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
Findings Of Fact The sole witness for the Petitioner, Dorothy J. Faircloth, established that the Respondent, Dr. Thomas K. Thomas, M.D., was licensed by endorsement by the Board on May 8, 1979. On-March 19, 1982, Witness Faircloth, as Executive Director of the Board, sent a letter to the Respondent, Dr. Thomas, indicating that the records of her office showed that he was licensed by endorsement on the above date and that he had not complied with Section 458.313, Florida Statutes, by demonstrating to the Board that he had actively engaged in the practice of medicine in Florida within a three year period after issuance of the license by endorsement, provided for in that Section, nor that he had continued that practice in Florida continuously for a minimum period of one year. That letter further informed him that if the establishment of his Florida practice was postponed due to the necessity of obtaining additional training or because of military service, then he should submit proper documentation in affidavit form or properly certified to establish that he was in an approved training program at the time of receiving his license, until a date certain, or was in the military service. The letter informed him that in order to avoid cancellation of his license by endorsement he should submit proper documentation in affidavit ford or properly certified to the effect that he had been actively engaged in the practice of medicine within the three-year period after issuance of that license and that he had continued his practice for a minimum of one year. This letter was elated March 19, 1982, and an identical letter pursuant to the Board's procedure was sent one month later on April 19, 1982, which constitute two written warnings sent to the Respondent's last known address and which indeed was shown to be the address from which the letter requesting this proceeding was posted. The doctor failed to demonstrate in the requested manner that he had complied with Florida practice requirements for his licensure by endorsement and accordingly on June 10, 1982, an order was entered by the Board of Medical Examiners declaring his licensure by endorsement void and of no force or effect. By his letter of June 21, 1982, the doctor petitioned for a formal proceeding, in which petition he acknowledged that he had not been able to come to Florida to practice medicine within the three years of acquiring his license by endorsement due to "circumstances beyond my control." This letter was admitted into evidence as a part of Exhibit One. The cause was then transmitted to the Division of Administrative Hearings for a formal proceeding, the hearing being held on the above date. Dr. Thomas failed to appear at the hearing. It was established that Dr. Thomas has not practiced in Florida since his licensure by endorsement on May 5, 1979.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law and the evidence in the record, it is therefore RECOMMENDED: That license number ME00345I6 issued to Dr. Thomas K. Thomas, M.D., on May 5, 1979, be revoked. DONE and ENTERED this 30th day of March, 1983, in Tallahassee, Florida. P. MICHAEL RUFF, 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 30th day of March, 10983. COPIES FURNISHED: Chris D. Rolle, Esquire Department of Legal Affairs The Capitol Tallahassee, Florida 32301 Thomas K. Thomas, M.D. 842 Moorland Grosse Point Wood, MT 48236 Dorothy J. Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue presented is whether Petitioner's application for licensure as a physician by examination pursuant to Section 458.311(8), Florida Statutes, should be granted.
Findings Of Fact Petitioner attended medical school in Cuba from September 1978 through July 1984. In that country, the academic year commences in September and ends in July. The medical school program in Cuba is a six-year curriculum which is divided into three phases, with each phase lasting two years. Phase I involves the study of normal structures and functions of the human body (basic science courses); Phase II involves the study of pathological structures and functions (clinical rotations in hospitals); and Phase III involves integral medical care. Clinical rotations continue through the first half of Phase III, the student's fifth year in medical school. During the second half of Phase III, the medical student undertakes a rotating internship in four disciplines or a vertical internship in an individual discipline. The four disciplines are internal medicine, pediatrics, obstetrics and gynecology, and surgery. The student must pass a theoretical and practical examination in each discipline in order to proceed to the next rotation. After the medical student successfully completes each Phase, including the internship, the student is awarded the degree of Doctor en Medicina. During Phase III, instruction is given in the form of lectures, small group seminars, individual instruction, practical training, and problem-oriented instruction. Students rotate to different teaching hospitals and polyclinics. At the teaching hospitals, students review clinical records with the principal professors and discuss, as a group, patient symptoms, diagnoses, and treatment. The polyclinics are neighborhood clinics emphasizing preventative medicine. While students are working at the polyclinics, they are not members of the staff; rather, the staff doctors supervise and consult with the medical students rotating through the various polyclinics. A medical student graduates after completion of the sixth year's curriculum without the necessity of taking a written examination. To practice medicine in Cuba, however, it is necessary for the medical school graduate to obtain a license and register with the national health registry. Upon registering, the physician receives a medical card, which carries the picture and signature of the physician. Petitioner completed a rotating internship from September 1983 through July 1984 as part of her medical education. She was assigned to a physician/specialist in each field of study during her internship rotation. She examined patients in front of her fellow students and/or the professor. She participated in discussions regarding pathology or symptoms, particular diagnoses, and appropriate treatments. She interviewed patients, performed physical examinations, and ordered laboratory tests if indicated. She did not participate in surgical procedures during the surgical rotation of her internship. Although Petitioner completed her medical school curriculum in July 1984, she did not receive a diploma. She did not register with the national registry and, therefore, did not receive a medical card. In September 1984 Petitioner left Cuba and went to Venezuela. Petitioner offered no evidence as to her activities from July 1984 when she completed her medical school curriculum until September 1984 when she left Cuba. Petitioner has taken the examination offered by the Educational Commission for Foreign Medical Graduates once, but she did not receive a passing grade on that examination.
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 licensure pursuant to Section 458.311(8), Florida Statutes. DONE and ENTERED this 22nd day of June, 1995, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of June, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 1, 4, 5, and 5 [sic] have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 2 has been rejected as not constituting a finding of fact but rather as constituting a conclusion of law. Petitioner's proposed finding of fact numbered 3 has been rejected as not being supported by the evidence in this cause. Respondent's proposed findings of fact numbered 2-9 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 1 and 10 have been rejected as not constituting findings of fact but rather as constituting conclusions of law. COPIES FURNISHED: Frank Valladares, Esquire 2955 Southwest 8th Street Suite 204 Miami, Florida 33135 Gregory A. Chaires, Esquire Christopher E. Butler, Legal Intern Office of the Attorney General Suite PL01, The Capitol Tallahassee, Florida 32399-1050 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0770 Tom Wallace, Assistant Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
The Issue Whether Petitioner's application for technologist license should be approved pursuant to Chapter 493, Florida Statutes. Petitioner appeared without counsel at the hearing and was advised of his rights in administrative proceedings. He acknowledged understanding such rights and elected to represent himself in this matter.
