Findings Of Fact In February, 1984 Petitioner applied to Respondent for licensure by examination under Section 458.311(2), F.S., but after review of said application at a meeting held on June 10, 1984, Respondent issued an Order dated July 21, 1984 denying said application. Petitioner received a degree which is designated Doctor of Medicine on May 2, 1983 from the Universidad Techologica de Santiago, (UTESA), Santo Domingo, Dominican Republic. He has been in residency at Orlando Regional Medical Center since June 28, 1983. Various required clerkships were performed by Petitioner between August 2, 1982 and February 28, 1983 in hematology, obstetrics and gynecology, pediatrics, dermatology and ENT/0phth., and were performed completely, or partially at osteopathic hospitals, or under the supervision of osteopathic physicians. An additional one month elective clerkship was also performed in April 1983 at Southeastern College of Osteopathy. Petitioner passed the exam given by the Educational Commission for Foreign Medical Graduates (ECFMG) on March 15, 1983, but has not been certified due to the need for additional institutional verification. Respondent informed Petitioner of the decision of ECFMG to withhold verification of certification and also informed Petitioner of its duty to approve or deny an application for licensure within ninety (90) days, unless waived by the applicant. Petitioner declined to consent to a waiver and requested Respondent to act on his application without verification of an ECFMG certificate.
The Issue At issue in this proceeding is whether petitioner's application for a medical license by endorsement should be approved.
Findings Of Fact The Findings of the Facts of tbe Recommended Order are adopted by the Board of Medicine as being based on competent substantial evidence.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered certifying petitioner's application to the Department of Professional Regulation, for licensure by endorsement with, should the Board be persuaded that such is appropriate, placement of petitioner on probation for such term and subject to such conditions as the Board may reasonably specify. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 24th day of April 1991. WILLIAM J. KENDRICK 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 24th day of April 1991.
The Issue The issues for consideration in this case are those promoted by an administrative complaint in which the Petitioner has accused the Respondent of violating certain provisions within Chapters 455 and 458, Florida Statutes, pertaining to licensure. This relates to the contention by Petitioner that Respondent has obtained his license to practice medicine in Florida by fraudulent means. These allegations are more completely described in the conclusions of law.
Findings Of Fact Respondent is a licensed physician having been issued license number ME0043541. On or about September 9, 1983, Respondent submitted an application to the Board of Medical Examiners, now known as the Board of Medicine, seeking a license to practice medicine in Florida. This request was for licensure by endorsement. On the form application there is a section which refers to the applicant's medical education. It instructs the applicant to be specific and account for each year of the medical education calling upon the applicant to give the name of the medical school and the location. In response to this requirement, Respondent indicated that he attended the Universidad del Noreste in Tampico, Mexico, from July, 1977 to May, 1978; from July, 1978 to May, 1979 and from June, 1979 until May, 1980. He further stated that he attended Universidad Cetec, Santo Domingo, Dominican Republic, from June, 1980 until May, 1981 and received a degree of doctor of medicine from that university on June 8, 1981. In submitting the application for licensure by endorsement, he did so under oath and in the course of signing the application he acknowledged the following in his affidavit and oath: "I have carefully read the questions in the foregoing application and have answered them completely, without reservation of any kind, and I declare under penalty of perjury that my answers and all statements made by me herein are true and correct. Should I furnish any false information in this application, I hereby agree that such action shall constitute cause for the denial, suspension or revocation of my license to practice medicine and surgery in the State of Florida. As part of the application process, Dorothy J. Faircloth, Executive Director to the Board of Medical Examiners, sent a letter to Dr. Traynor on September 30, 1983, requesting additional information. The text of that letter was as follows: Dear Dr. Traynor: With further reference to your application for licensure in Florida by you are required to provide to this office, in the form of an affidavit, a narrative report on all your activities relating to your medical education beginning with date of enrollment in medical school. Such report should include, but not be limited to, all classes attended (dates and name and location of institution) which were not conducted at the main teaching hospital of the medical school from which you received a medical diploma. You are also required to complete the enclosed form, providing additional information regarding your medical education and places of residence while in medical training. Upon receipt of the above requested material, you may be required to make a personal appearance before the Board for consideration of your application. The form referred to in the second paragraph of the correspondence from Ms. Faircloth is the form entitled: Attachment for Application for Licensure. Within that form it asks that the applicant "list all places of residence during medical school." This is broken down into various lines on the form requiring the applicant to state the city, state or country and the various period in which he resided in