Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
Findings Of Fact HRS stipulated that the challenging parties, petitioners and intervenor, are substantially affected by, and so have standing to challenge, the memoranda in question. According to the pleadings, the challengers are existing providers of surgical services faced with the prospect of increased competition from competitors likely to receive certificates of need for ambulatory surgical centers under the HRS policy articulated in the challenged memoranda. On June 6, 1985, Robert Maryanski, administrator of HRS' Office of Community Medical Facilities, "issued to staff regarding the review of ambulatory surgical [c]ertificate of [n]eed applications," (T. 71) including applications for certificates of need for limited or specialty ambulatory surgical centers, Deposition of Marta Hardy, p. 23, the following: PDCF POLICY MEMORANDUM #7 JUNE 6, 1985 SUBJECT: Policy on CON review of ambulatory surgical center proposals TO: PDCF (Liz Dudek) PDCF (Paul Reilly) PDCF (Wayne McDaniel) PDCF (Joe Mitchell) The following policies will be employed by this office in the review of ambulatory surgical center CON applications: Based upon a review of available literature and outpatient surgical information obtained from the American Hospital Association Survey, a 30 percent factor will be used as the optimum number of surgeries to be performed on an outpatient basis. In all instances, the potential for outpatient surgeries will be determined at a county level. "Specialty" ambulatory surgical center (e.g., opthalmic) will not be given special consideration. The break even level of operations approach is considered adequate to assess the potential for such facilities. In those instances when the outpatient surgical potential in a county is calculated to be slightly below the applicant's projected break even level of operation and there is no existing and/or approved ambulatory surgical center in the county-consideration will be given to approving the application, assuring all other appropriate criteria are satisfied, to foster competition for outpatient surgery as an alternative to more costly inpatient surgery. Proposals which include a captive population (e.g., health maintenance organization) will be given additional consideration as required by appropriate statutory criteria (e.g., Chapter 381.494(6)(c), Florida Statutes.) If "pre-existing clinics, which have been performing surgical procedures similar to those approval of the project, after assuring that all other appropriate criteria are satisfied. An architectural review will be conducted to verify that the existing facility meets, or will be capable of meeting, licensure requirements. In those instances, in which a hospital makes application for outpatient surgical capabilities or an increase in its existing outpatient surgery capability via the establishment or expansion of operating rooms dedicated to outpatient surgery, the hospital's current level of outpatient surgical procedures will be subtracted from the total hospitals' outpatient surgical procedures. The hospitals' outpatient surgical rate (minus the applicant hospital) will be computed separately from the applicant's outpatient surgical rate. The county's projected population will be used to project hospitals' (minus the applicant hospital) outpatient volume, as well as existing ambulatory surgical facilities' volume. These figures will be subtracted from the total outpatient surgical "pool" projection. The 2nd year break even point number of procedures for approved ambulatory surgical facilities (which either are not in operation or have not operated a full year), is next subtracted from the total "pool." At this point, the projected number of outpatient procedures which would be performed at the applicant hospital, is compared to the remainder from the previous calculations. Should the projected outpatient level equal or exceed the calculated break even level of operation, consideration will be given to approving the application, assuring all other appropriate criteria are satisfied. In the case of hospital ambulatory Surgical projects which do not involve additional operating rooms dedicated to outpatient surgery, the above ambulatory surgery methodology will not be used. Licensed and existing ambulatory surgical centers which have been operational one year or more, will be surveyed to determine the number of procedures performed over one year. These procedures will be applied to the projected population and deducted from the total outpatient potential as described above. In the case of those approved but unlicensed ambulatory surgery methodology will not be used. Licensed and existing ambulatory surgical centers which have been operational one year or more, will be surveyed to determine the number of procedures performed over one year. These procedures will be applied to the projected population and deducted from the total outpatient potential as described above. In the case of those approved but unlicensed ambulatory surgical centers, the previously calculated break even level of operation will be deducted from the total outpatient potential. In all instances, the projected year of operation will be based on the time required for construction, if appropriate, as reflected in the application plus two years from the date of this office's review. "Procedures" include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all other invasive procedures regularly construed of as surgeries. If you have any questions regarding this policy, please contact me upon receipt. This policy is effective on June 15, 1985. Petitioner's Exhibit A The June memorandum stated policy substantially similar to a memorandum authored by Mr. Maryanski's predecessor on February 21, 1985, which contained at least some of the elements of the policy that HRS applied earlier than October 9, 1983, Deposition of Nelson, p. 5, and even as early as December of 1982, Deposition of Porter, p. 11, and which reads: TO: PDCF STAFF SUBJECT: UPDATED POLICY ON CON REVIEW OF AMBULATORY SURGERY PROPOSALS At a meeting with Doug Mannheimer, members of PDCFR, and myself on February 14, the following guidelines for reviewing CON proposals for ambulatory surgery were agreed upon: Effective immediately, we will use 30 percent as the optimum number of surgeries to be performed on an outpatient basis as opposed to 29 percent. health maintenance organizations. The issue of how to deal with "pre-existing" unlicensed ambulatory surgery providers was also discussed. It was decided that if an applicant can demonstrate that it has been providing ambulatory surgical services historically in a facility which meets, or for a minor capital expenditure could meet, licensing requirements and that the provision of such services has been done profitably, this type of applicant should receive special consideration in CON reviews. However, in such cases, it will be necessary for the CON architect to verify that the existing facility meets, or almost meets, licensure requirements, and for the CON accountant to verify that the operation has historically been profitable. Data base issues were discussed. PDCFR was informed of the decision to remove the ambulatory surgery data collection burden from Nell Mitchem. The possibility of having PDCH and/or the local health councils collect such information on a semi-annual basis was discussed and will be explored further by Tom Porter. The method of counting procedures of existing ambulatory surgery centers was considered. The pros and cons of utilizing the center's break even point as described in its CON application versus its actual use was debated. It was decided that existing ambulatory surgery centers which have been in business one year or more will be surveyed to determine their actual use. In the case of those existing centers in business less than one year, the break even point will be used. The issue of counting dedicated hospital-based ambulatory surgery facilities was discussed. It was decided that in instances where a hospital applies for ambulatory surgical capabilities or an increase in that capability via the establishment or expansion of operating rooms solely dedicated to outpatient surgery, the hospital's current provision of outpatient surgery will be subtracted from the total of outpatient surgeries performed and then converted to an institution-specific rate and applied to projected population to determine the need. In the case of hospital ambulatory surgery projects not involving additional operating rooms or solely dedicated outpatient operating rooms, the ambulatory surgery methodology will not be employed. In these instances, the review will be primarily architectural. The definition of "procedures" was considered. It was determined that procedures should include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all procedures regularly thought of as surgeries. establishment or expansion of operating rooms solely dedicated to outpatient surgery, the hospital's current provision of outpatient surgery will be subtracted from the total of outpatient surgeries performed and then converted to an institution-specific rate and applied to projected population to determine the need. In the case of hospital ambulatory surgery projects not involving additional operating rooms or solely dedicated outpatient operating rooms, the ambulatory surgery methodology will not be employed. In these instances, the review will be primarily architectural. The definition of "procedures" was considered. It was determined that procedures should include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all procedures regularly thought of as surgeries. The method of computing the break even point was discussed. Tom Porter will work with Joe Mitchell to come up with an improved method for doing this. The issue of what year we project need to was discussed. It was decided that in all cases, the projection year would be based on the time shown in the application as required for construction and licensing of the facility plus two years from the date of the HRS review or date of administrative hearing, whichever is later. If you have any questions concerning this memorandum, please see me. /s/ Gene W. Eugene Nelson, Administrator COMMUNITY MEDICAL FACILITIES Petitioner's Exhibit B. The June memorandum supersedes the February memorandum but "not totally." Deposition of Marta Hardy, p. 10. The June memorandum made changes regarding the treatment of hospitals' applications. Deposition of Elizabeth Dudek, p. 23. On September 13, 1985, more than two weeks after the petitions