The Issue The issue in these two consolidated cases is whether disciplinary action should be taken against Luis J. Marti, M. D., hereinafter referred to as "Respondent Marti," and/or Jesus Escar, M.D., hereinafter referred to as "Respondent Escar," based upon the alleged violations of Chapter 458, Florida Statutes, contained in the separate Administrative Complaints filed against each of the Respondents.
Findings Of Fact Based on the stipulations of the parties; on the testimony of the witnesses, and on the exhibits received in evidence at the hearing; I make the following findings of fact. Respondent Escar is, and has been at all times material hereto, a licensed physician in the state of Florida, having been issued license number ME 0034247. Respondent Escar's last known address is 935 West 49th Street, Suite #107, Hialeah; Florida 33012. Respondent Marti is, and has been at all times material hereto, a licensed physician in the state of Florida, having been issued license number ME 0034842. Respondent Marti's last known address is 24355 West Flagler Street, Miami, Florida 33125. Respondent Marti went to medical school in Madrid, Spain. In approximately 1970, while Respondent Marti was in medical school in Madrid, Spain, Respondent Marti met Jose A. Tudela for the first time. At the time, Tudela had come to Madrid, Spain, for the purposes of starting medical school. In approximately 1975, while Respondent Marti was working as a resident at Cedars of Lebanon Hospital, Respondent Marti again saw Jose A. Tudela. At about the same time, Respondent Escar met Tudela for the first time. Tudela's father, Francisco Tudela, a physician, was an attending physician at Cedars of Lebanon Hospital. Respondents Marti and Escar saw Jose and Francisco Tudela in 1975 while on rounds at the hospital. In 1979, while Respondents Marti and Escar were working at Palm Springs General Hospital, Jose A. Tudela came to the hospital to apply for a position as a house physician and saw Respondents Escar and Marti. When Tudela applied for the position of house physician at Palm Springs General Hospital, Respondents Marti and Escar were both residents at the hospital. On the day that Jose A. Tudela came to apply for the position of house physician at Palm Springs General Hospital, Tudela came to the doctors' lounge at the hospital where he spoke with Respondents Escar and Marti. Tudela had with him a diploma which appeared to Respondents Escar and Marti to be authentic and which appeared to have been issued by the Universidad Central del Este. The diploma had on the back what appeared to be official stamps and seals and the signature of the Vice Consul of the United States. Additionally, a translation of the diploma was attached to the diploma. On the date that Tudela came to apply for the position of house physician at Palm Springs General Hospital, Tudela also showed Respondents Escar and Marti what appeared to be a transcript of his grades from the Universidad Central del Este and a letter purportedly from one Victoria Marcial de Gomez. The transcript and letter appeared to Respondents Escar and Marti to be original and authentic. The letter from Gomez, who purportedly was the medical director for the health center of Trujillo Alto Health Department, in the associated Free State of Puerto Rico, appeared to verify the fact that Dr. Jose A. Tudela had worked in the Health Center of Trujillo Alto for seven months. When Respondent Marti reviewed Tudela's documents, he knew it was important that foreign papers be certified because he had had the experience of having to leave Cuba and re-establish himself. Respondent Marti's own diplomas from Spain bear attestations of notarization of a foreign government. Respondent Escar believed that Tudela's documents were originals because of his experience in having seen similar original documents of other residents in the past. On or about August 1, 1979, Jose A. Tudela completed an application for employment as a house physician at Palm Springs General Hospital. The application contained basic personal information about Tudela and listed some of Tudela's education and work experience. According to the application, Tudela went to Belle Glade High School, in Belle Glade; Florida; Warwick High School, in Newport News, Virginia, where he graduated in 1965; and the University of Miami; in Coral Gables, Florida where he graduated in 1970. According to the application, Tudela worked in an unspecified capacity in the Centro de Salud, in Trujillo Alto, Puerto Rico, from 1978 to 1979. The application form does not contain any information about Tudela's medical education. Specifically, it does not contain any mention of University of Santo Domingo, Universidad Central del Este, or U.C.E. On or about August 8, 1979, Jose A. Tudela was employed by Palm Springs General Hospital as a house physician. Jose A. Tudela remained at Palm Springs General Hospital as a house physician until October 29, 1979. Tudela left Palm Springs General Hospital on that date to become a surgical assistant at Miami Children's Hospital. While employed a Miami Children's Hospital, Tudela received the highest score on every item on his employee evaluation form. That hospital never knew of any problem with Tudela's performance or credentials until this case occurred. Between approximately 1979 and 1983, Respondents Escar and Marti practiced medicine together as partners. In 1980, Jose A. Tudela approached Respondent Marti and asked Respondent Marti to sign an