those places. A copy of the executed form offered by the Respondent on October 7, 1983 may be found as a part of Petitioner's composite exhibit 5 admitted into evidence. In the course of describing his residence, he refers to Tampico, Mexico in the period August, 1977 through July, 1978; August, 1978 through July, 1979 and August, 1979 through July, 1980. He then describes his place of residence during medical school as being Santo Domingo, Dominican Republic, in the period July, 1980 through June, 1981. The attachment for application for licensure form then has a section which states "Medical Education: be specific. Account for each year. List all universities or colleges where you attended classes and received training as a medical student." In response to this request, the Respondent provided the same information which he had given in his initial endorsement application form described before. In swearing to the accuracy of those matters set forth in the Attachment for Application for Licensure offered on October 7, 1983, Respondent gave the same oath as related to the endorsement application form acknowledging the possibility of denial, suspension or revocation of any license which was received by the giving of false information. In reply to the first paragraph of the September 30, 1983 correspondence from Ms. Faircloth, Respondent offered a document entitled "Clinical Training." A copy of that document may be found as part of Petitioner's composite exhibit 5. That document states: CLINICAL TRAINING Kevin M. Traynor Aug. '77 - July '79: Basic science courses at Del Noreste; Tampico, Mexico August - Dec. '79: Del Noreste Hospital, Tampico, Mexico Pulmonary Ear, nose & throat Cardiology Ophthalmology Jan. - June '80: Del Noreste Hospital; Tampico, Mexico Traumatology (orthopedics) Forensic medicine Gastroenterology Dermatology July - Dec. '80: University Hospital; Cetec School of Medicine, Santo Domingo, Dominican Republic Neurology Infectious disease Endocrinology General surgery Jan. - June '81: University Hospital; Uni- versity Cetec School of Medicine, Santo Domingo, Dominican Republic Psychiatry Internal medicine OB-GYN Pediatrics By the representations set forth in the statement of clinical training which were made by the Respondent, the impression is given that all of his activities related to his medical education from the point of enrollment to the completion of his medical school training were conducted at the Universidad del Noreste and University Cetec and the hospitals affiliated with those institutions. Given that the Respondent is silent on other activities outside those settings, a reading of his explanation leads one to believe that he had no such activities. This is not a true depiction of his training in medical school. In this respect, the Respondent has misled the Florida Board of Medical Examiners in that the vast majority of clinical rotations which the Respondent participated in during his medical school education occurred during externships in the United States. In addition, Respondent, in his comments in the endorsement application form and in the Attachment for Application for Licensure form, has misled the Board of Medical Examiners by describing his residence in medical school as Santo Domingo, Dominican Republic, in the period July, 1980 through June, 1981. He was not residing in the Dominican Republic until January, 1981. Respondent's domicile or official residence was in Tampico, Mexico, until the end of 1980. Respondent did not receive medical education in the sense of attending classes and receiving training as a medical student in affiliation with the Universidad Cetec until January, 1981. This is contrary to his representations about residence and medical education in which he describes his association with Universidad Cetec dating from July, 1980. Respondent had made an inquiry about being admitted to Universidad Cetec in December, 1980, and was given the impression that that request would be approved. Respondent's official acceptance by Universidad Cetec occurred on January 8, 1981. In referring to the activities related to medical education spoken to in the September 30, 1983 correspondence from Ms. Faircloth, the records reveal that Respondent did externship at St. Francis Hospital in Miami Beach, Florida from July 9, 1975 through November 20, 1979. He further did externship at Kingsbrook Jewish Medical Center in Brooklyn, New York, from January, 1980 through May, 1980, rotations involving medicine, pediatrics and surgery. In that same institution from June 30, 1980 through July 13, 1980, Respondent did a rotation in neurology. In the period July, 1980 through December, 1980, Respondent performed unofficial and uncredited externship at Kingsbrook. All of these activities occurred under the aegis of his status as a medical student at Universidad del Noreste. In the period February, 1981 through May, 1981, while at Universidad Cetec, Respondent did an externship at Brookdale Hospital Medical Center in New York in hematology and renal and electrolytes. In April, 1981, as an extern at Nassau County Medical Center in East Meadow, New York, Respondent performed a clerkship in urology. Under the circumstances in examining the places of residence during medical school, while Respondent may have been in official residence in Mexico and the Dominican Republic, his actual residence was in various locations within the United States in the periods described in the preceding paragraphs. Following his graduation, Respondent also participated in training programs at Brookdale Hospital Medical Center related to an elective in emergency services from the period August 10, 1981 through September 4, 1981. He performed an elective in the period September, 1981 through October, 1981 in the Division of Pulmonary Medicine at the Down State Medical Center which is affiliated with the Department of Medicine, AIE University of New York. From 1981 through June, 1984, Respondent