Findings Of Fact The facts, as stipulated to by the parties and as set forth above, are hereby adopted.
The Issue Whether respondent's license to practice medicine should be disciplined on grounds that: (1) he engaged in gross or repeated malpractice or failed to practice medicine with the required level of care, skill, and treatment, and (2) he is unable to practice medicine with the requisite skill and safety by reason of illness or as a result of a mental or physical condition.
Findings Of Fact Based upon the evidence presented at hearing, the following facts are determined: Respondent is an 80-year-old physician licensed to practice medicine in Florida. He has been a general practitioner in the Miami area for over 40 years; during that time, he has earned the respect and esteem of the medical community. During the 1940s, he helped establish the first cancer clinic in Dade County; he is recognized as one of the community's early medical pioneers. He has never before been the subject of a disciplinary action for professional misconduct. (Testimony of Bishop, Boughton; R-2.) I. The Claresta Halloran Abortion On July 3, 1980, Ms. Claresta Halloran, age 35, visited respondent's office for a therapeutic abortion. She told respondent that her last menstrual period was "sometime in April." (P-3.) Respondent palpated her, examined her by use of a sounding instrument, and dilated her uterus. After determining that she was approximately 12 weeks pregnant, respondent attempted to abort the fetus by suction and curettage. Fearing that he had perforated Ms. Halloran's uterus, respondent had her transported to North Miami General Hospital for an exploratory laparotomy. Results of the exploratory surgery were negative; there was no evidence of perforation of the uterus or injury to the bowel. (Testimony of Boughton; P-3.) William Wickman, M.D., performed the exploratory surgery on Ms. Halloran at the hospital. His bimanual examination revealed an enlarged uterus, "the size of approximately [a] 12 week pregnancy." (Testimony of Boughton; P-3.) Two days after the surgery, Ms. Halloran passed a macerated fetus which, after pathological examination, was estimated to be of 17 weeks' gestation. Her convalescence from surgery was otherwise uneventful and she was discharged from the hospital the next day, July 6, 1980. (Testimony of Boughton; P-3.) Absent specialized training, abortions "from below," that is, by dilating the cervix and removing the contents of the uterus, should not be performed on pregnancies which have progressed beyond 12-weeks. This is because, after 12 weeks, the fetus's bones have developed calcium and sharp, razor-like edges which can perforate the uterus and endanger the health and safety of the patient. (Testimony of Rudolph.) Respondent has not received specialized training which would enable him to safely use the "from below" method on pregnancies beyond 12 weeks. However, his examination of Ms. Halloran led him to believe she had been pregnant for 12 weeks. In reaching that conclusion, he did not rely solely on the date of the patient's last menstrual period. His palpation and examination of the patient's uterus confirmed that the pregnancy was approximately 12 weeks. Dr. Wickman's subsequent examination of the patient at the hospital confirmed that the patient's uterus indicated an approximate 12-week pregnancy. (Testimony of Rudolph, Boughton; P-3.) There are other more advanced methods, such as sonography, which enable one to more accurately determine the gestational age of a fetus. However, the evidence does not support a finding that respondent's failure to use such methods constitutes malpractice or a failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. (Testimony of Rudolph.) Respondent admits that he erred in his diagnosis of the stage of Ms. Halloran's pregnancy. However, his diagnosis was not shown to have been unjustified or unreasonable in light of the facts known to him at the time. Both the date of the patient's last menstrual period and manual examination of the uterus supported a determination that the pregnancy was approximately 12 weeks. The "from below" abortion procedure which respondent utilized is only unacceptable for use on pregnancies in excess of 12 weeks. In short, respondent's treatment of the patient was consistent with his diagnosis. While the diagnosis was in error -- the fetus was of 17 weeks' gestation, not 12 weeks -- other physicians, under similar circumstances, would likely have made the same error. (Testimony of Boughton; P-3.) II. The Wilhemina Evans Abortion On August 5, 1980, Ms. Wilhemina Evans, age 18, visited respondent's office for a therapeutic abortion. She told respondent that her last menstrual period was at the end of April. He palpated her, placed a sounding instrument, and dilated her uterus. After concluding that she was at least 13 weeks pregnant; 2/ he attempted to abort the fetus "from below" by use of placental forceps and a curette. He thought the abortion had been successful and permitted the patient to, return home. (Testimony of Rudolph, Boughton; P-4.) The next day, the patient went to Jackson Memorial Hospital complaining of abdominal pain. Several minutes after arriving at the emergency room, she passed a 750-gram male still-born fetus. Subsequent pathological examination indicated that the fetus was of 24 weeks' gestation. (P-4.) Respondent failed, in several respects, to provide Ms. Evans with treatment which is recognized by a reasonably prudent similar physician as acceptable under similar circumstances. Without special training, the "from below" method of aborting the fetus should not have been used on a woman beyond 12 weeks pregnant. 