1, page 193, for which CETEC gave him credit. Melvin A. Shiffman, M.D., was temporary dean at Orange State University and submitted a letter to the Board of Medicine confirming Dr. Young's attendance from May through August, 1982, and that Dr. Young took the CETEC final examinations on all the subjects taught at Orange State for which they gave credit. Dr. Young began his clinical rotations upon completion of his basic sciences as follows: Basic Medicine at Pine Ridge Indian Health Hospital, Pine Ridge, South Dakota, from August 31, 1982 to September 30, 1982; surgery at Oral Roberts University School of Medicine from October 4, 1982 to December 22, 1982; surgery at Fitkin Hospital, Swaziliand, South Africa, in 1983; basic medicine at Pine Ridge Indian Hospital, Pine Ridge, South Dakota, from April 18, 1983 to May 29, 1983. While at Pine Ridge Indian Hospital the second time, Dr. Young was asked to leave by the acting hospital administrator, on the allegation that he was attending CETEC, which was not an approved school, which in fact it was. In shock at being asked to leave based on those allegations, Dr. Young travelled to Kansas City to stay with relatives to study for the Educational Commission for Foreign Medical Graduates (ECFMG) examination required for all foreign medical graduates. The Petitioner took and passed the ECFMG examination on July 27, 1983. Upon completion of the examination, Dr. Young continued his clinical rotations as follows: Psychiatry at Bay Front Medical Center, University of South Florida, St. Petersburg, Florida; medicine at University of Natal, Republic of South Africa, from September 26, 1983 to January 1, 1984; obstetrics/gynecology at Addington Hospital, University of Natal, Republic of South Africa, from January 3, 1984 to March 4, 1984; pediatrics from March 12 to May 13, 1984 at Addington Hospital; University of Natal; and surgery from May 13, 1984 to July 16, 1984 at Addington Hospital, University of Natal. In late May or early June, 1984, while Dr. Young was in the surgery rotation, he learned, upon calling home and speaking to his mother, that CETEC closed as of March 4, 1984. Dr. Young was shocked at learning of the closing, but decided to complete the surgery rotation, since he was working with a well known professor, and to return to the U.S. after that to try to find another medical school. Dr. Young registered at the University of Health Science in Antigua in September, 1984. The University of Health Science required Dr. Young to take their exams for credit of his basic sciences course work, which he took in December, 1984. Because the transcripts from CETEC were not available, Dr. Young produced to the University of Health Sciences cancelled checks showing payment for his tuition, which was accepted. The University of Health Sciences, therefore, required Dr. Young to pass their examinations for the basic science courses in lieu of the CETEC transcript. Dr. Young found the exams to be suspicious in that they seemed to be random photocopies of medical text book pages. Accordingly, Dr. Young went to the U.S. Embassy at Antigua to discuss the medical school and was advised to change schools because of problems they were having with the school. Dr. Young learned later that 30 former students filed suit in federal court against the school for the irregularities. Upon completion of the examinations, Dr. Young continued his rotations. He did a rotation in cardiology at Bay Pines Veterans Hospital, St. Petersburg, Florida from December 18, 1984 to January 31, 1985. He did a rotation in internal medicine at Metropolitan General Hospital, Pinellas Park, Florida from February 1, 1985 to April 30, 1985. He did a rotation in pediatrics with Dr. DeGall at All Childrens Office in St. Petersburg, Florida from May 1 to July 29, 1985. Dr. Young then enrolled in Grace University Medical School, St. Kitts, Nevis, West Indies, in December, 1985. Grace University gave Dr. Young credit for course work done for previous medical schools approved by the World Health Organization, but told him that he would be required to take validation exams for that course work and would probably need to take some additional clerkships. This was explained to the Board of Medicine by the Vice President and CEO of Grace University, J.P. McNaughton-Louden, M.D., by letter dated February 20, 1991, found at Joint Exhibit 1, page 103. In that letter, Dr. Louden also confirms that CETEC was approved by the World Health Organization, that CETEC closed while Dr. Young was taking rotations in South Africa, that students at University of Health Sciences in Antigua were advised by the U.S. Consul authorities to transfer because of problems, that Dr. Young would be given credit for studies done at medical schools approved by the World Health Organizations co-validated by examinations at Grace University, and that Dr. Young's clerkships had been accepted and that he graduated on June 4, 1986. The transcripts of Grace University found at Joint Exhibit 1, page 104, shows that Dr. Young was admitted in March, 1984, even though his actual enrollment was December, 1985, because the school dated the admission retroactively to the date that CETEC closed. Dr. Young listed what he considered to be his accurate date of enrollment on his application for licensure as December 21, 1985. Dr. Young did the following additional rotations for Grace University: pediatrics with Dr. DeGall in St. Petersburg, from December 29, 1985 to February 26, 1985; and general medicine and emergency medicine at a refugee camp under the auspices of the United States and Christian Missionary Life from March 3 to April 30, 1985. FLEX Exam Dr. Young took and passed the Federation of State Medical Boards' Licensing Examination (known as "FLEX") on the first attempt in December, 1988. Residency 21 Dr. Young completed one year of residency in internal medicine at Marshall University on January 31, 1989. Maurice A. Mufson, M.D., Dr. Young's professor and Chairman of the Department of Internal Medicine, submitted an evaluation of the residency to the Board of Medicine recommending him as qualified and competent. After completion of the one year residency in internal medicine, Dr. Young realized that in order to fulfill his desire to practice missionary medicine, he would need a broader education. Accordingly, he changed his residency to family practice. Marshall University gave Dr. Young seven months credit from his one year of internal medicine residency towards his family practice residency which was completed in June, 1991. Robert B. Walker, M.D., Dr. Young's professor and Chairman of the Department of Family and Community Health, submitted to the Board of Medicine and evaluation of Dr. Young's family practice residency recommending him as qualified and competent. The AMA physician profile on Dr. Young, submitted to the Board of Medicine by the AMA, shows that Dr. Young completed the family practice residency and one year of internal medicine residency. However, the AMA profile mistakenly shows Dr. Young's internal medicine residency as from 2/87 to 1/88, instead of the accurate dates of 2/88 to 1/89. Dr. Young brought this error to the attention of the AMA which did not correct it. Letters recommending Dr. Young for licensure were sent to the Board of Medicine by: Stephen Petrany, M.D., Dr. Young's former Director of the Family Medicine Residency at Marshall University; and Jack Ditty, M.D., a Board certified dermatologist in Kentucky who was adjunct professor at University of Kentucky and Marshall University (who writes that Dr. Young is of high moral character and has knowledge and experience which would be necessary to practice medicine in Florida.) Post-Residency After completion of his residency in 1991, Dr. Young became licensed to practice medicine in West Virginia. Since his licensure, there have been no complaints or probable cause determinations made against his license, and no malpractice claims have been filed against him. Since completion of his residency, he has served as Assistant Professor of Clinical Medicine at the University of West Virginia and as Adjunct Professor of Medicine at Marshall University School of Medicine. He also has worked as a ship's doctor for a cruise line, worked as Assistant Professor of Medicine at University of West Virginia, moonlighted as an emergency room doctor in Beckley, West Virginia, lectured extensively in the Republic of South Africa on sexually transmitted diseases, and has worked as an emergency room doctor for the U.S. Military in Arizona. ECFMG Certification The Educational Commission for Foreign Medical Graduates (ECFMG) verifies the medical education of each person to whom it awards a certificate following passage of its examination. The ECFMG's investigation of Dr. Young's medical education took several years, because of allegations involving a Mr. Pedro de Mesones falsifying information from some medical schools in the Dominican Republic, including CETEC, on behalf of some applicants to various state medical boards. Dr. Young never met nor spoke with Pedro de Mesones nor was he involved with him in any way. The ECFMG advised Dr. Young of this investigation by letter dated June 7, 1984, found at Joint Exhibit 1, page 167. Further complicating the ECFMG investigation of Dr. Young's medical education was the closing of CETEC. The Dominican Republic government established an agency known as CONES to assist in getting transcripts of students who attended CETEC. Dr. Young wrote to CONES in an attempt to obtain his CETEC transcript from CONES. Even though Dr. Young was unable to obtain transcripts of CETEC from CONES, ECFMG verified all of Dr. Young's medical education, clinical rotations, and residency. The ECFMG investigation of Dr. Young's medical education concluded with no irregularities in his credentials having been found. The ECFMG issued its certificate to Dr. Young on October 13, 1987; it is valid indefinitely. Specialty Board Certification Dr. Young is certified as a diplomate of the American Board of Family Practice for the period of 1992 - 1999. The certificate from the American Board of Family Practice indicates: that Dr. Young met the requirements to be certified as a Diplomate of the Board; that he has completed a 3-year residency; and that the American Board verified Dr. Young's medical education and found it to be authentic. Board of Medicine Investigation As part of the routine investigation of Dr. Young's