was involved in an internal medicine residency at Jersey Shore Medical Center/Fitken Hospital in Neptune, New Jersey. Beginning in 1984 through June, 1986, Respondent completed a cardiology fellowship program in Jacksonville, Florida, at the University Hospital which is part of JHEP, a training program associated with the University of Florida medical school. In explaining why he has reported his residence in his medical education as commencing in July, 1980 at Universidad Cetec, Respondent indicates that he had been told by the dean of the medical school at Cetec, upon his admission there, that his enrollment would be back-dated to the beginning of the fall semester, or June, 1980. To this end Respondent paid Universidad Cetec $2,500 which represented a tuition payment for the seventh semester running from approximately June, 1980 to December, 1980. This payment for back-dating and credit for the seventh semester was made on April 23, 1981. There is no indication that those records were back-dated to show acceptance of a seventh semester under association with Universidad Cetec. Respondent did not undertake any clinical training in that period which could be credited, with the exception of his urology clerkship at Kingsbrook Jewish Medical Center in the period June 30, 1980 through July 13, 1980. He did not stand examination in any of the subject areas pertaining to his medical education in that seventh semester running from June, 1980 to December, 1980, having foregone the examination sessions given by Universidad del Noreste at the conclusion of that seventh semester. In the final analysis, Respondent did not accomplish anything toward advancing his medical education in the seventh semester running from approximately June, 1980 through December, 1980 as recognized by either medical school which he attended. There is evidence that part of the unofficial work done by the Petitioner in the fall of 1980 at Kingsbrook Jewish Medical Center related to dermatology and E.R. Even accepting the concept explained by the Respondent to the effect that both of the medical schools he attended would allow a student to stand examination in medical subjects at times not correlated with the performance of clinical clerkships, to the extent that the seventh semester unofficial clinical clerkships being performed are germane, they have not been credited. Respondent claims that the period from the end of the fall of 1980 was not crucial in that he had fulfilled enough weeks in clinical rotation to allow his graduation. In any event, Respondent did graduate, was certified by the Educational Commission for Foreign Medical Graduates, passed the FLEX examination and has been licensed in the states of Georgia and New Jersey. In explaining his response to the requirements related to his application for licensure in Florida to practice medicine, Respondent indicates that he was of the persuasion that he need only provide information pertaining to his clinical training as credited by the two schools he attended. This is not a fair reading of the requirements expressed in the correspondence of September 30, 1983, in which all activities involving the medical education are sought. This contemplates that specific information as to the exact nature and location of the externship rotations performed in the United States should be explained. Respondent failed to do this and what he did offer by way of explanation is misleading in that clerkships are set forth pertaining to experience in the period July, 1980 through December, 1980 associated with the Universidad Cetec which did not occur at that time because the Respondent was not enrolled at Universidad Cetec during that period. In addition, the statement about clinical training given by the Respondent would have one believe that the training occurred in the affiliated hospitals associated with the two medical schools he attended which is erroneous. The clinical training statement by the Petitioner does not coincide with his actual clinical training, an example being that during the period January, 1980 through June, 1980 while affiliated with the Universidad del Noreste, he says that he received training in traumatology (orthopedics), forensic medicine, gastroenterology, and dermatology when in fact the training he was receiving at that time at Kingsbrook Jewish Medical Center was in the fields of medicine, pediatrics and surgery. It appears that Universidad del Noreste gave him credit for those subjects he relates, but this was not the clinical training he was undergoing in that time sequence. During the period July through December 1980 where he indicates that he received clinical training in neurology, infectious disease, endocrinology and general surgery, the only official training he received was in neurology. It is debatable whether the requirements for establishing residence as described in the endorsement application form and the Attachment for Application for Licensure form sought the official residence, that is, his residence in the country where he attended medical school or the actual residence where externships were being performed as well as when he was actually at the university. In any event, if it was seeking the official residence, his information is misleading in that he describes his official residence as Santo Domingo in the period July, 1980 through December, 1980, when in fact his official residence was Tampico, Mexico. Respondent was given his medical license by the State of Florida on December 5, 1983, based in part upon the information as set out in the endorsement application form, the Attachment for Application for Licensure form and the narrative on clinical training provided by the Respondent. Before the occasion of the present administrative complaint, there is no indication that the Respondent has been disciplined by the State of Florida. At present, Respondent is practicing medicine in Florida and is a resident of Stuart, Florida.