affidavit on behalf of Tudela. Therefore, on or about March 13, 1980, Respondent Marti signed a Form B-1 which was addressed to Rafael A. Penalver, M.D., Director, Office of International Medical Education, University of Miami School of Medicine; Miami; Florida. The form B-1 contained the following sworn statement: This is to certify that Jose A. Tudela born in Cuba and a graduate from the University Santo Domingo on 1978 was legally engaged in the practice of medicine from ---- to in Puerto Rico. I have known the applicant since 1975 and was acquainted with him/her during the time he practiced medicine. I was algo (sic) engaged in the practice of medicine in Miami U.S.A. during the years of 1975 and up. At some time after Respondent Marti signed the Form B-1, the abbreviation "(U.C.E.)" was added to the above-referenced sworn statement after the school name, "University Santo Domingo." Respondent Marti did not place the quoted abbreviation on the Form B-1. Prior to signing the subject Form B-1, Respondent Marti reviewed, for verification purposes, the employment application of Jose A. Tudela for Tudela's employment as a house physician at Palm Springs General Hospital. However, the employment application in question does not reflect any attendance by Tudela at any educational institution in the Dominican Republic or Santo Domingo. Furthermore, the employment application does not indicate the capacity in which Tudela worked in the Centro Salud in Trujillo Alto, Puerto Rico, and does not specifically indicate that Tudela practiced medicine in Puerto Rico. In 1980, Jose A. Tudela also approached Respondent Escar and asked Respondent Escar to sign an affidavit for him. Therefore, on or about March 13, 1980, Respondent Escar signed a Form B-1 which contained the following sworn statement: This is to certify that Jose A. Tudela born in Cuba and a graduate from the University of Santo Domingo on 1978 was legally engaged in the practice of medicine from ---- to in Puerto Rico. I have known the applicant since 1970 and was acquainted with him/her during the time he practiced medicine. I was algo (sic) engaged in the practice of medicine in Miami, Fla during the years of 1977 and up. The Form B-1 was addressed to Rafael A. Penalver, M.D., Director; Office of International Medical Education, University of Miami School of Medicine, Miami, Florida. At some time after Respondent Escar signed the Form B-1, the abbreviation "(U.C.E.)" was added to the above-referenced sworn statement after the school name, "University of Santo Domingo." Respondent Escar did not place the quoted abbreviation on the Form B-1. Respondent Escar relied upon Respondent Marti's verification of Tudela's background information in signing the Form B-1 described in the immediately preceding paragraph. Respondent Escar did not personally review Tudela's application for employment at Palm Springs General Hospital but discussed the information contained in the employment application with Respondent Marti. At the time Respondents Marti and Escar signed the Forms B-1, they did not know Tudela very well and did not know very much about his background. Although they both thought Tudela was probably a graduate of a medical school, they did not remember what school he had supposedly graduated from, as evidenced by the fact that they put the wrong school name on the Forms B- 1. Both Respondent Escar and Respondent Marti lacked personal knowledge of the information contained in the Forms B-1 which they signed for Jose A. Tudela. Neither of the Respondents saw or taught Tudela at medical school in the Dominican Republic. Furthermore, neither Respondent Escar nor Respondent Marti was in Puerto Rico at the time Jose A. Tudela allegedly practiced medicine at the Centro Salud in Trujillo Alto, Puerto Rico. Neither of the Respondents had any source of information about Tudela's alleged medical education in the Dominican Republic or his alleged practice of medicine in Puerto Rico other than statements Tudela may have made to them, statements Tudela wrote on the application form at Palm Springs General Hospital, and whatever information could be gleaned from a casual review of Tudela's forged credentials. Jose A. Tudela has never graduated from the Universidad Central del Este, which is located in the Dominican Republic, nor from any other medical school. Tudela enrolled in the Universidad Central del Este (U.C.E.) medical school in August, 1977. There is no evidence in the school records for U.C.E. that Tudela passed any of his courses. In May of 1978 Tudela was no longer at the university. Tudela was given a special concession at U.C.E. so that upon presentation of a pre-medical certificate which Tudela claimed to possess, Tudela could receive credit for the pre-medical program training. However, Tudela never presented the required proof of his pre-medical program. Tudela did not complete any of the twelve semesters at U.C.E. which make up the medical degree program including pre-medical training. Although Respondent Marti first met Tudela in 1970 and Respondent Escar met him in 1975, the Form B-1 signed by Respondent Marti states that he met Tudela in 1975, and the one signed by Respondent Escar states that he met Tudela in 1970. The reason for this error is that both of the forms were prepared by Respondent Marti and the forms were inadvertently switched at the time they were signed. The Forms B-1 signed by Respondents Marti and Escar were submitted to the Board of Medical Examiners by Jose