had been filed in Cases Nos. 85-2962RX and 85-2963RX, Mr. Maryanski signed the following memorandum: SUBJECT: Policy Memorandums TO: PDCF (Liz Dudek) (Wayne McDaniel) (Paul Reilly) (Joe Mitchell) Policy memorandums are statements of the current policy of the Office of Community Medical Facilities, and the Department of Health and Rehabilitative Services, regarding the subject to which it is addressed. The policy at issue is in a state of development, and should not be considered to have reached a level of general applicability to all cases. This memorandum is not intended to dictate the out-come of action being taken on any given case, but rather represents a momentary picture of this policy as it has developed through cases previously encountered. In order to provide for reasonably consistent actions taken in similar instances in this office, please utilize this policy memorandum as a guideline, subject to change and development on a case basis. Respondent's Exhibit No. 1 At some point staff were told "if there are reasons to deviate [from the policy embodied in the June memorandum] that they should come and discuss those reasons with their supervisor or" (T. 73) Mr. Maryanski. At least some HRS staff adhere to the policy stated in the June memorandum. Deposition of Elizabeth Dudek, p. 28. But the only reasons for deviating from the policy set out in the Maryanski memorandum of June 6, 1985, are the very reasons that would justify deviation from duly promulgated administrative rules. (T. 77) Petitioner's Exhibit A, the June memorandum, has application statewide and is addressed to all applications for certificate of need for ambulatory surgical centers. (T. 77) Without this policy in effect, "the only means [HRS] would have available would be to review am-surg applications according to statutory criteria." (T. 73) HRS has assigned to its Office of Comprehensive Health Planning, not to its Office of Community Medical Facilities (headed by Mr. Maryanski and, before him, by Mr. Nelson), responsibility for promulgating administrative rules. On July 6, 1984, HRS published notice of intent to adopt a rule governing applications for certificates of need for ambulatory surgical centers, at 10 Florida Administrative Weekly No. 27, pp. 2064-2067. Petitioner's Exhibit C. Additional or amended notice was published on March 15, 1985, at 11 Florida Administrative Weekly No. 11. After petitions challenging HRS' proposed rule 10-5.11(30) were filed, HRS abandoned the effort formally to adopt a rule specifying the criteria for granting certificates of need for ambulatory surgical centers, by filing notice of withdrawal with the Department of State on June 20, 1985. On deposition, HRS' Deputy Assistant Secretary for Health Planning testified that the June "memo was issued right after we withdrew the rule." At 6. Although in fact the notice of withdrawal of proposed rule 10-5.11(30) was not filed until after the June 6 memorandum was executed, the decision to withdraw the proposed rule, to judge from this testimony, antedated the memorandum which "in the absence of any kind of methodology, [HRS] decided to issue. . . to provide methodology guidelines to the staff within the office." Deposition of Marta Hardy, p. 6.
The Issue The issue in this case is whether Petitioner's application for a license by endorsement to practice medicine in the State of Florida should be granted or denied.
Findings Of Fact Petitioner is a medical doctor. Petitioner graduated medical school from the University of Miami in Miami, Florida, in May 1994. Petitioner signed an application for medical licensure by endorsement with the Board on January 9, 2003. On or about January 16, 2003, the Department of Health received Petitioner’s application for medical licensure by endorsement. Following receipt and review of the subject application, Petitioner was required to provide some additional information to the Board. Petitioner was eventually required to appear before the Credentials Committee of the Board to answer questions about his application. On October 17, 2003, the Board issued a Notice of Intent to Deny Licensure, in which the Board notified Petitioner of its intent to deny his application. That notice read as follows, in pertinent part: This matter came before the Credentials Committee of the Florida Board of Medicine at a duly-noticed public meeting on September 13, 2003 in Tampa, Florida[,] and the full Board on October 3-4, 2003, in Ft. Lauderdale, Florida. The applicant appeared before the Credentials Committee on September 13, 2003, and presented testimony regarding the application file. The application file shows: The applicant lied before the Committee and lied on the licensure application as to the following: the applicant took a leave of absence during his training; the applicant was placed on probation at 3 schools; the applicant did not finish his training in the normal time frame; and, the applicant answered #15 b, c, d and #31 incorrectly on the application. The applicant is guilty of violating Section 458.331(1)(gg), Florida Statutes, for misrepresenting or concealing multiple material facts at any time during any phase of a licensing or disciplinary process or procedure. Based on the foregoing, the Board may refuse to certify an applicant for licensure, or restrict the practice of the licensee, or impose a penalty, pursuant to Sections 458.3331(2) and 456.072(2), Florida Statutes. It is therefore ORDERED that the application for licensure be DENIED. Petitioner attended the following four postgraduate training programs (residency programs): Medical College of Pennsylvania; Sinai Hospital1; Wayne State University/Detroit Medical Center; and University of Medicine and Dentistry of New Jersey (“UMDNJ”). Petitioner’s dates of attendance in those four residency programs were as follows: Medical College of Pennsylvania from July 1, 1994 to June 30, 1995. Sinai Hospital from July 1, 1995 to June 30, 1999. Wayne State University/Detroit Medical from July 1, 1999 to June 30, 2001. UMDNJ from July 1, 2001 to June 30, 2003. Question number 15a on the application for medical licensure by endorsement asks, “Have you ever been dropped, suspended, placed on probation, expelled or requested to resign from a postgraduate training program?” Petitioner answered “yes” to question number 15a and submitted a written supplemental answer which stated, “I was placed on probation regarding the expectations of running a University service in a manner that kept attending physicians informed of patients’ clinical changes in July of 2000. Specific goals were given to me that I immediately fulfilled and was taken off probation in September of 2000 and remained in good academic standing until the time of my graduation.” On his application for licensure, Petitioner only admitted to being on probation at one residency program, Wayne State University/Detroit Medical Center. During the processing of the subject application, an employee of the Department of Health, Wendy Alls, advised Petitioner as follows by e-mail: “We are in receipt of your response to the inquiry from Wayne State University [Sinai Hospital], regarding your Residency from 7/95 to 6/99. It indicates that you were placed on probation and received negative reports. It also stated that limitations were placed upon you due to academic incompetence. Please respond.” On May 6, 2003, Petitioner submitted an e-mail response to Wendy Alls regarding his probation at Wayne State University [Sinai Hospital] which stated: “It is true that I did receive negative reports during my residency training from 7/95 to 6/99 for my work ethic. However, I was never formally placed on probation as per the guidelines of the Wayne State University. I, as well as the Graduate Medical Education Office, must receive formal written notification identifying the areas of deficiency and the duration of the probation period. Written notification must be submitted to both the GME office and myself after successful completion of the probation period. This was never done. In addition, no limitations or restriction were ever placed upon me due to academic incompetence or for any other reason for that matter.” Petitioner did not admit this on his initial application to the Florida Board of Medicine. Sinai Hospital submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital submitted a report to the Federation Credentials Verification Service (“FCVS”)2 and stated on the report that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital reported that Petitioner was placed on probation during his residency in response to faculty concerns regarding both academics and behavior. While at Sinai Hospital, Petitioner was informed of the issues he needed to improve during his probationary period. These issues included, but are not limited to the following: Petitioner’s tardiness, sleeping during conferences, unavailability when on call, failing to follow hierarchy, and inability to carry his share of the workload. Petitioner admitted at the formal hearing he was told that he was on probation at Sinai Hospital. During his appearance before the Credentials Committee on September 13, 2003, Petitioner testified under oath, that he did not disclose the fact he was on probation at Sinai Hospital because he was never informed that he “was ever placed on probation.” A letter dated November 4, 1999, from Dr. Andrew Saxe (who was then the general surgery residency program director at Sinai Hospital) states that Petitioner was on “probationary status” at Sinai Hospital during his residency from 1996 to 1997. Dr. Andrew Saxe also noted Petitioner’s probationary status in a memo dated April 28, 1999, which Petitioner himself signed. Petitioner signed a memo dated December 18, 1996, stating that he was on “probationary status” at Sinai Hospital during his residency. Petitioner also signed a memo dated April 16, 1997, stating that he was “off probationary status” at Sinai Hospital during his residency. Wayne State University/Detroit Medical Center submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1999 to 2000. Petitioner failed to fully disclose all of the reasons why he was placed on probation at Wayne State University/Detroit Medical Center. Wayne State University/Detroit Medical Center submitted a report to the FCVS and stated on the report that Petitioner was on academic probation during his residency for four months beginning in September 2000. The report stated that the probation was based on evaluations which cited “inadequate performances in clinical application of knowledge especially recognitions of own capabilities and limitations. There