The Issue The issue for determination is whether Respondent committed the offenses set forth in the administrative complaint and, if so, what action should be taken.
Findings Of Fact At all times material hereto, Herbert Richard Slavin (Respondent) was a licensed physician in the State of Florida having been issued license number ME 0036889. On April 21, 1995, the Agency for Health Care Administration, Board of Medicine (Petitioner) filed its Final Order in Case No. 91-05473, DOAH Case No. 93-3931, in which an administrative complaint had been filed against Respondent. Petitioner concluded in the Final Order that Respondent had violated Chapter 458, Florida Statutes, and as penalty, among other things, placed Respondent on probation for one (1) year, with conditions, including the limitation that Respondent could practice medicine only under the indirect supervision of a licensed physician who was approved by Petitioner or its Probationer's Committee as Respondent's monitoring physician. The Final Order was effective April 21, 1995. Respondent appealed the Final Order. On July 19, 1995, Petitioner granted Respondent a stay of its Final Order during the pendency of Respondent's appeal. On March 1, 1996, the appellate court issued its Mandate commanding compliance with its opinion. Although the appellate court's opinion was not entered into evidence and neither party offered testimony regarding the substance of the opinion, neither party disputes that the appellate court affirmed Petitioner's Final Order. Consequently, an inference is drawn and a finding is made that the appellate court's opinion affirmed Petitioner's Final Order. Commensurate with the Mandate, Petitioner's disciplinary action against Respondent, previously imposed by the Final Order, became effective. On April 19, 1996, Respondent obtained temporary approval of his monitoring physician, with formal approval to be subsequently made by Petitioner's Probationers Committee. On May 23, 1996, Petitioner's Probationers Committee approved the monitoring physician. At all times material hereto, Respondent was employed by the Institute of Advanced Medicine (Institute) as its Medical Director. As Medical Director of the Institute, Respondent's responsibilities include overseeing the activities of the Institute, supervising the Institute's nurse practitioner, and interpreting blood work. On April 8, 1996, three patients, R. G., F. S., and C. B., presented to the Institute. R. G., a male patient, had been receiving treatment from Respondent for approximately two years. He presented to Respondent's office for his regular physical examination. R.G. was examined by a nurse, including taking his blood pressure, and blood was drawn. Respondent was not present at the office. R. G. was not seen by any other physician. F. S., a 91 year old male patient, regularly presents to Respondent's office for blood work and presented on April 8, 1996, for that same purpose. Respondent was not present at his office. F. S. was not seen by any other physician. C. B., a male patient, had been receiving treatment from Respondent for approximately two and one-half years. He presented to Respondent's office for a regular blood analysis. Blood was drawn by a nurse. Respondent was not present at his office. C. B. was not seen by any other physician. On April 8, 1996, the nurse practitioner was present at Respondent's office. The nurse practitioner treated and diagnosed the patients and reviewed the results of blood work. On April 8, 1996, even though Respondent was not present at the Institute, he had the responsibility of supervising the nurse practitioner; however, another physician was available at the time, to supervise the nurse practitioner.2 On April 8, 1996, Respondent did not order any blood work, review lab results, or consult with the nurse practitioner.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the administrative complaint against Herbert Richard Slavin, M.D. DONE AND ENTERED this 11th day of June, 1997, in Tallahassee, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 11th day of June, 1997.
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 By application dated July 20, 1995, Petitioner applied to Respondent for a Clinical Laboratory Supervisor's license. Petitioner has not earned a doctoral degree in clinical laboratory science, one of the specialty areas, or one of the chemical or biological sciences. Petitioner does not have a masters degree in clinical laboratory science, one of the specialty areas, or one of the chemical or biological sciences. Petitioner does not have a baccalaureate degree in medical technology, one of the specialty areas, or one of the chemical or biological sciences. Petitioner does have a baccalaureate degree in business administration and has taken college level courses in biology, human anatomy and chemistry. Petitioner has demonstrated that she has five years of pertinent experience following receipt of the degree. Accompanying her application for licensure, Petitioner presented documentation that she completed an advanced clinical practicum as a Specialist in Blood Bank Technology in 1995 and has been certified by the national Board of Registry in Chicago, Illinois. Petitioner did submit an evaluation of her college transcript by a qualified staff member of the Board of Registry, Chicago, Illinois. Petitioner did not submit an evaluation of her college transcript by a Chairperson of a chemical or biological science department of a regionally accredited U. S. college or university. Petitioner did not file a motion for an extension of time in which to submit an evaluation of her college transcript prior to the expiration of the thirty day extension period.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying Petitioner's application for licensure as a Clinical Laboratory Supervisor. DONE AND ENTERED this 27th day of August, 1996, in Tallahassee, Florida. DANIEL M. KILBRIDE, 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 27th day of August, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 96-2187 Petitioner's proposed findings of fact. Petitioner did not submit proposed findings. Respondent's proposed findings of fact. Accepted in substance: paragraphs 1,4,5,6,7,8,9,10. Rejected as subsumed or irrelevant and immaterial: Paragraphs 2 (see Preliminary Statement) and 3 (see preliminary statement). COPIES FURNISHED: Lealand L. McCharen Assistant Attorney General Office of the Attorney General The Capitol, PL-01 Tallahassee, Florida 32399-1050 Diane Orcutt, Executive Director Board of Clinical Laboratory Personnel Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Mary Donna Lee, pro se 2544 Robert Trent Jones Drive Apartment Number 816 Orlando, Florida 32835
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 The issue for consideration in this hearing is whether Petitioner meets the academic requirements for licensure as a registered nurse in Florida.