A. Tudela as attachments to an Application for Continuing Medical Education Program, which was submitted as part of Tudela's application for licensure as a physician in Florida. Tudela applied for licensure in Florida under the provisions of a special law which provided that the Board of Medical Examiners would establish continuing education courses designed to qualify for licensure those individuals who were resident nationals of the Republic of Cuba and were residents of Florida on July 1, 1977. In order to qualify for the continuing education program set up by the Board of Medical Examiners for Cuban nationals, an applicant had to demonstrate that he was a graduate from a medical school with a medical degree and that he was a resident national of the Republic of Cuba and a resident of Florida on July 1, 1977. Upon approval of the applicant to participate in the continuing education program set up by the Board of Medical Examiners, the applicant would have to complete the continuing education program. Upon completion of the continuing education program, the applicant would be qualified to take the licensing examination. In or about March of 1980, Tudela submitted an Application for Examination, an Application for Florida State Board of Medical Examiners Continuing Education Program, and the necessary attachments, which included the Forms B-1 signed by Respondents Escar and Marti and copies of what purported to be his diploma and transcript of grades. After successfully completing the continuing medical education program and the licensure examination, Tudela became certified to practice medicine and surgery by the Board of Medical Examiners on August 23, 1982. At the time of Tudela's application for medical license, the staff of the Board of Medical Examiners conducted the initial review and made the initial determination as to whether an individual was qualified to take the continuing education course and to take the licensure examination for certification to practice medicine and surgery in Florida. In making such determinations, consideration is given to all of the information contained in an applicant's file, which includes such things as the applicant's degree or diploma, transcript of grades, and the Forms B-1. At the time Tudela applied for licensure, the staff of the Board of Medical Examiners did not verify the medical education of applicants and conducted no investigation into the school or the graduation of applicants for licensure. Prior to approving Tudela's application, neither the Board members nor the staff independently contacted the Universidad Central del Este to verify whether Tudela actually graduated from medical school. The Board members did not personally review Tudela's application. The staff reviewed the papers and presented the Board with a list of applicants who appeared to be eligible for the continuing education course and the licensure examination. The diploma and the transcript of grades which Tudela showed to the Respondents and filed with the Board of Medical Examiners are forgeries. They are very good forgeries and bear a remarkable resemblance to genuine diplomas and transcripts issued by the Universidad Central del Este. The false documents provided by Tudela to the Board as part of his application, along with the Forms B-1 signed by Respondents Marti and Escar, deceived the staff into recommending Tudela for the continuing education course, the licensure exam, and ultimately for certification to practice medicine. Tudela's application to the Board also contains several letters of recommendation from other physicians who were convinced of Tudela's competence. The Educational Commission for Foreign Medical Graduates granted Tudela a certificate despite his forged documents. In November 1984, an Administrative Complaint was filed against Jose A. Tudela which alleged that Tudela did not graduate from or obtain a degree of Doctor of Medicine from U.C.E., contrary to what Tudela had indicated in his application for licensure examination described above. In March 1985, the Board of Medical Examiners entered an order accepting the surrender for revocation of Jose A. Tudela's license to practice medicine in lieu of further prosecution of the charges contained in the Administrative Complaint which had been filed in November 1984. Tudela is not currently licensed as a physician in the state of Florida. No further action was taken against him for his having fraudulently obtained a medical license in Florida. Respondents Escar and Marti were both aware of the fact that the Forms B-1 which they signed were to be submitted as part of the application for the continuing medical education program which had been established by the Board of Medical Examiners for Cuban nationals as a prerequisite to take the licensure examination. In fact; Respondent Marti became eligible to take the medical licensure examination in Florida by completing the same continuing medical education program. When the Respondents Escar and Marti signed the subject Forms B-1, neither of them had any personal knowledge as to the truth or falsity of the statements therein regarding Tudela's medical education and experience; yet they deliberately certified, under oath, to the truthfulness of matters about which they were distinctly uninformed. When the Respondents Escar and Marti signed the subject Forms B-1, both of them knew the purpose of the forms and both knew that the Board of Medical Examiners would rely on the information in the forms.
