The Issue The issues are whether Petitioner has sufficiently completed the requirements necessary to receive a license to practice orthotic fitting from the Board of Orthotists and Prosthetists and whether the Petitioner has violated section 468.809, Florida Statutes, by practicing orthotics without a license or registration.
Findings Of Fact 1. The two rules governing the requirements for licensure as on orthotic fitter in the state of Florida are found in section 469.803(5)(c), Florida Statutes (2010), and Florida Administrative Code Rule 64B14-4.110(1)(b). Section 468.803(5)(c) requires: (c) to be licensed as an orthotic fitter the applicant must pay a license fee not to exceed $500 and must have: A high school diploma or its equivalent; A minimum of 40 hours of training in orthotics education, as approved by the board; Two years of supervised experience in orthotics acquired after completion of the required education, as approved by the board; and Completed the mandatory courses. Petitioner requested information from the Board regarding the requirements for licensure and received a publication containing both chapter 468, Florida Statutes, Part XIV, and rule 64B14. He completed the prerequisite education required by section 468.803(5)(c), on June 22, 2009. However, Petitioner testified that he only reviewed the requirements identified in section 468.803(5)(c) and did not consider the definition of "experience" contained in rule 64B14-4.110(1), for applicants for licensure as an orthotic fitter. Florida Administrative Code Rule 64B14-4.110(1)(b) construes supervised "experience" to require an applicant to complete two years of experience in orthotics under the supervision of a Florida licensed orthotist. The two years of experience may only begin accruing after the applicant has successfully completed the requisite education courses. Petitioner applied for a license in orthotic fitting on November 22, 2010, only 17 months after the completion date of his educational courses. Assuming Petitioner started gaining experience immediately upon completion of his education courses, Petitioner was still seven months shy of the two years of experience required to obtain a license as an orthotic fitter. Petitioner testified at hearing regarding the orthotic experience gained prior to applying for licensure. According to his testimony, his experience consisted of activity more accurately described as assistance than experience. The experience described was limited to helping patients stand up, holding a measuring stick, assisting with paperwork, and explaining paperwork to the patient. Petitioner’s role involved little more than observing and occasionally assisting a licensed physical therapist. This is surely not what is meant by “experience in orthotics under the direct supervision of a Florida licensed orthotist,” as contemplated by rule 64B14- 4.110(1)(b). The assistance provided by Petitioner was performed under the supervision of a licensed physical therapist. While his actions, as described at hearing, did not meet the requirements for supervision specified by rule 64B14-9.110, they also did not rise to the level of unlicensed activity.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered by the Board of Orthotists and Prosthetists denying Petitioner’s application for licensure as an orthotic fitter. DONE AND ENTERED this 2nd day of August, 2011, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 2011. COPIES FURNISHED: Frank Edward Maloney, Jr., Esquire Macclenny City Attorney 445 East Macclenny Avenue, Suite 1 Macclenny, Florida 32063-2217 Lee Ann Gustafson, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-6536 Bruce Deterding, Executive Director Board of Orthotists and Prosthetists Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 Nicholas Romanello, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, 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 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
The Issue The issues for determination are whether Respondent Lucien Armand, M.D., violated Section 458.331(1)(v), Florida Statutes (2006); Section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-9.009(2) and (4), and Section 458.351, Florida Statutes (2006); Section 458.331(1)(m), Florida Statutes (2006); and Section 458.331(1)(t), Florida Statutes (2006), as alleged in an Amended Administrative Complaint filed by the Department of Health before the Board of Medicine on June 20, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Lucien Armand, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 33997. Dr. Armand is board-certified in general surgery by the American Board of Surgery. Dr. Armand’s mailing address of record at all times relevant to this matter was 2071 Southwest 52nd Way, Plantation, Florida 33317. At the times relevant, Dr. Armand practiced medicine at 4100 South Hospital Drive, Suite 108, Plantation, Florida 33317. The office at which Dr. Armand practiced medicine was located very close to Plantation General Hospital (hereinafter referred to as “Plantation”). Dr. Armand has been the subject of three prior disciplinary matters arising out of five separate cases. Penalties were imposed in those three disciplinary matters. The Department summarized those disciplinary matters in paragraph 37 of its Proposed Recommended Order: In DPR Case Numbers 0019222, 0019123 and 0091224, Respondent was fined, received a reprimand, and was required to complete 30 hours of Continuing Medical Education (CME) in general vascular surgery and risk management within the surgical practice. In Case Number 94-10100, Respondent was required to submit to and comply with an evaluation at the University of Florida, to pay a fine, was reprimanded, was required to complete twenty hours of CME in general surgery in performing Laparoscopic Cholecystectomy, and was placed on Probation for two (2) years. In Case Number 1999- 58474, Respondent was restricted from performing Level II or above office surgery as defined in Rule 64B8-9.009(1)(d), Florida Administrative Code, until the Respondent demonstrated to the Board that he had successfully completed the University of Florida Comprehensive Assessment and Remedial Education Service (UF C.A.R.E.S.) course and complied with all recommendations, was reprimanded, was placed on probation for two (2) years, was required to attend the Florida Medical Association “Quality Medical Record Keeping for Health Care Practitioners” course, was required to perform 100 hours of community service, and was required to reimburse the Department for costs. Dr. Armand, who is 70 years of age, has been practicing medicine for 46 years. He has practiced medicine in Florida since 1979. During the eight months prior to the final hearing of this matter, Dr. Armand was working in South Sudan pursuant to contract with the United States State Department. October 6, 2006, Surgery on Patient W.C. On September 14, 2006, Patient W.C. presented to Dr. Armand and was diagnosed as having a slow-growing left inguinal hernia. Dr. Armand scheduled Patient W.C. for surgical repair of the inguinal hernia. The surgery was scheduled for October 6, 2006, at Dr. Armand’s office and, at the request of Patient W.C., under local sedation. At approximately 9:30 a.m., October 6, 2006, Patient W.C. arrived as scheduled at Dr. Armand’s office, accompanied by his wife and child. Patient W.C., who was not asked to execute any paperwork concerning the operation, was taken into a room where he was directed to lie down. There were two nurses in the room. Patient W.C. was given one shot of some form near the site of the procedure. This shot is the only medication he remembers receiving. He denied any recollection of having received medication intravenously, intramuscularly, or rectally. According to Dr. Armand, Patient W.C. was given “local anesthesia, Xylocaine 1% and ½% during the procedure and I gave some oral sedation, 10mg. of Valium, by mouth.” Page 171, Lines 19-21, Vol. II, Transcript of Final Hearing. At some point during the surgery, Patient W.C.’s intestines eviscerated, pushed themselves out through the hernia, making the hernia impossible to repair in the office. Due to the evisceration of Patient W.C.’s intestines, Dr. Armand eventually closed the incision and decided to transport Patient W.C. to Plantation to complete the procedure. Dr. Armand’s testimony that he closed and took patient W.C. to Plantation because Patient W.C. began “fidgeting” is not credited. While Patient W.C. did not have any clear recollection of the surgery while at Dr. Armand’s office, he did recall that “I was shaking myself and one of the nurses put something on my head and I went to sleep.” Page 40, Lines 20-22, Vol. I, Transcript of Final Hearing. Patient W.C. later indicated that “[o]ne of the ladies sprayed something on my face,” at which point Patient W.C. “went to sleep.” Page 41, Lines 23-24, and Page 42, Line 8, Vol. I, Transcript of Final Hearing. Patient W.C. did not remember anything else from this point in the surgery until he awoke at approximately 2:00 p.m., October 6, 2006, in a room at Plantation. Patient W.C. was transported to Plantation after he “fell asleep” by Dr. Armand. When Patient W.C. arrived at the Plantation emergency room, he was noted to be “sleepy” and, based upon Dr. Armand’s representation to the emergency room physician, Cornell Calinescu, M.D., was described as “somewhat sedated secondary to Valium and Clonidine.” Patient W. C. was also described by Dr. Calinescu and an emergency room nurse as able to speak. Upon admission to Plantation, Dr. Armand performed emergency surgery on Patient W.C. under general anesthesia, completing the procedure he had begun in his office. The surgery was completed without further complication. As noted above, Patient W.C. has no recollection of arriving at the Plantation emergency room, how he got to the hospital, or anything else that took place after falling asleep in Dr. Armand’s office, until he awoke in a hospital room later in the afternoon. Dr. Armand’s Medical Records for the October 6, 2006, Surgery. Dr. Armand’s office notes for Patient W.C. lack any documentation as to what took place in his office on October 6, 2006. Dr. Armand did not record the date of the procedure; the type of procedure performed; pre-operative care; any drugs that were prescribed, dispensed, and/or administered; the type and dosage of anesthetic sedation used; or post-operative care. Dr. Armand’s medical records for Patient W.C. also failed to include any informed consent for the procedure performed on October 6, 2006. As noted above, Dr. Armand did complete an operative report after the emergency surgery performed on Patient W.C. at Plantation. Office Surgery; Level of Anesthesia. Florida Administrative Code Rule 64B8-9.009 (hereinafter referred to as the “Office Surgery Rule”) prescribes standards for the performance of office surgery. In providing those standards, the Office Surgery Rule defines three levels of sedation and the conditions under which each level may be achieved and must be performed. Level II and Level III office surgery require registration of the physician’s office to perform. Dr. Armand’s office was not registered to perform Level II or Level III office surgery at the times relevant to this proceeding. Only the first and second levels of office surgery are relevant to this case. Florida Administrative Code Rule 64B8-9.009(3) describes the types of procedures appropriate for “Level I” office surgery, which Dr. Armand has argued he performed on Patient W.C., as follows: Minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-inducted alteration of consciousness other than minimal pre- operative tranquilization of the patient. Liposuction involving the removal of less than 4000cc supernatant fat is permitted. Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopes, skin biopsies, arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cysto-scopic procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints). . . . . 5. Chances of complication requiring hospitalization are remote. Florida Administrative Code Rule 64B8-9.009(4) describes the types of procedures appropriate for “Level II” office surgery, which the Department argues Dr. Armand utilized on Patient W.C., as follows: Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post- operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat. Level II Office surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. [Emphasis added]. While the Department relies in part upon the language of Florida Administrative Code Rule 64B8-9.009(4) that “[s]uch procedures shall include, but not be limited to . . . hernia repair . . .” to support its argument that the procedure performed by Dr. Armand on Patient W.C. was in fact performed as Level II surgery, this reliance is misplaced. Regardless of the proper interpretation of this language of the Rule (whether it clearly puts physicians on notice that all hernia repair surgery must be conducted as Level II surgery or not), at best it establishes a proscription. Such a proscription, cannot, however, be relied upon to establish the “fact” that Level II surgery was performed or not. The question of whether Dr. Armand performed the procedure defined as “Level II” office surgery is the disputed issue of fact in this case. Resolving this factual dispute requires an ultimate factual determination, which involves the application of a legal standard (the Rule) to the historical facts (what Dr. Armand actually did) as found by the trier-of-fact based upon the evidence. The Rule is not evidence of what Dr. Armand did; rather it is the yardstick against which Dr. Armand’s conduct must be measured and, ultimately, judged. The evidence either way concerning the level of surgery performed by Dr. Armand consisted of his testimony denying that Level II surgery was performed, the testimony of Patient W.C. concerning his condition, the description of Patient W.C.’s condition by emergency room personnel, and the opinion of the Department’s expert witness, Christian Brikedal, M.D., as to the level of surgery. Dr. Armand’s denial that he performed Level II surgery was not convincing because it was inconsistent with the patient’s description of his condition on October 6, 2006, and the description of his condition by emergency room staff when arrived at Plantation. Patient W.C. had no recollection of going to the hospital or anything that transpired there until he awoke at about 2:00 p.m. the afternoon of October 6, 2006. Emergency room staff noted that Patient W.C. was able to talk when he arrived. These facts, convincingly proved, are more consistent with what constitutes Level II surgery: “the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining . . . the ability to respond purposefully to verbal command and/or tactile stimulation.” This finding is further supported by Dr. Brikedal opinion that Patient W.C.’s condition was consistent with having undergone Level II sedatopm. Dr. Brikedal, whose testimony was convincing and uncontroverted, was asked the following question and gave the following answer at Page 22, Lines 7-14, Vol. I, Transcript of Final Hearing: Q Assuming W.C. is going to testify that as soon as the complication occurred that he was put to sleep and didn’t wake up until he was in the hospital, are you able to reach any conclusions about the level of sedation that occurred? A He would have to have been given a sedative I.V. or I.M. to be that sleepy. This opinion, as to Patient W.C.’s condition on October 6, 2006, supports a finding that Patient W.C. was under Level II anesthesia while surgery was being performed in Dr. Armand’s office. Having found that Patient W.C. was under the level of sedation described in the definition of “Level II” office surgery, leads inescapably to the finding that Dr. Armand administered Level II sedation to Patient W.C. The foregoing finding is further supported by the portion of the Office Surgery Rule quoted, supra, in finding of fact 24. Dr. Brikedal explained during the hearing why it is “appropriate and necessary to do an inguinal hernia repair” as Level II surgery: “Sedation to the point that the patient’s comfortable so they’re able to or they’re not pushing against you, inhibiting you from performing this very safely.” Page 24, Lines 20-22, Vol. I, Transcript of Final Hearing. As a board- certified general surgeon who has previously registered and had his office accredited as an office at which Level II surgery could be performed, Dr. Armand must have been aware of why it is prudent to perform hernia repairs as Level II surgery. While Dr. Armand may have begun the surgery as Level I, when Patient W.C.’s intestines eviscerated, Dr. Armand must have realized that taking Patient W.C. to Level II sedation would give him a better opportunity to correct the problem. Unfortunately for Dr. Armand, it was too late. Office Surgery Rule Procedures. Florida Administrative Code Rule 64B8-9.009(2) prescribes requirements for conducting “office surgery,” taking into account of the level of sedation utilized during a procedure. The hernia repair performed by Dr. Armand on Patient W.C. constituted “surgery” as defined in Florida Administrative Code Rule 64B8-9.009(1). Performance of the surgery in Dr. Armand’s office constituted “office surgery” as those terms are defined in Florida Administrative Code Rule 64B8-9.009(1)(d). The “office surgery” performed by Dr. Armand on Patient W.C. failed to comply, as required, with all the requirements of Florida Administrative Code Rule 64B8-9.009(2), applicable to conducting Level II office surgery and, in some instances, Level I office surgery: Dr. Armand failed to “maintain complete records” of the surgical procedure as required by Florida Administrative Code Rule 64B8-9.003, or a written informed consent from the patient as required by Florida Administrative Code Rule 64B8- 9.009(2)(a)(applicable in part to Level I and Level II surgery); No log of Level II surgery was kept as required by Florida Administrative Code Rule 64B8-9.009(2)(c); No adverse incident report was filed as required by Florida Administrative Code Rule 64B8-9.009(2)(k). This portion of the rule requires that “[t]he surgeon shall report to the Department of Health any adverse incidents that occur within the office surgical setting. . . .” (Emphasis added). This requirement is separate from any requirement that a hospital report adverse incidents and the burden of reporting is put directly