Findings Of Fact At all times pertinent to the issues herein, Respondent, Board of Nursing, has been the state agency responsible for the licensing of registered and licensed practical nurses in Florida and the regulation of the nursing profession in this state. On November 25, 1998, while residing in France, Petitioner, Pascal Canesse, filled out an application for nursing licensure (DH Form 1204. 8/98), seeking licensure by examination as a registered nurse in Florida which he submitted in January 1999. Prior to the hearing, the parties stipulated, and it is found, that: Petitioner attended the nursing program at Institute Formation en Soins Infirmiers (the Institute) in France from 1993 - 1995, The Official Transcript submitted by the Institute does not list classroom instruction or clinical practice in obstetrics. The Training Sessions, or clinical practice, portion of the Official Transcript submitted by the Institute includes a breakdown of 350 hours of surgery training that includes the following subject areas: emergency polyvalent intensive care digestive surgery and urology The Form B submitted by the Institute states that Petitioner had 600 hours of classroom instruction and 490 hours of clinical practice in surgical nursing. The Training Sessions, or clinical practice, portion of the Official Transcript submitted by the Institute lists a total of 1,715 hours of training. The theoretical Assessment portion of the Official Transcript submitted by the Institute does not include the number of hours of instruction but breaks down the training to include nursing care to patients in the following categories: psychosis patients patients with breathing problems patients with ENT-stomatology- dermamtology troubles patients with endocrinous troubles patients with digestive troubles patients with troubles of the nutriment duct pediatrics and child psychiatry elderly patients with neuropsychiatry troubes elderly patients patients with nervous system troubles patients in emergencies-intensive care-blood transfusions patients with hematology/urology/nephrology troubles In answer to question 6 on his application, Petitioner stated that he completed 40 hours of training in obstetrical nursing under the categories listed on the transcript. The Form B - Transcript of Nursing Education in a Foreign Country submitted by the Institute and relating to Petitioner reflects that he received 40 hours of classroom instruction in obstetrical nursing. No hours of clinical practical in obstetrical nursing are reflected. In correspondence to the Board dated June 10, 1999, Petitioner set forth his explanation of the discrepancies in the application, Form B, and his transcript. Petitioner contends that when he filled out his application and the supporting documentation therefor, he listed 525 hours of clinical medical nursing practice and 490 hours of clinical surgical nursing practice. While he reflected 40 hours of instruction in obstetric nursing, he failed to indicate any obstetric clinical practice. He claims the number of hours claimed as being in medical/surgical area comprises the number of hours in both, including obstetrics. His failure to enter any clinical practice in the obstetrics area was the result of a combination of that discipline with medical/surgical training as is done in France. This reflects clinical hours only. His claim of 40 hours training is for classroom work in obstetrics only. It is not combined with surgery. It would have been much clearer if he had marked down the course he took rather than just the hours taken. A review of the Official Transcript provided by the Institute to be submitted to the Florida authorities in support of Petitioner’s application clearly fails to specifically indicate any obstetrical training. The "Addendum to Transcript" dated May 4, 1999, reflects 70 hours of obstetric classroom in addition to two weeks' clinical obstetrics experience. This is different from the surgical nursing that had been combined with surgical nursing on the Form B originally submitted. Other documentation from the Institute, a letter dated June 25, 1999, indicates that two "weeks" is equivalent to 70 hours. That same letter notes that much of the training in France is hospital-based with a significant amount of training being clinical in nature with a heavy emphasis in surgery. The French authorities claim that those surgical hours are comprehensive, and it is in that curriculum that the students receive clinical and classroom obstetrics training, with the clinical portion being a full two weeks - that is, "a minimum of 70 hours." Petitioner also introduced a syllabus for the module in the Institute’s nursing training program which relates to gynecology. This reflects the areas covered and includes a significant amount of information apparently related to obstetrics and childbirth. The syllabus reflects an extensive amount of clinical instruction over the three years of nursing training. However, again, the supporting documentation does not clearly quantify that portion of the training which deals with obstetrics, nor does it show where the training is integrated into the surgical nursing training as claimed by Petitioner. Petitioner was unable to convincingly recall at which point in the three-year training program he took the required clinical