were also concerns over attention to details and work habits.” Petitioner’s supplemental answer to question 15a does not fully disclose his deficiencies in clinical knowledge and work habits at Wayne State University/Detroit Medical Center. At all times material to this case, Dr. Mark Granick has been the director of the plastic surgery program at UMDNJ. UMDNJ submitted a Training Evaluation Form to the Florida Board of Medicine and stated on the form that Petitioner was on academic probation during his residency “due to poor in-service exam scores.” After UMDNJ submitted the Training Evaluation Form, Petitioner contacted Dr. Mark Granick to discuss his probation at UMDNJ and the “program’s specifications in defining probation.” Dr. Mark Granick was prompted to send a second Training Evaluation Form to the Board, changing the substance of the first submitted Training Evaluation Form. The second Training Evaluation Form to the Board was submitted along with a letter from Dr. Mark Granick dated February 14, 2003, which stated he made an error in filling out the original form. When Dr. Mark Granick drafted Petitioner’s Fourth- Quarter Report on May 31, 2002, he was “documenting the reasons why I wanted him on a period of supervision, which I thought of as probation at that point in time.” Petitioner’s Fourth-Quarter Report dated May 31, 2002, was in fact signed by Petitioner. The Fourth-Quarter Report documented that Petitioner was “deficient on multiple occasions” with regard to Patient Care; Petitioner had a “poor acquisition of a central knowledge base in Plastic Surgery”; Petitioner’s tardiness needed to “stop”; Petitioner demonstrated “immaturity” in interpersonal skills; and, Petitioner had “been acting in an unprofessional manner.” Petitioner signed a memo dated January 8, 2003, stating that he was placed on “probation” at UMDNJ during his residency due to “poor performance on the in-service examination and overall perception of weakness in academic level.” Dr. Mark Granick testified that when he used the term “probation” in the January 8, 2003, memo, the word was consistent with his own thinking, and not consistent with university definitions. Dr. Mark Granick stated that Petitioner indicated to him during their meetings at UMDNJ that Petitioner understood he was on “probation” at UMDNJ. Dr. Mark Granick testified that in his mind he considered it “probation” when he put Petitioner under direct supervision, gave Petitioner academic support, and advised Petitioner of the areas in which he needed to improve. Although the period of academic supervision imposed on Petitioner did not qualify as probation at the university level, it did constitute “probation” in the mind of Dr. Mark Granick and was understood to be “probation” by the Petitioner himself. Petitioner misrepresented to the Board the circumstances which caused him to be placed on probation at Wayne State University/Detroit Medical Center. He also misrepresented his understanding of his probationary status at both Sinai Hospital and UMDNJ. Question number 15c on the subject application asks: “Did you take a leave of absence during a postgraduate training?” Petitioner answered “no” to question number 15c on the application. But Wayne State University/Detroit Medical Center documents show that Petitioner took a month-long leave of absence. Petitioner asserts that his month-long leave of absence from Wayne State University/Detroit Medical Center was not a “leave of absence” because he used a combination of sick time and vacation time. However, Petitioner signed a Family Medical Leave Act Certification asking for a leave of absence due to his being “unable to perform work of any kind” while training at Wayne State University/Detroit Medical Center. Petitioner requested a leave of absence for one month from his training program at Wayne State University/Detroit Medical Center in March of 2001. While on leave in March 2001, Petitioner was hospitalized for benzodiazepine poisoning, pace maker insertion, and possible seizure disorder secondary to cardiac rhythm disturbance. After Petitioner’s hospitalization, Petitioner needed to have a letter clearing him to resume unrestricted activity. During this period of time Petitioner was also told that he should avoid driving motor vehicles. Once questioned by the Credentials Committee, Petitioner admitted to taking a leave of absence in 2001 while training at Wayne State University/Detroit Medical Center. Prior to being questioned by the Credentials Committee, Petitioner concealed from the Florida Board of Medicine that he took a leave of absence while at Wayne State University/Detroit Medical Center. Question number 31 on the subject application asks “In the last five years, have you been treated for or had a recurrence of a diagnosed physical impairment?” Petitioner answered “no” to question number 31 on the application. However, after questioning by the Credentials Committee, Petitioner admitted he had a pacemaker. After his hospitalization, Petitioner had to be cleared by his doctors to return to his duties as a resident. Despite Petitioner’s own definition of “physical impairment,” he concealed his hospitalization, pacemaker, and possible seizure disorder from the Board. Question number 15b on the subject application asks “Was attendance in a postgraduate training program for a period other than the established time frame?” Petitioner answered “no” to question number 15b on the application. Petitioner attended the General Surgery postgraduate training program at Medical College of Pennsylvania for one year from July 1, 1994, to June 30, 1995. Petitioner attended the general surgery postgraduate training program at Sinai Hospital for four years from July 1, 1995, to June 30, 1999. Petitioner attended the general surgery postgraduate training program at Wayne State University/Detroit Medical Center for two years from July 1, 1999, to June 30, 2001. As indicated by the foregoing, Petitioner spent seven years attending general surgery postgraduate training programs. Physicians applying for licensure by endorsement in Florida are required to show that they have completed an “approved residency program” in a “slotted” position. The Accreditation Council for Graduate Medical Education (“ACGME”) accredits postgraduate training programs, sets the standards for training programs, and determines the number of “slotted” positions a program has. The Board considers an “approved residency program” to be one that has been accredited by the ACGME. The Board relies on the ACGME in making determinations for licensure. The Board relies on the information provided in the ACGME directory when processing applications. The ACGME established time frame for completing a general surgery postgraduate training program is five years. The ACGME-established time frame for completing the postgraduate training program in general surgery at Medical College of Pennsylvania, Sinai Hospital, and Wayne State University/Detroit Medical Center was five years when Petitioner attended these programs. Thus, a five-year general surgery residency was considered standard by ACGME, the Medical College of Pennsylvania, Sinai Hospital, Wayne State University/Detroit Medical Center, medical educators, and residents like Petitioner. Therefore, Petitioner would have had to complete all his postgraduate training in general surgery within five years in order to have finished his training within the “established time frame.” It took Petitioner seven years to complete all of his postgraduate training in general surgery. Petitioner’s attendance in his general surgery postgraduate training programs was for a period other than the normal time frame established by both ACGME and by the programs he attended. Question number 15d on the subject application asks, “Were you required to repeat any of your postgraduate training?” Petitioner answered “no” to question number 15d on the application. A memo dated December 3, 1997, written by Dr. Andrew Saxe (general surgery residency programs director at Sinai Hospital) and placed in Petitioner's training file, included the observation that "this is a consequence of his being asked to repeat the current clinical year." In a memo dated April 28, 1999, also written by Dr. Andrew Saxe and also placed in Petitioner’s training file, Dr. Saxe stated, “in light of prior probation and concerns regarding clinical competency an additional year of training would be of service to him.” At final hearing, Petitioner himself explained that each postgraduate year (“PGY”) runs from July 1st of one year to June 30th of the following year. On the Verification of Postgraduate Medical Education form submitted to FCVS, Sinai Hospital listed Petitioner as only completing PGY 2 through PGY 4 while attending their program. On the Verification of Postgraduate Medical Education form submitted to FCVS Wayne State University/Detroit Medical Center listed Petitioner as completing PGY 4 and PGY 5 in their program. While attending his postgraduate training programs, Petitioner was continuously evaluated, as evidenced in his training files. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 2 from July 1995 through June 1997. That means Petitioner was a PGY 2 for two years. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 4 from July 1998 through June 2000. That means Petitioner was a PGY 4 for two years. Therefore, Petitioner repeated both PGY 2 and PGY 4 levels of training. As demonstrated by Petitioner’s postgraduate training files, Petitioner’s education levels of training did not consistently progress through the calendar years. Petitioner concealed from the Board that he had to repeat PGY 2 and PGY 4. Over the course of the last year, the Board has licensed at least 55 applicants who were found to have made one or more material misrepresentations on their licensure applications, or in the course of the licensure process.3 Over the course of the last year, the Board has licensed a number of applicants alleged to have made material misrepresentations regarding one or more of the issues raised in this matter. In a few cases that are arguably similar to the facts presented in this case, the Board has granted the license application, but with conditions that required the applicant to file a new application, to pay a new application fee, and to pay an administrative fine in the amount of $5,000.00.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order denying Petitioner’s application for medical licensure by endorsement. DONE AND ENTERED this 29th day of April, 2004, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of April, 2004.