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD 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 9th day of August, 2005.
Findings Of Fact On April 27, 1987, Petitioner filed an application for licensure by endorsement with the Board of Chiropractic (the Board.) On September 13, 1988, an Order stating the Board's intention to deny Petitioner's application for licensure by endorsement was filed by the Board. Petitioner timely filed a request for formal proceedings resulting in the above-styled matter being placed before the Division of Administrative Hearings. As a result of attempts to negotiate a settlement between Petitioner and Respondent, Petitioner filed a second application for licensure on or about June 19, 1989. At the July 27, 1989, meeting of the Board, Petitioner's second application for licensure by endorsement was denied. At the time of the final hearing, an Order had not yet been filed, but was to be forthcoming. The grounds for the Board's denial of Petitioner's April, 1987, application were that: Pennsylvania did not require applicants for licensure to receive a score of at least 75% on each portion of the state licensure exam; Pennsylvania did not require completion of continuing education as required of licensees in Florida; and Pennsylvania permitted licenses to be inactive for five years before said licenses became null and void. The Board of Chiropractic determined that the requirements for licensure in Pennsylvania are not substantially similar to, equivalent to, or more stringent than the current requirements of Chapter 460, Florida Statutes. At the hearing, counsel for Respondent waived the grounds regarding inactive licenses and completion of continuing education. The grounds for the Board's denial of Petitioner's June, 1989, application for licensure by endorsement are that the Pennsylvania requirements for licensure are not substantially similar to, equivalent to, or more stringent than the current requirements of Chapter 460, Florida Statutes. Specifically, the licensure examination administered by the Pennsylvania State Board of Chiropractic does not cover physical diagnosis and x-ray interpretation of chiropractic and pathology films, both of which are covered in the practical examination given by the Florida Board of Chiropractic as a requirement for licensure. Petitioner has taken and successfully completed parts I and II of the National Beard written examination. Petitioner has not taken or passed the National Board Written Clinical Competency Examination (which has been administered only since September, 1987). Petitioner has taken and successfully completed the Pennsylvania state licensure examination in chiropractic. Petitioner has been licensed as a chiropractor in Pennsylvania for 6 years. The pertinent Pennsylvania law in effect at the time that the Board considered Petitioner's applications for licensure by endorsement is set out in the following portions of Section 625.501 and Section 625.502, 63 Pennsylvania Statutes: s. 625.501 Applications for license Requirement for licensure.-- An applicant for a license under this act shall submit satisfactory proof to the board that the applicant meets all of the following: (1) Is 21 years of age or older. Is of good moral character. Has a high school diploma or its equivalent. Has completed two years of college or 60 credit hours. Has graduated from an approved college of chiropractic, with successful completion of not less than the minimum number of hours of classroom and laboratory instruction required by regulation of the board, which minimum shall be at least 4,000 hours. Has passed the examination required under this act. Has not been convicted of a felonious act prohibited by the act of April 14, 1972 (P.L. 233, No. 64), known as The Controlled Substance, Drug, Device and Cosmetic Act, or of an offense under the laws of another juris- diction which if committed in this Commonwealth would be a felony under The Controlled Substance, Drug, Device and Cosmetic Act, unless the applicant satisfies all of the following criteria: At least ten years have elapsed from the date of conviction. Satisfactorily demonstrates to the board that he has made sig- nificant progress in personal rehabilitation since the conviction such that licensure of the appli- cant should not be expected to create a substantial risk of harm to the health and safety of his patients or the public or a substantial risk of further criminal violations. Satisfies the qualifica- tions contained in this act. An applicant's statement on the application declaring the absence of a conviction shall be deemed satisfactory evidence of the absence of a conviction, unless the board has some evidence to the contrary. As used in this section the term "convicted" shall include a judgment, an admission of guilt or a plea of nolo contendere. * * * s. 625.502. Examination * * * Nature and content of examination.-- The examination shall be oral, practical and written, upon the principles and technique of chiropractic and shall include the following subjects: anatomy, physiology, histology, chemistry, pathology, physics, bacteriology, diagnosis, hygiene and sanitation, symptomatology, chiropractic analysis, x-ray, chiropractic principles and a practical demonstration of chiropractic technique. * * * Testing organization.-- All written, oral and practical examinations required under this section shall be prepared and administered by a qualified and approved professional testing organization in accordance with section 812.1 of the act of April 9, 1929 (P.L. 177, No. 175), known as The Administrative Code of 1929, except that the oral and practical examinations shall not be subject to section 812.1 until such examinations are available from a testing organization. Score.