application for licensure filed with the Board of Medicine, the Board staff wrote to CONES requesting confirmation of the CETEC education and received a response dated March 6, 1992, by letter found at Joint Exhibit 1, page 87, stating that Dr. Young was not found on their lists and that they could not process the Board's request until they had Dr. Young's student registration number. However, an earlier certification by CONES dated May 12, 1987, found at Joint Exhibit 1, pages 9 and 10, shows that CONES did have Dr. Young's student identification number and had a file on him. Paul L. Allyn, M.D. also confirmed to the Board of Medicine by letter dated June 30, 1993, found at Joint Exhibit 1, page 88, that Dr. Young did attend CETEC. The transcript of the Credentials Committee Meeting at Joint Exhibit 2 shows that the committee focused on the March 6, 1992, letter rather than the May 12, 1987, letter. The Board staff contacted the University of Health Sciences to confirm Dr. Young's attendance and received a letter from its President dated October 21, 1991, found at Joint Exhibit 1, page 99. That letter states that Dr. Young did not receive credit for his previous medical education, that he attended the institution from September 19, 1984 to July 11, 1985, that he did not leave the institution in good standing, and that he was dismissed because he was unable to provide the school with official transcripts from the previous medical school he attended. Dr. Young had not seen that letter until a few months before hearing while reviewing the Board's file on him in preparation for the hearing. Dr. Young takes issue with the statements in the letter because the school did give him credit for the rotations he completed while enrolled at Universidad de Mundial and because he never had been told that he left the institution in poor standing. Dr. Young left the University upon advice of the U.S. Consulate in Antigua. The transcript of the Credentials Committee Meeting at Joint Exhibit 2 shows that the committee focused on this letter rather than Dr. Young's affidavits submitted with his application which contradict the letter. The Board obtained and reviewed the ECFMG file on Dr. Young in considering his application. In the ECFMG file at Joint Exhibit 1, page 230, is a letter to the ECFMG from John Casken, Quality Assurance Coordinator, Department of Health, Education, and Welfare, dated May 15, 1985, relating to Dr. Young's second clinical rotation at Pine Ridge Indian Health Hospital in 1983. In the letter, Mr. Casken states: that a closer look at Dr. Young's credentials after he presented himself for the second time showed that he had basically no medical education; that Dr. Young was asked to leave; and that, had they known in 1982 when he appeared for his first rotation what they knew in 1983, they would not have taken on Dr. Young as a m edical student. Dr. Young first saw that letter a few months before the hearing while preparing for trial. Dr. Young disagrees with that letter in that the schools he was attending, Universidad de Mundial, and after that, CETEC, were both approved by the World Health Organization. Further, a letter written on April 18, 1985, by Leonard L. Finger, Hospital Administrative Officer, Department of Health, Education, and Welfare, to the ECFMG, found at Joint Exhibit 1, page 231 , verifies Dr. Young's rotation without adverse comment. Further, the ECFMG found no problem with Dr. Young's education or with the rotations at Pine Ridge. The transcript of the Credentials Committee Meeting at Joint Exhibit 2 shows that the committee focused on Dr. Caskin's letter rather than Mr. Finger's letter and the fact that all of Dr. Young's medical schools were approved by the World Health Organization. Board of Medicine Practice and Policy The Board of Medicine has licensed individuals who have attended CETEC. The Board of Medicine and its staff rely upon the ECFMG certifications of applicants as verification of their education. The certification by the American Board of Family Practice complies with the requirement of Rule 61F6-22.004(2) and 61F6-22.018(3)(d). The ECFMG certificate complies with the requirements of Section 458.311(1)(f), (2), and (3), Florida Statutes; There is nothing in the rules of the Board or Chapter 458, and no Board policy or practice, which prohibits an applicant from going to more than one university or medical school, from going to more than one medical school and failing out of one, or from going to a school that later goes out of business.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration, Board of Medicine, enter a final order granting the Petitioner's application for licensure by endorsement. RECOMMENDED this 30th day of September, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-7146 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1. Accepted and incorporated. 2.-4. Accepted but subordinate and unnecessary. 5.-15. Accepted and incorporated. 16. The pediatrics rotation at Addington Hospital, University of Natal was from March 12 to May 13, 1984, and the surgery rotation was from May 13, 1984 to July 16, 1984. Otherwise, accepted and incorporated. 17.-30. Accepted and incorporated. 31.-37. Accepted but subordinate and unnecessary. 38. Accepted and incorporated to the extent not subordinate or unnecessary. Respondent's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. Accepted but subordinate and unnecessary. First sentence, rejected as being contrary to the greater weight of the evidence. Second sentence, accepted but subordinate and unnecessary. 7.-8. Accepted and incorporated to the extent not subordinate or unnecessary. 9.-10. Accepted and incorporated to the extent not subordinate or unnecessary. However, the lack of a credible Orange State transcript to support the Petitioner's testimony is more a reflection on Orange State's credibility than on the Petitioner's. Orange State was in existence for a short period of time, never was recognized by the State of California, and has been defunct for about ten years. It is understandable why the Petitioner has had difficulty getting a credible response from Orange State. The irregularities in the response from Orange State do not impugn the Petitioner's truthfulness in attempting to describe his unorthodox and circuitous medical education in his application for licensure. Last sentence, rejected as contrary to the greater weight of the evidence. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. However, it is even more understandable why the Petitioner has had difficulty getting a credible response from CETEC. As with Orange State, CETEC was closed about ten years ago. In the case of CETEC, which was in the Dominican Republic, the closing was under allegations of misconduct and fraud. Records were unavailable for a period of time while the government of the Dominican Republic investigated. Later, records were destroyed. As with Orange State, the irregularities in the response from CETEC do not impugn the Petitioner's truthfulness in attempting to describe his unorthodox and circuitous medical education in his application for licensure. Rejected as contrary to the greater weight of the evidence that the Respondent did not leave UHSA in good standing. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Accepted but subordinate and unnecessary. 14.-16. Accepted and incorporated to the extent not subordinate or unnecessary. Second sentence, rejected as contrary to the greater weight of the evidence. First sentence, accepted and incorporated. Accepted and incorporated to the extent not subordinate or unnecessary. Third and fourth sentences, rejected as contrary to the greater weight of the evidence. First two sentences, accepted and incorporated to the extent not subordinate or unnecessary. 20.-21. Accepted and incorporated to the extent not subordinate or unnecessary. The city in South Africa was Durban, not Durham. CETEC was the affiliate until it closed in March, 1994. The rest is accepted and incorporated to the extent not subordinate or unnecessary. First sentence, accepted. The rest is rejected as being contrary to the greater weight of the evidence. 24.-25. Accepted and incorporated. 25. Accepted but unnecessary. (No such finding was made.) COPIES FURNISHED: Paul Watson Lambert, Esquire 2851 Remington Green Circle Suite C Tallahassee, Florida 32308-3749 Gregory A. Chaires Assistant Attorney General Department of Legal Affairs Administrative Law Section PL-01, The Capitol Tallahassee, Florida 32399-1050 Dr. Marm Harris Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire General Counsel Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue As to Case 93-6927, whether Respondent, a licensed physician, violated the provisions of Section 458.331(1)(m), (t), (v), and (dd), Florida Statutes, as alleged in the Administrative Complaint and the penalties, if any, that should be imposed. As to Case 93-6928, whether Respondent violated the provisions of Section 458.319(5), 458.327(1)(a), and 458.331(1)(x), Florida Statutes, as alleged in the Administrative Complaint and the penalties, if any, that should be imposed. As to Case 93-6929, whether Respondent violated the provisions of Section 458.331(1)(x), Florida Statutes, as alleged in the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact Petitioner is the agency of the State of Florida that regulates the practice of medicine. Respondent is a licensed physician in the State of Florida and has been issued license number ME 0028412 by the Petitioner. CASE NO. 93-6927 On December 12, 1990, Susan D. Bernhardt conducted an inspection for the Florida Department of Health and Rehabilitative Services (DHRS) of an abortion clinic named Miami International Esthetics Center (MIEC). Ms. Bernhardt was hired as a consultant by DHRS to conduct random inspections of MIEC pursuant to a stipulation between DHRS and MIEC. Ms. Bernhardt is a registered nurse and is experienced in surgical procedures. Ms. Bernhardt observed Respondent perform an abortion on a patient at MIEC on December 12, 1990. Also present in the operating room was a nurse anesthetist, to whom Respondent referred as Mr. Martin. Respondent, Mr. Martin, and Ms. Bernhardt were present in the operating room at all times during the procedure. Mr. Martin administered anesthesia and the patient lost consciousness. Shortly after losing consciousness, the patient began making sounds which Ms. Bernhardt described as "crowing noises" and