3/ Moreover, if respondent was uncertain of the gestational age of the fetus, he should not have attempted to abort the fetus "from below" in an office setting. Despite the patient's obesity, respondent should have been able to determine the advanced gestational stage of the fetus. Finally, a reasonably prudent similar physician would have realized that the attempted abortion had been unsuccessful and would not have permitted the patient to immediately return home. Thus, it is concluded that respondent's treatment of Ms. Evans was inconsistent with acceptable medical practice. 4/ (Testimony of Rudolph.) III. Treatment of Skin Lesions of Bernice Riordan Since 1951, Bernice Riordan, age 68, has been a patient of respondent's. Over the years, he treated her for various ailments, including basal cell carcinomas and squamous cell carcinomas on her face and neck. He used different techniques to treat the carcinomas; electrocoagulation in 1955; electrodesiccation and silver nitrate in 1961, 1962, 1972, and 1976; bichloracetic acid in 1976; and 5-Fluorouracil in 1978. In April, 1961, respondent referred Ms. Riordan to a dermatologist for specialized treatment. In 1969, he referred her to Jackson Memorial Hospital for radiation therapy because of multiple lesions on her face. She was a difficult and eccentric patient; she continually resisted his efforts to refer her to specialists for treatment of her increasingly serious carcinomas. Finally, in 1980, he referred her to two specialists -- a plastic surgeon and another dermatologist. By 1980, the cancer of the skin on her face had destroyed the entire nose and perioral skin. (Testimony of Boughton; P-2.) The Department presented, by deposition, the testimony of Dr. Richard C. Childers, a dermatologist who had reviewed the patient records of Ms. Riordan. He graduated from medical school in 1969 and was licensed to practice medicine in Florida in 1971. Since 1974, he has engaged in the private practice of dermatology in Gainesville, Florida, with a clinical appointment at Shands Teaching Hospital. It was Dr. Childers' opinion that respondent should have referred Ms. Riordan, no later than 1959, to a specialist for treatment of recurring skin lesions. Dr. Childers also opined that respondent, on numerous occasions over the years, had used ineffective or inappropriate treatment techniques on Ms. Riordan's lesions. (P-2.) Dr. Childers' testimony is rejected as inadequate to establish that respondent failed to provide treatment to Ms. Riordan which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Dr. Childers is a specialist in dermatology, not a general practitioner. He practices in Gainesville, not Miami. When respondent applied many of the complained of treatment techniques to Ms. Riordan, Dr. Childers had not yet begun medical school. It would be patently unfair to measure treatment for carcinomas furnished by a general practitioner in 1961 by a specialist's with the standard of care applicable to general practitioners in the Miami area during the period in question. to establish an appropriate standard of care applicable to respondent's treatment of Ms. Riordan. (Testimony of Boughton; P-2.) IV. Respondent's Ability to Practice Medicine with Reasonable Safety to His Patients On April 27 and 30, 1981, a mental status examination was given psychiatrist's opinion, respondent's appearance, behavior, and overall thinking was intact; there was no evidence of psychosis. However, respondent's response was somewhat impaired. Dr. Bishop concluded that respondent suffers from of Bishop.) Respondent recognizes that his advanced age affects his ability to However, he believes that he is able to operate an office practice with reasonable skill and safety and without endangering his patients. He is willing his work. The practice of medicine is his avocation as well as his profession; it is the habit and pleasure of his life. (Testimony of Boughton.) interfere with his ability to practice medicine with reasonable skill and safety to his patients. The ability to remember facts is essential to a physician's patient's illness. (Testimony of Bishop.) However, the evidence is insufficient to demonstrate that respondent's his livelihood. The evidence on the extent which his impairment will affect his ability to practice is problematic. He is willing to submit to the supervision supervision of another physician, it is likely that he will be able to practice medicine with reasonable skill and safety to his patients. (Testimony of
Recommendation Based on the foregoing, it is That respondent's license to practice medicine be suspended until respondent submits to the Board an acceptable proposal which ensures that his the Board approves the proposal, respondent should be placed on a probationary status and his practice restricted to exclude the performance of surgery and DONE AND RECOMMENDED this 20th day of November, 1981, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of November, 1981.
