The Issue The issue is whether respondent's license as a medical doctor should be disciplined for the reasons stated in the administrative complaint.
Findings Of Fact Based on all of the evidence, the following findings of fact are determined. At all times relevant hereto, respondent, David Mark McGrew, was licensed as a medical doctor by petitioner, Department of Professional Regulation, Agency for Health Cost Administration, Board of Medicine (Board), having been issued license number ME 0042526. Respondent is engaged in the practice of medicine as a family practitioner at 4655 Keysville Avenue, Spring Hill, Florida. He has been licensed by the Board since 1983, is board certified in family practice, and is president of the Florida chapter of the Academy of Hospice Physicians. Except for this proceeding, which is based on a failure by respondent to comply with a previous Board final order disposing of a complaint, there is no evidence that respondent has been subjected to prior disciplinary action. The facts which gave rise to this dispute are as follows. On an undisclosed date in 1988 or 1989, the Board issued an administrative complaint against respondent alleging generally that he had inappropriately prescribed certain pain medication to a longtime patient. Although respondent was not represented by counsel, he entered into negotiations with the prosecuting attorney and eventually executed a stipulation wherein he agreed to certain conditions, including the imposition of a $500 fine to be paid within thirty days from date of the final order, a reprimand, and a requirement that he attend a three day course at the University of South Florida School of Medicine. However, respondent did not admit that his prescribing was inappropriate or excessive. The stipulation was presented to the Board at a meeting held on August 5, 1989. The dialogue of the relevant portion of the meeting was introduced into evidence as a part of joint exhibit 1 and petitioner's exhibit 3. It should be noted that a considerable amount of discussion was given to whether new conditions should be substituted for those contained in the stipulation. The discussion in the transcript does contain comments, albeit somewhat unclear, which lend support to the Board's contention that it intended to add a number of new conditions to the agreement but also retain the $500 fine. At the same time, however, the transcript discloses that respondent, who was not represented by counsel at the meeting, did not fully understand that certain features of the original agreement were being retained in the new agreement. This is evidenced by the fact that near the end of the meeting, respondent was requested to reiterate his understanding of the terms and when he did he failed to include a fine. No one corrected his misunderstanding. Accordingly, respondent left the meeting with the impression that the original stipulation had been rejected by the Board and a new agreement approved which required that respondent be reprimanded, he complete a course of at least two weeks duration in pharmacotherapeutics and addictionology within six months from the date of the final order, and for a period of one year after completion of the course, he use sequentially numbered duplicate prescriptions in prescribing controlled substances, retain one copy of the prescription in the patient's records, and furnish a DPR investigator a copy of all such prescriptions within thirty days after being written. Respondent believed that the Board no longer intended to impose a $500 fine, particularly since no specific mention of the fine was made by the Board's members while discussing the new conditions and because the Board had imposed a new (and more costly) requirement that he attend a two-week approved course. Finally, respondent was under the impression that the Board would lend assistance in finding a course of the nature prescribed at the meeting since respondent was unaware of any formal course of that duration. On August 17, 1989, the Board issued its final order concerning the stipulation. The order provided that "the (original) Stipulation as submitted be and is hereby approved and adopted in toto and incorporated by reference herein with the following additions:" Thus, the Board actually approved the original stipulation, including the fine, with certain modifications. The final order did not carry the advice that if respondent disagreed with the order, he must file an appeal with the district court of appeal within thirty days. This was probably because, in the original stipulation, respondent had specifically waived "all further procedural steps, and expressly waive(d) all rights to seek judicial review of or to otherwise challenge or contest the validity of the joint stipulation". Thus, the final order was never appealed, and its specific terms were not timely satisfied. However, for the reasons stated later, the failure by respondent to satisfy these conditions was not intentional and occurred because of his misunderstanding of the agreement and his failure to find a satisfactory two-week course. On August 22, 1989, respondent wrote the Board a letter acknowledging receipt of the final order and stating that he believed the Board had specifically rejected the fine in favor of a two-week educational course and that he "did not agree to a $500 fine." He asked what he should do about this disagreement, and then noted that he had contacted fourteen schools, individuals or organizations regarding courses that might satisfy the educational requirement imposed by the Board, and had been offered an internship at a pain clinic. After receiving no reply to his August 22, 1989, letter, respondent again wrote the Board on October 17, 1989, regarding his prior inquiry. He added that "it is my sincere desire to get this matter resolved at the earliest convenience." A second follow-up letter was sent by respondent to the Board on January 19, 1990, with copies of his two earlier letters. In addition, he made several telephone calls to the Board seeking to obtain a reply to his inquiries. On June 11, 1990, or some ten months after respondent's first letter, a Board administrative assistant replied to respondent's letter and acknowledged that "there was some confusion as to the administrative fine imposed by the Final Order dated August 17, 1989." The letter also stated: The tape of your appearance before the Board of Medicine on August 5, 1989, has been reviewed and there is no indication that the Board agreed to waive the $500 administrative fine which was due September 16, 1989. The amendment to the Stipulation concerned a formal course in pharmacotherapeutics and addictionology, to be a minimum of two weeks in length and approved by the Board. This course was to have been taken as soon as possible, but in any event, no later than six months after the date of the Final Order. After completion of the course reference (sic) above, the one year monitoring of your prescribing habits was to begin. At this time, there is no indication in your file that such a course has been approved by the Board or completed by you. In order to avoid possible disciplinary action against your license, please comply as soon as possible with the requirements of the Final Order. If you have further questions regarding this matter, please contact the Board office. (Emphasis in original) This letter prompted further correspondence between respondent and the Board. On June 26, 1990, respondent wrote another letter to the Board in which he acknowledged receipt of the Board's recent letter and gave a lengthy description of his unsuccessful efforts to find a course of the nature prescribed by the Board in its final order. He identified several shorter courses he had already attended plus future courses he planned to attend and asked that they be used collectively to satisfy the two weeks of educational training. He also asked for a copy of the tape of the Board's meeting. On July 25, 1990, a Board administrative assistant replied to respondent's letter and advised him that he was "in violation of the Final Order." The letter further stated that he was required to pay a $500 fine no later than September 16, 1989, or thirty days after the final order. As to the educational requirement, the assistant noted that the Board "acknowledges your attempts to receive guidance regarding the course of education, therefore, if it is your wish to attempt to comply with the requirement of the Order, we suggest that you consider the following individuals." The letter then identified two physicians in Minnesota who had "experience in assisting physicians fulfill particular course