to which Dr. Van Eldik referred to as "stridors". These sounds indicate that the patient's air passages are blocked, a condition that requires prompt action from the physician or from the person administering anesthesia since the condition can be life threatening. Ms. Bernhardt testified that she went to the patient and used her stethoscope to confirm that the patient was having breathing difficulties. She thereafter tilted the patient's head and restored her breathing. The amount of time that lapsed between the time the patient first experienced difficulties breathing and the time Ms. Bernhardt acted was not established. While it is clear that neither Respondent or Mr. Martin 1/ acted to provide the patient with any relief or to assure that her air passages were open so that she could receive adequate oxygen, it is not clear whether the action of Ms. Bernhardt obviated the necessity for either the physician or the nurse anesthetist to act. Consequently, it is found that Petitioner failed to establish by clear and convincing evidence that Respondent failed to properly supervise Mr. Martin by failing to order him to assist the patient when Ms. Bernhardt acted promptly to relieve the patient. Emergency equipment was maintained on a crash cart that was in the operating room during the procedure Ms. Bernhardt observed. As the operating surgeon, Respondent was responsible for making sure that appropriate emergency equipment was readily available. Appropriate emergency equipment would include emergency drugs on the crash cart. Throughout the procedure there were no emergency drugs present on the crash cart. Respondent failed to adequately supervise Mr. Martin to ensure that appropriate emergency equipment was readily available. As part of her inspection of MIEC, Ms. Bernhardt reviewed medical records at the clinic pertaining to patients of the Respondent. Some of the records that were reviewed by her are contained in Petitioner's Exhibit 5. Respondent's records reviewed by Ms. Bernhardt were of overall poor quality. Documentation concerning physical examination was scanty and often failed to include the size of the patient's uterine and a description of the presumptive signs of pregnancy. Anesthesia records were not filled out. Documentation concerning the recovery room period was virtually nonexistent. No vital signs or progress notes were charted. There was no follow-up documentation evidencing a pelvic examination and no notation of patient complaints or symptoms. The records reviewed by Ms. Bernhardt during her inspection did not justify or adequately document the course of treatment for the respective patients. A subpoena was served on Respondent by one of Petitioner's investigators that required him to turn over all medical records pertaining to certain named patients. A similar subpoena was served on Mr. Angel Caso, the owner of MIEC. In response to the subpoena that was served on his client, Respondent's attorney informed the investigator that Respondent did not have any medical records other than those that would have been maintained at the MIEC. In response to the subpoena that was served on him, Mr. Caso turned over medical records pertaining to 45 patients. These records reflect that the Respondent was their attending physician. Mr. Caso could not be subpoenaed by Petitioner to compel his attendance at the formal hearing because he could not be located. The medical records that were turned over to Petitioner pursuant to subpoena were admitted into evidence as Petitioner's Exhibit 5 as records received by Petitioner during the course of an official investigation. There was no evidence that any other medical records pertaining to these patients exist. The medical records that constitute Petitioner's Exhibit 5 do not justify or adequately document the course of treatment of the respective patients. CASE NO. 93-6928 Section 458.319(5), Florida Statutes, provides, as follows: (5) The licensee must have on file with the department the address of his primary place of practice within the state prior to engaging in that practice. Prior to changing the address of his primary place of practice, whether or not within this state, the licensee shall notify the department of the address of his new primary place of practice. The Petitioner maintains the addresses of physicians by computer. There is no statute or rule that requires a physician to notify the Department in writing as to a change of address, but the Department's policy is to require that address changes be in writing and that the request for a change of address come from the physician. There was no written notification from Respondent to the Petitioner that his business address had changed prior to September 1992. At the time of the formal hearing, Respondent's business address was 102 East 49th Street, Hialeah. His former business address was 4821 West 4th Avenue, Hialeah, Florida. At the times pertinent to this proceeding, Respondent's home address was 14710 Day Pine Avenue, Miami, Florida. As of December 17, 1990, Petitioner had been informed of that address. Petitioner's investigator, Diane Robie, interviewed Respondent at his business address on East 49th Street on August 22, 1991. Respondent had been at this address for approximately eight months as of August 22, 1991. This new business address was reflected by Ms. Robie's report, which was filed with Petitioner on October 8, 1991, but that report did not trigger a change of the business address Petitioner maintained for Respondent in its computers. Respondent's license to practice medicine was scheduled to expire on December 31, 1991. In mid October 1991, the Department of Professional Regulation (Department) mailed a renewal notice to Respondent's former business address on West 4th Avenue. As required by Section 458.319(4), Florida Statutes, the Department routinely mails to the physician a renewal form that the physician must use to renew his license. This mailing takes place 60 days before the physician's license is scheduled to expire. This renewal form is generated by computer and is sent to the mailing address that is on record with the Department and maintained by computer. It was the Department's policy to try to notify a physician at his home address if a renewal notice is returned from a stale office address. There was no evidence that the renewal notice and the renewal form that was mailed to Respondent at his former address in October 1991 was returned to the Department as being an incorrect address. The evidence failed to establish what happened to the renewal notice that was mailed to Respondent in mid-October 1991. There was no further attempt by the Department following the mid-October 1991 mailing to notify the Respondent at his home address or business address that his license was about to expire. Respondent's license expired on December 31, 1991, and his licensure automatically reverted to inactive status pursuant to Section 458.319(3), Florida Statutes. Respondent made no effort to contact the Department until June 1992 at which time his secretary/office manager contacted the Department by telephone and advised that Respondent had not received the renewal documentation. On August 10, 1992, the Petitioner wrote to Respondent at his home address. This was the first written communication between the parties since the mid-October 1991 mailing. Respondent mailed a check in the amount of $500.00 for the renewal of his license to the Department in September 1992. On October 6, 1992, the Department wrote Respondent at his former address on West 4th Avenue and advised that prior to the renewal of his license, Respondent had to pay an additional fee in the amount of $350.00 for the processing of his renewal application and that he would also have to submit proof that he had earned required continuing medical education credits. On February 15, 1993, the Department sent to Respondent a letter at his East 49th Street address that provided as follows: This letter is in response to your (sic) to your submission to renew your Florida medical license which was received in the Board office on 9-15-92. Unfortunately the Board of Medicine cannot comply with your request until the follow- ing is received: $350.00 renewal fee. (in addition to the $500 already submitted) You did not fill out the Financial Respon- sibility portion of the renewal application, therefore, you will need to fill out a new form, and have it properly notarized. Please submit an affidavit for your active practice activities between January 1, 1992, and the present date. Any person applying for reactivation of a license must show either that such licensee main- tained tail insurance coverage which provided liability coverage for incidents that occurred on or after January 1, 1987, or the initial date of licensure in this state, whichever is later, and incidents that occurred before the date on which the license became inactive; OR that such licensee MUST SUBMIT A NOTARIZED AFFIDAVIT STATING THAT SUCH LICENSEE HAS NO UNSATISFIED MEDICAL MALPRACTICE JUDGMENTS OR SETTLEMENTS AT THE TIME OF APPLICATION FOR REACTIVATION. After July 1, 1992, you will need to submit copies of at least 40 hours of Category I CME earned between January 1, 1990, and the present date. Five of these hours must be in Risk Management. Also one hour of HIV/AIDS Category I CME needs to be submitted. Once the above items are received, we will proceed with the issuance of an active Florida medical license. (Emphasis is in the original.) Respondent met all requirements for the renewal of his medical license on March 16, 1993, the date on which his license was reactivated. Between January 1, 1992, and March 15, 1993, Respondent engaged in the practice of medicine in the State of Florida without an active license. Case 93-6929 Petitioner filed an Administrative Complaint against Respondent on April 27, 1988, which was subsequently referred to the Division of Administrative Hearings and assigned DOAH Case No. 88-5546. On February 28, 1989, the parties to that proceeding executed a "Stipulation" which settled the dispute. On April 19, 1989, the Board of Medicine entered a Final Order that accepted the Stipulation and ordered the parties to abide by its terms. Pertinent to this proceeding, Paragraph 4 of the Stipulation required the following: 4. Within one (1) year of the date of filing of the Final Order incorporating the terms of this stipulation, Respondent shall complete twenty-five (25) hours of Category I Continuing Medical Education in the areas of Risk Management and/or Medical Records Keeping. Such continuing education shall be in addition to that amount required for renewal of licensure. Category I Continuing Medical Education is a course approved by the American Medical Association as a top level course. In March 1990, Respondent completed a 25 hour course sponsored by Jackson Memorial Hospital in the area of "Medical Records Keeping". Respondent notified Petitioner on March 21, 1990, that he had completed this course. This was the only course that Respondent claimed to have taken in satisfaction of the Final Order entered in DOAH Case 88-5546. This course has not been designated as a Category I Continuing Medical Education course by Jackson Memorial Hospital. The Petitioner advised the Respondent that the course he had taken did not satisfy its order. Respondent thereafter requested that the matter be reviewed by Petitioner's Probation Committee. This request was granted, but the Probation Committee determined that the course was not acceptable. Respondent did not comply with the order until March 16, 1993.