Findings Of Fact Petitioner Irving Zahler resides at Golden Beach, Florida. In September 1979, he submitted an application to Respondent for licensure as a clinical laboratory technologist in the specialties of serology, clinical chemistry, hematology, and immunohematology. His application reflected his education, laboratory training, and experience in the field. Specifically, it showed that he had been the director of a diagnostic laboratory for a period of 32 years. Prior to that period, from 1940 to 1949, he had been employed as a medical technician for the Veterans Administration, Bronx, New York. He has obtained 35 academic college credits in his field at accredited colleges or universities. (Testimony of Petitioner, Taylor, Exhibits 1-2). By letter of February 13, 1980, Respondent's director of Office of Laboratory Services advised Petitioner that his application had been denied because he did not have 60 semester hours of education as required under Section 10D-441.25(9), Florida Administrative Code. Petitioner informally requested review of the decision to determine if he met other qualification standards under the rule. By letter of arch 12, 1980, Respondent sent him another letter again informing him that his application had been denied for failure to show that he had achieved a satisfactory grade in the U.S Public Health Service approved proficiency examination in clinical laboratory technology, as specified in Section 10D-41.25(10), F.A.C. Petitioner thereafter requested an administrative hearing. (Exhibit 3). The U.S. Public Health Service proficiency examination was administered from 1975 to March 1979 when it was discontinued. Petitioner did not take the examination during that period and cannot do so at this time since it is not available to applicants. However, during the period 1967-1968, he passed qualifying examinations given by the Department of Health, Education and Welfare in General, microbiology, chemistry, mematology, serology, blood grouping and typing. These examinations qualified him to serve as the director of a clinical laboratory. In 1979 he was issued a license as a director of a clinical laboratory by the City of New York. (Testimony of Petitioner, Taylor, supplemented by Exhibit 4)
Recommendation That Petitioner Irving Zahler be issued a license as a clinical laboratory technologist in those specialties set forth in his application for licensure. DONE AND ENTERED this 10th day of June, 1980, in Tallahassee, Florida. THOMAS C. OLDHAM, Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Leonard Helfand, Esquire District 11 Legal Counsel 401 Northwest 2nd Avenue Room 1040 Miami, Florida 33128 Irving Zahler 100 Golden Beach Drive Golden Beach, Florida 33160 Department of Health and Rehabilitative Services Steven W. Huss, Staff Attorney Central Operations Services 1317 Winewood Boulevard Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES IRVING ZAHLER, Petitioner, vs. CASE NO. 80-710 DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, Respondent. /
The Issue Whether or not Petitioner is entitled to a license by endorsement to practice medicine pursuant to Section 458.313(1) F.S.
Findings Of Fact Petitioner William D. Plummer is an applicant for licensure as a physician by endorsement in Florida. On May 2, 1991, Petitioner filed a licensure application with the Department of Professional Regulation. On page one of the application is the question: Are you now or have you ever been licensed in any State, Canada, Guam, Puerto Rico or U.S. Virgin Islands? Yes No . Petitioner marked the "No" answer to this question on his application. On page four of the application is the question: Have you ever been denied an application for licensure to practice medicine by any state board or other governmental agency of any state or country? Yes No . Petitioner marked the "No" answer to this question on his application. On June 11, 1991, Petitioner was sent a notice that his application was incomplete. In that notice, he was asked: Are you now, or have you ever been licensed to practice medicine in any State? In response, Petitioner sent a letter stating only that he had received a Pennsylvania medical license on July 3, 1991. This date was subsequent to his making the initial Florida application on May 2, 1991. As part of the application process in Florida, Petitioner was asked to appear before the Credentials Committee of the Board of Medicine on January 25, 1992, in Tampa, to discuss various matters regarding his application. In the course of discussing various issues with the Credentials Committee Petitioner was asked: Were you ever denied a license to practice medicine in another state? In response, Petitioner stated, No. I have my Pennsylvania license. In my training initially--my medical training license took some time, and I think that was in 1985 and it was because we didn't have a program in Pennsylvania to work with the State Board. Later, Petitioner told the Committee, I thought there was a difference between a medical training license and a medical license. A medical training license is under supervision at a hospital. In point of fact, in 1985, Petitioner had applied for a graduate medical license in Pennsylvania in order to enter the residency program at Misercordia, Mercy Hospital where he had already been accepted. The Pennsylvania graduate medical license allows the licensee to work as a physician under supervision only as a resident in the institution named on the license. Petitioner's application for this license was rejected because the Pennsylvania Board found that Petitioner had "knowingly falsified" an answer regarding his addiction to alcohol. The Pennsylvania Board further prohibited Petitioner from reapplying for a graduate medical license until June 6, 1986. After formal hearing, the Pennsylvania Board entered its order as follows: ... an Applicant with a proclivity toward engaging in word ploys in these important matters runs the risk, as here, of being in error and thus committing an active concealment and misrepresentation. A more prudent course perhaps for such an Applicant would be to err on the side of giving excess (voluntary) information in responding to such a formal and serious written questionnaire. Medical residents in training programs "practice medicine." In Pennsylvania, residents are prohibited from practicing medicine unless they receive a graduate medical license from the State of Pennsylvania. Because of the Pennsylvania Board's denial of Petitioner's application for a graduate medical license, he was unable to accept the position at Mercy Catholic Hospital. However, in 1986, Petitioner reapplied for a graduate medical training license in Pennsylvania and the application was granted. This graduate medical training license was renewed annually thereafter while Petitioner continued to train in Pennsylvania. Petitioner still held the latest renewed graduate medical training license when he applied for Florida licensure in May 1991. Petitioner was granted his permanent unrestricted medical license in Pennsylvania in July 1991. (See Findings of Fact 2 and 5 supra.) At formal hearing, Petitioner explained that because Pennsylvania's graduate medical training license only allows participation in a residency training program at an approved institution named on the face