requirements." Finally, the letter noted that "failure to comply with a lawful order of the Board may be grounds for further disciplinary action." On August 18, 1990, respondent again wrote the Board and stated that he had just learned the Board was considering the issuance of another administrative complaint and was surprised. He also indicated he had contacted the two individuals mentioned in the Board's letter of July 25, 1990, and the courses offered by those individuals were "unstructured internship programs" of a type which had been previously rejected by the Board as being insufficient. Finally, respondent mentioned that he could attend a two-week course offered by a substance abuse center if this met the Board's approval. By letter dated August 29, 1990, a Board administrative assistant replied to respondent's letter and told him his suggested coursework would be presented to the Board at its September 20, 1990, meeting, and he would be notified of its decision. Thereafter, on October 8, 1990, respondent was advised by letter that the Board had rejected his request for approval of the two-week course at the substance abuse center. The Board also advised that respondent's request for partial credit for attending a conference on prescription drug abuse had been rejected. On October 24, 1990, the Board filed an administrative complaint against respondent for failing to comply with the terms of the final order issued on August 22, 1989. That prompted respondent to initiate this proceeding. At hearing respondent established that, although he had not yet attended a formal two-week course in pharmacotherapeutics and addictionology, he had no intent to defy the Board's order. Indeed, respondent has made a genuine effort to comply with this requirement by contacting numerous schools, individuals and organizations, including several suggested by the Board, but he has had no success in finding a two-week course that would meet the Board's approval. He has repeatedly asked the Board for assistance in finding such a course but was offered only very limited assistance. To illustrate his willingness to attend continuing medical education courses, respondent identified twenty-five courses of varying duration (but all less than two weeks) he has attended since the Board's final order, many of which deal with pain management and therapy. These courses total 173.25 hours, or twice the hours that would be included in a formal two-week course. He was also certified as a diplomate in the American Academy of Pain Management in 1990, which evidences further skills and knowledge obtained in this area after the Board's final order. He has expressed a complete willingness to attend the requisite course if he can find one that meets the Board's satisfaction. In the alternative, he has asked that the hours spent attending shorter courses in the same subject matter be used as credit towards satisfying the two-week course. This is a reasonable alternative and should be approved since the number of hours far exceeds the number he would receive in a two-week course. As to the fine, respondent has reviewed the transcript of the Board's meeting and still maintains that there is no indication in the transcript that the Board intended to assess a $500 fine when it imposed the new conditions. However, because he has now, for the first time, been given his "day in court" in this proceeding to explain his side of the story, he is willing to pay the fine if in fact the Board still intends to assess one. There is no evidence to show that respondent deliberately defied the Board's order that he pay the fine since he genuinely believes his position on that issue is correct. Finally, respondent is concerned that if he is found guilty in this proceeding, the disposition will be reported to the National Practitioners Data Bank and will be a permanent mark against his license to practice medicine.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent enter a final order dismissing with prejudice the administrative complaint. Respondent should also be required to comply with the terms of the final order issued on August 17, 1989, as discussed in paragraph 17 of this order. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 18th day of September 1992. DONALD R. ALEXANDER 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 18th day of September 1992. APPENDIX Petitioner: 1. Partially accepted in finding of fact 1. 2-3. Partially accepted in finding of fact 2. 4-5. Partially accepted in finding of fact 3. 6-8. Partially accepted in finding of fact 4. 9. Rejected as being unnecessary. 10. Partially accepted in finding of fact 13. 11-14. Partially accepted in finding of fact 3. 15. Partially accepted in finding of fact 9. 16. Partially accepted in finding of fact 10. 17. Partially accepted in finding of fact 11. 18. Partially accepted in finding of fact 4. Respondent: 1-2. Partially accepted in finding of fact 1. 3. Partially accepted in finding of fact 2. 4-5. Partially accepted in finding of fact 3. 6. Partially accepted in finding of fact 4. 7. Partially accepted in finding of fact 2. 8. Partially accepted in finding of fact 5. 9-10. Partially accepted in finding of fact 6. 11-12. Partially accepted in finding of fact 7. Rejected as being unnecessary. 14-18. Partially accepted in finding of fact 3. 19. Rejected as being contrary to the evidence. 20-22. Partially accepted in finding of fact 3. 23. Partially accepted in finding of fact 4. 24. Partially accepted in finding of fact 7. 25. Partially accepted in finding of fact 8. 26. Partially accepted in finding of fact 10. 27. Partially accepted in finding of fact 13. 28. Rejected as being unnecessary. 29. Partially accepted in findings of fact 9 and 10. 30. Partially accepted in finding of fact 10. 31. Partially accepted in finding of fact 11. 32. Partially accepted in finding of fact 12. 33. Rejected as being unnecessary. 34. Partially accepted in finding of fact 13. 35. Rejected as being unnecessary. 36. Partially accepted in finding of fact 13. 37. Rejected as being unnecessary. 38-39. Rejected as being irrelevant. 40-41. Partially accepted in finding of fact 10. 42-43. Partially accepted in finding of fact 13. 44. Rejected as being irrelevant. 45. Rejected as being unnecessary. 46-47. Partially accepted in finding of fact 13. Note - Where a proposed finding has been partially accepted, the remainder has been rejected as being unnecessary, irrelevant, not supported by the evidence, subordinate, or a conclusion of law. COPIES FURNISHED: Richard A. Grumberg, Esquire Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 Lee Sims Kniskern, Esquire Suite 630 2121 Ponce de Leon Coral Gables, Florida 33134-5222 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jack L. McRay, Esquire 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
Findings Of Fact Petitioner received his M.A. degree from New School of Social Research, Graduate Faculty of Political and Social Science in New York, New York, in sociology. He received further training in counseling as part of a Ph.D. program in clinical psychology at the Florida Institute of Technology. He is scheduled to receive his Ph.D. this year, having completed all coursework. Petitioner worked as a counselor under the supervision of Dr. Limbillo of the Naples Community Hospital Mental Health Clinic, in 1973 and 1974. He also worked as a counselor under the supervision of Dr. Hughes from 1975 to 1977 and Dr. Roca from 1977 to 1979.
Recommendation Based on the foregoing, it is RECOMMENDED: That Respondent enter a Final Order denying Petitioner's application for licensure as a marriage and family therapist by exception. DONE and ENTERED this 27th day of May, 1983, in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of May, 1983. COPIES FURNISHED: Daniel D. Peck, Esquire Suite A-204, Park Square 4089 Tamiami Trail, North Naples, Florida 33940 Drucilla Bell, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The Administrative Complaint herein charges Respondent with violation of Section 458.331(1)(x) F.S. (violating Rule 21M-28.002 F.A.C.) by failing to submit documentation verifying his continuing medical education for the period January 1, 1986 through December 31, 1987 in response to the Board of Medicine's random audit and further charges him with violation of Section 458.331(1)(a) by attempting to obtain, obtaining, or renewing a license to practice medicine by bribery, fraudulent misrepresentations, or through error of the department or board, to wit: falsely certifying that he had completed the continuing medical education requirements for the period from January 1, 1986 through December 31, 1987.