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Petitioner enter a final order that adopts the findings of fact and conclusions of law contained herein and which incorporates the following: Find Respondent not guilty of practicing beyond the scope of his competence in violation of Section 458.331(1)(v), Florida Statutes, as alleged in Count One of Case 93-6927. Find Respondent not guilty of practicing below the standard of care in violation of Section 458.331(1)(t), Florida Statutes, as alleged in Count Two of Case 93-6927. Find Respondent guilty of failing to keep proper medical records in violation of Section 458.331(1)(m), Florida Statutes, as alleged in Count Three of Case 93-6927. For this violation, Respondent should be reprimanded, assessed an administrative fine in the amount of $1,000.00, and placed on probation for a period of two years, to run concurrently with any other period of probation imposed on Respondent. Find Respondent not guilty of failing to properly supervise the nurse anesthetist when the patient experienced breathing difficulties in violation of Section 458.331(1)(dd), Florida Statutes, as alleged in Count Four of Case 93- 6927. Find Respondent guilty of failing to ensure that the crash cart was appropriately equipped, thereby failing to properly supervise the nurse anesthetist in violation of Section 458.331(1)(dd), Florida Statutes, as alleged in Count Four of Case 93-6927. For this violation, Respondent should be reprimanded and assessed an administrative fine in the amount of $250.00. Find Respondent guilty of violating the provisions of Section 458.319(5), Florida Statutes, and thereby violating Section 458.331(1)(x), Florida Statutes, by failing to timely notify Petitioner of his change of business address as alleged in Count One of Case 93-6928. For this violation, Respondent should be reprimanded and assessed an administrative fine in the amount of $250.00. Find Respondent guilty of violating the provisions of Section 458.327(1)(a), Florida Statutes, and thereby violating Section 458.331(1)(x), Florida Statutes, by practicing medicine in the State of Florida after his license expired as alleged in Count Two of Case 93-6928. For this violation, Respondent should be reprimanded and assessed an administrative fine in the amount of $1,000.00, and placed on probation for a period of two years, to run concurrently with any other period of probation imposed on Respondent. Find Respondent guilty of violating the provisions of Section 458.331(1)(x), Florida Statutes, by failing to timely comply with an order of the Board of Medicine alleged in Case 93-6929. For this violation, Respondent should be reprimanded and assessed an administrative fine in the amount of $250.00. DONE AND ENTERED this 31st day of January, 1995, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of January, 1995.
Findings Of Fact In February, 1984 Petitioner applied to Respondent for licensure by examination under Section 458.311(2), F.S., but after review of said application at a meeting held on June 10, 1984, Respondent issued an Order dated July 21, 1984 denying said application. Petitioner received a degree which is designated Doctor of Medicine on May 2, 1983 from the Universidad Techologica de Santiago, (UTESA), Santo Domingo, Dominican Republic. He has been in residency at Orlando Regional Medical Center since June 28, 1983. Various required clerkships were performed by Petitioner between August 2, 1982 and February 28, 1983 in hematology, obstetrics and gynecology, pediatrics, dermatology and ENT/0phth., and were performed completely, or partially at osteopathic hospitals, or under the supervision of osteopathic physicians. An additional one month elective clerkship was also performed in April 1983 at Southeastern College of Osteopathy. Petitioner passed the exam given by the Educational Commission for Foreign Medical Graduates (ECFMG) on March 15, 1983, but has not been certified due to the need for additional institutional verification. Respondent informed Petitioner of the decision of ECFMG to withhold verification of certification and also informed Petitioner of its duty to approve or deny an application for licensure within ninety (90) days, unless waived by the applicant. Petitioner declined to consent to a waiver and requested Respondent to act on his application without verification of an ECFMG certificate.
The Issue Whether Petitioner's application for license to practice medicine by endorsement pursuant to Chapter 458, Florida Statutes, should be approved. Petitioner appeared at the hearing unaccompanied by legal counsel and was advised of her rights and applicable procedures in administrative proceedings under Chapter 120, Florida Statutes. She elected to represent herself in this matter. This case arises from the provisional denial of Petitioner's application for licensure by endorsement to practice medicine, pursuant to Chapter 458, Florida Statutes. By Respondent's Order, dated January 29, 1982, the application was denied pursuant to subsection 458.313(1)(d), Florida Statutes, on the ground that Petitioner had not been certified by licensure examination of the Federation of State Medical Boards of the United States, Inc., and is not certified by the National Board of Medical Examiners as having completed its examination within the ten years immediately preceding the filing of the application for licensure by endorsement. In its Order, Respondent advised Petitioner-of her right to petition for a hearing. Petitioner so requested a hearing under Section 120.57, Florida Statutes, by letter to Respondent, dated May 2, 1982.
Findings Of Fact On October 1, 1981, Petitioner Elda Giannantonio filed an endorsement application with Respondent on a standard form provided by the agency, together with supporting documents and the standard application fee. (Exhibit 1) By "Final Order" of the Board of Medical Examiners, dated January 29, 1982,which recited action taken by the Board on December 4, 1981, it was found that Petitioner had not been certified by licensure examination of the Federation of State Medical Boards of the United States, Inc., and is not certified by the National Board of Medical Examiners as having completed its examination within the ten years immediately preceding the filing of the application for licensure by endorsement. It was therefore concluded by the Board that Petitioner had not met the statutory requirements for licensure by endorsement pursuant to Section 458.313(d), Florida Statutes. In all other respects, Petitioner has met the necessary requirements for licensure by endorsement. (Testimony of Faircloth, Exhibit 1, Stipulation) Petitioner was born and educated in Italy where she received her Medical degree in 1953. To be licensed by endorsement in Florida, a foreign graduate must have received a standard certificate after passing an examination given by the Educational Commission for Foreign Medical Graduates. Petitioner received such a certificate on March 28, 1962. (Testimony of Faircloth, Petitioner, Exhibit 1) A statutory requirement of all applicants for licensure by endorsement is that the applicant must have been certified by licensure examination of the Federation of State Medical Boards of the United States, Inc. (FLEX) or certified by the National Board of Medical Examiners as having completed its examination; provided that said examination required shall have been so certified within the ten years immediately preceding the filing of the application for licensure. The National Board of Medical Examiners examination is administered only to students at Medical schools in the United States. Petitioner has not been certified by either licensure examination. All states, including Florida, recognize the FLEX examination as the standard test for licensure. (Testimony of Petitioner, Faircloth, Exhibit 1) Petitioner was of the mistaken opinion that the fact she had Practiced medicine in New York and had been certified by the Educational Commission for Foreign Medical Graduates was sufficient to qualify her for licensure by endorsement, without the need for either National Board or FLEX certification. However, the instructions provided applicants by Respondent clearly showed that both requirements must be met by foreign graduates. (Testimony of Petitioner, Faircloth, Exhibit 2)
Recommendation That the application of Petitioner Elda Giannantonio for licensure by endorsement pursuant to Section 458.313, Florida Statutes, be denied. DONE and ENTERED this 24th day of August, 1982, in Tallahassee, Florida. THOMAS C. OLDHAM 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 24th day of August, 1982. COPIES FURNISHED: Elda Giannantonio, M.D. 27 Kohr Road Kings Park, NY 11754 Chris D. Rolle, Esquire Department of Legal Affairs The Capitol Tallahassee, Florida 32301 Dorothy J. Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Samuel Shorstein Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue At the commencement of the final hearing the parties stipulated that the specific issue for determination is whether Dr. Walker's medical clerkships constituted allopathic medical education. Counsel for respondent argued that this proceeding affects only Dr. Walker's eligibility to take the licensure exam. For the reasons set forth below, that characterization is rejected.