on the surgeon; and Dr. Armand did not have an established risk management program as required by Florida Administrative Code Rule 64B8- 9.009(2)(j). The Standard of Care. Dr. Birkedal provided an opinion to the Department and testified at the final hearing as to whether Dr. Armand’s treatment of Patient W.C. met the “level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers ” (Hereinafter referred to as the “Standard of Care”). In his original opinion dated December 22, 2007, Dr. Birkedal indicated that he did not believe that Dr. Armand’s care of Patient W.C. violated the Standard of Care. There were caveats or assumptions, however, which Dr. Birkedal recognized in his written opinion could change his opinion if not correct. In particular, at the time of his original opinion, Dr. Birkedalk had incorrectly assumed that the procedure performed on Patient W.C. was a Level I procedure. Dr. Birkedal recognized in his original opinion that, if his assumption were incorrect, that his opinion would change: “[i]f he did give an IV sedative, then he may have violated the standard of care if his office is not licensed to give IV sedatives.” At hearing, Dr. Birkedal was of the opinion that Dr. Armand had not simply performed Level I surgery and, therefore, opined that he had violated the Standard of Care because his office was not a properly licensed office surgery suite. Dr. Birkedal also offered other opinions at hearing concerning what he perceived were violations of the Standard of Care, but those “violations” were not alleged by the Department in the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Lucien Armand M.D., has violated Section 458.331(1)(v), Florida Statutes (2006); Section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-9.009 and Section 458.351, Florida Statutes (2006); Section 458.331(1)(m), Florida Statutes (2006); and Section 458.331(1)(t), Florida Statutes, to the extent found in this Recommended Order; and indefinitely suspending his license to practice medicine in Florida, but allowing him to continue to practice medicine outside the United States through his relationship with the United States Department of State after full disclosure of the Board’s final order to the United States Department of State. Should a medical license not be a condition of employment by the United States Department of State, his license should be revoked. DONE AND ENTERED this 17th day of June, 2009, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 17th day of June, 2009. COPIES FURNISHED: Diane Kiesling Assistant General Counsel Robert A. Milne Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS 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 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue Should Respondent Patricia Dee G. Stehpenson's license to practice medicine in the State of Florida be revoked, suspended or otherwise disciplined based on the allegations contained in the Administrative Complaint filed herein?
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times material to this proceeding, the Respondent was a licensed physician in the State of Florida, having been issued license number ME 0051453. The patient, a 73 year old female, presented to Respondent on July 11, 1991, with complaints of flashes of light over the past ten years which had increased over the past two years. The patient also complained of seeing halos around street lights at night. During this visit, Respondent diagnosed the patient as having 20/30 corrected vision in her right eye and 20/40 plus 2 corrected vision in her left eye, and that the patient had cataracts. However, Respondent did not recommend cataract surgery at this time. In January, 1992, the patient took the State of Florida driver's license test, including the eye test, and received her driver's license. However, the examiner notice that the patient was having trouble with the eye test and, although the examiner gave the patient her driver's license, the examiner suggested that the patient see an opthalmologist. At the time the patient received her driver's license in January, 1992, the patient was enjoying golf, bowling and driving. Although the patient did not immediately follow the driver's license examiner's advice concerning her eyes, the patient did visit with Respondent on May 8, 1992. At this visit, the patient advised the Respondent that the flashes and floaters had improved but that her vision was interfering with her golfing and driving. Again, Respondent did not recommend removal of the cataract. The patient's vision continued to interfere with her golfing and driving, notwithstanding the patient's testimony to the contrary which I do not find to be credible. The patient's next visit with Respondent was on October 16, 1992. At this visit, the patient advised Respondent that her vision had "lessened a lot" in the left eye. Visual acuity testing indicated corrected vision of 20/30 in the right eye and 20/40 plus 2 in the left eye. However, while the level of vision at which the patient was able to perceive letters (20/40 plus 2) did not change, the refraction (stronger glasses) required to achieve that level indicated more myopia, indicating that the cataract had progressed which supports the patient's complaint that her vision had "lessened a lot". Also at the October 16, 1992, visit, Respondent tested the patient's vision using brightness acuity testing (glare test) and measured the patient's vision as 20/70, with glare in the left eye. The glare test is a method whereby the doctor shines a light in the person's eye to determine the effect of glare on the person's vision. Although some ophthalmologists consider the glare test of no value, other ophthalmologists consider the glare test as another tool to assist the surgeon in making a decision concerning the necessity for cataract surgery. During the October 16, 1992, office visit, Respondent discussed with the patient: (a) the effect the cataract was having on the patient's activities (life-style); (b) the patient's complaint that her vision had lessened; (c) the results of the glare test showing the patient's vision as 20/70 with glare and; (d) other visual acuity testing; and (e)advised the patient that cataract surgery was indicated. Also, Respondent explained the cataract surgery procedures and discussed with the patient the risks and the benefits of the surgery. The patient had no reservations or objections to the surgery and consented to the surgery in hopes of improving her eyesight as well as her life- style. For a person with cataracts, a corrected vision of 20/40 or worse is the vision level where some cataract surgeons will recommend cataract surgery, while other cataract surgeons consider a corrected vision of 20/50 or worse, with or without glare, as the vision level where cataract surgery should be recommended. However, because the vision as determined by visual acuity testing (the ability of the person to perceive letters) does not always accurately reflect the person's quality of vision (the quality of perception on a day to day basis), neither vision level referred to above when considered alone can be used as a hard and fast rule to form a basis for cataract surgery. Since the quality of vision can only be described by the person with the cataract(s), the cataract surgeon must also determine, after consultation with the person, that the cataract(s) are interfering with the person's life-style. Therefore, a person with corrected vision of somewhat better than 20/40 or 20/70 with or without glare, may be a candidate for cataract surgery, provided the cataract is causing a reduction in the person's quality of vision beyond what is indicated by visual acuity testing and thereby interfering with the person's life-style. Furthermore, there are no written standards or guidelines which set a particular vision level for the cataract surgeon to follow when making a decision to recommend cataract surgery. The surgeon must take into consideration all factors and make a decision based on the surgeon's judgment as to what is best for that person. The patient's vision level and the interference the patient was experiencing with her life-style because of the cataracts in her left eye justified Respondent's decision to recommend and perform the cataract surgery on the patient, notwithstanding any of the testimony of Dr. Leslie Monroe to the contrary. On November 3, 1992, Respondent performed phacoemulsification (removal of cataract) with posterior chamber intracular lens implant (implantation of lens) on the patient's left eye. While the patient was in the holding area being prepared for surgery there were complications with the anesthesia. The anesthesiologist, Robert Dienes, M. D., first gave the patient a retrobulbar block which was repeated apparently due to Dr. Dienes' conclusion that the first retrobulbar block was ineffective. Apparently, Dr. Dienes also concluded that the second retrobulbar block was ineffective and gave the patient a superior lid peribulbar block. After giving the peribulbar block, Dr. Dienes noticed a dissecting subconjunctival hemorrhage and notified Respondent. Upon examining the patient's eye, Respondent found the globe (whole eye) to be soft with no active bleeding, indicating the eye was not full of blood and that there was no retina tear or rupture of the globe. Respondent also noticed that "the conjunctiva was real chemotic or it had blood behind it". Respondent also measured the patient's eye pressure with a Schiotz tonameter because there was no slit-lamp in the holding area. The patient's eye pressure was 5, with a 5.5 gram weight, which was normal. The patient's medical records do not reflect an indirect ophthalmoscopy being performed by Respondent on the patient's left eye between Respondent being advised of the dissecting subjunctival hemorrhage by Dr. Diemes and the Respondent performing surgery on the patient's left eye to remove the cataract and implant the lens. Furthermore, Respondent has no independent recollection of performing an indirect ophthalmoscopy during the above period of time before surgery. Respondent's normal practice under conditions and circumstances similar to those in this case has been to perform an indirect ophthalmoscopy during the above period of time before surgery. Therefore, it is assumed that Respondent performed an indirect ophthalmoscopy on the patient after being advised of the subconjunctival hemorrhage but before surgery, notwithstanding the fact that patient's medical records do not reflect such procedure being performed or the fact that Respondent has no independent recollection of performing such procedure during the above period of time. However, assuming arguendo that Respondent did not perform the indirect ophthalmoscopy before surgery, the Agency has failed to establish facts to show that under the conditions and circumstances of this case that such failure amounted to the failure of Respondent to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. After considering the conditions and circumstances surrounding the complication that arose while the patient was being anesthetized, Respondent made a decision that it was in the best interest of the patient to go forward with the removal of the cataract and implantation of the lens. The operation was completed without any further incident and there was a successful removal of the cataract and lens transplant. Respondent's decision to go forward with the surgery had no adverse effect on the subsequent treatment of the complication that arose while the patient was being anesthetized. In fact, the result of the treatment subsequent to the cataract surgery would have been the same even if Respondent had not gone forward with the surgery. Respondent, using a ophthalmoscope, was able to see the inside of the eye more clearly and assess the complication that arose while the patient was being anesthetized. While performing this indirect ophthalmoscopy, Respondent noted undulation of the vitreous with pigmented blood cells present and that the anesthesia needle had penetrated the globe. The patient was seen the next morning, November 3, 1992, by Respondent. After assessing the condition of the patient's left eye, Respondent referred the patient to Keye Wong, M. D., a retina specialist. Upon examining the patient's left eye on November 4, 1992, Dr. Wong noted vitreous hemorrhaging and retinal detachment. Dr. Wong performed an operation on the patient's left eye in an attempt to correct the damage and attach the retina. The patient's vision is not as good as it was before the operation, and still effects the patient's life-style. The patient has difficulty tolerating sunlight, which may or may not be a result of the complication experienced while the patient was being anesthetize. Respondent's action of going forward with the surgery after becoming aware of the complication that arose while the patient was being anesthetized did not cause, complicate, aggravate or result in any of the problems the patient has suffered postoperatively. Respondent did not fail to recognize, identify or treat properly the complications that arose before, during or after the surgery. The Agency has failed to establish facts to show that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances at anytime while Respondent was treating the patient, including both preoperative and postoperative treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Petitioner Agency for Health Care Administration enter a final order dismissing the Administrative Complaint filed herein against Respondent Patricia Dee G. Stephenson, M. D. DONE and ENTERED this 23rd day of January, 1996, at Tallahassee, Florida. WILLIAM R. CAVE, 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 23rd day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1560 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the Petitioner and the Department in this case. Agency's Proposed Findings of Fact. Proposed findings of fact 1-2 are adopted in substance as modified in Findings of Fact 1 and 2. The first sentence of proposed finding of fact 3 is adopted in Finding of Fact 3. The second and third sentence are not supported by evidence in the record. Proposed finding of fact 4 is adopted in substance as modified in Finding of Fact 5, otherwise not supported by evidence in the record. Proposed finding of fact 5 is adopted in substance as modified in Finding of Fact 7, otherwise not supported by evidence in the record. Proposed finding of fact 6 is adopted in substance as modified in Findings of Fact 12, 13, and 14, otherwise not supported by evidence in the record. Proposed findings of fact 7 and 8 are adopted in substance as modified in Findings of Fact 21 and 22, otherwise not supported by evidence in the record. Proposed finding of fact 9 is a restatement of Dr. Monroe's testimony and is not a finding of fact. However, see Findings of Fact 16 and 17. 8, Proposed findings of fact 10, 16, 17 and 19 are adopted in substance as modified in Findings of Fact 15, 16, 10, 8 and 9. Proposed finding of fact 11 is adopted in substance as modified in Finding of Fact 16, otherwise not supported by evidence in the record. Although proposed findings of fact 12, 13 and 15 are findings of fact, they are neither material nor relevant to this proceeding. See Finding of Fact 9. Proposed finding of fact 14 is a restatement of Dr. Grabow's testimony and is not stated as a finding of fact, but see Finding of Fact 10. Dr. Grabow's testimony was 20/50 vision with or without glare which is different than just 20/50 vision. 11. Proposed findings of Fact 18 and 20 are not supported by evidence in the record. Respondent's Proposed Findings of Fact. 1. Proposed findings of fact 1 through 27 are adopted in substance as modified in Findings of Fact 1 through 25. COPIES FURNISHED: Marm Harris, M. D., Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, Esquire Agency for Health Care Administration Fort Knox Building Number Three 2727 Mahan Drive Tallahassee, Florida 32308 Steve Rothenburg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 William E. Partridge, Esquire Lutz, Webb, Partridge, BoBo, and Baitty One Sarasota Tower 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236
The Issue This case arises out of Orlando Regional Medical Center's objection to the issuance of a Certificate of Need to Surgical Services of Orlando, Inc., for the construction and operation of an ambulatory surgical center in Orlando, Florida. At the formal hearing, Orlando Regional Medical Center called as witnesses, Herbert E. Straughn, Norton Baker, Terry Weibley, Marlene Mariani, Michael L. Schwartz, Janice Smith, Richard Douglas Signer, Cathy Canniff Gillam, Jack Bradley, Barbara W. Miner, John Bozard and Stephen Haar. The Intervenor, Surgical Services of Orlando, Inc., called as witnesses, Steven Haar, Janice Smith, John Bozard, Michael Means, Jerry Senne, James Leveretee, Stephen Foreman, John S. Lord, Robert C. Klettner, Albert S. Bustamante, Pedro Diaz- Borden, Alberto J. Herran, Marianna Johnson, Richard Toole, Don Newton, Hank Gerken, Gordon Kiester, Leonard J. Levine, Rufus Holloway, Brenda Brinkman, Betty Barker, Wayne Deschambeau, Mark Richardson and Rick Knapp. Department of Health and Rehabilitative Services called as its only witness, Mr. Thomas Porter. Surgical Services of Orlando, Inc., offered and had admitted into evidence 33 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, Orlando Regional Medical Center was given permission to file a late-filed exhibit with Surgical Services of Orlando, Inc., and the Department having the opportunity to object to said exhibit. That exhibit has been filed as Orlando Regional Medical Center Exhibit No. 9 and consists of excerpts from the Department of Health and Rehabilitative Services file relating to this application. That exhibit is admitted. The Department of Health and Rehabilitative Services offered and had admitted into evidence one exhibit. A map of Orlando reflecting the location of the various hospitals in Orange County was admitted as joint exhibit 1. Subsequent to the formal hearing, each of the parties submitted proposed findings of fact and conclusions of law for consideration by the Hearing Officer. To the extent that those proposed findings of fact and conclusions of law are inconsistent with this order, they were considered by the Hearing Officer and rejected as being unsupported by the evidence or as unnecessary to the resolution of this cause.