-- A license shall be granted to an applicant who meets the requirements of this act and who achieves: An overall score of at least 75% on the entire examination; or An average score of at least 75% on the oral and practical examina- tion and a passing score on the written examination administered by the National Board of Chiro- practic Examiners as such passing score is determined by the national board. (Emphasis added.) The Pennsylvania Board of Chiropractic does not have any published rules regarding licensure of applicants in the State of Pennsylvania. The Petitioner did not prove that the Pennsylvania Board of Chiropractic examines applicants in the area of x-ray interpretation and physical diagnosis. The Petitioner did not prove that the Pennsylvania State Board of Chiropractic required applicants to re-take Pennsylvania's entire examination if any portion was failed. The Petitioner did not prove that the requirement of the Florida Board of Chiropractic that applicants for licensure be tested on ability to make physical diagnoses and to interpret chiropractic and pathology x-ray films is unreasonably restrictive or an extraordinary standard that deters qualified persons from entering chiropractic medicine in Florida or that it creates or maintains an economic condition that unreasonably restricts competition. The Petitioner did not prove that the requirement of the Florida Board of Chiropractic that applicants for licensure must re-take the entire licensure examination if any portion of the examination is failed is unreasonably restrictive or an extraordinary standard that deters qualified persons from entering chiropractic medicine in Florida or that it creates or maintains an economic condition that unreasonably restricts competition. The Petitioner did not prove either that it would be unreasonably restrictive or an extraordinary standard that deters qualified persons from entering chiropractic medicine in Florida or that it would create or maintain an economic condition that unreasonably restricts competition for the Florida Board of Chiropractic to decide that "the requirements for licensure in Pennsylvania are [not] substantially similar to, equivalent to, or more stringent than the current requirements of this chapter [460, Florida Statutes.]" Cf. Section 460.4065, Florida Statutes (1987 and Supp. 1988).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Chiropractic enter a final order denying the applications of the Petitioner, Norman R. Wiedow, D. C., for licensure by endorsement. DONE and RECOMMENDED this 11th day of October, 1989, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of October, 1989.
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.
Findings Of Fact Petitioner filed an application for certification as a physician assistant pursuant to Section 458.347(7)(b), Florida Statutes, a special avenue of certification as a physician assistant for graduates of foreign medical schools. In furtherance of that application, he appeared before the Physician Assistant Committee of the Board of Medicine. Subsequent to his appearance before that Committee, on August 13, 1992, Respondent sent Petitioner a letter which provides, in pertinent part, as follows: This is to advise that your application for issuance of a temporary certification with the requirement that prior to issuance of temporary certificate you submit within 30 days of date of appearance, a new corrected and complete application to be reviewed by the Board staff. Please complete the enclosed application. You will be required, as a condition to take the examination, 2 new personalized letters of recommendation, specifically recommending you as a physician assistant. The letter did not enclose an application form for Petitioner to complete. Respondent admits that the information in the letter was incorrect because it confused temporary certification with the requirements for examination. It is apparent that the letter is also incorrect because it fails to advise Petitioner if his application was being granted or denied; moreover, the wording of the letter makes no sense. By Order dated August 26, 1992, the Board of Medicine notified Petitioner that his application for temporary certification as a physician assistant was denied pursuant to the Committee's August 1 determination and the Board's August 9 determination that the length of time since Petitioner had last worked in the field of medicine or received significant medical education or training precluded him from being able to establish that he could practice as a physician assistant with reasonable skill and safety to the public. That Order further advised Petitioner, however, that the Board had granted Petitioner's application to sit for the certification examination pursuant to Section 458.347(7)(b), Florida Statutes, because Petitioner was eligible to take the examination to become certified as a physician assistant and that passage of the examination would serve to establish Petitioner's qualifications for practice. The Order specifically provided that the Board's permission for Petitioner to sit for the certification examination was "contingent upon and subsequent to receipt within 30 days" of Petitioner's appearance before the Physician Assistant Committee of (1) a complete and correct application and (2) two more letters of recommendation which specifically recommend Petitioner as a physician assistant. It would have been difficult for Petitioner to timely comply with the Order entered August 26 requiring him to file documents within 30 days of his August 1 appearance before the Committee. By letter dated August 31, 1992, Petitioner requested an extension of one week by which to obtain the second letter of recommendation due to the devastation