Findings Of Fact At all times material, Respondent was licensed by the Florida Board of Medicine, License No. ME 0034111. Respondent's Florida license expired on December 31, 1989 and has not been renewed. The Board of Medicine does not permit licensees to renew their licenses during a period of suspension. Pursuant to an October 29, 1990 Final Order, Respondent's license was suspended until such time as he complied with a prior December 16, 1988 Final Order reprimanding him and imposing an administrative fine of $2500 for a violation of Section 458.331(1)(b) F.S., discipline in another state, Texas. This cause involves Respondent's last biennial license renewal for the period 1988-1989. Pursuant to Section 455.213(5) F.S. as a condition of renewal of a license, the Board of Medical Examiners (Board of Medicine) shall require licensees which it regulates to periodically demonstrate their professional competency by completing at least 40 hours of continuing education every two years, of which at least five hours shall concern risk management. Criteria for, and content of, continuing education courses shall be approved by the Board. Pursuant to Rule 21M-28.002 F.A.C. every physician licensed pursuant to Chapter 458 F.S. shall be required to complete 40 hours of continuing medical education (CME) approved by the Board in the 24 months preceding each biennial renewal period as established by the Department. At least five of such CME hours required for renewal shall concern risk management. Pursuant to Rule 21M-28.002(2)(a) F.A.C. "risk management" means the identification, investigation, analysis, and evaluation of risks and the selection of the most advantageous method of correcting, reducing, or eliminating identifiable risks. Pursuant to Section 21M-28.002(3) F.A.C., part of the application for renewal shall include a form on which the licensee shall state that he has completed the required continuing education. Additionally, the licensee is affirmatively charged with retaining such receipts, vouchers, certificates, or other papers, such as physician recognition awards issued by the American Medical Association (AMA), as may be necessary to document completion of the continuing medical education listed by the licensee on the renewal form for a period of not less than four years from the date the course was taken. The Board is affirmatively charged with randomly auditing such numbers of licensees as is necessary to assure that the continuing education requirements are met. On or about January 18, 1988, Respondent signed the following statement which was thereafter submitted as part of his request to renew his license to practice medicine: I hereby certify that during the period January 1, 1986, through December 31, 1987, I have obtained no fewer than forty (40) hours of continuing medical education courses which meets the requirement of Chapter 455.213(5), Florida Statutes, and Rule 21M-28.002(6), Florida Administrative Code. I further certify that at least five (5) of the forty (40) hours concern risk management pursuant to Rule 21M-28.002(2), Florida Administrative Code. I understand that I must maintain such receipts, vouchers, certificates, or other papers to document completion of the CME requirements for a period of not less than four (4) years from the date the course was taken. I affirm that these statements are true and correct and recognize that providing false information may result in a fine, suspension or revocation of my license as provided in Florida Statutes 455.2275, 775.082, or 775.084. The aforementioned statement concerning CME courses taken January 1, 1986 through December 31, 1987 was required as part of the renewal process for the licensing period from January 1, 1988 through December 31, 1989. Without this statement, Respondent would not have been permitted to renew his license to practice medicine in Florida, but having made it, he was permitted to renew his Florida license. That renewal was based, in part, on the aforementioned statement signed by Respondent regarding completion of the mandatory CME credits. Thereafter, Respondent was selected randomly for audit purposes to verify his continuing medical education for the January 1, 1986 through December 31, 1987 period covered in his statement made January 18, 1988, as a predicate to license renewal. Respondent was required, pursuant to rule, to retain his documentation of 1986-1987 CME courses up through that course's same month and day in 1990 (for 1986) and 1991 (for 1987). On February 17, 1989, the agency received some CME documentation from Respondent, but it was returned to Respondent because it failed to document the required 5 hours in risk management (TR-12). Thereafter, Petitioner prosecuted Respondent for failure to provide adequate documentation of 5 hours of risk management CME credits and 35 hours of Category I CME. (TR-12-13 and the Administrative Complaint herein.) Mr. George Schaffer, the Department of Professional Regulation (DPR) investigator, testified that he also wrote Respondent for documentation of all 1986-1987 CME credits (TR-26-27). Respondent replied to Mr. Schaffer's letter on June 12, 1990, stating, in pertinent part, as follows: I am in receipt of your letter of 6/7/90 concerning continuing education for 1985. To the best of my knowledge, this was submitted when requested. Due to lack of storage space, I am unable to keep papers from these activities longer than two years and I no longer have papers for CME 1985 in my possession. Part of my CME for that period was in Medical management and quality assurance and I did receive my MBA in June of 1986. (P-5) [Emphasis supplied.] Mr. Schaffer's letter is not in evidence, and Respondent's foregoing June 12, 1990 letter suggests that Respondent was under the impression that Mr. Schaffer was asking him to submit only 1985 materials concerning risk management courses. It is noted that as of 6/7/90, Respondent was only required by law to have available documentation from 6/7/86 forward (four years from date of any CME course), and that if Respondent had completed all his required CME credits between January 1, 1986 and June 6, 1986, he was not required by statute and rule to retain and produce the proof thereof after June 6, 1990, and given the agency's return of his documents to him in February 1989 with no question raised to all his CME credits, but only to his risk management credits, it is not unreasonable that he might not have retained all of his CME documentation. However, in his response to Mr. Schaffer, Respondent has admitted that, contrary to law, he has failed to retain any CME materials more than two years. Likewise, once he was timely informed in February 1989 that his risk management hours were incompletely documented, he was on notice as of that date to submit proper documentation for his risk management hours, and as of that date charged with retaining and producing that documentation. After the Administrative Complaint herein was filed, the Respondent mailed to the DPR attorney of record a January 2, 1991 letter from "Prof. The Hon. Dr. M.E. West, O.M." on stationery of the University of the West Indies, Mona, Jamaica Campus. That letter states: TO WHOM IT MAY CONCERN CATEGORY 1 CME HOURS This is to certify that Dr. The Hon. Albert B. Lockhart has participated in a going Medical Education in the area of Risk Management from 1985-90. The hours are as following:- 1985 10 hours 1986 12 hours 1987 10 hours 1988 15 hours 1989 12 hours 1990 10 hours TOTAL 69 hours (Signature) Prof. The Hon. Dr. M.E. West, OM (P-6) Rule 21M-28.002 (6) F.A.C. describes and defines the CME courses approved by the Board and does not on its face certify as approved the courses set out in the foregoing finding of fact. The letter from "Dr. West" is not verified or notarized, and there is no evidence in this record to establish who "Dr. West" is or what constitutes his authority with regard to "going" Medical Education, whatever that may be. Respondent did nothing further to establish his compliance with the Florida CME requirements. The result is that Respondent has only established that during 1986 and 1987, the years he was requested to document, he took 22 hours of medical education, which hours have not been shown to meet the quality standards established by the Board for either Category I CME or risk management courses, pursuant to rule. 1/
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of Count I of the Administrative Complaint by violation of Section 458.331(1)(x) F.S. and not guilty of Count II of the Administrative Complaint, imposing a $5,000 penalty, and suspending Respondent's license until such time as he has paid the penalty and proved to the satisfaction of the Board that he has completed an additional approved 35 CME hours and 5 risk management CME hours, such hours to be in addition to any hours previously earned or required by rule. DONE and ENTERED this 14th day of May, 1991, at Tallahassee, Florida. ELLA JANE P. DAVIS, 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 14th day of May, 1991.
The Issue The issue in this case is whether disciplinary action should be taken against the Respondent on the basis of her failure to timely comply with continuing education requirements established by Section 626.2815, Florida Statutes.
Findings Of Fact The Respondent is currently licensed by the Florida Department of Insurance ("Department") as a General Lines (2-20) Agent. During the period from August 1, 1995, through July 31, 1997, the Respondent was licensed as a General Lines (2-20) Agent and as a Life, Health, and Variable Annuity (2-15) Agent. At all times material to this case, insurance agents licensed in Florida have been required to complete continuing education courses every two years. Licensed insurance agents can meet their continuing education requirements by attending seminars, taking classroom courses, or taking self-study courses. During the period from August 1, 1995, through July 31, 1997, the Respondent was required to complete 28 hours of continuing education courses. /3 The required courses could be taken and completed at any time during that two-year period. At all times material, the Respondent has been aware of the continuing education requirements applicable to licensed insurance agents. The Respondent resides in Key Largo, Florida, and has lived at the same address for at least 10 years. Miami, Florida, is about 60 miles from Key Largo. Key West is about 100 miles from Key Largo. During the period from August 1, 1995, through July 31, 1997, there were 11 continuing education courses offered in Key largo. During that same period there were 73 continuing education courses offered in Monroe County. During that same period there were approximately 3,000 continuing education courses offered in Dade County. The Respondent waited until July 16, 1997, which was 15 days before the end of her two-year continuing education deadline, before taking any action to comply with the continuing education requirements. On that day she ordered two self-study courses from a course provider named Noble. If an insurance agent chooses a self-study course to fulfill the continuing education requirements, the course is not considered to be completed until the agent has taken a monitored examination on the course material and has achieved a score of at least 70 percent. The Respondent finished her study of the course materials she bought from Noble by the end of July 1997, but she did not take and pass the examinations on those materials until the end of August 1997, which was three or four weeks past the end of her compliance deadline. In July of 1997, the Respondent was nursing an infant child. Although Noble had a testing site in Miami, the Respondent did not want to go to Miami to take the examinations for her self-study courses, because a trip to Miami would interfere with nursing her child. The Respondent waited until the end of August, because by that time Noble had opened a testing site in Key Largo. All insurance agents who failed to comply with the continuing education requirements for the period ending July 31, 1997, were sent a Preliminary Notice of Non-Compliance. All agents who did not respond to the Preliminary Notice of Non- Compliance were sent a Final Notice of Non-compliance. Both preliminary and final notices were sent to the Respondent. The Department initiated disciplinary action against all insurance agents who were found to have failed to comply with the continuing education requirements. The Department offered each of the non-compliant agents an opportunity to settle the disciplinary actions by payment of an administrative fine in the amount of $250.00. Numerous insurance agents settled on those terms. In one case, such a disciplinary action was resolved by a stipulated six-month license suspension.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Department of Insurance issue a final order concluding that the Respondent is guilty of failing to comply with statutory and rule provisions regarding continuing education, and imposing a penalty consisting of a six-month suspension of the Respondent's license. DONE AND ENTERED this 8th day of October, 1999, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of October, 1999.