of the license, he did not consider it to be a "license to practice medicine," and accordingly he did not disclose to Florida the Pennsylvania Board's 1985 denial of such license. He represented that he believed that because the Pennsylvania graduate medical training license was institution-specific, limited to one year in scope, and only a prerequisite to supervised additional medical education, it did not constitute what Florida's inquiries were all about. By common English usage, Pennsylvania law, and Florida law, the authority that Dr. Plummer was denied in 1985 and granted in 1986 by the Pennsylvania Board constitutes a "license to practice medicine," contrary to his interpretation of that term when he filled out his Florida application and responded to inquiries during the course of Florida's licensure investigation. He should have identified it in response to each relevant question or inquiry. However, Petitioner's interpretation of Florida's questions and his answers thereto do not constitute attempting to obtain a license to practice medicine by fraudulent misrepresentation or concealment of a material fact for the following reasons: Petitioner's formal hearing testimony was credible and unrefuted. Petitioner was consistent in his interpretation of the questions on this subject in that he also did not disclose to Florida the "good" facts that the Pennsylvania Board had subsequently granted him the graduate medical license in 1986 and had renewed it annually and that he still held such a license at the time of filling out his Florida application. Also, in the Florida application, he readily and fully disclosed to Florida the "bad" facts of his detrimental past history of alcoholism. Dr. Lee testified as a medical physician licensed to practice in New York, Pennsylvania, and Iowa, that he considered Petitioner's interpretation of the Florida application questions concerning prior medical licensing reasonable and that he also considered Petitioner's answers to those questions reasonable. No contrary testimony was presented. The American Medical Association profile does not list Petitioner's Pennsylvania graduate medical training license as a "license to practice medicine." Various qualified credible witnesses acknowledged that Petitioner's failure to disclose his alcoholism to the Pennsylvania Board in 1985 was a denial symptom of his alcoholism at that time and was not symptomatic of his character makeup now that his alcoholism is in remission or at any time he responded during the Florida licensing process. Respondent presented no direct evidence to prove that Petitioner had a fraudulent intent in answering as he did. Although fraudulent intent may sometimes be inferred from the circumstances, the circumstances herein do not permit such an inference. On his initial Florida application, Petitioner could not correctly recall the dates of his medical training because he had not kept accurate records himself and because of his alcoholic condition in prior years. One representative error he made is that he listed a full year in one program which he attended for only four months. However, he approximated the dates as best he could and revealed all training programs, even those in which he was unsuccessful, and he consistently responded to the Board that he would defer to whatever the training institutions' records showed. He also concealed no rehabilitation programs he had been in. No intent to defraud or conceal can be inferred from these circumstances. Petitioner is an alcoholic. Petitioner's alcoholism had its inception sometime during his childhood, possibly as early as the age of eight years. Petitioner graduated from Pennsylvania State University summa cum laude, in 1976. He matriculated from the Uniformed Services University in 1980. Toward the end of his time in medical school, approximately 1980, Petitioner began to realize that he had a problem with alcohol. In 1980, Petitioner entered a surgical training program at Balboa Hospital in San Diego, California. As a direct result of his problems with alcohol, Petitioner left that surgical training program in 1981 without completing his training. Between 1981 and 1983, Petitioner was partially supported by his parents, performed odd jobs as a handyman and searched for a new training program. In July, 1983, Petitioner entered an internal medicine training program at St. Raphael Hospital in New Haven, Connecticut. After approximately five months and prior to completion of training in New Haven, Petitioner's problems with alcohol forced him to terminate participation in the internal medicine training program. In December 1983, Petitioner entered a rehabilitation program at Marworth in Waverly, Pennsylvania. He remained as an inpatient at Marworth until February 1984 when he was discharged to Little Hill--Alina Lodge, a continuing care facility in Blairstown, New Jersey, where he remained as an inpatient until May 1984. Petitioner left Little Hill--Alina Lodge with staff approval. Between May 1984 and November 1986, Petitioner worked at various odd jobs as a handyman and helped his parents relocate and build in Florida. He also waited for his graduate medical training license in Pennsylvania. (See Finding of Fact 7, supra) Petitioner described both the periods of 1981-1983 (See Finding of Fact 18 supra.) and 1984-1986 as periods of "self-employment" whereas "unemployment" might have been more accurate. This discrepancy was neither "fraud" nor "concealment," as those terms are generally understood. In November, 1986, Petitioner entered an internal medicine training program at Misercordia, Mercy Catholic Medical Center in Philadelphia, Pennsylvania. Petitioner's problem with alcohol caused him to behave in a manner which indicated the presence of an active physical impairment of alcoholism and resulted in Petitioner's suspension and later resignation from that program after approximately three and a half months and prior to completion of training. In June 1987, Petitioner returned to Marworth as an inpatient. He remained under treatment for approximately one month and then stayed on at Marworth as an inpatient for approximately a month. Thereafter, he worked as a janitor and groundskeeper for nearly two years while concentrating on his life problems that had contributed to his alcoholism. Many professionals reviewing his case have been favorably impressed with Petitioner's dedication and sacrifice during this period of time. In 1989, Petitioner entered an internal medicine training program at Robert Packer Hospital in Sayre, Pennsylvania. This hospital is part of the Guthrie Healthcare System where Petitioner is currently employed. (See Findings of Fact 28, 43, 49 infra.). In June 1990, Petitioner took a vacation to the Florida keys and while on vacation went on a four day drinking binge. Petitioner voluntarily reported himself for further treatment and returned to Pennsylvania. While awaiting placement in another rehabilitation program, he suffered an alcohol withdrawal induced seizure. In July 1990, Petitioner entered his fourth inpatient treatment program for alcoholism at Bethany Center in Homesdale, Pennsylvania, where he remained for one month. His absence was counted as vacation and sick time while he was able to complete his internal medicine training program at Robert