produced by Hurricane Andrew and Petitioner's inability to communicate with the doctor who would sign it. Petitioner did, however, submit another application which was postmarked August 31, 1992, and received by Respondent early in September. At hearing, Respondent advised that it was waiving the 30-day deadline contained in the August 26, 1992, Order due to the intervention of Hurricane Andrew and because Respondent had not strictly enforced such deadlines as to other applicants. Rather, Respondent simply required that Petitioner comply with its Order within a reasonable period of time. By letter dated December 21, 1992, Respondent advised Petitioner that his application was incomplete because the Board had only received Petitioner's new application, one letter of recommendation, and Petitioner's request for an extension of time for submittal of the second letter. The letter further advised that the Board's staff's review of Petitioner's recent application had revealed some discrepancies requiring an explanation by Petitioner. The letter, therefore, advised Petitioner to submit one more recommendation letter, provide an explanation for six specified areas, and submit pages 8 and 9 of the application regarding Petitioner's clerkships. The letter further advised Petitioner that all information must be received by the Board no later than December 31, 1992. On January 20, 1993, Respondent received an undated letter from Petitioner referencing Respondent's December 21, 1992, letter which was received by Petitioner on December 30. Petitioner's letter enclosed the additional letter of recommendation requested by the Board, responded specifically to the six areas of inquiry, and enclosed pages 8 and 9 of the Board's application form. On January 20, 1993, the Board received a letter from Dr. Jose M. Bermudez, recommending Petitioner as a physician assistant. On January 28, 1993, the Board sent Petitioner a letter advising him that the Board had received the letter of recommendation from Dr. Bermudez and pages 8 and 9 of the application. That letter further provided as follows: However, the Physician Assistant Committee required you to submit a new complete and accurate application, and two (2) additional letters of recommendation which specifically recommend you as a physician assistant. Enclosed you will find a complete physician assistant application. Please fill the application out in its entirety and submit it to the Board of Medicine as soon as possible. In compliance with that request, Petitioner submitted yet another application for certification as a physician assistant, which was received by the Board on February 8, 1993. On February 24, 1993, the Board of Medicine entered its Order denying Petitioner's application for certification as a physician assistant. The Order recited that the denial was based upon the determination made by the Physician Assistant Committee on January 8 and by the Board on January 13 because Petitioner "failed to submit a new and complete and accurate application and one new personalized letter of recommendation within the time frame allotted by the Board." That Order does not mention Petitioner's application to sit for the certification examination, the issue pending before the Board, since the Board had already denied Petitioner's application for certification by Order entered August 26, 1992. That February Order also advised Petitioner of his right to request an administrative hearing regarding the Board's determination. On February 26, 1993, the Board's staff sent Petitioner a letter advising him that he had been certified by the Board to take the examination for licensure as a physician assistant to be administered in September, 1993. On March 10, 1993, the staff sent Petitioner a letter acknowledging Petitioner's "request for a hearing on the denial of your application for certification as a physician assistant," and advising Petitioner that the February letter advising him that he had been certified to take the examination for licensure as a physician assistant had been sent to Petitioner in error. A "corrected" letter was enclosed. That "corrected" letter dated March 10 advised Petitioner that the Board had preliminarily denied him certification to take the examination for licensure as a physician assistant. By letter dated March 18, 1993, the Board's staff sent an additional letter to Petitioner advising Petitioner as to the correct dates for the examination. In applying for temporary certification as a physician assistant and/or to sit for the certification examination, Petitioner has filed an additional application each time he has been instructed to do so by the Board or by the Board's staff and has submitted a letter explaining the information given in his applications each time that the Board's staff has requested that he do so. Petitioner has filed at least three such applications and has responded by letter to inquiries regarding the contents of his applications at least three times. Additionally, Petitioner has personally appeared before the Physician Assistant Committee on August 1, 1992, to be questioned regarding his qualifications. The Board has discovered some "discrepancies" or omissions in analyzing those various documents. Petitioner's August application states that the ending date for medical school, assumedly the date he received his degree, was February 25, 1965. That date appears in three places. Further, the copy of his diploma submitted to the Board reflects that date. Yet, the December 21, 1992, form from the Board to Petitioner advises him that he must explain his ending date for medical school. In response to that indication that he must provide different information, Petitioner's letter received by the Board on January 20, 1993, states that the