The Issue Should Petitioner discipline Respondent for violating its order entered May 4, 1995, prohibiting Respondent from performing obstetric or gynecological surgical procedures without appearing before the Board of Medicine (Board) and demonstrating his ability to perform OB/GYN surgery with requisite skill and safety to patients? Section 458.331(1)(x), Florida Statutes.
Findings Of Fact Stipulated Facts Respondent is and has been at all times material hereto a licensed medical physician in the State of Florida, having been issued license number ME 0017399. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes. On or about May 4, 1995, the Board of Medicine issued a Final Order in Case No. 92-05546 imposing discipline on Respondent's license to practice medicine. This discipline was adopted by the Board of Medicine from a stipulated disposition ("consent agreement") voluntarily accepted by Respondent. Respondent does not now challenge the legality or validity of the May 4, 1995, consent agreement. The disciplinary terms of the May 4, 1995, consent agreement include, but are not limited to, the following restriction on Respondent's practice, in pertinent part: Respondent shall refrain from performing obstetric or gynecological surgical procedures until such time as he appears before the Board and Demonstrates that he may perform OB/GYN surgery with the requisite skill and safety to patients. For purposes of this Consent Agreement, OB/GYN surgery shall include, but not be limited to: abortion of a fetus, amniocentesis, dilation and curettage, delivery of a fetus, hysterectomy, PAP smear, cophorectomy, salpingectomy, tubal ligation, and any and all invasive procedures involving any portion of the reproductive organs of the human female, including the vulva, vagina, cervix, uterus, and adnexa of the uterus. Respondent did not appeal or otherwise legally challenge the May 4, 1995, Final Order of the Board of Medicine. At no time through July 1996 did Respondent physically appear before the Board of Medicine or petition the Board of Medicine with respect to the above stated restriction on his license and/or the demonstration [sic] to the Board that he could perform obstetric or gynecological surgical procedures as specified in the Final Order with the requisite skill and safety to patients. Between approximately January 1996 and July 1996, Respondent was employed as a physician at the Gulf County Health Department in Gulf County, Florida. During the period that Respondent was employed at the Gulf County Health Department, he performed PAP smears and gynecological cryosurgery. Irrespective of whether such violation was premeditated, intentional, or willful, Respondent violated the terms of the May 4, 1995, Final Order of the Board of Medicine by performing the gynecological procedures he performed during his practice at the Gulf County Health Department. At the time it was presented to the Board, Respondent received a copy of the Consent Agreement executed by him which formed the basis for the Board of Medicine Final Order. Respondent did not provide a copy of the Consent Agreement and/or the Board of Medicine Final Order to the Gulf County Health Department prior to or at the initiation of his employment there. Additional Facts At the time Petitioner imposed discipline against Respondent in Case No. 92-05546, Respondent appeared before Petitioner and an explanation was given concerning the circumstances involved with the discipline. Respondent signed the consent agreement leading to the discipline. The consent agreement included the statements of restrictions on Respondent's practice, the subject of the present case. Respondent had discussed entry into the consent agreement with counsel who represented his interests in Case No. 92-05546. While employed with the Gulf County Health Department in Gulf County, Florida, between January 26, 1996 and July 18, 1996, Respondent performed 21 PAP smears and two colposcopies/ biopsies in the Port St. Joe, Florida clinic. Respondent performed 29 PAP smears and one colposocopy/biopsy in the Wewahitchka, Florida clinic. In discussing the possibility that Respondent would be employed by the Gulf County Health Department, Respondent did not discuss with that agency the existence of the consent order which restricted his practice. Respondent mentioned a suit and the fact of his appearance before the Board of Medicine in the previous year, at the Board's behest, but not the consent order. Verna Mathes is the Community Health Nursing Director for the Gulf County Health Department. Ms. Mathes was involved with the efforts that lead to Respondent's employment with the Gulf County Health Department. Ms. Mathes spoke with someone at the State of Florida, Department of Business and Professional Regulation to ascertain whether Respondent's medical license was "in good standing," before Respondent was hired. That unnamed person replied that there were no disciplinary actions against Respondent's medical license. Subsequent to that conversation Respondent was hired. Before Respondent was hired by the Gulf County Health Department he telephoned the Board of Medicine and spoke to a secretary. His stated purpose for the call was to arrange to appear before the Board and "to know what steps I have to take in order to have any license up to date subject to the rules, whatever limitations had been posted." According to Respondent, the response by the secretary he spoke with was that the "register" does not show any limitation imposed upon Respondent's medical license. Assume that the communication from the person at the State of Florida, Department of Business and Professional Regulation was made to Ms. Mathes and that there was a communication from a secretary at the Board of Medicine made to Respondent. Assume the communications reflected the understanding which those persons had concerning Respondent's license status. This did not modify nor relieve Respondent of his obligation in Case No. 92-05546. That obligation was to abide by the restrictions on his practice in relation to the performance of OB/GYN surgery. Respondent could only engage in that surgical practice after appearing before the Board of Medicine and demonstrating the requisite skill and safety to patients in performing OB/GYN surgery. Any inquiry by Respondent and that by Ms. Mathes did not release Respondent from his obligation to appear. Once hired by the Gulf County Health Department, the OB/GYN surgeries that have been described were outside the expectations in the consent order related to Respondent's opportunities to practice medicine.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered which finds Respondent in violation of Section 458.331(1)(x), Florida Statutes, imposes a $5,000.00 fine, and requires twenty (20) hours of Continuing Medical Education in Obstetrics and Gynecology. DONE AND ENTERED this 7th day of April, 2000, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS 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 7th day of April, 2000. COPIES FURNISHED: Eric C. Scott, Esquire Agency for Health Care Administration Office of General Counsel Post Office Box 14229 Tallahassee, Florida 32317-4229 Thomas S. Gibson, Esquire Rish, Gibson and Scholz, P.A. 206 East Fourth Street Port St. Joe, Florida 32457 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact In the November 27, 1985 edition of The Florida Administrative Weekly, Volume 11, Number 48, the Board noticed Proposed Rules 21G-14.001(7) and 21G-14.005(1), Florida Administrative Code, which were timely challenged by petitioner and which provide as follows: 21G-14.001 Definitions. * * * (7) Office team approach - A methodology employed by a dentist in the administration of general anesthesia and parenteral conscious sedation whereby the dentist may use one or more qualified anesthetic auxiliaries who, working under the direct supervision of the dentists assist the dentist, and assist in emergency care of the patient. 