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 Whether the Petitioner has met the requirements for licensure as a medical doctor in the State of Florida set forth in Section 458.311(1)(f), Florida Statutes (1986 Supp.), as required by Section 458.313(1), Florida Statutes (1986 Supp.)?
Findings Of Fact The Petitioner applied for licensure by endorsement as a medical doctor in Florida in September of 1986. Following notification by the Respondent that additional materials were required to complete the Petitioner's application, the Petitioner timely submitted the materials. In March of 1987, the Petitioner appeared before the Foreign Medical Graduate Committee of the Respondent. On April 5, 1987, the Respondent entered an Order titled Notice of Intent to Deny the Application for Licensure by Endorsement of Hien B. Nguyen. The stated basis for the denial of the Petitioner's application was that the Petitioner had failed to demonstrate that he graduated from a medical school. The Petitioner began medical school in 1967 at the University of Saigon, Faculty of Medicine, in Saigon, Republic of Vietnam. The Petitioner Successfully completed the six years required course work in medicine at the University of Saigon, Faculty of Medicine, in 1974. Following the completion of the course work required to earn a medical degree at the University of Saigon, Faculty of Medicine, the Petitioner was drafted into the Republic of Vietnam's military. He attended training for approximately six months immediately following the completion of his medical degree course work. The Petitioner was required to complete a thesis before being eligible for a medical degree from the University of Saigon, Faculty of Medicine. Upon completion of military training, the Petitioner commenced and completed work on his thesis. The Petitioner's thesis consisted of a translation of "Central Nervous Disease in Children," of Nelson's Pediatric Textbook, from English into Vietnamese. The Petitioner presented his thesis on April 14, 1975. Thuc R. Bach, M.D. attended the presentation of his wife's thesis on April 14, 1975, and witnessed the Petitioner's thesis presentation. The Petitioner was awarded a Certificate from the University of Saigon, Faculty of Medicine, on April 14, 1975, which indicated that the Petitioner had completed work necessary to be awarded a medical degree. The Certificate was issued temporarily. After approximately five years the Petitioner was required to return the Certificate at which time he could be issued an official diploma. On approximately April 30, 1975, the government of the Republic of Vietnam fell to the army of North Vietnam. Following the fall of the Republic of Vietnam, the Petitioner was confined to a concentration camp where the Petitioner acted as camp doctor. Following the Petitioner's release from confinement in 1976, the Petitioner worked as a physician at Saint Paul Clinic in Saigon until 1979. From 1977 until 1980 the Petitioner also attended and taught at a medical training center in Saigon. In October, 1980, the Petitioner escaped from Vietnam. He resided in Galang, Indonesia until March, 1981, when he moved to the United States. The Petitioner has completed the following since his arrival in the United States: December, 1981: Sat for the Federation Licensing Examination and was subsequently certified by the Federation of State Medical Boards; January 24, 1983: Certified by the Educational Commission for Foreign Medical Graduates; July, 1984 - June, 1985: Interned at the Cook County Hospital, Chicago, Illinois; July, 1985 - June, 1987: Residency program at Cook County Hospital, and February 19, 1986: Licensed as a physician by the State of Illinois (the license is currently active and unrestricted). The Petitioner was presented with a certificate from the Faculty- Council-in-Exile of the Faculty of Medicine of the University of Saigon dated April 20, 1981. The certificate affirms that the Petitioner "Successfully completed the course of study leading to the degree of Doctor of Medicine..." The certificate is signed by the Dean Emeritus of the University and Dao Huu Anh, M.D., Associate Dean of the University. Prior to the fall of the government of the Republic of Vietnam, graduates of the University of Saigon, Faculty of Medicine, were presented with a certificate authorizing them to practice as a physician without restriction upon completion of the required courses of study and a thesis. Graduates were not issued an Official Diploma until five years had passed since the issuance of their certificate. Although the Petitioner completed the required courses of study, presented his thesis and received a certificate authorizing him to practice as a physician, the Petitioner was not able to obtain an Official Diploma five years later because of the fall of the government of the Republic of Vietnam. In light of the fall of the government of the Republic of Vietnam, it is doubtful that the records of the University of Saigon, Faculty of Medicine are available or that the Petitioner could obtain an Official Diploma. The Petitioner is a graduate of the University of Saigon, Faculty of Medicine, a medical school.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued GRANTING the Petitioner's application for licensure by endorsement as a medical doctor in the State of Florida. DONE AND ORDERED this 25th day of January, 1988, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of January, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-2969 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1 1. 2 2. 3 3. 4 4 and 5. 5 6. 6 7-10. 7 11-12. 13. The Petitioner worked at the training center from 1977 through 1980. 15. The Petitioner went from Vietnam to Indonesia in October of 1980. He did not travel to the United States until March of 1981. 10-12 Cummulative, summary of the evidence and unnecessary. Dr. Nghia Van Tran's letter was not accepted into evidence. 13 16. The last sentence is cummulative, a summary of evidence and unnecessary. The footnote is irrelevant. The burden of proof in this proceeding was on the Petitioner. The Respondent is not required to verify the signature of Dr. Dao. 14 10 and 17. 15 17-18. 16-18 Cummulative, summary of the evidence and unnecessary. The Respondent's Proposed Findings of Fact 1 1 and 3. 2-5 The Respondent's remaining proposed findings of fact are essentially summaries of the Respondent's inter- pretation of the evidence and argument concerning the evidence. The Respondent's interpretation of the evidence is rejected. The following is a brief discussion of why the Respondent's arguments have been rejected. The first two sentences are true and support the finding of fact that the Petitioner began medical school in 1967, completed his course work in 1974 and presented his thesis in April of 1975. See findings of fact 4-5 and 9. The third and fourth sentences are true but the Respondent has overlooked the fact that the Petitioner presented other evidence which supports his position. Therefore, even if the fifth sentence were correct, there is other evidence which supports findings of fact 4-5 and 9. The sixth sentence is irrelevant. Although the Board may have raised a question, the correct answer to that question is a matter of proof. The seventh sentence is true but irrelevant. The eighth sentence is not supported by the weight of the evidence. There was no testimony sufficient to support any finding of fact concerning Dr. Dao's signature on any document. Although the ninth sentence is correct, the weight of the evidence does not support the alleged fact set out in the tenth sentence. The eleventh sentence was taken into account in the weight given to Dr. Dao's statement. Although the twelfth sentence is correct the thirteenth and fourteenth sentences are not supported by the weight of the evidence. While it is true that the Petitioner's testimony with regard to when he completed his course work at the University of Saigon was not totally consistent, the weight of the evidence supports a conclusion that the Petitioner finished his course work in June of 1974. The Petitioner's explanation concerning the inconsistency in his testimony was credible. The first and second sentences are true. The third sentence is true but overlooks the fact that it corroborates non-hearsay evidence. The fourth sentence is law. The fifth sentence is true. The sixth and seventh sentences are true. The eight sentence is not supported by the weight of the evidence. The ninth and tenth sentences are true but they do not support the ultimate conclusion the Respondent suggests. It is possible that the Certificate in question could have been based upon other credible evidence. The first sentence is true. The second sentence is not supported by the weight of the evidence. The Petitioner testified that he completed his course work in 1974. The third sentence is true. The fourth and fifth sentences are not supported by the weight of the evidence. COPIES FURNISHED: Carolyn S. Raepple, Esquire Cheryl G. Stuart, Esquire Hopping, Boyd, Green & Sams 420 First Florida Bank Building Post Office Box 6526 Tallahassee, Florida 32314 M. Catherine Lannon, Esquire Assistant Attorney General Administrative Law Section Department of Legal Affairs Room 1601, The Capitol Tallahassee, Florida 32399-1050 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issues to be determined are whether Petitioner meets the requirements for licensure by endorsement pursuant to section 458.313, Florida Statutes (2013), and whether the Board’s interpretation of section 458.311(3), Florida Statutes, is an unadopted rule in violation of section 120.54(1), Florida Statutes (2013).