Findings Of Fact Petitioner is licensed by the State of Florida as a Clinical Laboratory Technician. Petitioner applied to the Respondent for licensure as a Clinical Laboratory Technologist with specialties in microbiology, serology, clinical chemistry, hematology, immunohematology and chemistry. On February 11, 1980, Respondent denied Petitioner's application for a technologist's license for the reason that Petitioner does not have the sixty semester hours or HEW exam required under Section 10D-41.25(9) or (10), Florida Administrative Code. Petitioner holds a high school equivalency diploma. Petitioner attended the Manhattan Medical Assistants' School in 1960-1961 and graduated from that school, receiving a diploma as a Laboratory Technologist. When Petitioner attempted to obtain a transcript of his studies at that school, he discovered that the school is no longer in business; and, accordingly, he is unable to obtain a transcript reflecting his studies there. Petitioner does not have a bachelor's degree from an a"credited college or university. Through the years, Petitioner has taken a number of continuing education courses, but these courses have not been affiliated with an accredited college or university. Prior to moving to Florida, petitioner was employed for seventeen years as a Laboratory Technologist at the New Rochelle Hospital Medical Center and was a supervisor of the evening and night shifts at that Center. Petitioner's witnesses testified as to the quality of Petitioner's work as an employee of the Department of Pathology at South Miami Hospital. Petitioner has taken the U. S. Public Health Service proficiency examination in clinical laboratory technology. A satisfactory score on all sections of that examination must be obtained in order to Pass the examination. Petitioner passed each section of the examination except for the hematology section. He attempted to retake the examination but was advised that the March 30, 1979, examination was the last test scheduled by HEW. That examination has been administered on five different occasions between the years 1975 and 1979. There is no information available as to whether the HEW examination will or will not ever be administered again. That examination is not the same as the licensure examination given by the Respondent but can act as a prerequisite, if satisfactorily completed, to the state licensure examination. An approved course of study is available to Petitioner at Miami-Dade Community College. Personnel at that school have advised him that he would receive thirty-two credits for his life's work and that he would be required to take six or seven examinations plus approximately a year's worth of courses. Petitioner does not desire to attend that college even on a part-time basis several times a week, since he is employed at two full-time jobs at this time.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That a Final Order be entered denying Petitioner's application for a technologist's license pursuant to the provisions of The Florida Clinical Laboratory Law. RECOMMENDED this 10th day of October, 1980, in Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The Collins Building Room 101 Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of October, 1980. COPIES FURNISHED: Richard N. Krinzian, Esquire 8585 Sunset Drive, Suite 190 Miami, Florida 33143 Morton Laitner, Esquire Dade County Department of Public Health 1350 N.W. 14th Street Miami, Florida 33125 Mr. Alvin J. Taylor, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
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 issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
The Issue The issue presented is whether Petitioner is entitled to licensure as a clinical laboratory technologist in microbiology.