Findings Of Fact Surgical Services of Orlando, Inc., (hereafter referred to as SSO), is a Florida corporation based in Orlando, Florida. The stock of the corporation is owned in equal shares by Steven Foreman, Dr. Rufus Holloway and Randall Phillips. Mr. Steven Foreman is a life underwriter and financial consultant, and real estate investor in the Orlando area. He is secretary and director of SSO. Dr. Rufus Holloway is an otolaryngologist in the Orlando area and is treasurer and a director of SSO. Randall Phillips is a hospital administrator presently employed by American Medical International, Inc. Orlando Regional Medical Center, Inc. (hereinafter referred to as ORMC) is an existing hospital located in Orlando, Florida. It is a not-for-profit regional tertiary care center with 1035 beds and 24 operating rooms. ORMC has two main divisions, the Orange Division and the Holiday Division and is presently constructing a new facility, Sand Lake Division, which will open sometime in mid 1985. The Sand Lake Division will have 4 operating rooms and 150 beds. Dr. Rufus Holloway and Steven Foreman have committed their personal resources to provide financial support for the complete development and operation of the applicant's proposed ambulatory surgical center. The facility will be constructed by a partnership, the Kaley Avenue Medical Partnership of Dr. Holloway, Mr. Foreman and Richard Toole, a citrus owner in the Orlando area, and will be leased to SSO. Two banks in the Orlando area have given commitments to provide the necessary financing for the proposed facility and start-up expenses. Pan American Bank has committed to provide a $2.5 million loan for the construction and equipping of the building and $750,000 line of credit. Dr. Holloway and Mr. Foreman, and the parties of the Kaley Avenue Partnership have sufficient financial resources to fulfill their commitments to the proposed project. The proposed building will be a one floor building containing 15,000 square feet. The total cost for the project will be $2,737,636. The building is to be constructed and equipped by the Kaley Avenue Medical Partnership and leased to SSO at $16 per square foot. The proposed site of the facility is on Kaley Avenue within two or three blocks of ORMC. Its service area will include all of Orange County. The facility will contain five operating rooms with only three of the rooms being completely equipped initially. These rooms will be used for general and local anesthesia. The remaining two rooms will be equipped as demand requires. The applicant has budgeted $743,000 for initially equipping the facility with an additional $160,000 required to equip the two remaining operating rooms. The equipment proposed by the applicant is adequate to perform those procedures which the applicant proposed to perform at its facility. In addition to the five operating rooms, the center will include laboratory, x-ray, administrative areas, as well as holding and recovery areas for the patients. The applicant projects a total number of procedures in the first year of 1,800 and 2,760 in the second year of operation. Based upon a Medicare utilization rate of 15 percent SSO projects an operating loss in the first year of $223,000 with the facility making a profit in the second quarter of the second year and generating a total profit of $766,000 in the second year. The projected break-even point is 2,448 procedures within a year. Projected revenues are based upon an average charge per case of $575. SSO also intends to accept Medicaid patients. Presently, Medicaid does not reimburse freestanding ambulatory surgical centers. Medicaid charges would be included as charity cases in the projected bad debt of 6 percent of gross revenues. Based upon an inflation rate of 8 percent per annum when SSO begins operation in January, 1986, its average charge per case will be competitive with other facilities in the area providing ambulatory surgical services. Medicare now reimburses 100 percent of the facility charges in a freestanding ambulatory facility and 80 percent for outpatient surgery in a hospital setting. Prior to opening, SSO will implement a marketing program directed to four different target groups: physicians, consumers (patients), employers and insurance carriers. SSO has retained a marketing expert who has prior experience in marketing ambulatory surgical care in Florida. Similar marketing has proven successful for other freestanding ambulatory surgical centers in Florida. SSO has budgeted $20,000 for pre-opening marketing expenses and $35,000 for the first year of operation. It is difficult upon this record to make a truly accurate comparison of outpatient surgical rates in existing facilities to the proposed average charge of SSO. ORMC presented evidence that the present average charge in ORMC and three other hospitals per outpatient case is as follows: ORMC $417.19 Florida Hospital $469.86 Winter Park $512.21 Orlando General $560.81 No average charges were presented into evidence for West Orange Hospital, Lucerne Hospital, or Brookwood Hospital. The evidence established that 8 percent is a reasonable inflation or increase rate for health care charges over the next two years. Applying an 8 percent inflation rate to the above average charges these charges for 1986, SSO's first year of operation would be: ORMC $486.61 Florida Hospital 548.04 Winter Park 597.44 Orlando General 654.13 In calculating its present average charge of $417.19, ORMC did not include those outpatient surgeries performed at the Orange Division which are charged at inpatient rates. A memo dated January 19, 1984, to John Bozard, ORMC Vice President for Finance, from Steve Horr, ORMC Assistant Controller/Reimbursement, reflects that Holiday Division had 484 outpatient surgical cases which are estimated to generate gross revenues of $228,547. This results in an average charge per case for the month of December 1983 of $472.20. It is concluded that in 1986 the SSO projected average charge of $575 will be competitive with those existing facilities in the Orange County area. There is presently no rule which contains a specific methodology for determining need for ambulatory surgery centers. HRS uses a methodology which is based upon policy but has not been proposed or promulgated as a formal rule. The present methodology utilizes the total surgery cases for the most recent 12 month period to determine a surgical utilization rate per 1,000 population. By separating inpatient and outpatient surgeries for the same 12-month period, a percentage ratio of outpatient surgery cases to total surgeries is established. Applying the utilization rate to future projected population, HRS then determines the total projected surgeries for future years and from this number calculates the projected outpatient surgeries which will be performed in existing facilities. Literature relating to ambulatory surgeries projects that 18 to 40 percent of all surgical procedures performed could be performed in an outpatient setting. In calculating total potential surgeries HRS utilizes 29 percent as the potential surgeries that can be performed in an outpatient setting. The 29 percent factor is the mean of 18 percent to 40 percent and appears reasonable in light of the fact ORMC, Holiday Division, Winter Park Memorial and Orlando General had outpatient surgery of 29.4 percent, 30.1 percent and 30.6 percent respectively for 1983. Applying the 29 percent factor to projected total surgeries, HRS calculates the projected potential ambulatory surgery for a given year in the future. Subtracting those outpatient surgeries which will be performed in existing facilities from the total potential outpatient surgeries provides the unmet need for outpatient surgical care. This need is reflected in total cases. In evaluating ambulatory surgical applications, HRS utilizes a two year planning horizon. It is projected that SSO would begin operation January 1, 1986, and therefore under the HRS methodology, 1986 and 1987 become the relevant years for the HRS methodology, 1986 and 1987 became the relevant years for looking at projected need. Using the methodology described above, HRS projects the potential number of outpatient surgical cases which could be performed in other than a hospital setting to be 7,203 and 7,347 for 1986 and 1987, respectively. HRS projects the break-even level of the SSO facility at 2,693 surgical cases per year. Subtracting the SSO break-even factor from 7,203 and 7,347 results in an unmet need even after the SSO facility is in operation of 4,510 and 4,654 surgical cases in 1986 and 1987. HRS calculated the outpatient utilization rate in existing hospitals in 1983 to be 15.3 percent. If the unmet need of 4,510 and 4,654 in 1986 and 1987 was met by these existing facilities, that utilization rate would increase to 24 percent or approximately 1 1/2 times the 1983 rate. The projected utilization for the SSO facility for 1986 and 1987 will constitute only about 20 percent and 30 percent respectively of the unmet need for outpatient surgery in those years. The applicant in projecting need used a five year planning horizon to project need for ambulatory surgical services in Orange County for the year 1989. Under SSO's methodology, an outpatient utilization rate of 30 percent, 35 percent and 40 percent was used to project the total potential outpatient or ambulatory surgeries for the year assuming a total surgical utilization rate of 101.45 cases per thousand. Using these assumptions, the applicant projected unmet need for ambulatory surgeries in Orange County in 1989 as: Percentage of Ambulatory Surgery Unmet Need 30% 6,357 35% 9,246 40% 12,136 Although the projected unmet need is somewhat lower than that projected by HRS, it does reflect a need for the SSO facility. The methodology used by ORMC utilizes what ORMC's experts described as the "excess capacity theory." This methodology is based upon the assumption that no need exists for an ambulatory surgical center until such time as all excess capacity in the existing operating suites in Orange County is utilized. Using this approach, ORMC contends that of the 79 total operating suites in Orange County, there are presently 39 excess operating suites available to perform outpatient surgery. By multiplying total number of hours per day per operating room times 260 days, ORMC calculates the total available hours of operation of an operating suite and by multiplying this number times the total number of suites, the total available hours or operating room time for a facility is determined. The total available hours is then divided by the average operating room time for all procedures performed to determine the total number of potential procedures. Using this approach, ORMC's expert opined that there is potential for 95,513 - 98,980 total surgical cases in the existing 79 operating rooms in Orange County These 79 rooms include the 4 new operating suites in ORMC's Sand Lake facility as well as the 4 suite in Florida Hospital's new freestanding ambulatory surgical center. Subtracting the total procedures of 47,712 from the potential capacity, ORMC projects an available excess capacity for growth of 47,801 to 51,268 surgical cases in Orange County. Also using total available hours, hours per average procedure and total hours required for procedure presently being performed, ORMC's expert calculated the number of operating suites presently required. By subtracting this number from the number of existing suites, the ORMC expert concluded that there are presently 39 excess operating suites in Orange County. Once the ORMC Sand Lake facility and the Florida Hospital Freestanding Ambulatory Center (FAC) open, there will be a total or 79 operating suites in Orange County. These are divided as follows: ORMC, Orange Division 14 ORMC, Holiday Division 10 Winter Park Memorial 10 Orlando General 4 West Orange 3 Lucerne 8 Brookewood 5 Florida Hospital 17 Florida Hospital, FAC 4 ORMC, Sand Lake 4 79 At present, ORMC, Holiday Division, is the only facility operating dedicated ambulatory surgical suites. There are no applications pending for dedicated outpatient facilities within hospitals or for a freestanding ambulatory surgical facility. No such applications have been filed for these types of facilities since the SSO application was filed. Each of the existing facilities listed above performs outpatient surgery to some degree. On August 16, 1982, Florida Hospital was issued a Certificate of Need to construct a freestanding ambulatory surgical center. That facility will contain four operating suites and is expected to begin operation in mid 1984. Once this facility is complete, Florida Hospital will not perform outpatient surgery in its 17 other suites, except when special equipment which is available only in those suites is required. Outpatient surgery at Winter Park Memorial and Orlando General now comprises approximately 30 percent of the total surgeries performed at those facilities. Lucerne Hospital operates no separate ambulatory surgery unit and favors SSO's application. ORMC has been performing outpatient surgery for over 20 years. However, the specific facilities in which outpatient surgery has been performed have changed during this period of time. Prior to August 1979, outpatient surgery was performed at the Five North unit in the Orange Division as well as at the Holiday Division. At that time, Orange Five North was closed for renovation and outpatient surgery was concentrated in Holiday One East. In October 1981, an outpatient surgery review committee was established by ORMC to examine more efficient ways to conduct outpatient surgery and to improve utilization of certain departments at the Holiday Division. The end result was a decision to concentrate outpatient surgery at ORMC in one designated unit to be known as Outpatient Day Surgery ("ODS"), and to provide a financial incentive for physicians and patients to utilize the unit. One of the primary reasons for concentrating outpatient surgery in Holiday One East was the inefficiency and increased cost of staffing the units. Outpatient census counts were resulting in overstaffing the 3 to 11 shift. To encourage doctors and patients to utilize Holiday One East, ORMC reduced the rates for outpatient surgery in the ODS unit by approximately 40 percent. Although some outpatient surgery continues to be performed at the Orange Division the charge for such surgeries is at the inpatient rates rather than the reduced rates utilized by the ODS. The ORMC Board of Directors approved the capital expenditure to renovate the Holiday One East area into the ODS unit on September 20, 1982. The ODS unit was renovated at a cost of approximately $600,000, which was below the