ending date for medical school was February 29, 1962. At hearing, Petitioner explained that he attempted to differentiate between the date he completed classes and the date he completed all requirements, including internships, in order to receive his diploma. The information contained in Petitioner's application is correct. The August application contains an answer in the negative to question numbered 9 asking Petitioner if he is or has ever been emotionally or mentally ill. Although Petitioner's subsequent February 1993 application contains no answer to that question, the Board did not have before it the February application when it decided in January to deny Petitioner's application. Even so, Petitioner had no intention to be incomplete or inaccurate when he failed to answer that question on the February application. In his August application Petitioner does not list the completion of any social service work in either section inquiring about post-graduate training or practice employment. In an application that Petitioner filed in 1985 requesting licensure as a physician, Petitioner had specifically detailed the social service work performed by him as part of his medical school training. In that application he listed the dates as January 1, 1963 to December 31, 1963. The letter Petitioner wrote to the Board in response to its December 1992 request for a better explanation states that his social service work was done between March 1, 1963 and September 30, 1963. There is no dispute regarding whether Petitioner did in fact complete his social service work requirement as part of his education in order to receive his diploma, and it is clear that such work was done in 1963. Although there is a discrepancy regarding which months during 1963 he did his social work, the discrepancy as to the months during which Petitioner did something 30 years ago does not make his application inaccurate. In fact, the August application may be more accurate than the 1985 application form. The August application required Petitioner to list in chronological order from the date of graduation to the present all practice experience and/or employment. Petitioner advised that from February 28, 1970, to April 30, 1976, he was in private practice in Nicaragua. The Board's December 1992 letter asked for clarification because a prior application indicated additional activity. Petitioner's response letter advised that he was also in pediatric practice at the General Hospital of Managua from 1970 to 1972. His 1985 application did not mention the pediatric practice at General Hospital. At final hearing, Petitioner explained that he was in private practice at the same time that he practiced at the clinic in the hospital. Petitioner's 1985 and February 1993 applications, although not the subject of this proceeding, also contained some minor discrepancies regarding Petitioner's employment experience. For example, one shows Petitioner beginning his employment with the Nicaraguan Red Cross on May 1, 1976, and the other shows Petitioner's employment beginning on May 31, 1976. The parties do not dispute that Petitioner in fact practiced with the Nicaraguan Red Cross during that time period. In further response to the question requiring Petitioner to list all of his practice experience or employment, Petitioner did not list his activities from September 10, 1984, and thereafter. The Board's December 21, 1992, letter to him requested that he account for all his activities for the time period of January 1, 1984, and thereafter. In his response he did not identify those activities except to say that during that time period he was living in Miami. The detailed information had been provided to the Board in response to a letter to Petitioner from the Board dated March 8, 1992, in conjunction with his original application for certification as a physician assistant, although he did not again provide that information when he was ordered by the Board to file a new application. In Petitioner's August application, he listed no ending date regarding his private practice begun on January 1, 1984 in Managua, Nicaragua. Petitioner's 1985 physician license application showed that that employment ended September 10, 1984, whereas his February application showed that practice to have ended on September 15, 1984. Such a discrepancy is not material to Petitioner's application or eligibility. The application form contains a section regarding clerkships and requests that each clerkship be specified. In the August application Petitioner did not specify his four individual clerkships. After being asked pursuant to the Board's staff's December 1992 letter to resubmit pages 8 and 9 as to his clerkships, Petitioner did so by referring to them as a group rather than breaking them down individually. He did the same in the February 1993 application. The parties do not dispute that Petitioner performed the required clerkships. It is unclear how many letters recommending him as a physician assistant Petitioner has submitted to the Board. Petitioner referenced his submittal of photocopies of the "last two" letters of recommendation, the originals of which had previously been submitted to the Board, in a letter that Petitioner sent the Board in March of 1992. In correspondence from the Board to Petitioner in May of 1992 reference is made to the requirement that Petitioner submit another letter of recommendation because the Board did not have the original of that letter in its file. When the Board's staff instructed Petitioner to appear before the Physician Assistant Committee on August 1, 1992, the absence of necessary letters of recommendation was not one of the reasons given. The Board's August 26, 1992, Order requests "two more letters", which indicates that letters had been