Findings Of Fact Applications for licensure as a medical technologist in microbiology are available from the Board's office. With the application, the Board staff sends directions for completing the application form, a copy of the relevant statutes and Board rules, the names and addresses of accredited and Board-approved medical technology training programs, and other materials. Petitioner's application for licensure as a medical technologist is dated January 20, 1999. She submitted that application and all required fees for licensure to the Board. Petitioner received her degree as a doctor of medicine from the Higher Institute of Medical Sciences in Havana, Cuba. That degree satisfies the educational requirements for licensure as a medical technologist in the State of Florida. In addition to minimum educational requirements, licensure as a technologist requires certain minimum experience working in a clinical laboratory performing a wide array of tests or completion of a technologist-level accredited or Board- approved medical technology training program. This requirement is clearly set forth in the materials the Board forwarded to Petitioner as part of her application package. The training program Petitioner completed in Cuba is not on the list of the Board's approved or accredited medical technology training programs. Petitioner acknowledges that she has not enrolled in, or completed, a technologist-level accredited or Board-approved technology training program. Therefore, in order to take the licensure examination and qualify for licensure Petitioner must have completed three years of full-time employment in a clinical laboratory performing a wide array of tests. None of Petitioner's work experience has been in the United States. With her application, Petitioner did not submit any employment verification forms from her employers. Instead, Petitioner submitted affidavits from people who knew her in Cuba and in Nicaragua. These affidavits conflict with each other, with Petitioner's resumé she submitted to the Board along with her application, and with Petitioner's testimony at the final hearing. On her application, Petitioner represented under oath that she was employed from June 1994 to July 1996 at the Institute of Tropical Medicine Pedro Kouri in Havana, from August 1996 to July 1997 at the Julio Trigo General Hospital in Havana, and from October 1997 to July 1998 at the National Center of Diagnostic and References in Managua, Nicaragua. She represented that she performed a wide variety of testing at each of these institutions, processing patient samples. However, on her resumé, which she submitted to the Board along with her application, Petitioner represents that at these three institutions, she was employed as a laboratory supervisor, charged with assessing laboratory personnel, and as a researcher. Her resumé also lists extensively the research studies she performed and her teaching experience. In support of her testimony at the final hearing that she possesses the required three years of pertinent clinical experience performing the required testing, Petitioner presented the testimony of Caridad Gonzalez and Biarda Villaverde. Ms. Gonzalez is a licensed medical technologist currently employed in the State of Florida. She testified that she worked with Petitioner at the Institute of Tropical Medicine Pedro Kouri from 1994 through 1996 and at the Julio Trigo General Hospital from 1996 through 1998. These dates conflict with those set forth in two affidavits Gonzalez provided to the Board as part of Petitioner's application for licensure. Further, in her own sworn application for licensure filed with the Board, Gonzalez never mentioned having been employed at the Institute of Tropical Medicine Pedro Kouri. Additionally, Gonzalez left Cuba and came to the United States in April 1997 and was not, therefore, employed in Cuba with Petitioner through 1998. Her testimony at final hearing, therefore, lacks credibility. Biarda Villaverde testified that she worked with Petitioner at the Institute of Tropical Medicine Pedro Kouri from June 1994 to June 1995 in a clinical setting. However, Villaverde and Petitioner worked in different laboratories at that institution. Villaverde, therefore, cannot support Petitioner's testimony as to the work performed by Petitioner since she did not work in the same laboratory. Further, the facility was a diagnostic, research, and teaching facility, where some tests were performed on animals, depending upon the type of research conducted. Villaverde testified that Petitioner was assigned to the research division at this facility. Research does not qualify for the work experience required for licensure as a medical technologist. Even if some of Petitioner's research experience could be counted toward the required clinical experience, Petitioner both admitted and denied at the final hearing that she performed research, primarily representing that she worked full-time performing the required array of testing on patient