Findings Of Fact Ralph Waldo Walker II graduated from the American University of the Caribbean in Plymouth, Montserrat, British West Indies. He obtained his medical school diploma in May 1982. As part of the curriculum in medical school he partiipated in clinical clerkship training at Mercy Medical Center in Des Moines, Iowa. All of his clerkships, except psychiatry, were at that hospital and were completed during 1981 and 1982. (Exhibit 1) In Iowa, hospitals are not licensed as osteopathic or allopathic, but rather are simply licensed as hospitals. In Des Moines there is only one hospital that is identified as osteopathic: Des Moines General. Unless a hospital is specifically identified as osteopathic, it is considered allopathic. It is possible, however, for both allopathic medical doctors and osteopaths to practice at either hospital. (transcript, p. 17, 18; Deposition of Dr. Gay, p. 5-7) During the time that Dr. Walker served his clerkship, Mercy Hospital had medical students from the medical school in Guadalajara, Mexico, the American University of the Caribbean, and the University of Osteopathic Medicine and Health Sciences in Des Moines. Less than half of the students rotating on a regularly scheduled basis were from the osteopathic school. Less than half of the students at Mercy during 1981 and 1982 were under the direct supervision of an osteopathic physician. (deposition of Dr. Gay, pp. 8, 10) In his clerkship experience at Mercy Medical Center, Dr. Walker was never supervised by an osteopathic physician. (transcript, p. 17) Mercy Medical Center is listed in the 1980-81 Directory of Residency Training Programs as a hospital approved by the American Medical Association for allopathic residency training in the speciality area of pathology. (deposition of Dorothy Faircloth, pp. 10-11) Dr. Waldo first applied for licensure in Florida in 1983. He paid the $350 application fee, and on February 10, 1984, he appeared before the Board of Medical Examiners' Foreign Medical Graduate Committee where he was guestioned at length regarding his background and education. Upon the affirmative recommendation of that committee, the full board voted to allow him to take the examination. (Exhibit 1, including transcript of the February 10, 1984, appearance) He took the June 1984 exam and failed; he repeated the process and failed the December 1984 exam. He applied for the June 1985 exam and was sent an admission card, but he decided instead to stay out and study. He applied again in August l985, and was sent an admission card for the December 1985 exam. (Exhibit 1) He was a1so reguired to appear again before the Board on November 23, 1985. The basis for the appearance, as stated by Executive Director Dorothy Faircloth, was a letter from a patient in Georgia. The letter was discussed and explained, and the Board questioned Dr. Waldo regarding his clerkships at Mercy Medical Center. The outcome of this appearance was denial of Dr. Waldo's application for licensure. The grounds for denial stated in the Board's order filed on February 6, 1986 are: The applicant's supervised clinical training was not obtained in either a hospital affiliated with a medical school accredited by the Liaison Committee on Medical Education or in a residency program accredited by the Accreditation Council for Graduate Medical Education in the specialty area in which the clinical training is being obtained, as required by Florida Administrative Code Rule 21M-22.18. Furthermore, the applicant's core clerkships were performed in an osteopathic institution, rather than an allopathic institution and do not constitute medical education as that term is used in Chapter 458, Florida Statutes. (Exhibit 1, including transcript of November 23, 1985, appearance before the Board) Dr. Walker. took the Federation licensing Examination (FLEX) in the State of Iowa and passed with scores of 78 and 81. A score of 75 on each component is considered a passing score in Florida. Dr. Walker became licenced to practice medicine in Iowa on August 22 1986. (Exhibit l, transcript, pp. 14, 26)
Recommendation Based on the foregoing, it is recommended that a final order be entered approving Ralph Waldo Walker's application for licensure to practice medicine in the state of Florida. DONE and RECOMMENDED this 31st day of December, 1986 in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of December, 1986.
Findings Of Fact Ruth Rogers is a licensed medical physician authorized to practice medicine in this state. The Complaint allegations centered around testimony of the Respondent, Ruth Rogers, during a custody proceeding in which the Child Protective Services (a State Agency) was attempting to gain custody of one Dena (Nikki) Decker based on facts which will be set forth in detail hereinafter. Jack McGowan, a medical doctor engaged primarily in pediatrics in Fort Pierce, Florida, testified that he first treated Dena Decker during August of 1973, at which time Decker was approximately seven weeks old. Dr. McGowan made subsequent treatments of Dena Deckur on a regular basis through December of 1976. During December, Dr. McGowan noted that Decker's lymph glands were enlarged and he ordered that certain lab work be performed, the results of which were returned to him sometime during early January of 1977. Based on the lab results, Dr. McGowan tentatively diagnosed Dena Decker as being a patient suffering from acute leukemia. To confirm this diagnosis, he referred her to the Shands Teaching Medical Center in Gainesville, wherein Dr. McGowan's diagnosis was confirmed. The treating physicians of Patient Decker at Shands Teaching Hospital were Drs. Jerry L. Arbosa and David Pockmore. It was their medical opinion that Dena was in fact suffering from acute lymphoblastic leukemia and that this disease should be treated by chemotherapy at Shands Teaching Hospital in Gainesville. Drs. Barbosa and Rockmore explained to the parents of Dena Decker the benefits and side effects of chemotherapy treatment, and they suggested that this was the best method of treating a patient such as Dena Decker, who was suffering from acute lymphoblastic leukemia. They noted, however, that there were some side effects, such as loss of hair and the destruction of certain "good" cells as well as "bad" cells. Dema Decker's parents requested time to consider the chemotherapy treatment and Drs. Barbosa and Rockmore stressed to her parents that "time was of the essence". After a few days, the parents of Dena Decker declined the treatment and at that juncture, Drs. Barbosa and Rockmore called in the Child Protective Services of Gainesville wherein a custody proceeding was convened, with the State seeking a custody award of Dena Decker. During that proceeding, Dr. Ruth Rogers, Respondent, testified that she would treat such a patient suffering from acute lymphoblastic leukemia with natural foods, herbs and optimal psychological support. It was Drs. Barbosa and Rockmore's opinion that the method of treatment outlined by the Respondent would be futile and that the patient would die in a short period of time. There was no evidence that the Respondent, Ruth Rogers, counseled with Dena Decker's parents or that she at any time treated Dena Decker by the method to which she testified during the custody proceeding in Gainesville. Following the conclusion of the Petitioner's case, Respondent's counsel moved for a directed verdict, summary judgment, or a judgment based on a failure on the Petitioner's part to establish a prima facie case. After some consideration, the undersigned concluded that, based on the evidence adduced during the Petitioner's case in chief, insufficient evidence was offered to establish that the Respondent had violated Chapter 458.1201(m), Florida Statutes, as alleged. Section 458.1201 is the section of the Medical Practices Act which deals with the power of the Board in the denial, suspension, revocation of license, and other discipline of medical practitioners. It reads, in pertinent part: "458.1201l--Demial, suspension, revocation of license; disciplinary powers-- The board shall have authority to deny an application for a license or to discipline a physician licensed under this chapter or any antecedent law who, after hearing, has been adjudged unqualified or guilty of the follow- ing: (Here is set forth several categories of disqualification or misconduct included in which is subsection (m))." Subsection (m) sets forth as grounds for. . . discipline of a physician, the following facets of misconduct: "(m) Being guilty of immoral or unprofessional conduct, incompetence, negligence or will- ful misconduct. Unprofessional conduct shall be any departure from, or the failure to conform to, the standards of acceptable and prevailing medical practice in his area of expertise as determined by the board, in which proceeding actual injury to a patient need not be established; when the same is committed in the course of his practice whether committed within or without this state." (Emphasis supplied) The administrative charge herein claimed to be proscribed by the above- quoted section of the statutes deals only with the testimony of the Respondent as to a method of treatment that she would use for treating acute lymphoblastic leukemia. Based on my examination of this record and an analysis of the reported case law, I conclude that the giving of such testimony is not proscribed unprofessional conduct as that term is included within this particular subsection of Chapter 485.1201(m). As the Court of Appeals stated in Lester v. Department of Professional and Occupational Regulation, Fla.App., 348 So.2d 923 (1977), the Court stated: "In construing the language and import of this statute we must bear in mind that it is, in effect, a penal statute since it imposes sanctions and penalties in the nature of denial of license, suspension from practice, revocation of license to practice, private or public reprimand, or probation, upon those found guilty of violating its prescriptions. This being true the statute must be strictly construed and no conduct is to be regarded as included within it that is not reasonably pro- scribed by it. Furthermore, if there are any ambiguities included such must be construed in favor of the applicant or licensee." This being so, I conclude that the above-cited conduct claimed to be violative of Chapter 458 is not proscribed by Chapter 458.1201(m) and I shall recommend that the Board enter a final administrative order dismissing the instant action against the Respondent.