Certificate of Need threshold requirement. The ODS unit opened on November 28, 1983. The ODS unit is open Monday through Friday, and utilizes a ten hour day with general anesthesia administered to outpatients from 7:30 a.m. to 1:00 p.m. ODS patients use a separate and distinct entrance to the Holiday Division and have a designated parking area east of the hospital. There are sixteen semi- private holding beds and four recliner chairs located within the ODS unit. The average case load and length of stay are such that holding beds may be used for more than one outpatient per day. As a result of instances where there have been shortages of holding beds for outpatients, ORMC beginning April 2, 1984, established an overflow area of ten beds on the third floor of the Holiday Division. As of May 29, 1984, this overflow area had been utilized on three occasions. The ODS unit contains two dedicated operating rooms where only local anesthesia can be administered. Outpatient procedures requiring general anesthesia are performed in the eight general operating suites of the Holiday Division. These eight operating suites are also used for inpatient surgery. Outpatients are placed in the same holding and recovery areas where inpatients are held. The staff in these areas serve inpatients and outpatients. The ODS unit averages 15 to 16 outpatients per day. In 1983, outpatient surgery comprised 29.4 percent of the total surgeries performed at the Holiday Division. This was a slight increase over the 27.7 percent outpatient percentage for that same division for the previous year. Presently, the two dedicated local anesthesia rooms are being utilized approximately 40 percent of the time. The present utilization rate of the entire Holiday Division is approximately 50 to 55 percent to as much as 80 percent depending upon the particular day of the week. The 80 percent rate is attained on a regular basis at least once per week. ORMC has been issued a Certificate of Need for a children's hospital. As presently designed and approved, the construction of the children's hospital will require the demolition of Holiday One East where the ODS unit is located. It is uncertain where the ODS unit would be relocated. The master facility plan approved by the ORMC Board of Directors includes the construction of a freestanding ambulatory diagnostic center which will include ambulatory surgery. Depending upon the staff and its efficiency and the quality of care provided, a freestanding ambulatory center offers several advantages over outpatient units within hospitals. In such a freestanding facility, only outpatient surgery is performed and the staff and physicians, including anesthesiologists, can be specialized in outpatient surgery. In the freestanding facility, outpatients are not mixed with inpatients. A substantial portion of those patients utilizing outpatient surgery are well patients having elective surgery performed. By specializing in outpatient surgery only, overall operating costs are likely to be less and should result in reduced patient costs. In a hospital setting, there is on occasion a problem with "bumping" elective surgery for emergencies. This would not occur in a freestanding ambulatory surgery facility. Patients will have shorter waits in the facility and Medicare patients will be reimbursed 100 percent rather than the 80 percent reimbursed in a hospital setting. The 550 application is consistent with the applicable criteria enumerated in Section 381.494(6)(c), Florida Statutes and need for its facility exists in Orange County. Of the thirteen governing criteria, the parties have stipulated that the criteria contained in Subsections 6, 7, 10 and 11 of Section 381.494(6)(c), Florida Statutes, are not applicable to this proceeding. In addition, the parties stipulated that Subsection 1 of Section 381.494(6)(c), Florida Statutes, is not applicable to this proceeding to the extent that there is no applicable district health plan or state health plan pertaining to ambulatory or outpatient surgery.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is, RECOMMENDED That HRS issue a Certificate of Need to Surgical Services of Orlando, Inc., to construct and operate a freestanding, five operating room ambulatory surgery center in Orange County. DONE AND ENTERED this 2nd day of July, 1984, in Tallahassee, Florida. MARVIN E. CHAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 1984. COPIES FURNISHED: Douglas L. Mannheimer, Esq. CULPEPPER, TURNER & MANNERED 318 North Call on Street Tallahassee, Florida 32302-3300 Fred W. Baggett, Esq. ROBERTS, BAGGETT, LaFACE, RICHARD, & WISER P.O. Drawer 1838 Tallahassee, Florida 32302 E. G. Boone, Esq. P.O. Box 1596 Venice, Florida 34284 Steven R. Bechtel, Esq. MATEER, HARBERT, FREY BECHTEL AND PHALIN, PA P.O. Box 2854 Orlando, Florida 32802 P. Joseph Wright, Esq. MURRAH AND DOYLE, P.A. P.O. Box 1328 Winter Park, Florida 32790 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue The issue is whether Respondent is guilty of deviating from the applicable standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failing to keep adequate medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty the Board of Medicine should impose.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0066606. Respondent has been board certified in plastic surgery since 1983 and is also board certified in hand surgery. Respondent has previously practiced in Kentucky. He relocated to Florida in 1994 to join a former physician colleague, Dr. Bolt, who had developed cancer and later died in early 1995. Respondent joined the Center for Cosmetic Surgery (Center), which Dr. Bolt had sold to two persons, including Jeff Davis. The record does not disclose whether Mr. Davis is a physician, but Respondent described him and the other principal/owner as felons. The Center held out Respondent as the medical director. This representation was obviously with Respondent’s knowledge and at least tacit consent. After Dr. Bolt’s death, Respondent recruited three more physicians for the Center, but none of them was board certified in plastic surgery. Mr. Davis served as the patient coordinator at the Center. The position of patient coordinator had significant marketing responsibilities. Typically, a prospective patient would contact the Center and schedule a free consultation. At the appointed time, the prospective patient would visit the Center and speak with a physician, such as Respondent. No physical examination would take place. During the discussion, the physician would make notes on a Physician’s Report, which the prospective patient would take to Mr. Davis, whose job was to sell the surgery. Using incentives such as free nose jobs, Mr. Davis was responsible for pricing surgical procedures and scheduling surgery, once the prospective patient agreed to have a Center physician perform the agreed-upon surgery. Mr. Davis was also responsible for collecting money from patients in payment for their surgery. Typically, one of Respondent’s patients would schedule surgery two to three months from the date of making the appointment. Before surgery, Respondent would see the patient before surgery for a physical examination and preoperative testing. Respondent determined what preoperative testing was necessary on a patient-by-patient basis. Following this visit, Respondent would dictate the findings from the physical examination and the treatment plan. A transcribing service was responsible for transcribing the dictation and filing it in the patient’s chart. In May or June of 1996, Respondent provided notice to the principals of the Center that he would be terminating his employment. He terminated his employment on November 1, 1996. After his departure, Respondent learned that Center employees had misinformed his patients as to Respondent’s nonavailability due to illness or surgery. It is unclear whether this situation existed before Respondent’s announced departure. Tensions developed between Respondent and the principals of the Center. Respondent determined that he could lawfully contact those patients still needing care, so he sent those patients an announcement that he was associating himself with the American Institute of Plastic Surgery. Litigation between Respondent and the Center principals followed, including a legal action by Respondent to obtain patient records. The litigation over the records concluded with the agreement by the Center to provide records as needed, but they have provided Respondent with incomplete records. A. S. first contacted the Center in June 1995 after seeing an advertisement on television. She chose the Center and two other facilities for plastic surgery that she was considering. At the time, A. S. was 48 years old. Wanting to improve her appearance, A. S. wanted a face lift and work on her lower eyelids. She had had her lower eyelids done in 1978 or 1979 and had had a “mini-lift” in 1984. A. S. met Respondent during her first visit to the Center. A. S. and Respondent spoke for 15-20 minutes. Respondent asked her what procedures she wanted done, and she said that she wanted a face lift and work on her lower eyelids. He showed her a copy of his resume and marked a picture of a face, as they discussed procedures. A. S. did not fill out any forms or questionnaires. Respondent did not explain much concerning the procedures that A. S. was contemplating. He mentioned that she would have a thin line, which would not be noticeable, under her eyes and told how long the stitches would remain in place. He did not discuss the possibility of scarring or other risks associated with the surgery. Following her visit with Respondent, A. S. saw Mr. Davis. They discussed costs and financing. Mr. Davis gave her an estimate of the cost of the surgery that she was considering. A. S. had already checked another plastic surgery center and, later on the same day that she visited the Center, she visited the third, and last, plastic surgery facility that she was considering. The next day, Mr. Davis called A. S. and asked if she had made a decision. Mr. Davis said that Respondent had told him that Respondent wanted to do A. S.’s nose, evidently for aesthetic reasons. Mr. Davis offered the nose work at no additional charge. Although Respondent had not offered to do A. S.’s nose for free or for a charge, he was aware that Mr. Davis would offer free additional work of this kind as an incentive to the patient to select the Center for the work that she was already considering. A. S. talked the matter over with her daughter. A. S. decided to have the surgery at the Center. She then informed Mr. Davis of her decision. Three to five days later, A. S. visited the Center to discuss payments with Mr. Davis because she did not have all of the money necessary for the surgery. During this visit, Mr. Davis suggested a brow lift. He said that Respondent was good at this procedure and would be working in this area anyway. At the end of this visit, a nurse gave A. S. some paperwork prohibiting her from smoking for two weeks before the surgery due to the anticipated bleeding. A. S. had smoked one pack of cigarettes a day since she had been a teenager. A. S. discussed the effect of smoking on the surgery with the nurse, but not with Respondent. As directed, she stopped smoking and never resumed smoking again. A. S. next visited the Center on June 26, 1995, for the surgery. No one performed a physical examination of A. S. On this date, Respondent performed a browlift, rhinoplasty, and facelift. After A. S. awoke from the general anesthesia, she did not receive any instructions from Respondent or staff regarding the care of her bandages, which extended across a large part of her face and top of her head. She was scheduled to return to the Center two days later. A. S.’s daughter drove her home. Once they got there, she noticed that her mother’s face seemed grey. A. S. told her to call Respondent. The daughter informed his answering service of her mother’s condition. She then waited one-half hour for Respondent or his staff to contact her. After hearing nothing, the daughter called the answering service again and waited another half-hour. After a third call and another half-hour wait, Respondent called A. S. and told her to cut the bandage under her neck. By cutting the bandages, A. S. revealed an open cut on her neck. When she returned for her followup visit two days later, A. S. asked Respondent about the cut, which extended along the right side of the neck below the ear. Respondent assured her that it would close up, which it did. When Respondent expressed concerns about her eyes and a dent in her nose, Respondent assured her that they would discuss these matters after the swelling went down. About one week later, Respondent returned to the Center for a second followup visit. During the second followup visit, Respondent removed the stitches. Now that some of the swelling had gone down, A. S. discovered that Respondent had not performed the surgery on her lower eyes. A. S. could not recall Respondent’s explanation for not performing this surgery. A. S. complained to Respondent that, since the surgery, her right eye had become smaller than her left eye, the right eyebrow had become lower than the left eyebrow, and the right side of her face from the eye down had become looser. Also, she complained about the extensive marks, scarring, loose skin, redness, and a dent under her chin; the dent in her nose and a misshapen right nostril; a swollen bump on her left cheek; a big chunk of skin gone from her hairline; and a gully on the left side of her face. Respondent assured her that he would fix these problems with revisions to the eyes and nose and the area under the neck. He did not offer any revisions to hair line, whose appearance worsened as the swelling reduced. Respondent later performed some relatively minor revisions to the right side of A. S.’s face at no cost to A. S. He reset the remaining revisions for a date in mid-December, 1995. Despite A. S.’s persistence at trying to obtain the additional revisions, Respondent failed to perform them. Repeatedly, Center employees canceled scheduled surgery dates, claiming that Respondent was ill or busy with unscheduled surgery. They rescheduled the December surgery to a date in mid- February, 1996. When she reported on this date, a Center employee took her to Mr. Davis, who informed her that the Center had lost money on her surgery and would not perform revision surgery until she paid additional money. They rescheduled her surgery for a date in late March. When A. S. reported on the date for her surgery in March, Mr. Davis told her that they would not do the revision surgery until she paid another $300. A. S. charged this sum on her credit card, so