Findings Of Fact Based upon the stipulations of the parties and the documentary evidence presented, the following facts are found: Petitioner, Leon Rawner, M.D., is a licensed medical doctor in the state of Wisconsin and an applicant for licensure as a medical doctor by endorsement in Florida. The Florida Board of Medicine is the agency charged with the licensing and regulation of allopathic medical doctors pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Applicants for licensure by endorsement must meet the requirements specified in section 458.313. Those requirements include meeting the qualifications identified in section 458.311(1)(b)-(g) (alternative one) or section 458.311(1)(b)-(e), (g), and (3) (alternative two). Petitioner is over 21 years of age, and has submitted a set of fingerprints on a form and under procedures specified by the Department of Health, along with a payment in an amount equal to the costs incurred by the Department of Health. Petitioner has successfully passed the required criminal background screening. Petitioner’s application for licensure by endorsement demonstrates that he is licensed to practice medicine in another jurisdiction, the state of Wisconsin, and that he has been active in the practice of medicine for at least two of the four years immediately preceding the application. Petitioner has a clean record in his current medical practice in Wisconsin and is not under any investigation in any jurisdiction for an act or offense which would constitute a violation under section 458.331, and has not committed any act or offense in any jurisdiction which would constitute the basis for disciplining a physician pursuant to section 458.331. Petitioner has completed the equivalent of two academic years of pre-professional, postsecondary education, as determined by rule of the Board, which included, at a minimum, courses in anatomy, biology, and chemistry prior to entering medical school. Petitioner received a bachelor’s degree from Brandeis University, an accredited United States university. Petitioner has passed the appropriate medical licensure examinations, the United States Medical Licensing Examination, Step-1, Step-2, and Step-3. Petitioner holds an active, valid certificate issued by the Educational Commission for Foreign Medical Graduates (ECFMG) and has passed the examination used by the Commission. In 2006, Petitioner graduated with a degree of Doctor of Medicine from American University of the Caribbean School of Medicine. Petitioner graduated from an allopathic foreign medical school (American University of the Caribbean School of Medicine) which is recognized by the World Health Organization. Petitioner completed all of the formal requirements for graduation from American University of the Caribbean School of Medicine. Petitioner’s application for licensure demonstrates that he has completed the academic year of supervised medical training prior to graduation as required under section 458.311(3)(d). Petitioner did not graduate from an allopathic medical school or allopathic college recognized and approved by an accrediting agency recognized by the United States Office of Education. Petitioner did not graduate from an allopathic medical school or allopathic college within a territorial jurisdiction of the United States recognized by the accrediting agency of the governmental body of that jurisdiction. Petitioner is not a graduate of an allopathic foreign medical school registered with the World Health Organization and certified pursuant to section 458.314, Florida Statutes, as having met the standards required to accredit medical schools in the United States or reasonably comparable standards. Petitioner has not completed an approved residency or fellowship of at least two years in one specialty area. Petitioner’s application for licensure demonstrates that he does not meet the postgraduate training requirements under section 458.311(1)(f)3. Petitioner completed one year of residency training in the Internal Medicine Program at Mt. Sinai-Elmhurst Hospital Center, Queens, New York. Besides the residency training program at Mt. Sinai– Elmhurst Hospital Center, Queens, New York, Petitioner has not completed any other residency or fellowship training. Petitioner does not have two years of any residency or fellowship training which can be counted toward regular or subspecialty certification by a board recognized and certified by the American Board of Medical Specialties. Since January 24, 2011, Dr. Rawner has been practicing medicine in Wausau, Wisconsin, as a staff physician with Knee Pain Solutions Center. Accordingly, he has been in the active practice of medicine for the two years preceding his Florida application. Dr. Rawner submitted his application for licensure by endorsement on March 13, 2013. Supplemental documentation was filed with the Board by letter dated March 18, 2013. In that letter, Dr. Rawner expressly stated that he was relying on the second alternative for establishing licensure by endorsement, which does not include the requirements identified in subsection 458.311(1)(f). On April 3, 2013, the Board requested additional information, and in response, Dr. Rawner provided a copy of his undergraduate degree and information related to his one year of supervised medical training. Other information requested in the April 3, 2013, letter was sent directly to the Board office by the appropriate agencies, including an official United States medical examination transcript, indicating that Dr. Rawner passed USMLE Steps I, II, and III; a letter from the residency program director, indicating that Dr. Rawner completed one year of residency training; confirmation from the Wisconsin Medical Board confirming his current, valid medical license in the state of Wisconsin; an American Medical Association (AMA) profile letter; and Dr. Rawner’s fingerprints and clear background check. Program Operations Administrator Chandra Prine notified Dr. Rawner by letter dated June 26, 2013, that he was required to appear before the Credentials Committee of the Board. The purpose of the appearance was to discuss: Failure to meet the training requirement pursuant to section 458.313(1)(a), 458.311(1)(f)3.c., Florida Statutes. Failure to complete an academic year of supervised clinical training pursuant to section 458.311(3)(d), Florida Statutes. Dr. Rawner appeared before the credentials committee of the Board of Medicine on August 1, 2013. The committee recommended that his license be denied. On August 22, 2013, the Board of Medicine issued a Notice of Intent to Deny Licensure, stating that it intended to deny Dr. Rawner’s application because Dr. Rawner did not meet the requirements of section 458.313(1), which requires an applicant to meet the qualifications outlined in either section 458.311(1)(b)-(g) (alternative one), or in section 458.311(1)(b)- (e), (g) and (3) (alternative two). The notice stated that with respect to alternative one, Dr. Rawner did not meet the requirements of section 458.311(1)(f)3., because he had not completed an approved residency or fellowship of at least two years in one specialty area. With respect to alternative two, the Board determined that Dr. Rawner did not meet the requirements of section 458.311(3)(c) because, in the Board’s view, the section was inapplicable to Dr. Rawner because he had completed all requirements of the foreign medical school, with none outstanding, and did not meet the requirement of (3)(d) because he had not completed an academic year of supervised clinical training in a hospital affiliated with a medical school approved by the Council on Medical Education of the American Medical Association. Dr. Rawner filed a Petition for Administrative Hearing with respect to the Notice of Intent to Deny, and the matter was reconsidered at the credentials committee’s meeting on October 3, 2013. The credentials committee voted to reconsider the application based on the issues presented in the Petition. On October 22, 2013, the Board issued an Amended Notice of Intent to Deny Licensure. With respect to alternative two, in the Amended Notice, the Board stated: [t]he application file reveals that Dr. Rawner fails to meet subsection (3) for the reasons set forth below. Subsection (3) provides: Notwithstanding the provisions of subparagraph (1)(f)3., a graduate of a foreign medical school need not present the certificate issued by the Educational Commission for Foreign Medical Graduates or pass the examination utilized by that commission if the graduate: Has received a bachelor’s degree from an accredited United States college or university. Has studied at a medical school which is recognized by the World Health Organization. Has completed all of the formal requirements of the foreign medical school, except the internship or social science requirements, and has passed part I of the National Board of Medical Examiners examination or the Educations Commission for Foreign Medical Graduates examination equivalent. Has completed an academic year of supervised clinical training in a hospital affiliated with a medical school approved by the Council on Medical Education of the American Medical Association and upon completion has passed part II of the National Board of Medical Examiners examination or the Educational Commission for Foreign Medical Graduates examination equivalent. Subpart (3)(c) provides in relevant part all of the formal requirements of the foreign medical school, except the internship or social service requirements, and has passed certain examinations. A plain reading of this subpart is that the foreign medical school has an internship or social service requirement and that the internship or social service requirement has not been completed. The application file demonstrates that Dr. Rawner graduated in June, 2006, with a degree of Doctor of Medicine from the American University of the Caribbean School of Medicine. Thus, subpart (3)(c) is inapplicable to Dr. Rawner, because the application file reveals that he completed all of the formal requirements of the foreign medical school and there are no outstanding or pending internship or social service requirements. Based on the foregoing, the Board finds that the Applicant has not demonstrated that he meets the requirements for licensure by endorsement set forth in Section 458.313(1)(a), Florida Statutes. The Amended Notice no longer listed failure to complete an academic year of supervised clinical training as a basis for the denial of Dr. Rawner’s application. There is no persuasive evidence presented that Respondent’s interpretation of the requirements of section 458.311, Florida Statutes, as it applies to this case, is a statement of general applicability.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Florida Board of Medicine enter a Final Order approving Leon Rawner, M.D.’s application for licensure by endorsement. DONE AND ENTERED this 28th day of April, 2014, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 2014. COPIES FURNISHED: Donna C. McNulty, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399 Amy W. Schrader, Esquire GrayRobinson, P.A. 301 South Bronough Street, Suite 600 Post Office Box 11189 Tallahassee, Florida 32302 Allison M. Dudley, Executive Director Board of Medicine Department of Health Division of Medical Quality Assurance Boards/Councils/Commissions 4052 Bald Cypress Way Tallahassee, Florida 32399 Jennifer A. Tschetter, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399 Edward A. Tellechea, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399