Packer Hospital on schedule in April 1992. The Guthrie Health Care System immediately offered him his current position, with full knowledge of his excellent academic record and clinical references and his alcohol recovery history. (See, Findings of Fact 43 and 49 infra). Currently, Petitioner participates in the Physician's Health Program of the Pennsylvania Medical Society and since January 1991 has been participating, through counseling, in a program of recovery from alcoholism with the Bradford Sullivan Drug and Alcohol Program. Both the Florida Physician Resource Network and the Pennsylvania Physician's Health Program impaired physicians programs have opined that Petitioner's history of alcoholism should not bar his licensure in Florida at the current time. (See, Findings of Fact 31-39 infra.) Dr. Roger Goetz is the Director of Florida's PRN and is the Department of Professional Regulation's consultant charged with implementing Florida's Impaired Practitioner Program. The Physician Resource Network includes the Physician Recovery Network (PRN). In the past five years, the PRN has evaluated approximately 350 physicians with impairments at the request of the Board of Medicine. Over this period, Dr. Goetz cannot recall a single instance where an applicant endorsed by PRN has failed to maintain sobriety. PRN statistics show that at least 97 per cent of the practitioners on contract have not reverted to alcohol or chemical use. Petitioner is willing to enter such a contract with PRN if he is licensed. Dr. Goetz believes Petitioner will be able to practice medicine with skill and safety to patients in Florida, provided he enters into a contract with the PRN. Dr. Goetz opined that Petitioner's relapse in 1990 does not indicate the likelihood of future relapses because Petitioner has continued with a more effective treatment program and support system geared to his needs as a physician. Dr. Goetz, on behalf of PRN, recommended a five-year contract for Petitioner designed to identify pre-relapse behavior and entail that he remain chemically abstinent, be subjected to random body fluid analysis, establish a doctor/patient relationship and receive care from another physician for his personal health, obtain a monitoring physician, attend group therapy, attend Alcoholics Anonymous meetings, have significant family members involved in his recovery, notify the PRN of any problems in his life, including changes in his physical health, be willing to withdraw immediately should there be any problems surrounding his practice, and participate and cooperate with the PRN at all times. Such a contract would provide Petitioner with an environment in Florida which is similar to his current recovery environment in Pennsylvania. Dr. Goetz testified that to the extent of his knowledge Petitioner has a good reputation for truth and veracity. At the request of PRN, Petitioner was evaluated for chemical dependency by Leah H. Williams, M.D. in July 1991. Dr. Williams reported to PRN that she was in favor of Florida licensure for Petitioner. In September 1991, Petitioner received a thorough outpatient evaluation from Dr. Lynn Hankes, PRN's approved evaluator. Dr. Hankes also endorsed Florida licensure for Petitioner, contingent upon Petitioner entering the PRN program and participating in ongoing psychotherapy. Penny Ziegler, M.D., Medical Director of the Pennsylvania Physician's Health Program, supports Petitioner's application for licensure in Florida. Nicholas F. Colangelo, Ph.D., a psychologist, supports Petitioner's application for licensure in Florida. Dr. Colangelo may be considered as a past and currently treating psychologist for Petitioner. They have known each other since Petitioner was at Marworth. Dr. Colangelo is a nationally certified alcohol and drug counselor who is Vice-President of Clearbrook, Inc., an alcohol and drug addiction treatment facility. He is a recovering alcoholic who has been sober for over seventeen years. Twenty-five to thirty-five per cent of his addiction counseling focuses on professionals. According to Dr. Colangelo, professionals and other high-achieving individuals like Petitioner often have difficulty accepting that they must submit to the whole program for recovery from alcoholism but once they do, they recover at a higher than average rate. In Dr. Colangelo's opinion, Petitioner has demonstrated conduct which gives him a better than average prospect for continued sobriety. Dr. Colangelo opined that Petitioner's current employment in a tertiary care facility, the Guthrie Clinic, coupled with the management of the ongoing licensure proceedings in Florida, provide Petitioner with as much environmental stress as he has ever experienced, but the existence of environmental stress does not play a significant role in Petitioner's continued sobriety. Dr. Colangelo perceived Petitioner as a person of truth and veracity. Petitioner is currently employed by the Guthrie Healthcare System, a multi-specialty private medical practice clinic employing approximately 110 physicians in non-surgical areas of medicine. Petitioner is responsible for the initial evaluation of nonsurgical patients. It is within his job duties to determine the type of medical care to be provided to each nonsurgical patient entering the clinic. In that position, he sometimes provides all primary care to the patient or directs the patient to the appropriate subspecialist. Apart from the four days in 1990, Petitioner has been continuously sober for five and one-half years. That 1990 four day relapse did not detrimentally affect his patient care. At that time, Petitioner contacted Florida's PRN. He has maintained contact with Dr. Goetz ever since. According to Dr. Colangelo and Dr. Goetz, two years of continuous sobriety is a benchmark most professional associations accept for granting a license or privilege. The American Board of Internal Medicine uses such a two year benchmark. Petitioner has met all credentialing requirements to obtain certification by the American Board of Internal Medicine. Dr. Ferrol Lee currently is responsible for the nonsurgical quality of medicine at Guthrie, with overall supervision of the 110 physicians employed there, including Petitioner. He has worked with Petitioner both during Petitioner's residency at Robert Packer and during his current employment. He views Petitioner as a hard worker whose personal struggle with alcoholism gives him valuable insight into the care of patients who struggle with similar problems. He ranks Petitioner within the top 5-10 residents of the 100 he has worked with over the past nine years. Dr. Lee testified that Petitioner has continually demonstrated good moral character and has a flawless reputation for truth and veracity. Dr. Lee endorses Petitioner's licensure in Florida. The State of Pennsylvania has never taken disciplinary action against Respondent's license to practice medicine in that state.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that a final order be entered certifying Petitioner for licensure with placement of Petitioner on probation for five years subject to his entering into and abiding by a contract acceptable to the Physicians Recovery Network. RECOMMENDED this 20th day of April, 1993, at Tallahassee, Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of April, 1993.