they would do the surgery. Mr. Davis told her that Respondent was too busy, and he rescheduled the surgery for April 8. On April 8, when A. S. reported for surgery, a Center employee sedated A. S., but, after A. S. waited a couple of hours, another Center employee informing her that the surgery could not take place either because Respondent was not coming into work that day or he was in emergency surgery. When A. S. called from home later that day to reschedule the surgery, a Center employee told her that Respondent was in surgery. The employee advised A. S. to call the Center each morning to see if Respondent had any cancellations. A. S. did as advised, but the Center was never able to accommodate her. Subsequently, A. S. sent Respondent two or three letters and left telephone messages for him to contact her on at least ten occasions. Realizing that Respondent and the Center would not perform the revision surgery, A. S. went to another plastic surgery facility in 1998 for work on her right nostril and under her neck. A surgeon repaired the nostril, but, due to financial constraints, could not do all of the work required to repair the damage under A. S.’s neck, which would require about $4000 in surgery. In the meantime, Respondent sent A. S. a card announcing the relocation of his practice to the American Institute for Cosmetic Surgery. A. S. wrote Respondent a letter at his new address, but Respondent never responded. A. S. never sued Respondent. All she wanted was that he perform the revisions that she could not afford to purchase elsewhere so as to reduce or, if possible, eliminate the deformities that Respondent caused surgically. Respondent violated the applicable standard of care in several ways. First, preoperatively, his evaluation of A. S. was scanty. He did not take an ample history, and he did not adequately evaluate her medical status. He did not prepare a surgical plan with a description of all risks and a discussion of these details with the patient. Perhaps most importantly, Respondent never performed a physical examination of A. S. before surgery. Respondent violated the applicable standard of care operatively. The results in this case are so substandard in number and degree as to preclude assigning the outcomes to bad luck, as opposed to a hurried, careless surgery. Respondent violated the applicable standard of care postoperatively. He did not adequately the many problems that he caused. Perhaps most obviously, he failed to adequately treat the open wound in the neck, and he failed to form a plan to address the many revisions necessitated by his careless surgery. The Board of Medicine has previously disciplined Respondent for, among other things, his deviation from the applicable standard of care in treating three plastic surgery patients whose surgery he performed in 1995-96 and 1998.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of violating Section 458.331(1)(m), Florida Statutes, in his treatment of A. S. and revoking his license. DONE AND ENTERED this 6th day of December, 2000, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 6th day of December, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health Bin C03 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health Bin A02 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health Bin A02 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Kim M. Kluck Carol Gregg Senior Attorneys Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jerry C. Lingle 1419 Northeast 16th Terrace Fort Lauderdale, Florida 33304
Findings Of Fact Manatee Eye Clinic owns land adjacent to its existing offices and in close proximity to Manatee Memorial Hospital, on which it proposes to construct a freestanding ambulatory surgery center for ophthalmic surgery. On December 13, 1983, Manatee Eye Clinic filed an application for a certificate of need with the Department of Health and Rehabilitative Services (HRS) for approval of a capital expenditure in the amount of $627,640 for construction of a freestanding ambulatory surgery center for ophthalmic surgery. On April 27, 1984, Petitioner received written notice that the Department had denied the application. Manatee Eye Clinic consists of five practicing ophthalmologists in Manatee County, each of whom are [sic] duly licensed and provide quality ophthalmic care in the area. Manatee Eye Clinic, and the members thereof, have available sufficient resources, including health manpower, management personnel, as well as funds for the capital and operating expenditures for the project. Petitioner's proposed medical facility would be constructed in a sufficiently cost-effective manner and makes adequate provision for conservation of energy resources and incorporates efficient and effective methods of construction. Should this certificate of need be granted, Manatee Eye Clinic will accept Medicaid, Medicare, third-party pay, private pay, and charity care. The relevant service area for the proposed facility is Manatee County. The five ophthalmologists at MEC perform approximately 1,200 eye surgeries per year involving cataract removal and lens implant. At present all of these surgeries are performed at Manatee Memorial Hospital. The founder of MEC, Dr. Robert E. King, has twice served as chief of surgery at Manatee Memorial. He is presently a director on the board of directors of the company that recently purchased Manatee Memorial Hospital and removed it from its former status of a not-for-profit hospital to its current status as a for-profit hospital. If this application is granted, Manatee Memorial Hospital will lose all of these patients. Cataract eye surgery, as it is performed today, is ideally performed in an outpatient surgery setting. The five ophthalmologists currently perform an additional 600 outpatient surgical procedures per year in the existing clinic. These procedures would be performed in the freestanding surgery facility if this application is approved. Manatee Memorial Hospital is located one city block from MEC. L. W. Blake Memorial Hospital, some seven miles from MEC, has five operating rooms available for outpatient surgery but is not currently used by any of the doctors at MEC. Additionally, Ambulatory Surgical Center/Bradenton was licensed in December, 1982. This facility has not been used by MEC doctors. During the latest reporting period, 1983/1984, Manatee County and the Ambulatory Surgery Center performed the following procedures; Hospital Inpatient Outpatient Total L. W. Blake Memorial Hospital 8,800 2,752 11,552 Manatee Memorial Hospital 6,766 1,654 8,420 Ambulatory Surgery Center -- 1,525 1,525 TOTALS 15,566 5,931 21,497 (Exhibit 19) There is no shortage of operating rooms in Manatee County available for outpatient surgery. Petitioner's primary argument against using the operating rooms at Manatee Memorial Hospital are: operating room nurses are rotated and this results in nurses not being as well qualified as they would be if their duties were limited to ophthalmic surgery; eye surgery is generally elective and such surgery may be bumped from a scheduled operation by emergency general surgery; the patients are generally older than 65 and are less comfortable in hospital surroundings than they would be at an outpatient surgical facility; access to the ambulatory surgical center would be easier for these elderly patients than is access to the existing hospitals for the same outpatient surgery; the hospital charges for the outpatient surgery are approximately twice the charges proposed by Petitioner; and Medicare will pay 100 percent of the charges in a freestanding surgical facility (up to a maximum) but only pays 80 percent in a hospital setting, thereby making the use of a freestanding facility cheaper for the patient and for Medicare. MEC doctors currently use their own scrub nurses during eye surgeries performed at Manatee Memorial Hospital leaving only the circulating nurse to be provided by the hospital. No incident was cited wherein one of Petitioner's patients was "bumped" from a scheduled operation. The complication rate for cataract surgery has dropped from 10 percent to 0.1 percent in recent years as surgical procedures have improved. As proposed, the partnership owning MEC will erect and own the surgery center, will lease the equipment, most of which is presently owned by MEC, to the Petitioner; and the rent for the building will be a fixed amount per month plus 50 percent of the net operating profits of Petitioner. Proposed charges by the freestanding surgery center will be $904 per patient (for cataract removal and lens implant) This does not include the surgeon's fee. There are no methodology rules to determine need for a freestanding outpatient surgery facility. DHRS has consistently determined need for ambulatory surgery centers by taking the most recent number of surgical procedures performed in all inpatient and outpatient facilities in the county and dividing it by the county's base population for the latest year, here 1983. This gives the rate of surgeries per 1,000 population for the latest year for which statistics are available and is projected forward to the second year of operation (here 1987). The same is done for outpatient surgeries. DHRS uses the figure of 29 as the percentage of surgeries that can be performed in an outpatient setting to determine the need for outpatient surgery facilities in 1987. From this is subtracted the number expected to be performed in existing hospital and freestanding outpatient facilities to determine net need through 1987 for freestanding outpatient facilities. Applying this procedure, to which Petitioner generally concurs, except for the 29 percent factor, the following need is shown. The 1983 population of Manatee County is 162,997. 21,497 surgeries performed in 1983 x 1000 4 162,997 131.9 surgeries per 1000 population. The 1987 projected population of Manatee County is 182, 120. Multiplying this population by 131.9 per 1000 equals 24,061 surgeries expected to be performed in Manatee County in 1987. HRS estimates that 29 percent of these surgeries could be performed in an outpatient setting in 1987. Multiplying 24,051 by .29 equals 6,978 outpatient procedures possible. In 1983 there were 4,406 outpatient surgeries performed in a hospital setting in Manatee for a rate per thousand of 27. Multiplying this rate by the projected population for 1987 yields 4,931 outpatient surgeries that can be performed in a hospital setting in 1987. Subtracting from this number the projected outpatient surgeries to be performed in a hospital setting in 1987 (6,978 - 4,931) shows 2,047 to be performed in a freestanding facility. Ambulatory Surgery Center performed 1,525 procedures from June, 1983, to May, 1984. When this is projected to 1987, Ambulatory Surgery Center is expected to perform 1,715 surgical procedures. Substracting this from 2,047 leaves 332 procedures as a net need through 1987. This is below the pro forma break-even point of Petitioner and indicates the project is not financially possible. The 29 percent factor was obtained from American Hospital Association report of 1981. In 1981, 18 percent of the total surgeries were done on an outpatient basis while it was estimated that 20 to 40 percent of all surgeries could be performed on an outpatient basis. DHRS averaged the 18 percent and the maximum of 40 percent to arrive a mean of 29 percent to project need for outpatient surgery facilities. The latest figures from the American Hospital Association report is for 1982 and this shows the latest percentage of surgeries performed on an outpatient basis to be 20.8 percent. If this figure is averaged with 40 percent, the mean would rise to 30.4 percent. This is the percentage Petitioner contends should be used. Using this figure, the outpatient surgeries possible in 1987 would rise to 7,315 and a need for 669 procedures would exist in 1987. This would meet the higher break-even number presented by Respondent of 556 procedures for the second year of operation. It is noted that the experts' estimated surgical procedures that could be performed in an outpatient setting varied from 20 to 40 percent. In arriving at the 29 percent used DHRS averaged the latest actual percentages available in 1981 with 40 percent to obtain an arbitrary figure of 29 percent to use in calculating need for outpatient facilities. It is further noted that between June of 1983 and May Of 1984 Manatee Memorial Hospital performed 1,654 outpatient surgery procedures and 6,766 inpatient surgery procedures (Exhibit 14) and Blake Memorial Hospital performed 2,752 outpatient surgery procedures and 8,800 inpatient surgery procedures (Exhibit 15). Accordingly, 23.8 percent of Blake's surgery procedures are done as outpatient surgery and 19.6 percent of the surgeries performed at Manatee Memorial Hospital are done as outpatient surgeries. If the 1,200 outpatient surgeries per year performed at Manatee Memorial Hospital by MEC had been removed during this period, the percentage of outpatient surgery would have been reduced to 6.3 percent for Manatee Memorial Hospital. No evidence was presented regarding the number of ophthalmic surgeries that were performed at Blake Memorial Hospital during this period. Regardless of the potential loss of outpatient surgery cases at Blake if this application is granted, the percentage of outpatient surgeries performed in a hospital setting in Manatee County is, according to the latest data available, 22.1 percent (combining Blake and Manatee Memorial). Using 29 percent of the total surgeries projected for 1987 in Manatee County to obtain an estimate of the outpatient surgery that can be expected to be performed in a hospital setting in 1987 results in a much higher figure than the current growth rate in outpatient surgeries would suggest. Accordingly, I find a 29 percent factor more credible than a higher percentage would be in forecasting need for outpatient surgical facilities in 1987. This conclusion is further supported by the fact that most ophthalmic surgery today is performed in an outpatient setting. This was not true only a few years ago. Accordingly, there can be little additional growth resulting from ophthalmic surgery procedures going from inpatient to outpatient procedures. As a consequence, future growth in outpatient surgery must come from other surgical procedures.
The Issue The issues are as follows: (a) whether Respondent acted upon Petitioner’s application for renewal as an office surgery accrediting organization within the time frames established under Section 120.60(1), Florida Statutes; and (b) whether Respondent properly denied Petitioner’s application for renewal of its status as an approved physician office surgery accrediting organization.