The Issue The issue is whether Respondent failed to comply with the continuing education requirements for his massage therapy license and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a massage therapist in Florida, holding license number MA 0006561. On or about January 31, 1993, Respondent signed and submitted to the Board of Massage a Renewal Notice stating in part that he has complied with all applicable requirements for relicensure and that his file may be subject to audit to determine his eligibility for relicensure. The renewal period covered the 25 months ending January 31, 1993. Petitioner randomly selected Respondent's file for audit. In response to a request for information, Respondent indicated, by form dated January 7, 1994, that he had attended 18 hours of classes in acupuncture and three hours of classes in HIV/AIDS. Both classes were taken during the relevant period, but at Huntsville Hospital in Ontario, Canada. By written response dated January 28, 1994, Petitioner rejected the proffered coursework because Huntsville Hospital is not an approved provider. The record does not disclose what, if anything, took place following the issuance of the January 28, 1994, notification, which went to Respondent's Canadian address. On March 2, 1994, Petitioner sent a letter to Respondent, at his Canadian address, warning him of Petitioner's intent to initiate disciplinary action. The March 2 letter "warns" that Respondent must respond by February 23, 1994, or else "this matter will be closed." The deadline had already passed when the letter was sent. The unclear reference to closing the file does not defeat the warning contained elsewhere in the letter that, if Petitioner did not receive adequate documentation, it would submit the audit information to the probable cause panel for consideration of possible disciplinary action. There is no evidence that Respondent submitted false or forged documentation to Petitioner or the Board of Massage. It would appear that Respondent attended courses, but the courses were unapproved. There is no evidence that he submitted the courses for approval by the Board of Massage. There is no evidence that he has taken other courses to satisfy these requirements, although he claimed in a responsive pleading to have satisfied the HIV/AIDS course requirement.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Massage enter a final order dismissing Counts II and III of the Administrative Complaint, finding Respondent guilty of violating Rule 61G11-28.009, and suspending his license until he demonstrates proof of completion of all coursework presently required for license renewal. ENTERED on July 5, 1995, in Tallahassee, Florida. ROBERT E. MEALE 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 on July 5, 1995. COPIES FURNISHED: Susan E. Lindgard Senior Attorney Department of Business and Professional Regulation 1940 North Monroe Street Northwood Centre, Suite #60 Tallahassee, FL 32399-0792 Joseph Baker, Executive Director Board of Massage Department of Business and Professional Regulation 1940 North Monroe Street Northwood Centre, Suite #60 Tallahassee, FL 32399-0792 William P. Mills 2069 Gulf of Mexico Drive Longboat Key, FL 34228 William P. Mills RR #4, Box 62 Huntsville, Ontario Canada POA IKO
The Issue The issue in this case is whether the Petitioner, Rene Delgado Leon, M.D., is eligible for examination for licensure to practice medicine in the state of Florida. The Petitioner, of course, contends that he is eligible. The Respondent, Board of Medical Examiners, contends that the Petitioner has failed to demonstrate eligibility, having previously advised him, inter alia: Your application and supporting documentation contained substantial omissions of material information relative to your medical education. Additionally, your application and supporting documentation does not provide sufficient information to demonstrate that you can practice medicine with reasonable skill and safety. See Section 458.301, Florida Statutes.
Findings Of Fact Based on the stipulations of the parties, on the exhibits received in evidence, and on the testimony of the witnesses at the hearing, I make the following findings of fact. The Petitioner, Dr. Rene Pedizo Delgado Leon, was born on November 26, 1936, in Cuba. All of his formal education prior to medical school was obtained in Cuba. He attended medical schools, off and on, at various times and places between 1955 and June of 1980. His medical education commenced in 1955 at the Medical School of the University of Havana and ended when he-was awarded his medical degree from the University of Dominica in June of 1980. The Petitioner's first language was Spanish and he is not completely fluent in the English language. When communicating in English he appears to have a tendency to interpret statements and questions in a very literal manner. The Petitioner does not appear to have intended to deceive the Board of Medical Examiners or to misrepresent information about his education and experience. Nevertheless, he has not been very clear about a number of details. Since receiving his degree from the University of Dominica in 1980, the Petitioner has completed a residency in pathology, has passed the FLEX exam in conjunction with his application for licensure in the state of Georgia, and has been licensed to practice medicine in the state of Georgia. There were several discrepancies between information given by the Petitioner to the Board of Medical Examiners and to the Hearing Officer concerning various aspects of his background, particularly concerning his medical education. With regard to his medical education, Petitioner listed on his first application that he attended medical school in Havana, Cuba, from April 1954 until December 1962. On his second application he stated that he attended medical school in Havana, Cuba, from September 1955 until September 1960. He testified before the Foreign Medical Graduate Committee that he attended medical school at the University of Havana from 1955 until 1962. At the final hearing he testified that he attended the University of Havana from 1955 until 1962. On his first application, in response to the direction that he list all universities or colleges where he attended classes and received training as a medical student, he stated only that he attended the University of Dominica from June of 1977 until June of 1980. He subsequently filed a form, received by the Board on October 26, 1983, stating that he had attended the University of Zaragoza, Zaragoza, Spain, and received training as a medical student from November of 1974 until April of 1975. On his second application, he stated that he had attended the University of Zaragoza as a medical student from November of 1974 until April of 1975. At the final hearing he testified that in 1973 while he was in Zaragoza he applied to revalidate old courses taken in Havana and that thereafter he took all examinations up to the third year. He stated that he took other courses in Zaragoza, but that he did not take the examinations for any of the medical courses taken in Zaragoza. He also testified that he was given credit for courses at Zaragoza even though he did not take the examinations. The next segment of his medical education was consistently testified to as having been had at the Universidad Central del Este in the Dominican Republic. He attended the Universidad Central del Este for only one semester, during which he took six or seven subjects. He testified that Universidad Central del Este did give him some credit for the third year of medical school; in spite of the fact that he did not take examinations in any of the third-year courses he took in Zaragoza. In January of 1979 he transferred to Universidad Nordestana and spent approximately one year there. Univeraidad Nordestana gave him two and one half to three years of credit. Although his initial application showed that he had attended the University of Dominica in the West Indies from June of 1977 until June of 1980, his subsequent written and oral testimony was that he was enrolled at the University of Dominica only from January of 1980 until June of 1980. He testified before the Foreign Medical Graduate Committee that at the time he transferred from Nordestana, he was basically finished with his medical education and he said he transferred to Dominica because they did not talk in English in Santo Domingo. He also testified that he transferred to Dominica so that he could get some exposure to how medicine was practiced in the United States. Petitioner testified that although he transferred to the University of Dominica and he received his degree from the University of Dominica six months after he transferred there, he did not pay any monies to the University of Dominica. His explanation of why he did not pay money to the University of Dominica is that he wrote things for them, like a pathology booklet. The application form which Petitioner completed requested that he specify all places of residence since beginning medical training. On his first application he showed that he resided in Dominica, West Indies, from January of 1980 until June of 1980. On his second application he listed as residences since initiation of medical training only the University of Miami, Jackson Memorial, VA Hospital, and the University of South Florida, Tampa. In August of 1983 he followed up the second application with a letter to Mrs. Faircloth which stated that his place of residence while attending medical school was the "students quarters and dormitories" at Portsmouth, University of Dominica, West Indies. However, at the hearing before the Foreign Medical Graduate Committee and at the final hearing, Petitioner admitted that he was, in fact, on the campus of the University of Dominica only one day, and that was on graduation day. In fact, when he testified before the Foreign Medical Graduate Committee, he was specifically asked, "When you left Nordestana, where did you go?" To that question he replied, "Oh, to