21G-14.005 Application for Permit. (1) No dentist shall administer or super- vise the administration of general anesthesia, or parenteral conscious sedation in a dental office for dental patients, unless such dentist possesses a permit issued by the Board. The dentist holding such a permit shall be subject to review and such permit must be renewed biennially. The cited statutory authority for these proposed rules includes Sections 466.004(3) and 466.017(3), Florida Statutes. Parenteral conscious sedation is defined by proposed Rule 210-14.001(6), which is not challenged in this case, as 21G-14.001 Definitions. * * * (6) Parenteral conscious sedation - A depressed level of consciousness produced by the parenteral administration of pharma- cologic substances, that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command. This modality includes administration of medications via all parenteral routes, that is: intravenous, intramuscular, subcutaneous, submucosal, or inhalation. A patient who is receiving parenteral conscious sedation will frequently slip in and out of consciousness, or a state of general anesthesia. General dentists do not receive adequate training in undergraduate dental school in the administration of general anesthesia and the treatment of medical emergencies which may result there from, and are not qualified to administer general anesthesia or treat resulting medical emergencies. The evidence is undisputed that a dentist who lacks the additional training in general anethesia and parenteral conscious sedation, which would be required under these rules, is not capable of competently and safely administering anesthesia or sedation himself, and does not possess the ability to competently assess all risks attendant to the administration of general anesthesia or parenteral conscious sedation. Additionally, such a dentist is not able to competently assess whether a patient is an acceptable risk for anesthesia or sedation, or to react to medical complications that may arise, such as respiratory obstruction and arrest, allergic or idiosyncratic reaction to drugs, cardiac arrest, miocardial infarction, seizures, and hypertensive crises. Since general dentists without further training in anesthesia are not qualified to administer general anesthesia in their dental office, or treat resulting medical emergencies, they are also not qualified to supervise the administration of general anesthesia in their office. The educational training received by undergraduate dentists in accredited dental schools in the United States and Canada offers only a brief didactic exposure to general anesthesia and parenteral conscious sedation of about 48 classroom hours. Clinical training is not offered. It is only at the graduate level of training, internship or residency programs that dental schools are required to offer training in dealing with medical emergencies. The general dentist does not maintain the equipment necessary to deal with medical emergencies and life threatening occurrences. Life threatening medical emergencies can develop while a patient is under general anesthesia, and a dentist administering or supervising the administration of general anesthesia must be able to deal with such emergencies. Undergraduate dental schools devote less than twenty-one hours in their entire program to the handling and treatment of medical emergencies and the evaluation of patients, and this does not prepare a general dentist without further training to deal with such emergencies. Certified registered nurse anesthetists (CRNA) are licensed by the Board of Nursing as advanced registered nurse practitioners. According to Nursing Board Rule 210-11.22, Florida Administrative Code, amended June 18, 1985: 210-11.22 Functions of the Advanced Registered Nurse. All categories of Advanced Registered Nurse Practitioner may perform functions listed in Section 464.012(3), F.S. The scope of practice for all categories of ARNPs shall include those functions which the ARNP has been educated to perform including the monitoring and altering of drug therapies, according to the established protocol and consistent with the practice setting. Specific activities which a CRNA may perform are enumerated in Section 464.012(4)(a), Florida Statutes (1984 Supplement). However, Section 464.012(3) specifies that these activities must be within the framework of an established protocol and that a licensed medical doctor, osteopathic physician or dentist shall maintain supervision for directing the specific course of medical treatment on any patient. Thus, a CPNA is not authorized to work independently on patients, but must operate within established protocols and under supervision. In order to become a CRNA, a registered nurse with at least one year's clinical experience in critical care nursing has to graduate from a two year accredited nurse anesthetist program comprised of approximately 425 contact hours, and also conduct 450 administrations of anesthesia consisting of 800 hours of actual anesthesia time. Thus, a CRNA has more training and experience in the administration of anesthesia than a general dentist receives in undergraduate dental school. The proposed rules in question were adopted to preclude a general dentist from employing a CRNA to administer anesthesia in his office unless he has received training beyond undergraduate dental school in anesthesia and has obtained a permit from the Board. As expressed in the Purpose and Effect portion of the notice for these proposed rules: The effect of the proposed amendment will be further assurance that those dentists who are using anesthesia, and related forms of sedation, have met minimal standards designed to protect the public's health, safety and welfare . . . * * * The purpose of the proposed rules is to implement the provisions of Section 466.017 (3)(e), F.S., as enacted by the 1985 Florida Legislature. The rules are designed to insure that those dentists who utilize general anesthesia or parenteral conscious sedation in a dental office for dental patients on an outpatient basis meet certain minimum qualifications. It is the opinion of the Board that dentists who administer or supervise the administration of general anesthesia or parenteral conscious sedation on an outpatient basis must satisfy certain training, equipment, and staffing requirements prior to engaging in such activity. The effect of the proposed rules is the establishment of a permitting procedure, as well as the requirement that adverse occurrences resulting from the use of nitrous- oxide inhalation analgesia, parenteral conscious sedation, general anesthesia be reported. These new procedures and require- ments should enhance the protection of the public from-licensees who are otherwise not competent to use general anesthesia, parenteral conscious sedation, or nitrous- oxide inhalation analgesia. The Economic Impact Statement (EIS) accompanying these proposed rules states, in pertinent part that: The proposed amendment will have some economic impact upon those licensees who are currently authorized to use general anesthesia and parenteral sedation. Upon the effective date of these rules, these individuals will be required to pay a permit application fee as well as expend those funds necessary to bring their training, equipment, and staffing level up to the requirements of the proposed rules. The precise number of dentists to be affected by the proposals and the precise impact upon them, other than the permit application fee, is not known at this time. * * * The proposed rules should have an economic impact upon those dentists who currently admin- ister or supervise the administration of general anesthesia and parenteral conscious sedation. Although the proposed rules do not in any way affect a dentist's ability to utilize general anesthesia or parenteral conscious sedation in a hospital or other medical facility, the rules will require the dentist to obtain a permit and to maintain his office at certain equipment and staffing level. Aside from the permit appli- cation feed the precise economic impact upon those dentists who currently utilize general anesthesia or parenteral sedation is not known at this time. It is anticipated that any additional costs to the practitioner will be passed on to the consumer. The fact that patient costs might increase as a result of these proposed rules was supported by Petitioner's witnesses Ira Gunn and Barbara Quick, but neither witness offered any more detailed information about the economic impact of these proposed rules than is contained in the Economic Impact Statement. Further, Petitioner offered no evidence to show that the proposed rules would affect persons other than those referenced in the Economic Impact Statement. It has not been demonstrated that the Economic Impact Statement is either inadequate, misleading or inaccurate. The evidence in the record is insufficient to support a finding that Petitioner is a non-profit corporation registered in Florida and is composed of a majority of the licensed nurse anesthetists in Florida, that it is the only Florida association of general membership representing nurse anesthetists, or that many of its members will be substantially affected by these rules. There is no evidence of Petitioner's legal status, its purposes as reflected in any by-laws, its membership, or the number of members who will be substantially affected by the rules. Thus, Petitioner has not proven the allegations in its petition regarding its standing in this matter.