Findings Of Fact Background In Florida, physicians who perform certain surgical procedures in their offices are required to register the office and have the office inspected by Respondent unless the office is accredited by a nationally recognized accrediting agency or an accrediting organization approved by Respondent. § 458.309(3), Fla. Stat. (2003); Fla. Admin. Code R. 64B8-9.0091. In order to avoid physician office inspection by Respondent, a physician must submit written documentation of a current office-accreditation survey by one of the nationally recognized or Board-approved accrediting organizations. Fla. Admin. Code R. 64B8-9.0091(2)(a) and 64B8-9.0091(3)(a). A physician is also required to submit a copy of a current accreditation survey within 30 days of accreditation of the office. Fla. Admin. Code R. 64B8-9.0091(3)(b). Florida Administrative Code Rules 64B8-9.0092(1)(b) and 64B8-9.0092(7) list the approved national and Board-approved accrediting organizations. Petitioner is the only Board-approved accrediting organization. Florida Administrative Code Rule 64B8-9.0092(1)(a) provides that "accredited" means that an office has achieved either "full" accreditation or "provisional" accreditation when the office is in "substantial compliance" with accrediting standards. Petitioner provided Respondent with a complete application for renewal as an office surgery accrediting agency on January 17, 2003. Florida Administrative Code Rule 64B8- 9.0092(5) specifies that such entities must apply for renewal every three years and shall submit their applications for renewal at least three months prior to the third anniversary of their initial approval. Petitioner conducted office surgery accreditation inspections for approximately three years prior to the final hearing in this matter. Physicians who conduct office surgery are required to comply with Florida Administrative Code Rule 64B8-9.009 regarding the Standard of Care for Office Surgery. Florida Administrative Code Rule 64B8-9.0091(2)(a) specifically provides that all nationally recognized and Board-approved accrediting organizations shall be held to the same surgery and anesthesia standards for Florida office surgery sites as adopted by rule. Petitioner's accreditation standards, as outlined in its original application for approval as an accrediting agency and its subsequent application for renewal, include the requirement that physicians comply with the standard of care rules for office surgery as outlined in Florida Administrative Code Rule 64B8-9.009. In fact, Petitioner asserts that its standards meet or exceed the requirements of Chapters 455 and 458, Florida Statutes (2003), and rules promulgated there under. Petitioner's accreditation standards should have remained the same throughout the three years preceding the submission of its renewal application. Petitioner did not file any changes or amendments to its accreditation standards prior to submitting its renewal application on January 17, 2003. Submission of Corrective Action Plans Throughout the first three years of its operation, Petitioner provided Respondent with copies of all the accreditation reports for the facilities it inspected and accredited as required by Florida Administrative Code Rule 64B8- 9.0092(4)(e). That same rule also required Petitioner to furnish Respondent copies of any corrective action plans within 30 days of receipt from the inspected physician office. Petitioner did not provide Respondent with any corrective action plans or any compliance information until after Petitioner filed its renewal application. Petitioner did not offer any corrective action plans as evidence during the hearing even though Petitioner found deficiencies (non- compliance with accreditation standards) in 24 of the 25 office inspection files entered as evidence by the Respondent in this hearing. The only materials submitted by Petitioner that address the deficiency corrections are copies of photographs, invoices, packing slips, order forms, and correspondence from the inspected offices, which are supposed to constitute evidence of subsequent compliance accreditation standards. Beth Sautner is Petitioner's Executive Secretary. Ms. Sautner's duties required her to submit the requisite accreditation materials to Respondent and to communicate with Respondent regarding such activities when needed. The greater weight of the evidence indicates that Respondent's staff never told Ms. Sautner to only send the facility inspection form and that submission of corrective action plans and compliance materials was unnecessary. Ms. Sautner knew that a rule required the submission of corrective action plans. Nevertheless, Petitioner never filed any petition seeking a waiver of such rule. Action on the Application Respondent considered Petitioner's renewal application on three separate occasions. It was first considered on February 8, 2003, in Orlando, Florida, at Respondent's regularly scheduled meeting. At that meeting Petitioner waived the 90-day provision in Section 120.60(1), Florida Statutes (2002), until after Respondent's August 2003 meeting. Respondent next considered Petitioner’s renewal application at a regularly scheduled meeting on June 7, 2003, in Miami, Florida. Finally, Respondent voted to deny the application at the August 2, 2003, meeting in Orlando, Florida. Respondent filed the Notice of Intent to Deny Petitioner's application for renewal as an office surgery accrediting organization on August 28, 2003. Accreditation Process Upon the request and payment of an accreditation fee, Petitioner arranges for the inspection of an office by an inspector. Inspection is required when the physician conducts level II office surgery lasting more than five minutes or level III office surgery. The inspectors are physicians affiliated with Petitioner who personally visit the facility to conduct the inspection. The inspectors use an inspection form when conducting the accreditation inspection. The form contains a pass or fail check-off space next to each statement reflecting an accreditation standard. The form contains comment sections following the standards and at the end provides for a pass or fail designation along with two additional sections. The inspectors use the final sections for outlining minor deficiencies to be corrected within 20 working days and for major deficiencies requiring a second inspection. The form has signature lines for the inspector and the physician being inspected. After completing the inspection, the inspector forwards the form to Ms. Sautner. Next, the inspector and Ms. Sautner review the form to determine what is needed in order to complete the process. The inspector tells Ms. Sautner what is needed and she attempts to collect the requisite compliance documentation from the inspected facility. The appropriate materials are then forwarded to Ms. Sautner who sends them to the inspector for a final accreditation determination. The final accreditation determination is always made by an inspector and never by Ms. Sautner. Once the final accreditation determination is made, Ms. Sautner orders an accreditation certificate from Scribes, Inc. Scribes, Inc. sends the certificate directly to the newly accredited facility. At times, Ms. Saunter orders the certificate in advance but places it on hold until she is notified that an accreditation determination has been made. Ms. Sautner usually contacts Scribes, Inc. by e-mail to request release (delivery) of the certificate. Scribes, Inc. then sends Petitioner a facsimile copy of the physician’s accreditation certificate. Petitioner accredits offices for three years. The accreditation period begins to run from the date of the original office inspection. The certificate that Petitioner issues through Scribes, Inc. contains a month and year which reflect the final month of the facility accreditation. Therefore, if a facility’s accreditation certificate has a May 2005 date, it reflects an accreditation from May 2002 through May 2005. This is true even when the physician did not document that his or her facility fully complied with Petitioner's accreditation standards until, in some cases, months after the initial inspection. After Petitioner requests Scribes, Inc. to send a certificate to a newly accredited facility, Petitioner sends a copy of the facility inspection form, the accreditation certificate, and a cover letter to Respondent. This documentation notifies Respondent that Petitioner has inspected the physician's office and that the office is entitled to recognition as an accredited facility. Throughout the hearing Petitioner's witnesses testified that physicians' offices were not accredited until they demonstrated that they had met all of the accreditation standards. The weight of the evidence indicates that Petitioner routinely accredited a facility retroactive to its inspection date. A review of every accreditation certificate in evidence shows that each facility’s period of accreditation starts the month Petitioner performed the inspection and ends three years later. This is true even when the inspection form reveals that the physician’s office did not fully comply with Petitioner's accreditation standards at the time of inspection and the physician did not demonstrate compliance until months after the initial inspection. Ms. Sautner's testimony adds support for the proposition that Petitioner gave physicians accreditation credit retroactively to the inspection date. She was responsible for notifying Scribes, Inc. to release accreditation certificates bearing specific months and years exactly three years after the date of the inspections, as opposed to three years after the date of compliance with standards. Petitioner's inspectors considered the inspection date to be the accreditation date. They knew the subsequently issued accreditation certificates would reflect compliance with accreditation standards for a period of time before the physicians actually demonstrated compliance. It is noteworthy that, upon completion of the inspections, Petitioner gave a "pass" or, in a couple of cases, a provisional pass, to every physician’s office that Petitioner inspected before it submitted its renewal application. This adds credence to the supposition that Petitioner considered the inspection date to be the date that a facility was entitled to accreditation, even though the physicians did not demonstrate compliance until some time after the inspection. It is clear that Petitioner was not routinely accrediting physicians' offices without requiring some evidence of demonstrated compliance with accreditation standards. Instead, Petitioner usually required the physicians to furnish some documentation showing compliance after an inspection revealed deficiencies but allowed the new period of accreditation to begin retroactively on the date of the inspection. The most persuasive evidence indicates that the date Petitioner completed the accreditation process occurred sometime after the inspection: (a) on the date Ms. Sautner authorized Scribes, Inc., to release the physician's accreditation certificate; or (b) the date that Scribes, Inc., faxed Ms. Sautner a copy of the accreditation certificate sent to the physician. Therefore, the information provided to Petitioner was inaccurate to the extent it reflected that physicians' offices were in full compliance as of their inspections date. Given the above, Respondent presented ample evidence which demonstrates that Petitioner's accreditation process was misleading. At the very least, Petitioner lacked sufficient quality assurance policies and procedures to ensure that physicians were not recognized as accredited before they were entitled to such recognition. Regardless of whether any physicians were actually performing surgery in their offices between the inspection dates and the dates of compliance, Petitioner's accreditation procedure created a false impression of the adequacy of the facilities that Petitioner inspected. This mischaracterization of the status would lend support for the acceptability of procedures performed in that setting when the physician was not entitled to that recognition, with potential consequences to the health and well being of the patients. Marwan Shaykh, M.D. Petitioner inspected Dr. Shaykh’s facility on May 30, 2002. The date that appears on his accreditation certificate is May 2005. Hence, his accreditation covers May 2002 through May 2005. During the inspection, Petitioner determined that Dr. Shaykh’s office did not have the following required medications: adrenalin (expired), dextrose (expired), verapamil hydrochloride (expired), succinylcholine, and nitroglycerin. Petitioner also discovered that Dr. Shaykh’s office did not have the following required monitoring and/or emergency equipment: ambu bag and emergency power able to produce adequate power to run required equipment for a minimum of two hours. (hereinafter “emergency power”). After the inspection, Dr. Shaykh provided Petitioner a copy of an invoice from the Apothecary at Memorial. The invoice indicated that Dr. Shaykh ordered adrenalin (ephedrine), dextrose, verapamil hydrochloride, succinylcholine, and nitroglycerin (nitroquick) on July 2, 2002. The invoice was dated August 15, 2002. Dr. Shaykh also provided Petitioner a copy of an invoice from Physician Sales and Services, Inc. The invoice reflected that Dr. Shaykh ordered an ambu bag (resuscitator adult disp) on July 16, 2002. The invoice was dated July 16, 2002. Finally, Dr. Shaykh provided Petitioner a copy of a letter which read in part: Please find enclosed the copies of the anesthesia record where the EBL is recorded, the physician job description and a copy of the surgery log. In addition, invoices indicate the replacement of Dextrose 50 percent, Isuprel 1:5000, Verapamil 5mg/2ml, succinylcholine 20mg/ml to the crash cart and Administration sets (Micro drips) and Adult Resuscitator bag (Ambu Bag) to the surgery room. The letter appears to be a cover letter that accompanied the above-discussed invoices. The letter is undated and does not indicate when Petitioner received it. However, if it accompanied the medication invoice from the Apothecary, Dr. Shaykh must have sent it to Petitioner on or after August 15, 2002. Ms. Sautner ordered and placed a hold on Dr. Shaykh’s accreditation certificate on June 6, 2002. She released the hold on July 16, 2002. The certificate itself has a fax date of June 11, 2002. It appears that Scribes, Inc., faxed it to Petitioner on that date. Based on the foregoing, it is not clear whether the fax date on Dr. Shaykh’s certificate of June 11, 2002, or Ms. Sautner's stated release date of July 16, 2002, is the actual release date. Nevertheless, regardless of which date is the correct release date, it is apparent that Petitioner sent Dr. Shaykh an accreditation certificate before he documented compliance with Petitioner's accreditation standards because the Apothecary invoice was dated after both possible release dates. Karen Chapman, M.D. Petitioner inspected Dr. Chapman’s facility on April 6, 2002. The date that appears on her accreditation certificate is April 2005. Hence, her accreditation covers April 2002 through April 2005. During the inspection, Petitioner determined that Dr. Chapman’s office did not have multiple (14) medications, one of which was inderal. Petitioner also discovered that Dr. Chapman’s office did not have a required ambu bag among other missing monitoring and/or emergency equipment. After the inspection, Dr. Chapman provided Petitioner copies of invoices from Southern Anesthesia + Surgical dated April 11, 2002, which reflected