The Issue The issue in this case is whether Petitioner's application for a license by endorsement to practice medicine in the State of Florida should be granted or denied.
Findings Of Fact Petitioner is a medical doctor. Petitioner graduated medical school from the University of Miami in Miami, Florida, in May 1994. Petitioner signed an application for medical licensure by endorsement with the Board on January 9, 2003. On or about January 16, 2003, the Department of Health received Petitioner’s application for medical licensure by endorsement. Following receipt and review of the subject application, Petitioner was required to provide some additional information to the Board. Petitioner was eventually required to appear before the Credentials Committee of the Board to answer questions about his application. On October 17, 2003, the Board issued a Notice of Intent to Deny Licensure, in which the Board notified Petitioner of its intent to deny his application. That notice read as follows, in pertinent part: This matter came before the Credentials Committee of the Florida Board of Medicine at a duly-noticed public meeting on September 13, 2003 in Tampa, Florida[,] and the full Board on October 3-4, 2003, in Ft. Lauderdale, Florida. The applicant appeared before the Credentials Committee on September 13, 2003, and presented testimony regarding the application file. The application file shows: The applicant lied before the Committee and lied on the licensure application as to the following: the applicant took a leave of absence during his training; the applicant was placed on probation at 3 schools; the applicant did not finish his training in the normal time frame; and, the applicant answered #15 b, c, d and #31 incorrectly on the application. The applicant is guilty of violating Section 458.331(1)(gg), Florida Statutes, for misrepresenting or concealing multiple material facts at any time during any phase of a licensing or disciplinary process or procedure. Based on the foregoing, the Board may refuse to certify an applicant for licensure, or restrict the practice of the licensee, or impose a penalty, pursuant to Sections 458.3331(2) and 456.072(2), Florida Statutes. It is therefore ORDERED that the application for licensure be DENIED. Petitioner attended the following four postgraduate training programs (residency programs): Medical College of Pennsylvania; Sinai Hospital1; Wayne State University/Detroit Medical Center; and University of Medicine and Dentistry of New Jersey (“UMDNJ”). Petitioner’s dates of attendance in those four residency programs were as follows: Medical College of Pennsylvania from July 1, 1994 to June 30, 1995. Sinai Hospital from July 1, 1995 to June 30, 1999. Wayne State University/Detroit Medical from July 1, 1999 to June 30, 2001. UMDNJ from July 1, 2001 to June 30, 2003. Question number 15a on the application for medical licensure by endorsement asks, “Have you ever been dropped, suspended, placed on probation, expelled or requested to resign from a postgraduate training program?” Petitioner answered “yes” to question number 15a and submitted a written supplemental answer which stated, “I was placed on probation regarding the expectations of running a University service in a manner that kept attending physicians informed of patients’ clinical changes in July of 2000. Specific goals were given to me that I immediately fulfilled and was taken off probation in September of 2000 and remained in good academic standing until the time of my graduation.” On his application for licensure, Petitioner only admitted to being on probation at one residency program, Wayne State University/Detroit Medical Center. During the processing of the subject application, an employee of the Department of Health, Wendy Alls, advised Petitioner as follows by e-mail: “We are in receipt of your response to the inquiry from Wayne State University [Sinai Hospital], regarding your Residency from 7/95 to 6/99. It indicates that you were placed on probation and received negative reports. It also stated that limitations were placed upon you due to academic incompetence. Please respond.” On May 6, 2003, Petitioner submitted an e-mail response to Wendy Alls regarding his probation at Wayne State University [Sinai Hospital] which stated: “It is true that I did receive negative reports during my residency training from 7/95 to 6/99 for my work ethic. However, I was never formally placed on probation as per the guidelines of the Wayne State University. I, as well as the Graduate Medical Education Office, must receive formal written notification identifying the areas of deficiency and the duration of the probation period. Written notification must be submitted to both the GME office and myself after successful completion of the probation period. This was never done. In addition, no limitations or restriction were ever placed upon me due to academic incompetence or for any other reason for that matter.” Petitioner did not admit this on his initial application to the Florida Board of Medicine. Sinai Hospital submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital submitted a report to the Federation Credentials Verification Service (“FCVS”)2 and stated on the report that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital reported that Petitioner was placed on probation during his residency in response to faculty concerns regarding both academics and behavior. While at Sinai Hospital, Petitioner was informed of the issues he needed to improve during his probationary period. These issues included, but are not limited to the following: Petitioner’s tardiness, sleeping during conferences, unavailability when on call, failing to follow hierarchy, and inability to carry his share of the workload. Petitioner admitted at the formal hearing he was told that he was on probation at Sinai Hospital. During his appearance before the Credentials Committee on September 13, 2003, Petitioner testified under oath, that he did not disclose the fact he was on probation at Sinai Hospital because he was never informed that he “was ever placed on probation.” A letter dated November 4, 1999, from Dr. Andrew Saxe (who was then the general surgery residency program director at Sinai Hospital) states that Petitioner was on “probationary status” at Sinai Hospital during his residency from 1996 to 1997. Dr. Andrew Saxe also noted Petitioner’s probationary status in a memo dated April 28, 1999, which Petitioner himself signed. Petitioner signed a memo dated December 18, 1996, stating that he was on “probationary status” at Sinai Hospital during his residency. Petitioner also signed a memo dated April 16, 1997, stating that he was “off probationary status” at Sinai Hospital during his residency. Wayne State University/Detroit Medical Center submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1999 to 2000. Petitioner failed to fully disclose all of the reasons why he was placed on probation at Wayne State University/Detroit Medical Center. Wayne State University/Detroit Medical Center submitted a report to the FCVS and stated on the report that Petitioner was on academic probation during his residency for four months beginning in September 2000. The report stated that the probation was based on evaluations which cited “inadequate performances in clinical application of knowledge especially recognitions of own capabilities and limitations. There were also concerns over attention to details and work habits.” Petitioner’s supplemental answer to question 15a