Findings Of Fact Petitioner is a hospital licensed by the State of Florida and is located in Jacksonville, Florida. Respondent, the affected state agency, as defined in Subsection 120.52(1), Florida Statutes, is responsible for the regulation of health care facilities, to include Petitioner. The Department also considers the question of provision of additional health care in the community through its certificate of need program. Intervenor has made application to provide ambulatory surgery in Duval County, Florida, through a freestanding surgery center. Jacksonville, Florida, is in Duval County. This case is part of a consolidated hearing process and is the companion matter to Saint Vincent's Medical Center, Petitioner v. State of Florida, Department of Health and Rehabilitative Services and Ambulatory Care - Duval Development Corp., d/b/a Jacksonville Surgical Center - Ambulatory Surgical Center, Respondents, D.O.A.H. Case No. 83-337 and Riverside Hospital, Petitioner v. State of Florida, Department of Health and Rehabilitative Services and Ambulatory Care - Duval Development Corp. d/b/a Jacksonville Surgical Center - Ambulatory Surgical Center, Respondents, D.O.A.H. Case No. 83-482. The first three days of the hearing were conducted on the dates alluded to in this order. That presentation was transcribed. In addition, deposition testimony was presented and accepted as part of the record in this matter. The campanion cases concern the propriety of the grant of a certificate of need to the Intervenor in this cause to allow construction and operation of a freestanding ambulatory surgery center which would be used for performing outpatient surgeries. At all times relevant to this case, Saint Vincent's had a department in which outpatient surgical procedures were performed and are expected to be performed in the future. With the advent of the establishment of the Intervenor's facility, that health care unit will be in competition with Petitioner in the realm of providing surgical procedures. As recently as 1975, Respondent knew that ambulatory surgery centers, such as that proposed by the Intervenor, would need permission to construct such a facility. This permission relates to the need to apply and receive a certificate of need from the Department. The authority for such regulation was pursuant to applicable provisions of Chapter 381, Florida Statutes. Notwithstanding this regulatory role to be fulfilled, Respondent did not undertake a program for enacting rules to consider the question of need for ambulatory surgical centers. This lack of rulemaking was primarily due to inactivity of applicants seeking ambulatory surgical center certificates of need. This circumstance changed in late 1982. In December, 1982, Respondent received approximately thirteen applications for ambulatory surgical center certificates of need, as contrasted with approximately ten applications over the prior three years. At the same time Respondent was in the throes of having to revamp its certificate of need review process related to the overall health industry, brought about by statutory changes which abolished health system agencies and created local health councils. In 1983, at the time of the hearings, Respondent had received 27 applications for ambulatory surgery centers. This glut of applications by would-be ambulatory surgical centers and the 1982 applications were examined without formal rules defining the need question, related to expected numbers of surgical procedures that might be conducted on an outpatient or ambulatory basis. The determination of this ratio of outpatient surgical procedures to inpatient surgical procedures is a vital part of the need question. 1/ Absent promulgated rules, Department officials began their attempt to ascertain the percentage comparison between outpatient and inpatient surgeries, as that item was involved in the establishment of a methodology for considering the need question. Based upon information provided by applicants for ambulatory surgery centers and its own research, Respondent concluded that anywhere from 18 to 40 percent of total surgeries could be expected to be outpatient surgeries. Having utilized a median projection related to population expectations in the certificate of need process, the Department decided to use a median projection for the expected percentage of outpatient surgery. Thus, 29 percent was selected as the percentage of outpatient surgeries in the total number of surgical procedures and that percentage was utilized in the computation of the number of expected outpatient surgical procedures. Utilization of this 29 percent factor in the computation of the number of procedures to be expected on an outpatient basis may be seen in Petitioner's Exhibit 2 and Respondent's Exhibit 1, application reviews. Once the Department decided to employ the 29 percent factor, it has consistently, on a statewide basis, utilized that factor in evaluating the question of the grant of certificates of need for ambulatory surgical center applicants. This has been done in more than one batch or cycle and was done in the instance of Intervenor's application which is at issue. Although the 29 percent factor is not the only determining element of the certificate of need process, it is an integral part of that process and can affect the outcome of the grant of the certificate, as has been the case in two instances alluded to in the course of the hearing. This policy choice by the agency is not emerging. It is not one of a series of approaches that have been experimented with in trying to arrive at a concluding agency position, prior to the formal adoption of a rule. This percentage factor has been the only number utilized in the review of all ambulatory surgery center applications commencing late 1982 to the time of final hearing in this action. This choice has not stood the test or scrutiny of the rulemaking process set forth in Section 120.54, Florida Statutes. Notwithstanding the stated willingness of the agency to modify its position when presented with a more credible method, that contingency or eventuality has not occurred and every applicant for ambulatory surgery center certificate of need has had its application measured against the 29 percent factor commencing December 1982, to the exclusion of other techniques suggested by applicants. In the face of the facts reported above and the record considered, and recognizing that the agency should be afforded an opportunity to establish a record basis for the utilization of the 29 percent factor, even if it were found to be an invalid rule, a decision was reached at the time of hearing on the question of the utilization of the 29 percent factor and whether it was a rule not duly promulgated. It was found that the 29 percent factor is an unpromulgated rule and could not stand as law without first being subject to an assessment of the quality of the record basis for the agency's policy choice. The argument related to this case may be found at pages 798 through 829 of the transcript. The ruling is announced at pages 829 through 832. Respondent subsequently presented additional evidence in support of its policy choice and that may be found in succeeding sections within the transcript. This written order memorializes the ruling announced at hearing.
The Issue In DOAH Case No. 04-0025, the issue is whether the Agency for Health Care Administrative (AHCA) correctly assigned conditional licensure status to Lady Lake NH, L.L.C., d/b/a/ Lady Lake Specialty Care Center (Lady Lake) for the period of August 26, 2003, through October 3, 2003. In DOAH Case No. 04- 1065, the issues are as follows: (a) whether Lady Lake committed a violation of 42 C.F.R. Section 483.25, as it relates to care of patients with or who develop pressure sores; (b) whether Lady Lake committed a violation of 42 C.F.R. Section 483.75, as it relates to clinical records; and (c) if so, what, if any, penalty should be imposed.