Recommendation Based on the foregoing findings and conclusions, hereby RECOMMEND: That the Administrative Complaint filed herein against the Respondent be DISMISSED. RECOMMENDED this 28th day of August, 1978, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael I. Schwartz, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 David Rogers, Esquire 3101 Maguire Boulevard Post Office Box 20065 Orlando, Florida 32814 George S. Palmer, M.D. Execuivo Director State of Florida, Board of Medical Examiners 2009 Apalachee Parkway, Suite 220 Tallahassee, Florida 32301
The Issue The issue in this case is whether Petitioner wrongfully revoked the Respondent's Pinellas County paramedic certification.
Findings Of Fact The Director is responsible for, inter alia, providing paramedic certifications in Pinellas County. Respondent, Adam C. Baginski, was duly-certified as a paramedic by Pinellas County in February 2005. Respondent was employed by Sun Star, n/k/a Paramedics Plus (hereinafter referred to as "Sun Star"), and had filed an application through his employer for certification by Pinellas County. Respondent had first entered the general health care field as a life guard; he then became an EMT in 1994. After training received at the University of Toledo, Respondent became a paramedic in 2001. He held three positions in Ohio before coming to Florida, where he became employed by Lee County. After approximately nine months, he resigned his position with Lee County and went to work with Sun Star. The application process in Pinellas County to obtain paramedic certification entails a training seminar and a background check. The requisite background check is performed and attested to by the employer. At the training seminar, applicants are required to submit written responses to a two- page questionnaire. The questionnaire contains the following preface: Please answer the following questions so that we may gather the necessary data to provide a positive, educational and stress- free learning experience. All information will be confidential. At the end of the questionnaire, this statement is found: By signing this release, I understand that any falsification, incomplete or misleading information contained on this application or in any documents presented to obtain County Certification may be grounds for immediate suspension and/or revocation of may [sic] County Certification. The Director processed Respondent's application for certification by first reviewing the questionnaire. On the first page of the questionnaire, Respondent listed all of his work experience in Ohio, but did not list his Lee County experience. He does not remember why he omitted that employment history, but thinks it may have been due to lack of adequate space on the line provided.1 A cursory review of the questionnaire would show that appropriate space is provided. Notwithstanding the omission, the Director issued a paramedic certification to Respondent.2 Upon receipt of his certification, Respondent began performing paramedic services for Pinellas County through his employer. He was generally partnered with one particular EMT for ambulance runs, but sometimes had a different partner if circumstances so dictated. (E.g., if his partner was ill or on vacation, he may be temporarily assigned to another EMT. It was generally the duty of the EMT to drive the ambulance and for the paramedic to perform direct care to the patient.) On July 11, 2007, Respondent was on duty with Kristin Burns as his EMT for that shift. Respondent cannot remember why his regular partner was not there on that day.3 Respondent and Burns were responding to an emergency call when they were interrupted by dispatch and told to go to a different location. The new location was a doctor's office located at 929 First Avenue North in downtown St. Petersburg. Before arriving on the scene, Respondent and Burns received telephone/radio reports indicating the fire department was already on the scene. Fire department employees had assessed the patient (William Newcomb) and determined him to be stable. As a result, the call was "downgraded" so that Respondent and Burns could proceed to the scene without lights or siren. A downgrade indicates the situation is no longer critical. Upon arrival, Respondent talked to a firefighter and was told that the patient believes he has had a seizure and wants to go to the VA hospital. It was again confirmed that the situation was not an emergency. The patient had walked to his eye doctor's office because he was having vision impairment. When the doctor could not see him, the patient called 911 and asked for an ambulance to take him to the hospital. There was no distress noted by the firefighters or Respondent. The patient came out of eye doctor's office building and, using a walker, walked himself directly towards the waiting ambulance. Respondent began to question the patient at that time, attempting to assess his condition. All he was able to ascertain was that the patient wished to go to the VA hospital. The cot was taken out of the ambulance, the patient was strapped in, and the ambulance headed toward the VA hospital.4 During the trip to the VA hospital, Respondent and the patient were in the rear of the ambulance; Burns was driving. Respondent was seated in the "CPR seat" which is the seat to the right of the patient. There is a window between the driver compartment and the back of the ambulance that allows some visual contact between the driver and the paramedic. Burns did not actually see Respondent provide any care to the patient (but it is unclear how well she could have seen into the rear of the vehicle due to its configuration). Newcomb does not remember what care was rendered to him during the trip to the hospital. He believes his pulse and temperature may have been taken; his oxygen level was taken. He does not specifically remember what else was done. He cannot remember who helped him into the ambulance or much else about the trip. He does maintain that Respondent talked to him a lot about Newcomb's not needing the ambulance, but remembers little other than that. Newcomb signed the patient care report (twice) acknowledging Sun Star's billing practices and receipt of--or offer of--a Notice of Privacy Rights. The patient care report filled out by Respondent to officially record the Newcomb case indicates Newcomb's vital signs were taken three times in the ambulance trip. In addition, a visual check was done to track any changes in the patient's eyesight. Respondent noted that Newcomb had no facial droops, he was speaking clearly, and he was using purposeful movements of his extremities. Each of these is a visual means of ascertaining a hostile patient's condition. Newcomb doesn't remember the trip well, and Burns did not see Respondent taking vital signs, but Respondent maintains he took the vital signs, and they are recorded on the patient care report. There is no clear evidence as to whether that happened or not. The conversations between Respondent and Newcomb were only partially overheard by Burns. She was driving an ambulance with a diesel engine in mid-day traffic. The window between the cab of the ambulance and the back was not open. There was no radio communication between Burns and Respondent during the ride to the VA hospital. Burns could maintain some partial visual contact with Respondent during the ride. She could see through the window by turning her head around or she could glance in the rear view mirror. She remembers seeing Respondent sitting in the CPR seat at the patient's head. Respondent remembers sitting in the CPR seat at the patient's side. Newcomb remembers Respondent sitting at his right side. Whether Burns was able to see substantially all of Respondent's actions was not well established in the record. When the ambulance reached the VA hospital, Newcomb walked under his own power to the triage area in the emergency room. Respondent walked in front of Newcomb, Burns walked behind. Whether Newcomb walked voluntarily or because Respondent told him to do so is not clear. Burns testified that Respondent told the patient to walk; the patient testified that he was more or less able to get out of the ambulance on his own and walk; and Respondent testified that the patient moved out of the cot on his own accord. What actually transpired is unclear, but Newcomb expressed several times that EMT Burns was attentive to him. There is no evidence that he asked Burns for a wheelchair or other assistance. When the ambulance arrived at the hospital, Newcomb was reported to be stable with no apparent distress. He ended up remaining at the hospital for about three hours, after which he walked out on his own power (using his walker), caught a taxi, and went home. Back at the doctor's office, Newcomb had advised either the firefighters or Respondent that he (Newcomb) was HIV positive. Newcomb is extremely emotional and sensitive about his condition. It appears he drew conclusions about Respondent's feelings concerning the condition even though it was not discussed in any detail. Respondent must deal with HIV positive and AIDS patients regularly in the course of his work; it is unlikely this particular situation was significantly repulsive to him. The dialogue between Respondent and Newcomb during the ride to the hospital was sometimes loud, sometimes heated, and not necessarily friendly. Burns heard some words exchanged concerning whether the ambulance was necessary. Respondent remembers the patient as uncooperative; Newcomb's recollection is that Respondent was rude. There is insufficient evidence to ascertain anything other than that Respondent and Newcomb were not on amicable terms as patient and caregiver. Respondent's demeanor and "bedside manner" were considered relevant by the Director in making a decision to revoke the paramedic certification. Past allegations against Respondent were discussed but none of them were founded; thus, they have no weight in this proceeding. Respondent had, however, been counseled by his employer regarding his relations with patients. The counseling came about as a result of complaints by patients, family members, and other caregivers. Sun Star also disciplined Respondent based on the Newcomb complaint, denying him a full week's worth of work shifts. The basis of the discipline was that Respondent had allegedly treated Newcomb unkindly because of the fact that Newcomb was HIV positive. It is clear from Respondent's demeanor in the final hearing that he may not be a "people person." However, he is very knowledgeable about his work and possesses all the necessary medical skills. There was no evidence to support the allegation that he treated Newcomb unprofessionally due to Newcomb's HIV status.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Pinellas County Emergency Medical Services, Office of the Medical Director, reversing the decision to terminate Respondent's certification as a paramedic in Pinellas County. DONE AND ENTERED this 14th day of February, 2008, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of February, 2008.