samples. Several of the accredited or Board-approved technologist training programs are located in South Florida, where Petitioner resides. A training program takes one to two years to complete, depending upon the program. Although Petitioner expressed her unhappiness with the length of time her application for licensure has been pending, she could have completed a program, thus obtaining the minimum required experience for licensure, had she chosen to do so upon learning the minimum requirements for licensure. Petitioner's argument that she should be given credit for her work in the laboratories in Cuba and Nicaragua since they complied with World Health Organization quality control standards is without merit. The World Health Organization does not regulate or set quality control standards for clinical laboratories. The World Health Organization only gathers statistical data and publishes studies.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying Petitioner's application for licensure as a clinical laboratory technologist in microbiology. DONE AND ENTERED this 4thday of December, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of December, 2000. COPIES FURNISHED: Zenia Flores de Apodaca 1698 West 65th Street Hialeah, Florida 33012 Mary S. Miller, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 Joe Baker, Jr., Executive Director Board of Clinical Laboratory Personnel Department of Health 4052 Bald Cypress Way Bin A07 Tallahassee, Florida 32399-3257 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way A02 Tallahassee, Florida 32399-1701
The Issue The issues presented concern the question of whether Dr. Paul Joseph Rucinski (Petitioner) has completed the prerequisites for standing the license examination of the State of Florida, Department of Professional Regulation, Board of Medicine (Respondent). This examination is known as the FLEX examination. In particular, Petitioner has been denied the opportunity to take this examination based upon the perception held by the Respondent that Petitioner did not complete core clerkship training in internal medicine, one of the prerequisites to undergo the examination session.
Findings Of Fact Petitioner attended medical school at Ross University in the British West Indies and received his medical degree. Consequently, for purposes of license examination in Florida, Dr. Rucinski is considered to be a foreign medical graduate. Part of the medical training in his undergraduate course work was received in the United States. This education was in association with completion of clerkships necessary to obtain his medical degree. An organization known as the Jacksonville Health Education Program, constituted of certain hospitals in the city of Jacksonville, Florida, was providing clerkship training for medical students during the time within which Petitioner received his clerkship training. The Jacksonville Health Education Program (JHEP) was affiliated with the University of Florida School of Medicine and as such was part of that institution's educational program. In this connection, Petitioner was referred to JHEP as an organization which could arrange for his clinical clerkship training. As described in Petitioner's Exhibit 4 admitted into evidence, Petitioner received clerkship training in psychiatry, ob/gyn, surgery, pediatrics, family practice, dermatology, anesthesiology, general surgery, emergency room medicine and critical care, all through JHEP. Respondent takes no issue with the sufficiency of that training to establish credentials for license examination in Florida. This point of view is held because Respondent is convinced that the institutions within which the training in the various specialties was conducted were allopathic institutions. The only contention in this cause arises based upon the Respondent's belief that the clerkship training which Petitioner received in internal medicine was not given in an institution associated with JHEP and did not have allopathic emphasis. Instead, the focus of the training in internal medicine was alleged by the Respondent to be osteopathic. This speaks to core clerkship training the Petitioner received in internal medicine at Jacksonville General Hospital, Jacksonville, Florida, now known as Jacksonville Medical Center. The period of time within which the training was received was November 5, 1982, to January 27, 1983, and again on April 11, 1983, to June 17, 1983. The clerkship in internal medicine was supervised by Dr. Glenn J. Gerber, an osteopathic physician. According to Dr. Gerber, Petitioner successfully completed his core clerkship training in internal medicine as evidenced by the evaluation forms set forth in Petitioner's composite Exhibit 7 admitted into evidence. Although Dr. Gerber is not licensed pursuant to Chapter 458, Florida Statutes, to practice allopathic medicine, he was board certified by the American Board of Internal Medicine in the field of internal medicine effective 1978. This board is a board pertaining to allopathic