Findings Of Fact AHCA is the agency that is responsible for licensing nursing homes and for enforcing Chapter 400, Part II, Florida Statutes, and Florida Administrative Code Chapter 59A-4. This includes enforcement of federal nursing home regulations in the Code of Federal Regulations specifically referenced in this case. Lady Lake owns and operates Lady Lake Specialty Care Center (the facility), a 120-bed skilled nursing facility located in Lady Lake, Florida. The facility operates under license # SNF130470994. At all times material here, the facility was licensed under AHCA's authority. Accordingly, the facility was required to comply with all applicable statutes, rules, and regulations. The facility is a long-term care provider under Medicaid and Medicare. As such, it is subject to federal regulation relating to compliance with 42 CFR Section 483. AHCA has the statutory authority and mandated duty, pursuant to Section 400.23(7), Florida Statutes, to evaluate all nursing homes facilities periodically (at least every 15 months). After each such evaluation, AHCA must assign a licensure status of "standard or conditional" to each licensee. On or about August 26, 2003, AHCA conducted a monitoring survey at the facility. As a result of the survey, AHCA cited the facility for a quality of care deficiency. AHCA based the deficiency upon finding of an alleged lack of proper care of one male resident (hereinafter referred to as "the resident"). More specifically, the citation was for an alleged violation of 42 CFR Section 483.25(c), which pertains to quality of care as it relates to pressure sores. A violation of 42 CFR Section 483.25(c) is commonly referred to as a Tag F-314 deficiency. AHCA determined that the scope of the Tag F-314 deficiency was isolated. AHCA also determined that the nature of the Tag F-314 deficiency was a Class II violation. Pursuant to leave granted, AHCA also charged Lady Lake with violating 42 CFR Section 483.75(l)(1), and/or Section 400.141(21), Florida Statutes, by failing to properly document treatment and care. This violation is commonly referred to as a Tag F-514 deficiency. AHCA determined that the scope of the Tag F-514 deficiency was isolated. AHCA concluded that the Tag F-514 deficiency was a Class II violation. AHCA assigned conditional licensure status to the facility for the period August 26, 2003, to October 3, 2003. AHCA seeks to impose an administrative fine in the amount of $2,500 for the Tag F-314 deficiency and $2,500 for the Tag F-514 deficiency. Lady Lake admitted the 81-year-old resident to the facility on July 31, 2003. At that time, the resident was severely contracted and bedridden. He had much comorbidity, including but not limited to, severe dementia, severe cardiac disease, peripheral vascular disease, end-stage Parkinson's disease, incontinence, cancer, and diabetes mellitus. The resident was non-verbal, non-ambulatory, and emaciated. The resident's records include a Transfer Summary from the Marion County Hospice, dated July 30, 2003. The Transfer Summary indicates that the resident's legs were contracted, that his skin was intact, and that he was using a low-air mattress. When the resident was a patient at the Marion County Hospice, he suffered a number of pressure sores on his feet and legs and at least one Stage III pressure sore on his coccyx. These pressure sores developed at the hospice even though the resident received appropriate care because they were unavoidable given his physical condition. The resident was at "high risk" for pressure sores. He scored a "9" on the Braden Scale for evaluating such risks. A score below "12" is a "high risk" patient. Pressure sores are classified as follows: (a) in Stage I as a persistent area of skin redness (without a break in the skin) that cannot be blanched and which does not disappear within 30 minutes when pressure is relieved; (b) in Stage II as a partial loss in the thickness of skin layers that presents clinically as an abrasion, blister, or shallow crater; (c) in Stage III as a loss of a full thickness of skin layers, exposing the subcutaneous tissues and presenting a deep crater with or without undermining adjacent tissue; and (d) in Stage IV as missing a full thickness of skin and subcutaneous tissues, exposing the muscle and/or bone. Upon admission to the facility, the resident had a red area on the plantar region of the foot below and toward the outer aspect of the great right toe. This red area was a pressure sore in the initial stage with undetermined damaged below. In fact, the resident could have suffered pressure trauma during transit from the hospice to the facility, causing damage to the foot. The facility's Assistant Director of Admissions (ADON) instructed the admission nurse to document the resident's pressure sore so that the facility would not be blamed. However, the admission nurse did not record the red area as a Stage I pressure sore. Instead, she noted that there was no skin impairment with the exception of a reddened area on the outer aspect of the right great toe. She also noted that sheepskin heel protectors were in place. The first charge nurse to attend the resident on the day of his admissions made the same observations. There is no way to determine at the time of a Stage I pressure sore how much underlying tissue has been damaged and how large the wound may become. A wound may look very small, but within a short period of time become huge because there is underlying tissue damage. Additionally, a reddened area on one spot may surface as an open area somewhere else due to underlying tissue damage. The damaged tissue must be removed before new tissue can fill the wound. Tissue damage equates to tissue death. A pressure sore may unavoidably escalate to a Stage III or Stage IV due to tissue damage beneath the skin. This is especially true in cases where the patient, such as the resident here, has severe peripheral vascular disease and lack of adequate blood supply. The healing of the resident's pressure sore was negatively impacted by its location on the foot. The resident's peripheral vascular disease caused a decreased amount of blood circulation to the foot. Further, the resident was not active and therefore was not achieving a good heart rate, which meant that the cardiac output was low. Cardiac output is important in providing blood with oxygen, hemoglobin, and red blood cells to the wound to assist in the healing process. Between the time that the resident was admitted and August 7, 2003, there was no physician order for specific treatment of the reddened area on the resident's foot. There is no persuasive evidence that any such treatment was required. The Weekly Skin Review dated August 7, 2003, identified the damaged tissue on the resident's foot as a pressure sore. The August 7, 2003, Skin Grid indicates that it was a new site of skin impairment that was not present on admission. The pressure sore was documented as a new site of skin impairment because it was no longer just a reddened area typical of Stage I, but had progressed to Stage II, clearly visible as a black/blue area, 3 cm by 3 cm, with no depth or drainage. On August 7, 2003, the resident's doctor ordered a skin preparation to be applied to his right plantar foot region three times daily. At that point in time, the nurses transferred the order to the Treatment Administration Record (TAR), which is just one of the places that the facility uses to document treatment. On the day it was ordered, the treatment was rendered to the resident one time. This is most likely because the facility had to secure the doctor's order and receive the product from the pharmacy before treatment could begin. On August 8, 2003, the nurses on two shifts recorded the skin preparation treatment on the TAR. On August 9 and 10, 2003, all three shifts noted the skin preparation treatment on the TAR. On August 11, 2003, two nurses noted the skin preparation treatment on the TAR. The third nurse presented credible testimony that she provided the treatment even though she did not record it on the TAR. On August 11, 2003, the doctor issued an order for the pressure sore to be cleaned daily, treated with TAO, and covered with non-stick telfa. The TAR reflects that the nurses changed the dressing once on August 12, once on August 14, twice on August 15, once on August 16, twice on August 18, and once on August 20. However, the greater weight of the evidence indicates that the facility's staff complied with the doctor's orders even through they did not always document their treatments. On August 13, 2003, the Weekly Skin Review identified no new areas of skin impairment. The August 14, 2003, Skin Grid notes that the Stage II pressure sore had not changed in size, but was pink in color. On August 20, 2003, the Weekly Skin Review identified no new areas of skin impairment. The August 20, 2003, Skin Grid notes that the Stage III pressure sore had not changed in size or color but had some drainage and minimal odor. On August 21, 2003, the resident's doctor issued an order for the pressure sore to be treated twice a day with Santyl in the middle and TAO on the edges then wrapped with curex until healed. The facility's staff complied with the doctor's orders and recorded the treatments on the TAR twice a day until the doctor discontinued them on August 27, 2003. The resident was placed on the facility's Magnolia Wing. The facility usually places Medicare patients on this wing. The nurses on the Magnolia Wing use Medicare documents such as the forms for Daily Skilled Nursing Notes (DSNN). Because the resident was a private-pay patient, the nurses were not required to document his condition on the Medicare forms on a daily basis. In fact, the nurses were not required to fill out the DSNN at all. They were only required to chart his progress on a weekly basis or when there was a significant change that required charting. The use of the DSNN was at the facility's discretion. Under the facts of this case, the nurses were not expected to check off every box on the DSNN that was relevant or to write a comment on each shift. They were expected to "document by exception," noting anything on their shift that was out of the ordinary for the resident. It is acceptable practice in long-term care nursing to "chart by exception" as it would be insurmountable to chart every thing that a resident does on a daily basis. While the records reflect that some nurses charted routine care of the resident, that charting is indicative of the nurses' training or experience in another setting. The facility's system of documentary communication included, but was not limited to, Nurse's Notes, TAR, and