previously submitted. The staff's December 21, 1992, communication to Petitioner acknowledges receipt of one additional letter but requests another, which request was complied with at least by the submittal of the letter from Dr. Bermudez received by the Board on January 20, 1993. Petitioner applied to be certified as a physician assistant and the Board determined that he was eligible to take the examination. Thereafter, through a series of mistakes and correct acts, the Board's staff requested Petitioner on a number of occasions to file additional applications which he did. When the Board's staff asked for clarification he responded in writing and by telephone call, and the Board agrees that it has telephone slips in Petitioner's file. Each time the Board's staff asked for different information than had been given in Petitioner's previous application(s), Petitioner provided more and/or different information. There is no suggestion that Petitioner attempted to provide inaccurate or false information, and it is found that Petitioner provided correct and complete information to the best of his ability. Petitioner's mistakes are certainly no greater than the mistakes made by the Board's staff in sending Petitioner conflicting instructions, conflicting correspondence, and one letter that did not make any sense.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered permitting Petitioner to sit for the physician assistant examination to be administered during September of 1993. DONE and ENTERED this 12th day of July, 1993, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1993. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 93-1550 Respondent's proposed findings of fact numbered 1-10 have been adopted in substance in this Recommended Order. Respondent's proposed finding of fact numbered 11 has been rejected as not being supported by the weight of the evidence in this cause. COPIES FURNISHED: Catherine Lannon, Esquire Department of Legal Affairs The Capitol PL-01 Tallahassee, Florida 32399-1050 Enrique Rueda Arguello 9409 Fountainbleau Boulevard, Apt. #101 Miami, Florida 33172 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the Respondent is guilty of unprofessional conduct. Whether her license as a registered nurse, certificate no. 8829 should be suspended or revoked or whether Respondent should be put on probation.
Findings Of Fact The Respondent, Christine Richter, who holds license no. 88294-2 was employed as a registered nurse at Tallahassee Memorial Hospital, Tallahassee, Florida, during the month of February, 1977. She worked as a certified nurse and anesthetist under Ann Marie Connors, the chief nurse anesthetist. The chief nurse anesthetist reported to the Associate Executive Director April 11, 1977, that there were gross discrepancies in the narcotics record kept by the Respondent and at that time she presented him with some of the records. On April 12, 1977, Respondent was requested by the Associate Executive Director to report to his office for a conference. Nurse Connors, the chief nurse anesthetist, was also called to be present at that conference. At the conference the Associate Executive Director asked Respondent for an explanation as to the discrepancies between the narcotic and barbiturate administration record and the patient records. In reply the Respondent stated that she needed a hysterectomy and could not afford it. Upon the insistance of the Associate Executive Director that she give an explanation for the discrepancy in the hospital records, she indicated that she needed to improve her charting. She gave no explanation for discrepancies in the narcotics chart which she signed, and indicated that she would resign. The Director stated that he would accept her resignation and she left the conference. The Respondent mailed her written resignation to the Tallahassee Memorial Hospital the following day. The Accreditation Manual for Hospitals, 1976 edition, published by the Joint Commission on Accreditation of Hospitals "Anesthesia Services" pages 59 through 64 is used as the standard for anesthetic procedure. A department standard book approved by the American Hospital Association and the joint commission on the accreditation of hospitals is required to be read by each employee of the Tallahassee Memorial Hospital as it pertains to the department in which the work is to be performed. The instructions in the department standards book are the same as in the Accreditation Manual for Hospitals as far as anesthesia services is concerned. Medical records of eight patients were introduced into evidence together with Narcotic and Barbiturate Record no. 081291. This shows the date, time, patient's name, room number, doseage, attending physician and administering nurse. The doseage of drugs secured by and signed for by the Respondent, Christine Richter, was more than the records show was administered to the various patients. No accounting was made for the difference between the amounts of drugs secured and the amounts, if any, administered to the patients, although it is the duty of the nurse checking out drugs to account for its use in writing on a form provided for that purpose. The Respondent offered no verbal explanation for the missing drugs when given the opportunity to explain her actions by the Associate Executive Director at Tallahassee Memorial Hospital and her immediate supervisor, Ann Marie Connors, chief nurse anesthetist.
Recommendation Revoke the license of Christine Richter. DONE AND ENTERED this 12th day of December, 1977, in Tallahassee, Florida. DELPENE C. STRICKLAND Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1005 Blackstone Building 233 East Bay Street Jacksonville, Florida 32202 Rivers Buford, Jr., Esquire Post Office Box 647 Tallahassee, Florida 32302