Dominica." However, he later admitted that when he left Nordestana, he went to Miami and he did not go to Dominica until he went six months later in order to graduate. On both of his written applications, Petitioner was asked to list the degrees earned other than M.D. On neither application did he list a bachelor's degree. Yet, in testimony before the Committee and at the final hearing, he testified that he had earned the equivalent of a B.S. in chemistry at the University of Havana. He testified that the reason that he omitted it was that he thought the question referred to medical education. However; in response to the same question, he listed that he had obtained a Licensee in Science and a Doctor in Science from the University of Zaragoza. With regard to the matter of what clerkships, if any, Petitioner performed as part of his medical education, the record shows that he was enrolled at the University of Dominica, the school from which he received a medical degree, from January or February of 1980 until June of 1980. The record also shows that during that five- or six-month period he performed what purported to be clerkships at the VA Hospital and at Coral Gables Hospital, in Miami, and at the same time was an employee of the VA Hospital. He testified that his clerkship at the VA Hospital was in pathology and that he was employed full time in the same area as he was receiving clerkship credit. He arranged the clerkships himself and informed the university of the clerkships. He testified that he did the same activities as the other clerks did, but he worked approximately forty hours and they worked thirty to forty hours. He effected his transfer to the University of Dominica by writing to the New York office and by taking some "required" examinations in basic sciences and clinical studies. He took the examinations in Miami and passed everything but gynecology. He eventually passed gynecology, but not until May of 1980 after he had almost completed clerkships. He testified that when he did his "rotation" at the VA Hospital, he was told that he could "moonlight." He testified that he did all of the autopsies while the other medical students watched. He testified that he went in to work at about 7:00 a.m. and left around 4:00 p.m. and that the other residents did not arrive until about 8:00 a.m. However, he did testify that the clerks arrived at 6:00 a.m. Petitioner testified that he was doing a clerkship at the time, not a residency, and that it was the extra time that he put in that justified his being both paid and given credit for an educational experience. Dr. Robert M. Clark was Petitioner's supervisor during the period of approximately January of 1980 until June of 1980. Petitioner worked in the morgue as a Physician's Assistant and also did "resident physician work." Petitioner was paid at the same time as he was doing a rotation because there was a shortage of residents. Petitioner had the same exposure to pathology as the other residents, all of whom were from the University of Miami. None of the other students were paid employees. A Physician's Assistant requires two years of medical school. Dr. Clark was introduced to Petitioner by Dr. Kuhnhardt. Dr. Kuhnhardt was not connected in any way with the medical school at the University of Dominica. The only other purported clerkship about which there was testimony at the hearing related to a clerkship at Coral Gables Hospital. That clerkship was under Dr. Hurst. That clerkship was done from January of 1980 until June of 1980, the same period during which the clerkship at the VA Hospital was done. Petitioner testified that he went to Coral Gables Hospital after he left the VA Hospital, usually after 4:00 p.m., and stayed however long was necessary, possibly as late as 8:00 or midnight. Dr. Hurst only let the students observe medical procedures. That clerkship was conducted in a community hospital. As for the supervision by the school, the testimony was that the school played no role in arranging the clerkships. Petitioner testified that people from the school came for general meetings every once in a while during the clerkships. As for evaluation, Petitioner testified that the school sent evaluation forms to him and he distributed the forms to whoever was supervising him.
Recommendation Based upon all of the foregoing it is my recommendation, because of the contradictions and uncertainties on the record in this case regarding the nature of the Petitioner's medical education, that the Board of Medical Examiner issue a final order denying the Petitioner's application for licensure by examination without prejudice to the filing of any future application for licensure by examination or endorsement, unless; for reasons analogous to those set forth in the Lopez decision, supra, the Board is persuaded that the shortcomings in the application and its supporting evidence may be overlooked in light of the Petitioner's achievements since 1980. DONE AND ORDERED this 3rd day of January, 1986, at Tallahassee, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of January, 1986. COPIES FURNISHED: M. Catherine Lannon, Esquire Assistant Attorney General Department of Legal Affairs Room LL-04, The Capitol Tallahassee, Florida 32301 Jorge A. Sibila, Esquire 2751 Coral Way Miami, Florida 33145 Dorothy Faircloth; Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche; Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 APPENDIX The following are my specific rulings on each of the proposed findings of fact submitted by each of the parties. Rulings on Petitioner's proposed findings: The Petitioner's proposed findings of fact consist of a two- line introductory clause and six unnumbered indented paragraphs. The six unnumbered indented paragraphs are addressed below in the order in which they appear in the Petitioner's proposed findings of fact. First Paragraph: Rejected. This paragraph is merely a commentary on the state of the record and does not contain any proposed finding of fact. Second Paragraph: Rejected for the same reason as the first paragraph. Third Paragraph: Rejected in part and accepted in part. Rejected portions are rejected for the most part for the same reason as the rejection of the first two paragraphs. The "fully explained" portion of this paragraph is rejected as not supported by the greater weight of the evidence. Findings have been made consistent with the portions of this paragraph relating to when Petitioner's medical education began and ended, his completion of a residency in pathology, and his passing of the FLEX examination. Fourth Paragraph: The first sentence of this paragraph is rejected in part because it is merely a commentary on the state of the record and in part because it is inconsistent with the evidence of record. Dr. Clark did not explain the Petitioner's work in detail: to the contrary, his testimony was rather vague about a number of the details and he failed to recall a number of specific details. The last sentence of this paragraph is rejected because it is not supported by competent substantial evidence. Fifth Paragraph: Rejected for the same reason as the first paragraph. Sixth paragraph: The first sentence of this paragraph is rejected because the Petitioner's explanations were incomplete. With regard to the second sentence of this paragraph, it is accepted that the Petitioner is "not fluent/native in the English language or in legal terminology," and that the Petitioner did not intend to deceive the Board or misrepresent information to the Board. m e remainder of the second sentence is rejected on the grounds that it is in part irrelevant and immaterial as well as on the grounds that the ultimate factual conclusion urged in the second sentence is not warranted by the evidence in the record. Rulings on Respondent's proposed findings: The Respondent's proposed findings of fact consist of seventeen separately numbered paragraphs. The paragraph numbers which follow correspond to the numbers of the paragraphs of the Respondent's proposed findings. Accepted in substance with certain gratuitous editorial material deleted. Accepted in substance. Accepted in substance with the exception of the sentence reading: "In contradiction, he testified at the final hearing, on both direct and cross-examination, that he furthered his medical education in Spain in 1970." The quoted sentence is rejected because it does not accurately reflect the totality of the Petitioner's testimony on this subject. Some other redundant material in this paragraph is also rejected. Rejected on the grounds that it consists of irrelevant and cumulative details which are not necessary to the disposition of this case. Accepted in substance with certain gratuitous editorial material deleted. The first sentence of this paragraph is accepted. The second sentence is accepted with the exception of the words ". . . at which time he needed three years." The quoted language is rejected as not being supported by persuasive competent substantial evidence. Accepted. The first two sentences of this paragraph are accepted in substance. The last sentence is rejected as irrelevant in part, cumulative in part, and not supported by competent substantial evidence in part. Accepted in substance with certain gratuitous editorial material deleted. Accepted. Accepted in part and rejected in part. Reasons for rejection include the feet that although most of this paragraph is an accurate summary of portions of the Petitioner's testimony; some of the testimony on this subject was not persuasive and has not been used as the basis for findings of fact. The parenthetical mention of the pathology booklet is rejected because there is no competent substantial evidence as to when Petitioner wrote any pathology books Accepted in substance. Accepted in part and rejected in part. Reasons for rejection include the fact that although much of this paragraph is an accurate summary of portions of Dr. Clark's testimony, much of the testimony on this subject was not persuasive and has not been used as the basis for findings of fact. Portions of this paragraph have also been rejected on the grounds that they constitute commentary on the quality of the testimony or argument and are not proposed findings of fact. Accepted in part and rejected in part. Reasons for rejection include the fact that although most of this paragraph is an accurate summery of portions of the Petitioner's testimony, much of the testimony on this subject was not persuasive and has not been used as the basis for findings of fact. Accepted. Rejected as findings of fact because it constitutes argument rather than proposed findings of fact. [Much of the argument is well taken, but it is argument nevertheless and not appropriately part of the findings of fact.] Rejected for the same reason as Paragraph 16.