medicine. Moreover, Dr. Gerber's unrefuted testimony establishes that training in internal medicine for allopathic medical students versus osteopathic medical students does not differ. To his understanding, textbooks do not exist which deal with osteopathic internal medicine separate and apart from allopathic internal medicine. During the time that Dr. Gerber taught at the Jacksonville General Hospital, to include the time of instruction pertaining to Petitioner, other students who sought medical degrees in allopathic medicine were involved in training which he conducted. Dr. Gerber served as the director of clinical education for the Jacksonville General Hospital during the period 1981 through 1984. The nature of the internal medicine training which Petitioner received through Jacksonville General Hospital was under the auspices of an internal medicine service for students as well as residents. The daily functions of the core internal medicine training included daily rounds where patients were met who had been admitted the night before and involvement with patients who were being managed on an ongoing basis. This training included frequent pathology rounds, cardiology rounds almost daily and radiology rounds daily. Typically, different topics were considered which had been assigned the night before. An example would be miocardial infraction. Discussions were entered into on current management and therapy. On October 18, 1976, Jacksonville General Hospital was informed by letter that it had been accepted as a member of the JHEP Consortium. This correspondence was from D. J. Lanahan, president of the JHEP Board of Trustees and appears on the stationery of J. Hillis Miller Health Center, College of Medicine, University of Florida, Jacksonville Division. A copy of the letter is found as Petitioner's Exhibit 10 admitted into evidence. This correspondence does not set forth a circumstance whereby Jacksonville General Hospital is received as a member for purposes of offering core clerkship training in allopathic medicine, nor does it establish a contrary position. On the other hand, Lois Gray, director of medical legal affairs at Jacksonville Medical Center, offered unrefuted testimony that Dr. Gerber held a faculty appointment with JHEP. Petitioner's Exhibit 11 admitted into evidence, which describes the nature of JHEP's affiliation with the University of Florida, J. Hillis Miller Health Center, speaks to the concept of undergraduate medical education but it is silent on the question of Jacksonville General Hospital's involvement in the education of undergraduate medical students and their clinical clerkship training. Respondent's Exhibit 4 admitted into evidence concerns the fact that the Jacksonville General Hospital in the years 1982 and 1983 was associated with the American Osteopathic Association and provided internship programs and residency programs related to osteopathic medicine; however, this excerpt of the yearbook and directory of osteopathic physicians does not exclude the possibility of affiliation with the accrediting organization related to hospitals that provide allopathic care. In fact, Jacksonville General Hospital was recognized as an allopathic facility by the Joint Commission on Accreditation of Hospitals in the relevant time frame. Further, an excerpt of the 1982-83 directory of residency training programs accredited by the accreditation council of graduate medical education, a complimentary copy from the American Medical Association, was offered and received as Respondent's Exhibit 5 admitted into evidence. This document speaks to the provision of residency training by Jacksonville hospitals affiliated with JHEP. It does not include an indication that Jacksonville General Hospital was one of the institutions providing residency training in the Jacksonville, Florida, area in the relevant years. However, it does not speak to undergraduate medical training. Therefore, it does not establish the fact that Jacksonville General Hospital did not offer allopathic medical training in internal medicine to the Petitioner as part of core clerkship training. Finally, Respondent's attempt to introduce the remarks of Dr. Will Neal of the University of Florida, School of Medicine, does not serve to corroborate competent evidence offered by the Respondent on the subject of Jacksonville General Hospital's lack of affiliation with JHEP and failure to provide undergraduate medical training in allopathic medicine. His remarks are hearsay and stand alone and cannot be utilized in fact finding for reasons explained in the conclusions of law. Jacksonville General Hospital, in 1982, had among its active staff, 40 M.D.s and 31 D.O.s. On the whole, Dr. Rucinski is found to have received appropriate allopathic medical training in his core clerkship in internal medicine. Dr. Rucinski is currently undergoing training at the University of Wisconsin, affiliated hospitals program, St. Luke's Hospital, Milwaukee, Wisconsin. This is a hospital that has