that Dr. Chapman ordered all the missing medications with the exception of inderal. Dr. Chapman also provided Petitioner a copy of undated correspondence which asserted that Karen Chapman ordered and received inderal 1mg/mL, on April 11, 2002. Both the Southern Anesthesia + Surgical invoice copies and the undated correspondence regarding the inderal contain a fax strip across the top. The date on the fax strip indicates that Dr. Chapman sent the invoice copies and the inderal correspondence to Petitioner on February 12, 2003. Ms. Sautner was unable to provide an order or release date for Dr. Chapman’s accreditation certificate. However, the inspection file contained an accreditation certificate which had a fax date across the top of May 10, 2002. The Southern Anesthesia + Surgical invoice copies and the undated correspondence regarding the inderal were obviously faxed to FLACS over seven months after the accreditation certificate was sent to Dr. Chapman. Petitioner attempts to explain this discrepancy away by claiming that it had all compliance documentation prior to issuing accreditation but in some cases it could not find the documents when it conducted an audit in 2003. In those instances, Petitioner contacted the physicians and asked them to send the compliance materials again after the fact. Such an explanation is unacceptable because it does not explain why the compliance documentation was not in the file in the first place. Additionally, Petitioner has provided no documentation of compliance materials from Dr. Chapman disclosing whether she ever obtained a required ambu bag. Lucien Armand, M.D. Petitioner inspected Dr. Armand’s facility on June 8, 2001. The date that appears on his accreditation certificate is June 2004. Hence, his accreditation covers June 2001 through June 2004. During the inspection, Petitioner determined that Dr. Armand’s office did not have the following required medications: adrenalin (epinephrine) 1/10,000 dilution, calcium chloride, dextrose, dilantin (phenytoin), dopamine, and inderal (propranolol). After the inspection, Dr. Armand provided Petitioner on some unknown date a copy of an invoice from Medical III Pharmacy. The invoice reflected that on April 23, 2001, Dr. Armand ordered dilantin, dopamine, and inderal. The invoice was dated April 30, 2001. Dr. Armand also provided Petitioner, on some unknown date, unsigned correspondence indicating that he had “re- supplied” his emergency cabinet with adrenalin, calcium chloride, dextrose, dilantin, dopamine, and inderal. Ms. Sautner placed Dr. Armand’s accreditation certificate on hold on June 22, 2001. The certificate had a fax date across the top of June 28, 2001. The above-referenced invoice from Medical III Pharmacy is of course not probative as to whether Dr. Armand obtained the missing crash cart medications after the inspection because the invoice indicates that the drugs were ordered before the inspection. Furthermore, Dr. Armand’s unsigned correspondence indicating that he had “resupplied” his emergency cabinet with adrenalin, calcium chloride, dextrose, dilantin, dopamine, and inderal is obviously problematic because it is unsigned and provides no objective proof of compliance. Scott Warren, M.D. Petitioner inspected Dr. Warren’s facility on April 11, 2001. The date that appears on his accreditation certificate is May 2004. Thus, his accreditation covers May 2001 through May 2004. During the inspection, Petitioner determined that Dr. Warren’s office did not have required intubation forceps. After the inspection, Dr. Warren provided Petitioner a copy of an order receipt from an unknown pharmaceutical vendor. The order receipt reflected that, on an unknown date, Dr. Warren ordered adult and child sized McGill Forceps (a type of intubation forceps). The invoice was not dated but a fax strip across the top reveals that Dr. Warren's office faxed a copy of the receipt to Petitioner on July 11, 2001. Ms. Sautner placed a hold on Dr. Warren’s accreditation certificate on June 22, 2001. The certificate had a fax date across the top of June 29, 2001. The copy of the Magill Forceps receipt was faxed to Petitioner ten days after Petitioner released the accreditation certificate to Dr. Warren. Therefore, Petitioner could not have verified compliance prior to the awarding of accreditation. Furthermore, this discrepancy cannot be attributed to Petitioner's 2003 audit because the fax receipt date was approximately one and a half years prior to the audit. Juan Flores, M.D. Petitioner inspected Dr. Flores' facility on July 21, 2002. The date that appears on his accreditation certificate is July 2005. Accordingly, his accreditation covers July 2002 through July 2005. During the inspection, Petitioner determined that Dr. Flores’ office did not have inderal (propranolol) or nasal airways. Dr. Flores provided Petitioner correspondence dated July 30, 2002, from a Laura Leyva. The correspondence indicated that Dr. Flores’ facility had acquired the requisite nasal airways. On November 14, 2003, Petitioner received a fax copy of an invoice numbered 9927 from Prime Medical Care, Inc. The invoice dated July 15, 2002, documents Dr. Flores' acquisition of inderal. Dr. Flores’ accreditation certificate had a fax date of September 6, 2002, across its top. The Prime Medical Care, Inc., invoice copy was faxed to Petitioner on November 14, 2003, over a year after the accreditation certificate was sent to Dr. Flores. Petitioner again explains this discrepancy by raising the 2003 audit excuse. However, the explanation does not explain why the compliance documentation was not in the file in the first place. Mina Selub, M.D. Petitioner inspected Dr. Selub’s facility on May 17, 2002. The date that appears on her accreditation certificate is May 2005. Therefore, her accreditation covers May 2002 through May 2005. During the inspection, Petitioner determined that Dr. Selub’s office did not have heparin, nasal airways, and intubation forceps. Dr. Selub sent Petitioner a copy of a customer packing slip on an unknown date. The customer packing slip revealed that Dr. Selub ordered heparin from McKesson Medical Surgical on May 3, 2002. The packing slip had a handwritten note indicating that the heparin was received on June 1, 2002. Dr. Selub also submitted a copy of a second customer packing slip to Petitioner on an unknown date. The second customer packing slip revealed that Dr. Selub ordered Magill Forceps from McKesson Medical Surgical on May 13, 2002. The packing slip had a handwritten note indicating that Dr. Selub did not receive the forceps, which were reordered from Henry Schein. Petitioner never received any other documentation indicating that Dr. Selub actually ordered or received intubation forceps. Additionally, Dr. Selub also failed to provide any documentation of compliance with the nasal airway requirement. Ms. Sautner placed a hold on Dr. Selub’s accreditation certificate on June 6, 2002. She released the hold on July 12, 2002. The accreditation certificate has a July 15, 2002, fax date across the top. The above-referenced invoice for heparin from McKesson Medical Surgical indicates that the medication was ordered before the inspection. However, the hand written notation on that same invoice indicates that Dr. Selub's office received the heparin on June 1, 2002. The lack of any documentation regarding the ordering and/or receipt of the intubation forceps is more problematic. Apparently Petitioner issued Dr. Selub's office an accreditation certificate without obtaining further written verification of compliance with accreditation standards. Abelardo Acosta, M.D. Petitioner inspected Dr. Acosta’s facility on November 17, 2001. The date that appears on his accreditation certificate is November 2004. Hence, his accreditation covers November 2001 through November 2004. During the inspection, Petitioner determined that Dr. Acosta’s office did not have the following required medications: succinylcholine, magnesium sulfate, heparin, dopamine, inderal (propranolol), and dilantin (phenytoin). Petitioner also discovered that Dr. Acosta’s office did not have the following required monitoring and/or emergency equipment: tonsillar suction and nasal airways. After the inspection, Dr. Acosta provided Petitioner with the following documentation: (a) a copy of a packing slip from Southern Anesthesia + Surgical dated November 26, 2001, reflecting that Dr. Acosta ordered dopamine, succinylcholine, dilantin, magnesium sulfate, and heparin; (b) a copy of a statement from Southern Anesthesia + Surgical dated July 15, 2002, which reflected that Dr. Acosta had ordered inderal (propranolol); (c) a copy of an invoice from Armstrong Medical Industries, Inc., with an order date of January 2, 2002, which reflected that Dr. Acosta ordered a suction unit; and (d) a copy of a packing slip from Physician Sales & Service dated December 3, 2001, reflecting that Dr. Acosta ordered numerous types of airways and a yankuar suction unit. Ms. Sautner placed a hold on Dr. Acosta’s accreditation certificate on December 5, 2001. She released the hold on December 12, 2001. The certificate has a December 12, 2001, fax date across the top. The statement from Southern Anesthesia + Surgical dated July 15, 2002, which reflected that Dr. Acosta ordered inderal, constitutes undisputed evidence that Petitioner did not verify Dr. Acosta’s full compliance with Petitioner's crash cart accreditation requirements prior to the awarding of actual accreditation on December 12, 2001. Charles Graper, M.D. (Level II Accreditation) Petitioner inspected Dr. Graper’s facility for level II accreditation on March 25, 2001. The date that appears on his accreditation certificate is March 2004. Thus, his accreditation covers March 2001 through March 2004. During the inspection, Petitioner determined that Dr. Graper’s office did not have dextrose 50 percent, a required medication. Dr. Graper failed to provide Petitioner with any subsequent documentation to demonstrate compliance with accreditation standards regarding the need to have dextrose 50 percent as part of the office’s crash cart. Ms. Sautner released Dr. Graper’s accreditation certificate on April 4, 2001. The certificate has a April 19, 2001 fax date across the top. Petitioner failed to verify that Dr. Graper obtained dextrose 50 percent for his crash cart after his inspection for level II surgery and before the release of his accreditation certificate by Petitioner on April 4, 2001. Leigh Phillips, III, M.D. Petitioner inspected Dr. Phillips' facility for level II and III surgery on January 31, 2002. The date that appears on his accreditation certificate is January 2005. Hence, his accreditation covers January 2002 through January 2005. During the inspection, it was determined that Dr. Phillips' office did not have the following required medications: dextrose 50 percent and 36 ampules of dantrolene (missing 18). After the inspection, Dr. Phillips provided Petitioner a copy of an order acknowledgment form from Southern Anesthesia + Surgical dated February 7, 2002. The order acknowledgment form reflected that Dr. Phillips ordered dextrose 50 percent. Dr. Phillips' inspection file also contained a handwritten letter from Dr. Mel Propis dated January 31, 2003. The letter indicated that Dr. Propis had just returned from the office of Dr. Phillips and while there he had counted 36 ampules of dantrolene and the dextrose 50 percent in the crash cart. Ms. Sautner did not know the date that she advised Scribes, Inc., to release Dr. Phillip’s accreditation certificate. However, her records indicate that the certificate was faxed to her on February 19, 2002. Dr. Propis’ correspondence dated January 31, 2003, verifying Dr. Phillips' receipt of the requisite dantrolene was provided to Petitioner approximately 11 months after Petitioner received a copy of Dr. Phillips' accreditation certificate. Such constitutes further undisputed evidence that FLACS did not verify Dr. Phillips' full compliance with accreditation standards prior to awarding him accreditation. Brandon Kallman, M.D. and Francisco Prado, M.D. (combined inspection) Petitioner inspected Drs. Kallman and Prado’s facility on June 2, 2002. The date that appears on their accreditation certificates is June 2005. Hence, their accreditation covers June 2002 through June 2005. During the inspection, Petitioner determined that the physicians’ office did not have the following required medications: adrenalin (1:10,000 dilution), magnesium sulfate, heparin, dopamine, pronestyl (procainamide), and dilantin (phenytoin). Drs. Kallman and Prado provided Petitioner with a copy of a packing slip from Southern Anesthesia + Surgical dated July 12, 2002. The packing slip reveals that Drs. Kallman and Prado ordered the missing adrenalin (epinephrine), dopamine, pronestyl (procainamide), and dilantin (phenytoin). However, as evidenced by the fax strip across the top of the packing slip copy, the documentation was provided to Petitioner via fax transmission on July 22, 2002. Drs. Kallman and Prado also provided Petitioner with a copy of a packing slip from Henry Schein. The packing slip is dated July 18, 2002. The packing slip has a date of July 23, 2002, on the fax strip across the top. The packing slip in the record is illegible. Therefore, one cannot determine whether the packing slip served as documentation for receipt of the missing magnesium sulfate and heparin. Additionally, Drs. Kallman and Prado provided Petitioner with copies of an e-mail dated October 14, 2002, and multiple photos dated October 11, 2002. The photos depict the facility’s crash cart, its drawers, and the presence of dantrium. The original inspection form dated June 2, 2002, did not reveal any missing dantrium. Finally, Dr. Kallman provided one more document which purports to be some attempt at curing the deficiencies that were discovered during the inspection. The document in question is a short handwritten letter on Dr. Kallman’s letterhead signed by Dr. Kallman and dated July 16, 2002. The body of the letter reads as follows: Herewith are the documents requested. I will fax tomorrow a copy of Ms. Mad. Katz RN ACLS certification. Let this letter also reflect that we have ordered from Henry Schein the appropriate missing drugs for the crash cart. They are currently on back order. I will send a copy of the shipping slip upon arrival. Ms. Sautner released Drs. Kallman and Prado’s accreditation certificate on July 17, 2002. The certificate contains a July 23, 2002, fax date across the top. It may be that the illegible packing slip from Henry Schein verifies the receipt of magnesium sulfate and heparin by Drs. Kallman and Prado. Even so, the packing slip was dated July 18, 2002, one day after Ms. Sautner released the accreditation certificate on July 17, 2002. Additionally, the packing slip from Southern Anesthesia + Surgical was provided to Petitioner after the accreditation certificate release date. Needless to say, the e-mail and multiple photos are dated almost three months after the release of the accreditation certificate. The inspection file for Drs. Kallman and Prado is particularly problematic because the handwritten correspondence from Dr. Kallman put Petitioner on notice that he and Dr. Prado did not yet have the requisite drugs needed to meet the accreditation standards. Nevertheless, the very next day, with no further verification, Petitioner released the accreditation certificate. Dr. Luis Zarate, M.D. Petitioner inspected Dr. Zarate’s facility for level II and III office surgery on September 14, 2002. The date that appears on his accreditation certificate