obstetrics training. At one point, in his deposition, he claimed it was integrated in his emergency medicine training. At hearing, however, he claimed it was integrated with medical surgical training. The fact that the obstetrical clinic may have been integrated with another service is not, of itself, disqualifying. The Board of Nursing accepts integrated nursing training, under certain conditions. When course integration is claimed, however, the Board requires the submission of a detailed course outline that delineates where the specific course content, here, obstetrics, is presented. Further, the Board considers the integration of obstetrics with emergency surgery as inappropriate because the basic nature of the disciplines is not the same. While one is reactive, the other is pro-active. No doubt, Petitioner was exposed to an obstetrics curriculum which included both classroom and clinical instruction. From the state of the evidence presented, however, it is impossible to determine the breadth and content of this exposure. According to Ms. Jacobsen, the Board’s nursing education director, staff which reviewed Petitioner’s application was concerned over the unexplained inconsistency in the supporting documentation submitted therewith. None of the information on the various submitted documentation matched. On its Notice of Educational Deficiencies dated May 20, 1999, it was suggested that Petitioner have his school write a letter explaining the discrepancy. The Institute’s letter of June 25, 1999 asserts that the required clinical training was provided, but does not define with any particularity at which point in the training the obstetrics discipline is treated. It appears to be integrated into the surgical clinical training, but from the state of the documentation presented, the particulars cannot be determined.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law it is recommended that Petitioner’s application to sit for examination for licensure as a registered nurse in Florida be denied until he provides sufficient explanation of the clinical training he received in obstetrical nursing or proof of completion of the required training at an alternative approved site. DONE AND ENTERED this 28th day of April, 2000, in Tallahassee, Leon County, Florida. ARNOLD H. POLLOCK 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) 921-6947 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 2000. COPIES FURNISHED: Doris A. Bunnell, Esquire 608 15th Street, West Bradenton, Florida 34205 Lee Ann Gustafson, Esquire Office of the Attorney General Department of Legal affairs The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 William Large, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Ruth Stiehl, Executive Director Board of Nursing Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether the Petitioner has met the requirements for licensure as a medical doctor in the State of Florida set forth in Section 458.311(1)(f), Florida Statutes (1986 Supp.), as required by Section 458.313(1), Florida Statutes (1986 Supp.)?
Findings Of Fact The Petitioner applied for licensure by endorsement as a medical doctor in Florida in September of 1986. Following notification by the Respondent that additional materials were required to complete the Petitioner's application, the Petitioner timely submitted the materials. In March of 1987, the Petitioner appeared before the Foreign Medical Graduate Committee of the Respondent. On April 5, 1987, the Respondent entered an Order titled Notice of Intent to Deny the Application for Licensure by Endorsement of Hien B. Nguyen. The stated basis for the denial of the Petitioner's application was that the Petitioner had failed to demonstrate that he graduated from a medical school. The Petitioner began medical school in 1967 at the University of Saigon, Faculty of Medicine, in Saigon, Republic of Vietnam. The Petitioner Successfully completed the six years required course work in medicine at the University of Saigon, Faculty of Medicine, in 1974. Following the completion of the course work required to earn a medical degree at the University of Saigon, Faculty of Medicine, the Petitioner was drafted into the Republic of Vietnam's military. He attended training for approximately six months immediately following the completion of his medical degree course work. The Petitioner was required to complete a thesis before being eligible for a medical degree from the University of Saigon, Faculty of Medicine. Upon completion of military training, the Petitioner commenced and completed work on his thesis. The Petitioner's thesis consisted of a translation of "Central Nervous Disease in Children," of Nelson's Pediatric Textbook, from English into Vietnamese. The Petitioner presented his thesis on April 14, 1975. Thuc R. Bach, M.D. attended the presentation of his wife's thesis on April 14, 1975, and witnessed the Petitioner's thesis presentation. The Petitioner was awarded a Certificate from the University of Saigon, Faculty of Medicine, on April 14, 1975, which indicated that the Petitioner had completed work necessary to be awarded a medical degree. The Certificate was issued temporarily. After approximately five years the Petitioner was required to return the Certificate at which time he could be issued an official diploma. On approximately April 