association with the American Medical Association. Dr. Rucinski is a resident in postgraduate year 3. Dr. Rucinski is interested in general medicine, family practice. As part of his postgraduate training, he has had extensive training in internal medicine which he has successfully responded to. He has not been able to discern differences in the underlying emphasis in the internal medicine training received as a resident in St. Luke's Hospital and that received at Jacksonville General Hospital. Against this background, prior to August 15, 1986, Petitioner made timely application to take the FLEX examination to gain a license to practice medicine in the state of Florida. This examination was to be given December 2- 4, 1986. On November 12, 1986, Dr. Rucinski was invited to appear before the Foreign Medical Graduate Committee of the Board of Medicine. A copy of that invitation may be found as part of Petitioner's Exhibit 6 admitted into evidence. In addition to the invitation, a second item within that exhibit describes the subjects upon which he could be interrogated and makes specific reference to items which could be submitted in furtherance of this session, but these items were not exclusive. This speaks to his passport and visa involved with time periods when he was out of the United States during his medical training. The second page indicated that the Petitioner should be prepared to provide documentation of his physical location for periods of medical education. Petitioner made the appearance on November 21, 1986, and was examined by members of the Foreign Medical Graduate Committee, and it was determined to deny Petitioner's opportunity to stand the FLEX examination based upon the belief held by the committee members that his internal medicine clerkship was osteopathic training and unacceptable. Petitioner was made aware that the committee would recommend to the Board of Medicine that he not be allowed to take the FLEX examination. These remarks were offered at the time of Petitioner's appearance before the foreign medical graduate committee on November 21, 1986. On the next day, the Board of Medicine, in furtherance of the recommendation of the committee, declared Petitioner ineligible to stand examination. On November 24, 1986, Petitioner was advised in writing of the decision of the Board of Medicine. A copy of that exhibit may be found as Petitioner's Exhibit 5 admitted into evidence, and it states that the request to stand examination is denied. It goes on to suggest that an order would be prepared which set forth the reasons for denial. The letter identifies the fact that the Petitioner could then request a hearing pursuant to Section 120.57, Florida Statutes, following receipt of the final order. That final order was entered on February 19, 1987, and may be found as part of Respondent's composite Exhibit 1 admitted into evidence. It indicates that the reason for denial is that the Petitioner had failed to complete allopathic medical education as described in Chapter 458, Florida Statutes, related to the inadequacy, as the Board of Medicine saw it, of Petitioner's core clerkship in internal medicine, in that the training was osteopathic in nature and not allopathic medical education. The Petitioner received a copy of the order of denial in late February 1987. Petitioner took issue with this point of view and petitioned for a formal Section 120.57(1), Florida Statutes, hearing. That petition was received as filed before the Respondent on March 15, 1987. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action pursuant to Section 120.57(1), Florida Statutes. Respondent's Exhibit 4 is admitted into evidence. The proffered testimony of Dr. Will Neal is not accepted as evidence which can lead to factual findings. This determination is made in accordance with Section 120.58, Florida Statutes. Although a reasonably prudent person might expect the individual who is associated with the University of Florida medical school, such as Dr. Neal, would have some understanding of those institutions which are part of the JHEP program, his remarks do not constitute an exception to the proposition that hearsay evidence is not competent evidence. Furthermore, his remarks do not serve to supplement, corroborate or explain otherwise competent evidence. Consequently, they cannot be relied upon in determining relevant facts in this inquiry. In the deposition of Dr. Gerber wherein he attempts to explain the similarities between the core clerkship program in internal medicine at Jacksonville General Hospital and the residency program in internal medicine that he had some involvement with at St. Vincent's Hospital in Jacksonville, Florida, is not accepted, based upon the belief that it is irrelevant testimony. Petitioner, who seeks licensure, has the burden to prove his entitlement to stand the FLEX examination. See Balino vs. Dept. of Health & Rehab. Serv., 348 So.2d 349 (Fla. 1st DCA 1977). To that end, Respondent has accepted his candidacy for licensure with