The Issue Whether Lazaro Saavedra is eligible for licensure by endorsement as a registered nurse in Florida, as provided in Chapter 464, Florida Statutes, and Chapter 210, Florida Administrative Code?
Findings Of Fact Petitioner, Lazaro Saavedra, received his education in Cuba (Tr. 109). There is evidence that he attended medical school for a period of four to five years beginning in 1960 (Tr. 109, 110, 119; JX-4), but he did not complete his medical education (Tr. 109). Petitioner asserts that he attended nursing school in Cuba from 1959 to 1962 (Tr. 108), and was licensed to practice nursing in Cuba (Tr. 118-119, 125). The record in this cause is devoid of any documentation of Petitioner's nursing education. While a witness apparently had a paper that may have been some sort of copy of Petitioner's nursing degree, it was neither identified for the record or offered into evidence (Tr. 85, ln. 11-15; 86, ln. 2-6). Petitioner attempted to prove his nursing education by his own testimony, but he was unable to describe well the content of his nursing program (Tr. 124, ln. 24-25, 125). He was unclear and imprecise regarding the dates of his nursing education and its overlap with his medical education (Tr. 109, 110, 124). The only testimony Petitioner offered to prove his attendance in nursing school, other than his own, was that of Bruno Barreiro. Mr. Barreiro knew Petitioner to be a nursing student (Tr. 91). He later saw Petitioner on "rounds" at a hospital (Tr. 92), but stated that medical students and nursing students took rounds together (Tr. 99). The witness expressed no knowledge of Petitioner as a graduate or as a practicing licensed nurse (Tr. 91, 98). Petitioner attempted to prove his nursing education and licensure in Cuba by the testimony of witnesses who "knew him as a nurse" in Cuba. Alicia de la Rua is a Florida licensed nurse who worked in the same hospital as Petitioner in Cuba for three months in 1964 (Tr. 55, 56, 59). They did not work together (Tr. 59), but were on the same ward in separate men's and women's sections (Tr. 61). Ms. de la Rua never saw Petitioner's nursing diploma or license (Tr. 60) and has no personal knowledge that he attended nursing school in Cuba (Tr. 61). She did see him dressed as a nurse and acting as a nurse in the principal hospital in Matanzas, Cuba (Tr. 55, 61-62). Francisca Garcia is licensed as a nurse in Florida. She met Petitioner in 1965 or 1966 in the clinic Petitioner's father and brother, who were medical doctors, operated in Havana (Tr. 69, 91, 118-119). Petitioner treated Ms. Garcia's nephew by giving him a vaccination (Tr. 70). In Cuba that treatment could have been performed by someone with a medical education or even a nurse's aide (Tr. 70). Although Ms. Garcia states that she saw Petitioner's diploma or license at the clinic (Tr. 65, ln. 9-15), no such document has been offered in this proceeding, and her testimony about the diploma is not persuasive due to Petitioner's failure to offer any copy of the degree for admission into evidence, although a copy was apparently available at the hearing. See Finding of Fact 2, above. Petitioner first sought licensure in Florida in 1977 (JX-4). The basis for that application was his incomplete medical education, and the application was denied (Tr. 111, 117). On that application, Petitioner did not indicate any nursing education, either under "Official Name of Nursing Program" (JX-4, ln. 8) or under a question regarding receipt of nursing education in another country (JX-4, ln. 10). The latter question was left blank; all other questions on the application were answered (JX- 4), including that Petitioner had not written a nursing licensing examination before. Petitioner again applied for licensure by examination in 1981 (JX-5). On the 1981 application, Petitioner did refer to his nursing education, but in vague terms, giving the Official Name of Nursing Program as "Registered Nurse" (JX-5, ln. 8). This application also contains the false statement that Petitioner had never before made application for licensure in Florida (JX-5, ln. 9), and the statement that he had not written a nursing licensing examination before. Petitioner applied for licensure a third time, this time by endorsement rather than by examination, in an application received by the Board on May 18, 1984 (JX-3). This application contains several false statements or omissions. Petitioner again failed to advise the Board of his previous applications (JX-I, section 4E). Petitioner stated that he had never held a license to practice nursing in another country (JX-3, section 4F). Petitioner again stated that he had never written a nursing licensure examination in Florida or any other state or country (JX-3, section 6A). Petitioner made a further false answer to the question "Have you ever been denied a license to practice nursing in Florida . . .?" (JX-3, section 6D). Truthful answers to these questions are necessary so that the Board and its staff may review sufficiently and evaluate an application, taking into consideration any previous Board actions (Tr. 146, 147). To prove eligibility for licensure by endorsement, an applicant who was educated and licensed in Cuba before a prescribed date must demonstrate that licensure by means of official documents (Tr. 140). If original documents are unavailable, as is often the case with Cuban nurses (Tr. 98), the Board requires some other competent, substantial proof, including affidavits of other nurses or doctors licensed both in Cuba and in Florida (Tr. 140, 149). Those affidavits must be consistent with other information received by the Board concerning the applicant's qualifications (Tr. 149). The Board amended its rules by emergency rule effective May 18, 1984 (RX-1), to provide that nurses licensed in Cuba prior to December 31, 1961, would be eligible for licensure by endorsement upon successful completion of a refresher course (Tr. 142, 143). Although Petitioner purportedly graduated from nursing school after that date, the Board reconsidered his application because he had been approved to begin and had completed the refresher course at Miami-Dade Community College before the effective date of the emergency rule (Tr. 144, 145). Petitioner completed the variable time nursing refresher program at Miami-Dade (Tr. 46; JX-2), which was a 16- week course designed for people who had never taken a licensing examination (Tr. 45, ln. 9-14). This program contained no clinical component or direct patient care (Tr. 46, 47). According to the dean of the Miami-Dade program, Dr. Jeanne Stark, who also developed the program (Tr. 46, 47), an individual with a medical background but who had not had a nursing education could successfully attend and complete the 16-week variable time refresher program (Tr. 47-50). Petitioner was approved to take the refresher course by the Board (Tr. 51), prior to his 1984 application, on the basis of affidavits provided by the Cuban Nurses in Exile Association that he was licensed in Cuba (Tr. 141, 142). Those affidavits are no longer relied on by the Board as proof of licensure because of inconsistencies and inaccuracies in them (Tr. 141, 144).
Recommendation Based on the foregoing, it is recommended that the Board of Nursing enter a final order DENYING the application of Lazaro Saavedra for licensure by endorsement. DONE AND ORDERED this 4th day of April 1986 in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY, JR., Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of April 1986.