does not fully disclose his deficiencies in clinical knowledge and work habits at Wayne State University/Detroit Medical Center. At all times material to this case, Dr. Mark Granick has been the director of the plastic surgery program at UMDNJ. UMDNJ submitted a Training Evaluation Form to the Florida Board of Medicine and stated on the form that Petitioner was on academic probation during his residency “due to poor in-service exam scores.” After UMDNJ submitted the Training Evaluation Form, Petitioner contacted Dr. Mark Granick to discuss his probation at UMDNJ and the “program’s specifications in defining probation.” Dr. Mark Granick was prompted to send a second Training Evaluation Form to the Board, changing the substance of the first submitted Training Evaluation Form. The second Training Evaluation Form to the Board was submitted along with a letter from Dr. Mark Granick dated February 14, 2003, which stated he made an error in filling out the original form. When Dr. Mark Granick drafted Petitioner’s Fourth- Quarter Report on May 31, 2002, he was “documenting the reasons why I wanted him on a period of supervision, which I thought of as probation at that point in time.” Petitioner’s Fourth-Quarter Report dated May 31, 2002, was in fact signed by Petitioner. The Fourth-Quarter Report documented that Petitioner was “deficient on multiple occasions” with regard to Patient Care; Petitioner had a “poor acquisition of a central knowledge base in Plastic Surgery”; Petitioner’s tardiness needed to “stop”; Petitioner demonstrated “immaturity” in interpersonal skills; and, Petitioner had “been acting in an unprofessional manner.” Petitioner signed a memo dated January 8, 2003, stating that he was placed on “probation” at UMDNJ during his residency due to “poor performance on the in-service examination and overall perception of weakness in academic level.” Dr. Mark Granick testified that when he used the term “probation” in the January 8, 2003, memo, the word was consistent with his own thinking, and not consistent with university definitions. Dr. Mark Granick stated that Petitioner indicated to him during their meetings at UMDNJ that Petitioner understood he was on “probation” at UMDNJ. Dr. Mark Granick testified that in his mind he considered it “probation” when he put Petitioner under direct supervision, gave Petitioner academic support, and advised Petitioner of the areas in which he needed to improve. Although the period of academic supervision imposed on Petitioner did not qualify as probation at the university level, it did constitute “probation” in the mind of Dr. Mark Granick and was understood to be “probation” by the Petitioner himself. Petitioner misrepresented to the Board the circumstances which caused him to be placed on probation at Wayne State University/Detroit Medical Center. He also misrepresented his understanding of his probationary status at both Sinai Hospital and UMDNJ. Question number 15c on the subject application asks: “Did you take a leave of absence during a postgraduate training?” Petitioner answered “no” to question number 15c on the application. But Wayne State University/Detroit Medical Center documents show that Petitioner took a month-long leave of absence. Petitioner asserts that his month-long leave of absence from Wayne State University/Detroit Medical Center was not a “leave of absence” because he used a combination of sick time and vacation time. However, Petitioner signed a Family Medical Leave Act Certification asking for a leave of absence due to his being “unable to perform work of any kind” while training at Wayne State University/Detroit Medical Center. Petitioner requested a leave of absence for one month from his training program at Wayne State University/Detroit Medical Center in March of 2001. While on leave in March 2001, Petitioner was hospitalized for benzodiazepine poisoning, pace maker insertion, and possible seizure disorder secondary to cardiac rhythm disturbance. After Petitioner’s hospitalization, Petitioner needed to have a letter clearing him to resume unrestricted activity. During this period of time Petitioner was also told that he should avoid driving motor vehicles. Once questioned by the Credentials Committee, Petitioner admitted to taking a leave of absence in 2001 while training at Wayne State University/Detroit Medical Center. Prior to being questioned by the Credentials Committee, Petitioner concealed from the Florida Board of Medicine that he took a leave of absence while at Wayne State University/Detroit Medical Center. Question number 31 on the subject application asks “In the last five years, have you been treated for or had a recurrence of a diagnosed physical impairment?” Petitioner answered “no” to question number 31 on the application. However, after questioning by the Credentials Committee, Petitioner admitted he had a pacemaker. After his hospitalization, Petitioner had to be cleared by his doctors to return to his duties as a resident. Despite Petitioner’s own definition of “physical impairment,” he concealed his hospitalization, pacemaker, and possible seizure disorder from the Board. Question number 15b on the subject application asks “Was attendance in a postgraduate training program for a period other than the established time frame?” Petitioner answered “no” to question number 15b on the application. Petitioner attended the General Surgery postgraduate training program at Medical College of Pennsylvania for one year from July 1, 1994, to June 30, 1995. Petitioner attended the general surgery postgraduate training program at Sinai Hospital for four years from July 1, 1995, to June 30, 1999. Petitioner attended the general surgery postgraduate training program at Wayne State University/Detroit Medical Center for two years from July 1, 1999, to June 30, 2001. As indicated by the foregoing, Petitioner spent seven years attending general surgery postgraduate training programs. Physicians applying for licensure by endorsement in Florida are required to show that they have completed an “approved residency program” in a “slotted” position. The Accreditation Council for Graduate Medical Education (“ACGME”) accredits postgraduate training programs, sets the standards for training programs, and determines the number of “slotted” positions a program has. The Board considers an “approved residency program” to be one that has been accredited by the ACGME. The Board relies on the ACGME in making determinations for licensure. The Board relies on the information provided in the ACGME directory when processing applications. The ACGME established time frame for completing a general surgery postgraduate training program is five years. The ACGME-established time frame for completing the postgraduate training program in general surgery at Medical College of Pennsylvania, Sinai Hospital, and Wayne State University/Detroit Medical Center was five years when Petitioner attended these programs. Thus, a five-year general surgery residency was considered standard by ACGME, the Medical College of Pennsylvania, Sinai Hospital, Wayne State University/Detroit Medical Center, medical educators, and residents like Petitioner. Therefore, Petitioner would have had to complete all his postgraduate training in general surgery within five years in order to have finished his training within the “established time frame.” It took Petitioner seven years to complete all of his postgraduate training in general surgery. Petitioner’s attendance in his general surgery postgraduate training