is September 2005. Hence, his accreditation covers September 2002 through September 2005. During the inspection, Petitioner determined that Dr. Zarate’s office did not have the required 36 ampules of dantrolene. Petitioner's inspection file for Dr. Zarate does not contain any documentation of ordering or receipt of dantrolene by Dr. Zarate or by anyone else on his behalf. Ms. Sautner did not have a release date for Dr. Zarate’s accreditation certificate. The certificate had an October 3, 2002, fax date. When Petitioner inspected Dr. Zarate, he was working in the same facility as Drs. Kallman and Prado. It is possible that the dantrolene photo contained in Drs. Kallman and Prado’s inspection file was meant to document Dr. Zarate’s compliance with the dantrolene requirement. Even if that is the case, Drs. Kallman and Prado's dantrolene photos were dated October 11, 2002, which means that the photos were taken after Petitioner released Dr. Zarate’s accreditation certificate. Dr. Andrew Weiss and Dr. Anthony Rogers Petitioner inspected Drs. Weiss and Rogers’ facility on December 6, 2001. However, the date that appears on their accreditation certificates is November 2004. Hence, their accreditation covers December 2001 through November 2004. During the inspection, Petitioner determined that the physicians’ office did not have two required medications: pronestyl (procainamide) and inderal (propranolol). Drs. Weiss and Rogers provided Petitioner with a copy of an invoice from Henry Schein dated February 6, 2003. The invoice reveals that Drs. Weiss and Rogers ordered the missing pronestyl (procainamide) and inderal (propranolol). The inspection file also contains a printed statement under the title “Andrew Weiss, M.D.” which states that “[a]ll ACLS approved drugs were present at the time of accreditation. Inspector found no deficiencies.” However, during the hearing, Ms. Sautner admitted that the statement was inaccurate and inserted into the file by error. Ms. Sautner placed a hold on the certificates for Drs. Weiss and Rogers on December 5, 2001 and December 10, 2001. She did not know the release dates of the certificates. The fax date on the certificates was December 12, 2001. The above-mentioned Henry Schein invoice dated February 6, 2003, is persuasive evidence that Drs. Weiss and Rogers ordered and received the requisite pronestyl (procainamide) and inderal (propranolol) over one year after Petitioner received a copy of Drs. Weiss and Rogers’ accreditation certificates. Such constitutes undisputed evidence that FLACS did not verify Drs. Weiss and Rogers’ full compliance with FLACS’s accreditation standards prior to awarding accreditation. Richard Edison, M.D. Petitioner inspected Dr. Edison’s facility on April 22, 2001. The date that appears on his accreditation certificate is April 2004. Thus, his accreditation covers April 2001 through April 2004. During the inspection, Petitioner determined that Dr. Edison’s office did not have the following required medications: adrenalin (1:10,000 dilution), succinylcholine, dilantin (phenytoin), and lanoxin (digoxin). Petitioner also discovered that Dr. Edison’s office did not have the following required monitoring and/or emergency equipment: intubation forceps. Dr. Edison’s inspection file contains a handwritten letter dated May 7, 2001, from Pam Rolm, R.N. Ms. Rolm wrote the letter on the letterhead for Dr. Edison’s facility, Cosmetic Surgery Center. The letter reads in part as follows: This letter is in response to request for information for certification. The following medications have been updated and the expired ones disposed of: 1) phenytoin, 2) Lanoxin, 3) succinycholine, and 4) Albuterol Inhaler. We have a McGill forceps in both anesthesia carts and an extra pair in the ORI medication cart. Dr. Edison’s inspection file also contains three invoices from Prime Medical Care, Inc. All three invoices have a fax strip across the top with a February 14, 2003, date and the sender name of Cosmetic Surgery Center. The first invoice dated December 11, 2000, indicates that Dr. Edison ordered ephedrine sulfate 50mg/ml. The second invoice dated October 30, 2001, indicates that Dr. Edison ordered lidocaine, heparin, verapamil, procainamide, and phenylephrine. The third invoice dated April 25, 2001, indicates that Dr. Edison ordered succinylcholine, albuterol inhaler, phenytoin, and digoxin. Ms. Sautner testified that she ordered and placed a hold on the certificate for Dr. Edison on May 4, 2001. She released the hold on May 10, 2001. The certificate has a May 22, 2001, fax date across the top. The above-referenced correspondence dated May 7, 2001, does not address whether Dr. Edison ordered/obtained the missing adrenalin (1:10,000 dilution). Additionally, the first invoice is dated four months prior to the inspection. The second invoice is dated months after Petitioner released the accreditation certificate. The third invoice is appropriately dated but does not show that Dr. Edison ever ordered/obtained the missing adrenalin (1:10,000 dilution). Accordingly, Petitioner released Dr. Edison’s accreditation certificate before he documented compliance with the requirements that he possess adrenalin (1:10,000 dilution) and intubation forceps. Dr. Alton Ingram, M.D. Petitioner inspected Dr. Ingram’s facility on April 28, 2002. The date that appears on his accreditation certificate is April 2005. Therefore, his accreditation covers April 2002 through April 2005. During the inspection, Petitioner determined that Dr. Ingram’s office did not have a required tonsillar suction unit with backup suction. Dr. Ingram’s inspection file contains a copy of a photograph of a tonsillar suction unit with a hand-written date of July 29, 2002. Ms. Sautner placed the certificate for Dr. Ingram on hold on June 6, 2002. She released the hold on July 19, 2002. The date on the certificate is not legible. The date on the photograph of the tonsillar suction unit is after Petitioner released the accreditation certificate. Petitioner accredited Dr. Ingram before he documented full compliance with accreditation standards. Mont Cartwright, M.D. (Heathrow Facility) Petitioner inspected Dr. Cartwright’s Heathrow facility on March 3, 2001. The date that appears on his accreditation certificate is March 2004. Thus, his accreditation covers March 2001 through March 2004. During the inspection, Petitioner determined that Dr. Cartwright’s Heathrow office did not have the required dopamine, heparin, and inderal. In an undated letter, Dr. Cartwright’s staff advised Petitioner that Dr. Cartwright’s Heathrow facility had obtained the missing medications. Ms. Sautner released the hold on Dr. Cartwright’s accreditation certificate on April 4, 2001. The fax date on the certificate is April 19, 2001. Mont Cartwright, M.D. (Orlando Facility) Petitioner inspected Dr. Cartwright’s Orlando facility on May 13, 2001. The date that appears on his accreditation certificate is May 2004. Hence, his accreditation covers May 2001 through May 2004. During the inspection, Petitioner determined that Dr. Cartwright’s Orlando office did not have the required dilantin and heparin. Dr. Cartwright’s office staff sent Petitioner correspondence dated June 7, 2001. The letter claims that the “crash cart” in Dr. Cartwright’s Orlando facility had been “brought up to standards in accordance with compliance. ” Ms. Sautner testified that she released the hold on Dr. Cartwright’s accreditation certificate on June 22, 2001. The fax date on the certificate is June 28, 2001. Inadequate Quality Control Petitioner asserts that it has appropriate quality assurance programs and processes which Respondent reviewed without objection. Dr. R. Gregory Smith, one of Petitioner’s current co-directors for facility inspections, describes Petitioner's quality assurance program in the following manner: Right. We have regular board meetings. We go over the forms and changes and things like that. We talk to inspectors and say, you know, try to check all the boxes and that type of thing. Q. You basically go over your work again – A. Yes. – make sure everything is accurate? A. Right. Plus, I think the actual meeting with the Board of Medicine to iron out any issues is also quality assurance. Petitioner's renewal application included a two-page document titled, “Quality Improvement Plan.” The document can best be described as a description of the quality assurance exercises for physicians' offices. The document does not describe Petitioner's internal quality assurance program. Other than the above-quoted description provided by Dr. Smith, Petitioner failed to present any evidence that outlines Petitioner’s own quality assurance program. In fact, the manner in which Petitioner deals with its own errors indicates that Petitioner has inadequate quality assurance processes. In situations where an inspector fails to check yes or no on an item when conducting an inspection, Petitioner takes the position that an inspector is not to make any changes after the fact. Rather, Petitioner claims that it assumes the worse, treats the blank as a no answer, and asks the physician undergoing inspection to provide a letter of attestation, a packing slip, or some other material that documents compliance with the accrediting standard. Petitioner's inspection files reveal instances where Petitioner did not follow the above-referenced quality assurance policy. For example, the inspection form for Harold Reed, M.D., revealed no check under yes or no on page 3 under the crash cart medication succinylcholine. After the inspection, Dr. Reed did not provide Petitioner with any materials documenting compliance with the requirement to have succinylcholine on the facility's premises. It may be that the inspector made a clerical error during the inspection or he may have remembered seeing the medication in Dr. Reed's refrigerator after the inspection. In any event, Petitioner did not follow its alleged quality assurance policy of requiring the physician to show compliance after the inspection. Dr. Leonard Rubinstein’s inspection file presents another example of Petitioner's failure to follow its alleged quality assurance policies. The inspection form reveals no check under yes or no on page 3 under the crash cart medications lasix and magnesium sulfate and on page 4 under oximeter in the monitoring and emergency equipment section. After the inspection, Dr. Rubinstein did not provide Petitioner with any documentation showing the presence of the missing items. Petitioner did not attempt to determine whether the inspector had made a “clerical error” or whether Dr. Rubinstein procured the missing items. In other words, Petitioner did not follow its own policy regarding the treatment of situations where the inspector fails to check no or yes on an inspection item. Dr. Michael Freeman’s inspection file presents another example of Petitioner’s failure to follow its alleged quality assurance policies. Dr. Freeman’s inspection form reveals no check under yes or no on page 3 under the crash cart medication mazicon. The inspection file contains no deficiency documentation, and thus, does not address the mazicon issue. Again, Petitioner did not follow its own policy regarding the treatment of situations where the inspector fails to check no or yes on an inspection item. Conditions Posing a Potential Immediate Threat Dr. Hector Vila, Jr., a licensed Florida physician and an Assistant Professor of Anesthesiology and Oncology at the University of South Florida, H. Lee Moffitt Cancer Center, testified during the final hearing on the issue of whether any of the facilities inspected by Petitioner posed a potential immediate threat to patients due to the deficiencies discovered during the inspection. Dr. Vila has administered anesthesia in office surgery settings in the past and currently serves as an office surgery inspector for the Respondent. Dr. Vila is an expert in office surgery and anesthesia. His testimony regarding Petitioner's failure to report conditions posing a potential immediate threat to patients is persuasive. For example, the office of Marwan Shaykh, M.D, posed a potential immediate threat to patients because it did not have nitroglycerin and epinephrine (adrenalin) on the premises. Such medications are necessary to resuscitate a patient who may suffer a respiratory arrest due to either a surgical or anesthetic complication. It would be nearly impossible to resuscitate a patient without such items. Dr. Shaykh failed to provide documentation of compliance with the nitroglycerin and adrenalin requirement until August 15, 2002, or sometime thereafter. Dr. Shaykh demonstrated compliance approximately two months after Petitioner recognized Dr. Shaykh as being accredited. It is true that Dr. Shaykh’s office was located adjacent to a hospital. Therefore, it is possible that the same teams that respond to emergencies in the hospital could go to Dr. Shaykh's office if he needed them. It is also true that Dr. Shaykh performs in vitro fertilization procedures, which could be terminated in case of an emergency. However, after Petitioner recognizes Dr. Shaykh as being accredited, he could practice any type of medicine and perform any procedure as long as he is properly trained to do so. Furthermore, the office surgery accreditation rules do not provide any type of exemption based on the location of the physician’s office because to do so would undermine the reason for the rule. Office surgery facilities are not hospitals no matter how close to the hospital they may be located. If Dr. Shaykh felt that his close proximity to the hospital did not make compliance with the office surgery rules necessary, he should have filed a petition for waiver or variance from the relevant rules rather than ignore the need to have crucial resuscitative drugs in his crash cart. The office of Karen Chapman, M.D., posed a potential immediate threat to patients because it lacked 16 of the 22 medications required in an office surgery facility’s crash cart. The office also lacked an ambu bag, a piece of equipment used to resuscitate patients. Two of the 16 missing medications were the nitroglycerin and adrenalin, which are absolutely necessary to resuscitate a patient who may suffer a respiratory arrest due to either a surgical or anesthetic complication. The ambu bag is also used on patients under respiratory arrest and it is considered a crucial piece of equipment. Dr. Chapman’s office failed to provide documentation of compliance with the crash cart requirements until February 12, 2003. She did not demonstrate compliance until approximately nine months after she obtained her accreditation. Dr. Chapman may have informed Petitioner that she did not intend to open her new practice until she obtained accreditation. However, Dr. Chapman obtained her accreditation and presumably opened her practice almost nine months before she provided Petitioner with documentation of her compliance with the crash cart medication requirements. She never provided any materials documenting whether she obtained the required ambu bag.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent enter a final order denying Petitioner’s application for renewal as an office surgery accrediting agency. DONE AND ENTERED this 15th day of April, 2004, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of April, 2004. COPIES FURNISHED: Alfred W. Clark, Esquire 117 South Gadsden Street, Suite 201 Post Office Box 623 Tallahassee, Florida 32302-0623 Edward A. Tellechea, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 Rosanna Catalano, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