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.
The Issue The issue in this case is whether Petitioner's application for a license by endorsement to practice medicine in the State of Florida should be granted or denied.
Findings Of Fact Petitioner is a medical doctor. Petitioner graduated medical school from the University of Miami in Miami, Florida, in May 1994. Petitioner signed an application for medical licensure by endorsement with the Board on January 9, 2003. On or about January 16, 2003, the Department of Health received Petitioner’s application for medical licensure by endorsement. Following receipt and review of the subject application, Petitioner was required to provide some additional information to the Board. Petitioner was eventually required to appear before the Credentials Committee of the Board to answer questions about his application. On October 17, 2003, the Board issued a Notice of Intent to Deny Licensure, in which the Board notified Petitioner of its intent to deny his application. That notice read as follows, in pertinent part: This matter came before the Credentials Committee of the Florida Board of Medicine at a duly-noticed public meeting on September 13, 2003 in Tampa, Florida[,] and the full Board on October 3-4, 2003, in Ft. Lauderdale, Florida. The applicant appeared before the Credentials Committee on September 13, 2003, and presented testimony regarding the application file. The application file shows: The applicant lied before the Committee and lied on the licensure application as to the following: the applicant took a leave of absence during his training; the applicant was placed on probation at 3 schools; the applicant did not finish his training in the normal time frame; and, the applicant answered #15 b, c, d and #31 incorrectly on the application. The applicant is guilty of violating Section 458.331(1)(gg), Florida Statutes, for misrepresenting or concealing multiple material facts at any time during any phase of a licensing or disciplinary process or procedure. Based on the foregoing, the Board may refuse to certify an applicant for licensure, or restrict the practice of the licensee, or impose a penalty, pursuant to Sections 458.3331(2) and 456.072(2), Florida Statutes. It is therefore ORDERED that the application for licensure be DENIED. Petitioner attended the following four postgraduate training programs (residency programs): Medical College of Pennsylvania; Sinai Hospital1; Wayne State University/Detroit Medical Center; and University of Medicine and Dentistry of New Jersey (“UMDNJ”). Petitioner’s dates of attendance in those four residency programs were as follows: Medical College of Pennsylvania from July 1, 1994 to June 30, 1995. Sinai Hospital from July 1, 1995 to June 30, 1999. Wayne State University/Detroit Medical from July 1, 1999 to June 30, 2001. UMDNJ from July 1, 2001 to June 30, 2003. Question number 15a on the application for medical licensure by endorsement asks, “Have you ever been dropped, suspended, placed on probation, expelled or requested to resign from a postgraduate training program?” Petitioner answered “yes” to question number 15a and submitted a written supplemental answer which stated, “I was placed on probation regarding the expectations of running a University service in a manner that kept attending physicians informed of patients’ clinical changes in July of 2000. Specific goals were given to me that I immediately fulfilled and was taken off probation in September of 2000 and remained in good academic standing until the time of my graduation.” On his application for licensure, Petitioner only admitted to being on probation at one residency program, Wayne State University/Detroit Medical Center. During the processing of the subject application, an employee of the Department of Health, Wendy Alls, advised Petitioner as follows by e-mail: “We are in receipt of your response to the inquiry from Wayne State University [Sinai Hospital], regarding your Residency from 7/95 to 6/99. It indicates that you were placed on probation and received negative reports. It also stated that limitations were placed upon you due to academic incompetence. Please respond.” On May 6, 2003, Petitioner submitted an e-mail response to Wendy Alls regarding his probation at Wayne State University [Sinai Hospital] which stated: “It is true that I did receive negative reports during my residency training from 7/95 to 6/99 for my work ethic. However, I was never formally placed on probation as per the guidelines of the Wayne State University. I, as well as the Graduate Medical Education Office, must receive formal written notification identifying the areas of deficiency and the duration of the probation period. Written notification must be submitted to both the GME office and myself after successful completion of the probation period. This was never done. In addition, no limitations or restriction were ever placed upon me due to academic incompetence or for any other reason for that matter.” Petitioner did not admit this on his initial application to the Florida Board of Medicine. Sinai Hospital submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital submitted a report to the Federation Credentials Verification Service (“FCVS”)2 and stated on the report that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital reported that Petitioner was placed on probation during his residency in response to faculty concerns regarding both academics and behavior. While at Sinai Hospital, Petitioner was informed of the issues he needed to improve during his probationary period. These issues included, but are not limited to the following: Petitioner’s tardiness, sleeping during conferences, unavailability when on call, failing to follow hierarchy, and inability to carry his share of the workload. Petitioner admitted at the formal hearing he was told that he was on probation at Sinai Hospital. During his appearance before the Credentials Committee on September 13, 2003, Petitioner testified under oath, that he did not disclose the fact he was on probation at Sinai Hospital because he was never informed that he “was ever placed on probation.” A letter dated November 4, 1999, from Dr. Andrew Saxe (who was then the general surgery residency program director at Sinai Hospital) states that Petitioner was on “probationary status” at Sinai Hospital during his residency from 1996 to 1997. Dr. Andrew Saxe also noted Petitioner’s probationary status in a memo dated April 28, 1999, which Petitioner himself signed. Petitioner signed a memo dated December 18, 1996, stating that he was on “probationary status” at Sinai Hospital during his residency. Petitioner also signed a memo dated April 16, 1997, stating that he was “off probationary status” at Sinai Hospital during his residency. Wayne State University/Detroit Medical Center submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1999 to 2000. Petitioner failed to fully disclose all of the reasons why he was placed on probation at Wayne State University/Detroit Medical Center. Wayne State University/Detroit Medical Center submitted a report to the FCVS and stated on the report that Petitioner was on academic probation during his residency for four months beginning in September 2000. The report stated that the probation was based on evaluations which cited “inadequate performances in clinical application of knowledge especially recognitions of own capabilities and limitations. There were also concerns over attention to details and work habits.” Petitioner’s supplemental answer to question 15a does not fully disclose his deficiencies in clinical knowledge and work habits at Wayne State University/Detroit Medical Center. At all times material to this case, Dr. Mark Granick has been the director of the plastic surgery program at UMDNJ. UMDNJ submitted a Training Evaluation Form to the Florida Board of Medicine and stated on the form that Petitioner was on academic probation during his residency “due to poor in-service exam scores.” After UMDNJ submitted the Training Evaluation Form, Petitioner contacted Dr. Mark Granick to discuss his probation at UMDNJ and the “program’s specifications in defining probation.” Dr. Mark Granick was prompted to send a second Training Evaluation Form to the Board, changing the substance of the first submitted Training Evaluation Form. The second Training Evaluation Form to the Board was submitted along with a letter from Dr. Mark Granick dated February 14, 2003, which stated he made an error in filling out the original form. When Dr. Mark Granick drafted Petitioner’s Fourth- Quarter Report on May 31, 2002, he was “documenting the reasons why I wanted him on a period of supervision, which I thought of as probation at that point in time.” Petitioner’s Fourth-Quarter Report dated May 31, 2002, was in fact signed by Petitioner. The Fourth-Quarter Report documented that Petitioner was “deficient on multiple occasions” with regard to Patient Care; Petitioner had a “poor acquisition of a central knowledge base in Plastic