programs was for a period other than the normal time frame established by both ACGME and by the programs he attended. Question number 15d on the subject application asks, “Were you required to repeat any of your postgraduate training?” Petitioner answered “no” to question number 15d on the application. A memo dated December 3, 1997, written by Dr. Andrew Saxe (general surgery residency programs director at Sinai Hospital) and placed in Petitioner's training file, included the observation that "this is a consequence of his being asked to repeat the current clinical year." In a memo dated April 28, 1999, also written by Dr. Andrew Saxe and also placed in Petitioner’s training file, Dr. Saxe stated, “in light of prior probation and concerns regarding clinical competency an additional year of training would be of service to him.” At final hearing, Petitioner himself explained that each postgraduate year (“PGY”) runs from July 1st of one year to June 30th of the following year. On the Verification of Postgraduate Medical Education form submitted to FCVS, Sinai Hospital listed Petitioner as only completing PGY 2 through PGY 4 while attending their program. On the Verification of Postgraduate Medical Education form submitted to FCVS Wayne State University/Detroit Medical Center listed Petitioner as completing PGY 4 and PGY 5 in their program. While attending his postgraduate training programs, Petitioner was continuously evaluated, as evidenced in his training files. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 2 from July 1995 through June 1997. That means Petitioner was a PGY 2 for two years. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 4 from July 1998 through June 2000. That means Petitioner was a PGY 4 for two years. Therefore, Petitioner repeated both PGY 2 and PGY 4 levels of training. As demonstrated by Petitioner’s postgraduate training files, Petitioner’s education levels of training did not consistently progress through the calendar years. Petitioner concealed from the Board that he had to repeat PGY 2 and PGY 4. Over the course of the last year, the Board has licensed at least 55 applicants who were found to have made one or more material misrepresentations on their licensure applications, or in the course of the licensure process.3 Over the course of the last year, the Board has licensed a number of applicants alleged to have made material misrepresentations regarding one or more of the issues raised in this matter. In a few cases that are arguably similar to the facts presented in this case, the Board has granted the license application, but with conditions that required the applicant to file a new application, to pay a new application fee, and to pay an administrative fine in the amount of $5,000.00.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order denying Petitioner’s application for medical licensure by endorsement. DONE AND ENTERED this 29th day of April, 2004, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of April, 2004.
Findings Of Fact Respondent B. Delores Lane Eckard holds a Florida license as a registered nurse, No. 1091372. She has been so licensed since September 10, 1979. Petitioner's Exhibit No. 1. Before she was fired in July of 1983, respondent worked twelve-hour night shifts in the surgical intensive nursing unit at Baptist Hospital in Pensacola. A burn victim, Marc MacInvale, was among the patients respondent attended, during the shift that began at seven o'clock on the evening of June 15, 1983. Because of the extent of his burns, Mr. MacInvale had been placed in a private room, and hospital staff observed "reverse isolation" techniques. In or on his nightstand, Ms. Eckard found two, ten milligram ampules of Valium. Knowing that it was against hospital policy for the ampules to be there, she picked them up, intending to return them to the medication cart. She put them in her pocket for safekeeping, while she finished tasks in Mr. MacInvale's room. After she got home from work, on the morning of June 16, 1983, she undressed and went to bed. When she awoke and gathered up her clothes for washing, she discovered that the ampules were still in the pocket of her uniform. She was aware that a nurse had been fired two weeks earlier when Valium had been discovered in her locker at Baptist Hospital; and she decided against notifying the hospital or anybody she worked with of the whereabouts of the Valium. Instead, she placed the ampules in a clear plastic bag together with a piece of paper with Marc MacInvale's name on it and put the clear plastic bag in her "work purse," with the intention of returning the Valium to the hospital, when she next went to the hospital. In these circumstances, failure to report promptly that she had removed a patient's medicine from his room and that he did not receive it fell below minimal standards of acceptable and prevailing nursing practice, according to uncontroverted testimony. The clear plastic bag with the ampules and the piece of paper with "Marc MacInvale" written on it were still in Ms. Eckard's purse when she was arrested in the early morning hours of June 17, 1983, for driving under the influence of intoxicants. Celebrating with friends at a restaurant in anticipation of her June 18 birthday, she had drunk two glasses of wine and a "brandy manhattan," but had ingested no other intoxicating substances, before setting out for home. After her arrest, she demonstrated poor coordination and balance, slurred speech and difficulty in understanding. After twice registering less, the breathalyzer registered 1.0. Formal charges were apparently filed, and, on October 19, 1983, respondent pleaded nolo contendere. Petitioner's Exhibit No. 2. The police examined the contents of respondent's purse on June 17, 1983, and an assistant state's attorney eventually inquired of William Allen Foster, Baptist Hospital's director of security, whether Valium had been prescribed for Marc MacInvale. Norma Jean Vaughan, respondent's supervisor, confronted her, after she learned that Ms. Eckard had been arrested with Valium in her purse. Respondent volunteered blood and urine samples for analysis. The results of analysis were negative, but Baptist Hospital terminated her employment nevertheless. At the time, things were not going well on the domestic front, either. Ms. Eckard's husband had beaten her, and they were separated. In despair, she recorded the following: "Begin a good-bye tape. Um, I don't want anybody feeling sorry for me. I just want everyone to know why - I never thought that I would come to this point in my life. Cir- cumstances have, uh, made it so that I have, and the decision has been made and is irrevocable. In my forty-three years, I've spent the first (voice shaky, clearing throat) well, five years, with a divorced mother. Then, I spent until I was eleven in an orphanage. This taught me a lot of compassion, if, nothing more. Through my teen years, I had various stepfathers; many were - had means and, uh, were very good to me. I married young and was very happy - raised three chil, well, two children, and, uh, thought I did a decent job. Thought our marriage was well organized and pretty happy, overall. We had everything under control. We saved our money. We made good investments. Everything was going our way. I decided after the children were grown that I wanted to be a nurse. I could do what I wanted to do now. My job with the children was over as far as their, their primary needs were concerned. They had other interests in their lives, and