the exception of the question of his training in internal medicine while a medical student. That training must have been allopathic medical education as envisioned by Section 458.331(3), Florida Statutes (Supp. 1986). On balance, Petitioner has carried the burden. He received training in an institution which he was led to believe had affiliation with JHEP, an accepted educational outreach from the University of Florida medical school. The institution where he received internal medicine training and core clerkship was one accredited by the accrediting agency for allopathic hospitals. The training was supervised by an osteopathic physician. Nonetheless, this physician and the Petitioner have established that the nature of training in internal medicine for allopaths and osteopaths at the student level is akin. Moreover, the expertise of Dr. Gerber in internal medicine had been recognized by the board certifying organization related to allopathic internal medicine practice. It is not unreasonable to expect that these credentials could be brought to bear in the training of Dr. Rucinski. Finally, although it does not speak directly to the question of his competence gained through undergraduate medical training at the point in time wherein he sought the opportunity to take the FLEX examination, Dr. Rucinski's successful performance in his residency program in an allopathic hospital in the subject area of internal medicine should allay any fears that he is not a fit candidate to stand examination at this point in time. Respondent, in considering the fitness of the Petitioner to stand license examination in the December 1986 examination session did not act contrary to the purposes of Section 120.60, Florida Statutes. Based upon a consideration of the facts found and conclusions of law reached, it is, RECOMMENDED: That a final order be entered which grants the Petitioner the opportunity to take the FLEX examination for licensure to practice medicine in the state of Florida in accordance with Section 458, Florida Statutes. DONE AND ENTERED this 10th day of September, 1987, at Tallahassee, Florida. CHARLES C. ADAMS, 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 10th day of September, 1987. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-1593 Having considered the fact proposals of the parties, those proposals were accepted with the following exceptions: Petitioner's facts At paragraph 2, the reference to December 21, 1986, is corrected to November 21, 1986. Paragraph 5 is subordinate to facts found. Paragraph 6 is a recitation of a statutory provision. It is not fact finding. Paragraphs 7 through 18 are subordinate to facts found. Paragraph 19 constitutes legal argument and not fact finding. Respondent's facts Paragraphs 1, 2 and 3 are subordinate to facts found. Paragraph 4 is accurate, but it is also noted that Jacksonville General Hospital offered allopathic care as well. Paragraphs 5 and 6 are subordinate to facts found. Paragraph 7 is contrary to facts found. Paragraph 8 is subordinate to facts found. COPIES FURNISHED: Frank M. Gafford, Esquire Post Office Box 1789 34 North Marion Street Lake City, Florida 32056-1789 Patricia V. Russo, Esquire M. Catherine Lannon, Esquire Assistant Attorneys General Department of Legal Affairs Room 1601, The Capitol Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Board of Medicine 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
Findings Of Fact Petitioner took the examination for licensure as a laboratory supervisor in 1981, 1982, 1984 and 1985. In the fall of 1984 he passed that portion of the examination covering Immunohistology but failed the portion covering Supervision and Administration. His score on the Immunohemotology portion was 32 with 31 required for a passing grade. On the Supervision and Administration portion his score was 47 with 48 required to pass. On June 6, 1985, the rules affecting laboratory personnel licensing was changed to require candidates for the examination for which Petitioner applied to hold a bachelor's degree. Petitioner does not hold a bachelor's degree and acknowledged that he does not meet the current academic requirements to sit for the examination. Although the required procedures for making rule changes were followed by Respondent, Petitioner contends that he was not advised of the proposed changes, and, had he been so advised, he would have applied to retake the examination in Supervision and Administration before the rule changes became effective and would have qualified to sit for the examination. Respondent's witness presented Petitioner's record. This record shows that Petitioner, in October 1984 passed the Immunohistology portion of the examination and failed the Supervision and Administration portion by one point. This record also revealed that Petitioner applied to retake the examination in Supervision and Administration in January 1985 and sat for this examination in April 1985. On the examination his test score was 39 with 48 required to pass.