Surgery”; Petitioner’s tardiness needed to “stop”; Petitioner demonstrated “immaturity” in interpersonal skills; and, Petitioner had “been acting in an unprofessional manner.” Petitioner signed a memo dated January 8, 2003, stating that he was placed on “probation” at UMDNJ during his residency due to “poor performance on the in-service examination and overall perception of weakness in academic level.” Dr. Mark Granick testified that when he used the term “probation” in the January 8, 2003, memo, the word was consistent with his own thinking, and not consistent with university definitions. Dr. Mark Granick stated that Petitioner indicated to him during their meetings at UMDNJ that Petitioner understood he was on “probation” at UMDNJ. Dr. Mark Granick testified that in his mind he considered it “probation” when he put Petitioner under direct supervision, gave Petitioner academic support, and advised Petitioner of the areas in which he needed to improve. Although the period of academic supervision imposed on Petitioner did not qualify as probation at the university level, it did constitute “probation” in the mind of Dr. Mark Granick and was understood to be “probation” by the Petitioner himself. Petitioner misrepresented to the Board the circumstances which caused him to be placed on probation at Wayne State University/Detroit Medical Center. He also misrepresented his understanding of his probationary status at both Sinai Hospital and UMDNJ. Question number 15c on the subject application asks: “Did you take a leave of absence during a postgraduate training?” Petitioner answered “no” to question number 15c on the application. But Wayne State University/Detroit Medical Center documents show that Petitioner took a month-long leave of absence. Petitioner asserts that his month-long leave of absence from Wayne State University/Detroit Medical Center was not a “leave of absence” because he used a combination of sick time and vacation time. However, Petitioner signed a Family Medical Leave Act Certification asking for a leave of absence due to his being “unable to perform work of any kind” while training at Wayne State University/Detroit Medical Center. Petitioner requested a leave of absence for one month from his training program at Wayne State University/Detroit Medical Center in March of 2001. While on leave in March 2001, Petitioner was hospitalized for benzodiazepine poisoning, pace maker insertion, and possible seizure disorder secondary to cardiac rhythm disturbance. After Petitioner’s hospitalization, Petitioner needed to have a letter clearing him to resume unrestricted activity. During this period of time Petitioner was also told that he should avoid driving motor vehicles. Once questioned by the Credentials Committee, Petitioner admitted to taking a leave of absence in 2001 while training at Wayne State University/Detroit Medical Center. Prior to being questioned by the Credentials Committee, Petitioner concealed from the Florida Board of Medicine that he took a leave of absence while at Wayne State University/Detroit Medical Center. Question number 31 on the subject application asks “In the last five years, have you been treated for or had a recurrence of a diagnosed physical impairment?” Petitioner answered “no” to question number 31 on the application. However, after questioning by the Credentials Committee, Petitioner admitted he had a pacemaker. After his hospitalization, Petitioner had to be cleared by his doctors to return to his duties as a resident. Despite Petitioner’s own definition of “physical impairment,” he concealed his hospitalization, pacemaker, and possible seizure disorder from the Board. Question number 15b on the subject application asks “Was attendance in a postgraduate training program for a period other than the established time frame?” Petitioner answered “no” to question number 15b on the application. Petitioner attended the General Surgery postgraduate training program at Medical College of Pennsylvania for one year from July 1, 1994, to June 30, 1995. Petitioner attended the general surgery postgraduate training program at Sinai Hospital for four years from July 1, 1995, to June 30, 1999. Petitioner attended the general surgery postgraduate training program at Wayne State University/Detroit Medical Center for two years from July 1, 1999, to June 30, 2001. As indicated by the foregoing, Petitioner spent seven years attending general surgery postgraduate training programs. Physicians applying for licensure by endorsement in Florida are required to show that they have completed an “approved residency program” in a “slotted” position. The Accreditation Council for Graduate Medical Education (“ACGME”) accredits postgraduate training programs, sets the standards for training programs, and determines the number of “slotted” positions a program has. The Board considers an “approved residency program” to be one that has been accredited by the ACGME. The Board relies on the ACGME in making determinations for licensure. The Board relies on the information provided in the ACGME directory when processing applications. The ACGME established time frame for completing a general surgery postgraduate training program is five years. The ACGME-established time frame for completing the postgraduate training program in general surgery at Medical College of Pennsylvania, Sinai Hospital, and Wayne State University/Detroit Medical Center was five years when Petitioner attended these programs. Thus, a five-year general surgery residency was considered standard by ACGME, the Medical College of Pennsylvania, Sinai Hospital, Wayne State University/Detroit Medical Center, medical educators, and residents like Petitioner. Therefore, Petitioner would have had to complete all his postgraduate training in general surgery within five years in order to have finished his training within the “established time frame.” It took Petitioner seven years to complete all of his postgraduate training in general surgery. Petitioner’s attendance in his general surgery postgraduate training programs was for a period other than the normal time frame established by both ACGME and by the programs he attended. Question number 15d on the subject application asks, “Were you required to repeat any of your postgraduate training?” Petitioner answered “no” to question number 15d on the application. A memo dated December 3, 1997, written by Dr. Andrew Saxe (general surgery residency programs director at Sinai Hospital) and placed in Petitioner's training file, included the observation that "this is a consequence of his being asked to repeat the current clinical year." In a memo dated April 28, 1999, also written by Dr. Andrew Saxe and also placed in Petitioner’s training file, Dr. Saxe stated, “in light of prior probation and concerns regarding clinical competency an additional year of training would be of service to him.” At final hearing, Petitioner himself explained that each postgraduate year (“PGY”) runs from July 1st of one year to June 30th of the following year. On the Verification of Postgraduate Medical Education form submitted to FCVS, Sinai Hospital listed Petitioner as only completing PGY 2 through PGY 4 while attending their program. On the Verification of Postgraduate Medical Education form submitted to FCVS Wayne State University/Detroit Medical Center listed Petitioner as completing PGY 4 and PGY 5 in their program. While attending his postgraduate training programs, Petitioner was continuously evaluated, as evidenced in his training files. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 2 from July 1995 through June 1997. That means Petitioner was a PGY 2 for two years. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 4 from July 1998 through June 2000. That means Petitioner was a PGY 4 for two years. Therefore, Petitioner repeated both PGY 2 and PGY 4 levels of training. As demonstrated by Petitioner’s postgraduate training files, Petitioner’s education levels of training did not consistently progress through the calendar years. Petitioner concealed from the Board that he had to repeat PGY 2 and PGY 4. Over the course of the last year, the Board has licensed at least 55 applicants who were found to have made one or more material misrepresentations on their licensure applications, or in the course of the licensure process.3 Over the course of the last year, the Board has licensed a number of applicants alleged to have made material misrepresentations regarding one or more of the issues raised in this matter. In a few cases that are arguably similar to the facts presented in this case, the Board has granted the license application, but with conditions that required the applicant to file a new application, to pay a new application fee, and to pay an administrative fine in the amount of $5,000.00.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order denying Petitioner’s application for medical licensure by endorsement. DONE AND ENTERED this 29th day of April, 2004, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of April, 2004.