I accepted my displacement. I went to nursing school and, uh, worked very hard to make the grades that I did. I went far and beyond what I had to do to advance my knowledge in medicine and to prepare myself to be the best nurse that I could be. I've worked five years in nursing and, uh, even though I worked Surgical Floor, many people feel like all you do is change bandages, do your job and that's it. The emotional needs of the patient are completely ignored. They hurt, you give them pain meds or you tell them, 'That's too bad; you can't have any pain medicine for another so many hours. And then, that's it. There's no, there's no, uh, efforts to make them more comfortable during that waiting period where they, where they're suffering so much. Or maybe they feel that nobody loves them. Nobody cares. They feel the isolation (pause) the, like no one's with them. They're in an alien environment. A lot of this is ignored by a lot of nurses. I was in reverse isolation when I was burned, and I spent three months in a wheelchair. I know what it is to be alone in an isolation room and, uh, the nurses saying, 'Oh, my God, do I have to dress that again?'. You know. Nobody, it's not a very pleasant thing, but I know the feeling of isolation. I know the feeling of not feeling wanted even though you are. Uh, and I've tried to take, in my nursing, the total body into, to mind to try to fill the needs of the total person, not just the colostomy. It's not a colostomy patient. It's not, it's not a cardiac, and uh, and uh, an abdominal mass, a tumor or whatever. It's a person to me. The compassion that my patients and the families feel that I've afforded has been given freely because I do care about that person as a human being. I have found though (choked up - brief pause - then voice somewhat shaky), now that my life has essentially fallen apart. The marriage that I thought would last forever, you know. Now, we're in our middle years and the kids are grown and we're making good money and we can afford nice things, uh, we can have a nice bank account. We can go places and do things, but then you find that this doesn't happen - that somewhere along the, that time of getting there, that you've lost what originally drew you together. Those dreams of making it there. You've made it. Where is there to go? (Big sigh.) I guess, and with my husband's illness, he can't help, I guess, what he said to me. I never thought anyone would want to hurt me. I've been fairly well protected all my life. I'm not a worldly person as far as the streets are concerned or, or what goes on in this world. I'm well versed in politics and, and in things like that, but my world consists of my work and my home. Now, I come home to an empty house, and I have no goal as far as nursing is concerned. That's been taken away from me also. So - and I feel sort of deserted because, with the exceptions that I've made for other people and for the hospital, things that, things that I would like to change that, that bother me have never been changed and never will be. Those are accepted. Uh, doctors that harm my patients - that has had to be accepted - reported and nothing really accomplished by it. That person is still there. (Click. Recorder apparently turned off and then back on. Clearing throat and then continuing in a somewhat deeper tone of voice.) Yet, when I, as a nurse, inadvertently make an error without malice or without forethought, and with every intention of correcting my error, my only thought was protecting my job - a job that I love dearly, that I was afraid of losing. This was the only reason it wasn't reported to you by myself. Then, I am terminated. And the only other reason for my existence is taken away from me. This is not to make you feel guilty. I know you have your job to do. I know there have been exceptions made. I know of one girl in particular where her whole life was a damn exception, and she has actually come close to killing patients, and it could be proven by records, etc. by actual observations. And yet, she's welcomed with open arms when she comes back. She left in a world of glory. It's as one of our other nurses said, 'She could fall in a bucket of (pause) and come up smelling like a rose very time.' My assets are frozen now. I have no means of support other than my job. I have no other place I want to go or would go. I've thought it over, and I know where my place in life lies and I know what my future holds. It holds nothing at this point because I can't make that decision to divorce my husband or to have him come back here. Those are my options at this point for survival. Those decisions I cannot make. The decision to work - the only reason I had any medication at all was the fact that I had been beaten half to death, and I was forced to go to Dr. - to the doctor simply as a, because I needed the slip to come back to work. At that point, he saw that I was just falling apart as far as my nerves were concerned, simply because my system couldn't adjust to the beatings that I had, had been inflicted upon me. He suggested that I take something until I got over that hump. I've never taken medication before, and, uh, as I told you, I told him I didn't want anything heavy because my system was just not used to medication and anything that I took, even an aspirin, one aspirin, would cure a headache. So, uh, my system is super sensitive to medication apparently. Therefore, he prescribed what he did and, uh, I took it. It's the lowest dosage he could have give - that he could give me. Uh, he said I could take up to 30 milligrams without any harm. The maximum I took was 10, and this was only, you know, when I was really upset and, or felt that I was not in control. For instance, like when I had to meet with my husband or things like this due to the legal matters, or uh, other business interests that we had that brought us together. I'm not making this tape to defend myself. I don't think any defense really is necessary because I've done nothing really wrong. I made an error in judgement, and I've paid dearly, both financially, emotionally, etc...I've lost everything for one error in judgement. I would hope that this would never happen to anyone else because it leaves you with very few options in your life. So, I appreciate your support as far as your confidence in my nursing care. (Click. Recorder apparently turned off and then back on.) I appreciate the fact that you didn't take my license away. I guess that would have been the ultimate defeat. Um (pause) at this point, as I said, um, I have no options. I feel that you're put on this earth for a purpose. My purpose has ended." She mailed the tape recording to Baptist Hospital where various people listened to it on July 8, 1983. Mr. Foster tried to reach respondent by telephone, but got a busy signal. He then called the police department. Three policemen appeared at her home to find her talking to a friend on the telephone. At least one of the policemen stayed to talk for an hour or two, then left and called Mr. Foster. He told Mr. Foster he did not think that Ms. Eckard "needed to be Baker Acted," but said that he would look in on her again later in the day. On December 4, 1983, Ms. Eckard was arrested a second time for allegedly driving under the influence of alcohol, but the state's attorney's office did not pursue these charges. The arresting officer testified at the hearing in the present case. Neither his testimony that she was driving nor his testimony that she was intoxicated has been credited.