30, 1975, the government of the Republic of Vietnam fell to the army of North Vietnam. Following the fall of the Republic of Vietnam, the Petitioner was confined to a concentration camp where the Petitioner acted as camp doctor. Following the Petitioner's release from confinement in 1976, the Petitioner worked as a physician at Saint Paul Clinic in Saigon until 1979. From 1977 until 1980 the Petitioner also attended and taught at a medical training center in Saigon. In October, 1980, the Petitioner escaped from Vietnam. He resided in Galang, Indonesia until March, 1981, when he moved to the United States. The Petitioner has completed the following since his arrival in the United States: December, 1981: Sat for the Federation Licensing Examination and was subsequently certified by the Federation of State Medical Boards; January 24, 1983: Certified by the Educational Commission for Foreign Medical Graduates; July, 1984 - June, 1985: Interned at the Cook County Hospital, Chicago, Illinois; July, 1985 - June, 1987: Residency program at Cook County Hospital, and February 19, 1986: Licensed as a physician by the State of Illinois (the license is currently active and unrestricted). The Petitioner was presented with a certificate from the Faculty- Council-in-Exile of the Faculty of Medicine of the University of Saigon dated April 20, 1981. The certificate affirms that the Petitioner "Successfully completed the course of study leading to the degree of Doctor of Medicine..." The certificate is signed by the Dean Emeritus of the University and Dao Huu Anh, M.D., Associate Dean of the University. Prior to the fall of the government of the Republic of Vietnam, graduates of the University of Saigon, Faculty of Medicine, were presented with a certificate authorizing them to practice as a physician without restriction upon completion of the required courses of study and a thesis. Graduates were not issued an Official Diploma until five years had passed since the issuance of their certificate. Although the Petitioner completed the required courses of study, presented his thesis and received a certificate authorizing him to practice as a physician, the Petitioner was not able to obtain an Official Diploma five years later because of the fall of the government of the Republic of Vietnam. In light of the fall of the government of the Republic of Vietnam, it is doubtful that the records of the University of Saigon, Faculty of Medicine are available or that the Petitioner could obtain an Official Diploma. The Petitioner is a graduate of the University of Saigon, Faculty of Medicine, a medical school.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued GRANTING the Petitioner's application for licensure by endorsement as a medical doctor in the State of Florida. DONE AND ORDERED this 25th day of January, 1988, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of January, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-2969 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1 1. 2 2. 3 3. 4 4 and 5. 5 6. 6 7-10. 7 11-12. 13. The Petitioner worked at the training center from 1977 through 1980. 15. The Petitioner went from Vietnam to Indonesia in October of 1980. He did not travel to the United States until March of 1981. 10-12 Cummulative, summary of the evidence and unnecessary. Dr. Nghia Van Tran's letter was not accepted into evidence. 13 16. The last sentence is cummulative, a summary of evidence and unnecessary. The footnote is irrelevant. The burden of proof in this proceeding was on the Petitioner. The Respondent is not required to verify the signature of Dr. Dao. 14 10 and 17. 15 17-18. 16-18 Cummulative, summary of the evidence and unnecessary. The Respondent's Proposed Findings of Fact 1 1 and 3. 2-5 The Respondent's remaining proposed findings of fact are essentially summaries of the Respondent's inter- pretation of the evidence and argument concerning the evidence. The Respondent's interpretation of the evidence is rejected. The following is a brief discussion of why the Respondent's arguments have been rejected. The first two sentences are true and support the finding of fact that the Petitioner began medical school in 1967, completed his course work in 1974 and presented his thesis in April of 1975. See findings of fact 4-5 and 9. The third and fourth sentences are true but the Respondent has overlooked the fact that the Petitioner presented other evidence which supports his position. Therefore, even if the fifth sentence were correct, there is other evidence which supports findings of fact 4-5 and 9. The sixth sentence is irrelevant. Although the Board may have raised a question, the correct answer to that question is a matter of proof. The seventh sentence is true but irrelevant. The eighth sentence is not supported by the weight of the evidence. There was no testimony sufficient to support any finding of fact concerning Dr. Dao's signature on any document. Although the ninth sentence is correct, the weight of the evidence does not support the alleged fact set out in the tenth sentence. The eleventh sentence was taken into account in the weight given to Dr. Dao's statement. Although the twelfth sentence is correct the thirteenth and fourteenth sentences are not supported by the weight of the evidence. While it is true that the Petitioner's testimony with regard to when he completed his course work at the University of Saigon was not totally consistent, the weight of the evidence supports a conclusion that the Petitioner finished his course work in June of 1974. The Petitioner's explanation concerning the inconsistency in his testimony was credible. The first and second sentences are true. The third sentence is true but overlooks the fact that it corroborates non-hearsay evidence. The fourth sentence is law. The fifth sentence is true. The sixth and seventh sentences are true. The eight sentence is not supported by the weight of the evidence. The ninth and tenth sentences are true but they do not support the ultimate conclusion the Respondent suggests. It is possible that the Certificate in question could have been based upon other credible evidence. The first sentence is true. The second sentence is not supported by the weight of the evidence. The Petitioner testified that he completed his course work in 1974. The third sentence is true. The fourth and fifth sentences are not supported by the weight of the evidence. COPIES FURNISHED: Carolyn S. Raepple, Esquire Cheryl G. Stuart, Esquire Hopping, Boyd, Green & Sams 420 First Florida Bank Building Post Office Box 6526 Tallahassee, Florida 32314 M. Catherine Lannon, Esquire Assistant Attorney General Administrative Law Section Department of Legal Affairs Room 1601, The Capitol Tallahassee, Florida 32399-1050 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issues are whether Petitioner has sufficiently completed the requirements necessary to receive a license to practice orthotic fitting from the Board of Orthotists and Prosthetists and whether the Petitioner has violated section 468.809, Florida Statutes, by practicing orthotics without a license or registration.
Findings Of Fact 1. The two rules governing the requirements for licensure as on orthotic fitter in the state of Florida are found in section 469.803(5)(c), Florida Statutes (2010), and Florida Administrative Code Rule 64B14-4.110(1)(b). Section 468.803(5)(c) requires: (c) to be licensed as an orthotic fitter the applicant must pay a license fee not to exceed $500 and must have: A high school diploma or its equivalent; A minimum of 40 hours of training in orthotics education, as approved by the board; Two years of supervised experience in orthotics acquired after completion of the required education, as approved by the board; and Completed the mandatory courses. Petitioner requested information from the Board regarding the requirements for licensure and received a publication containing both chapter 468, Florida Statutes, Part XIV, and rule 64B14. He completed the prerequisite education required by section 468.803(5)(c), on June 22, 2009. However, Petitioner testified that he only reviewed the requirements identified in section 468.803(5)(c) and did not consider the definition of "experience" contained in rule 64B14-4.110(1), for applicants for licensure as an orthotic fitter. Florida Administrative Code Rule 64B14-4.110(1)(b) construes supervised "experience" to require an applicant to complete two years of experience in orthotics under the supervision of a Florida licensed orthotist. The two years of experience may only begin accruing after the applicant has successfully completed the requisite education courses. Petitioner applied for a license in orthotic fitting on November 22, 2010, only 17 months after the completion date of his educational courses. Assuming Petitioner started gaining experience immediately upon completion of his education courses, Petitioner was still seven months shy of the two years of experience required to obtain a license as an orthotic fitter. Petitioner testified at hearing regarding the orthotic experience gained prior to applying for licensure. According to his testimony, his experience consisted of activity more accurately described as assistance than experience. The experience described was limited to helping patients stand up, holding a measuring stick, assisting with paperwork, and explaining paperwork to the patient. Petitioner’s role involved little more than observing and occasionally assisting a licensed physical therapist. This is surely not what is meant by “experience in orthotics under the direct supervision of a Florida licensed orthotist,” as contemplated by rule 64B14- 4.110(1)(b). The assistance provided by Petitioner was performed under the supervision of a licensed physical therapist. While his actions, as described at hearing, did not meet the requirements for supervision specified by rule 64B14-9.110, they also did not rise to the level of unlicensed activity.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered by the Board of Orthotists and Prosthetists denying Petitioner’s application for licensure as an orthotic fitter. DONE AND ENTERED this 2nd day of August, 2011, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 2011. COPIES FURNISHED: Frank Edward Maloney, Jr., Esquire Macclenny City Attorney 445 East Macclenny Avenue, Suite 1 Macclenny, Florida 32063-2217 Lee Ann Gustafson, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-6536 Bruce Deterding, Executive Director Board of Orthotists and Prosthetists Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 Nicholas Romanello, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