Medication Administration Record (MAR). Other documentary forms were used for skin assessments and wound care treatment. The facility's staff also communicated with each other about the resident's condition by conducting shift-change meetings and nurses' rounds and by checking the dates and nurses' signatures on bandages. These methods of communication met the community standard for good nursing. The nurses and their assistants were not required to document every time they turned and repositioned the resident because it was not an "activity of daily living" for charting purposes. The nurses noted on the TAR that the resident needed to be turned every two hours. They made this notation merely as a reminder to turn the resident. There was no doctor's order to accomplish this task. There was a bear symbol on the resident's door to remind the staff that he needed skin precautions, including turning and repositioning. In any event, turning and repositioning the resident would have had no effect on the foot wound because his foot was not on the bed. Reviewing the MAR, TAR, Nurses' Notes, and DSNN together, there is consistent documentation of treatment being rendered in accordance with the doctor's orders. There is no persuasive evidence that any lack of documentation in the resident's medical records adversely impacted the resident's health and welfare or constituted a deficiency. Lady Lake substantially complied with the requirement to document the care and treatment of the resident. The resident was admitted to the facility on a pressure reduction mattress. The facility provided him with a low-air mattress on August 21, 2003. His mattress was upgraded on two occasions. Providing a long-term care patient like the resident with a pressure-relieving mattress is such a routine intervention that it does not require charting or a doctor's order. Regardless of the type of mattress provided, it did not impact the pressure sore because the resident's foot did not rest on the mattress. On August 26, 2003, AHCA's surveyor asked to observe the resident's wound. A nurse removed the dressing from the resident's foot. AHCA's surveyor had to pry the resident's right foot from where it pressed against his left leg in order to observe the Stage III pressure sore on the ball of the resident's right foot. The wound was crater-like, with irregular edges that were red and meaty looking. The surveyor was unable to determine its depth due to what appeared to be drainage. The bandage could not be reapplied because the nurse assisting the surveyor did not have a key to the medication cart. On August 26, 2003, the wound was covered with a slimy or gelatinous material, which could be attributed at least in part to the Santyl treatment. Santyl is a collagenase debriding agent that dissolves necrotic tissue without causing any harm to the new healing tissue. The use of Santyl can cause a wound to appear gelatinous and green or brown. It would not have been appropriate, at the time of the survey, to remove the gelatinous material from the wound to determine its depth. Because healing starts at the base of the wound, it should not be forcibly cleaned or rubbed. A wound can be left undressed for a period of time if it has not dehydrated. There was no evidence that the resident's wound became dehydrated on August 26, 2003, or at any other point in time. The resident's pressure sore never became infected. An infection would have been likely if he had not received appropriate treatment for the wound. The surveyor did not see any pillows on the bed or in the resident's room. However, the greater weight of the evidence indicates that the resident would have had many more skin problems if the facility staff had not been turning and repositioning him with pillows every two hours. Without pillows, the facility's staff would not have been able to position the resident on his back to feed him. The staff used pillows to separate the resident's legs to relieve the pressure on the foot to the extent possible. Repositioning with pillows is a standard procedure in long-term care facilities. The bandage on the pressure sore acted as padding to eliminate any friction on the pressure sore. The resident's pressure sore never progressed to Stage IV, which requires exposed bone or muscle. The only record of a Stage IV pressure sore is found in the Minimum Data Set (MDS). It is necessary to record a pressure sore as Stage IV on the MDS when it has a blister and the depth cannot be determined. Furthermore, there is no difference in the care rendered to a patient with a Stage III or Stage IV pressure sore. The resident's pressure sore changed to a Stage II before he was transferred out of the facility. The greater weight of the evidence indicates that the resident's ability to reach his highest practicable mental, physical and psychosocial well-being was not compromised by Lady Lake in regard to the quality of care provided or in regard to documenting his condition.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That AHCA enter a Final Order dismissing the Administrative Complaints in both cases. DONE AND ENTERED this 15th day of December, 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 December, 2004. COPIES FURNISHED: Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Tom R. Moore, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308-5403 Charlene Thompson, Acting Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308
The Issue The issue in this case is whether the challenged portions of the proposed amendments set forth in the Fourth Notice of Change for Rule 64B8-9.009, Florida Administrative Code (FAC), published in the Florida Administrative Weekly on February 18, 2000, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Background Rule 64B8-9.009, Florida Administrative Code, is the Board's Rule governing the standards of care for office surgery. The Rule was first adopted on February 1, 1994 as a Rule 61F6- 27.009, Florida Administrative Code. It was transferred to Rule 59R-0.009, Florida Administrative Code, and was amended on May 17, 1994; September 8, 1994; and November 15, 1994, and then was finally transferred to Rule 64B8-9.009, Florida Administrative Code. In February of 1998, the Board directed its Surgical Care Committee to evaluate Rule 64B8-9.009 and to make recommendations for any modifications or amendments to the Rule. The 1998 Florida Legislature also addressed the issue of office- based surgery and provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings . . . " including office-surgery environments. As discussed below, hearings were conducted by the Board and its Surgical Care Committee to consider changes to the office surgery rule. The Parties R. Gregory Smith, M.D., Charles Graper, D.D.S., M.D. and Florida Academy of Cosmetic Surgery Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Smith practices cosmetic surgery, plastic surgery, and oralmaxillofacial surgery in his office. Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery and a degree in medicine. Approximately 30 percent of FACS members use general anesthesia (Level III) in their office surgery procedures. At least one representative of FACS has attended each public rulemaking hearing relating to proposed Rule 64B8-9.009, Florida Administrative Code. FACS actively participated in the rulemaking process, expressing concerns relating to transfer agreements, hospital privileges, and the requirement for an anesthesiologist in Level III surgery. FACS' purposes include addressing adverse outcomes in the field of cosmetic surgery and implementing recommended approaches to improve patient safety. Petitioner Charles E. Graper, D.D.S., M.D., is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Graper is Board-certified by the American Board of Oral and Maxillofacial Surgery, Board- certified in general cosmetic surgery, Board-eligible in general plastic surgery, and is a Fellow of the American College of Surgeons. Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. Graper has experience in performing Level III office surgery using general anesthesia. The Board of Medicine The Board of Medicine (Board) regulates the practice of medicine in Florida, and is the agency that adopted the rule at issue. The Florida Society of Plastic Surgeons, Inc., Florida Chapter, American College of Surgeons and Florida Society of Dermatologists The FSPS, FCACS, and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. As licensed physicians (M.D.s), members of FSPS, FCACS, and FDS are subject to the regulations promulgated by the Board of Medicine. A substantial number of physician members of the FSPS, the FCACS, and the FSD perform office surgery and are affected by the proposed amendments to Rule 64B8-9.009, Florida Administrative Code. FSPS is a Florida not-for-profit corporation whose 270 members are board-certified plastic surgeons (of the approximately 375 such physicians statewide) licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSPS was created and exists for the purposes of promoting plastic surgery as a science and profession. FSPS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members, and has participated throughout the rulemaking process with respect to Florida Administrative Code Rule 64B8-9.009. FCACS is a Florida not-for-profit corporation whose 1400 members are surgeons licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FCACS was created and exists for the purposes of promoting surgery as a science and profession. FCACS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including Petitioner Graper, routinely perform office surgery. FSD is a Florida not-for-profit corporation whose 462 members are board-certified dermatologists licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSD was created and exists for the purposes of promoting surgery as a science and profession. FSD regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including David Allyn, M.D., and Diane Calderone, M.D., routinely perform office surgery. The Florida Society of Anesthesiologists, Inc., Florida Hospital Association, Inc. and Association of Community Hospitals and Health systems The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues related to anesthesiology. The FHA and the ACHHS are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members. The Florida Nurses Association (FNA) The Florida Nurses Association is a professional association of approximately 7,500 nurses licensed in the state of Florida, including approximately 1,700 advanced registered nurse practitioner (ARNP) members and a substantial number of CRNAs. Among its many purposes, the FNA represents the legal, legislative, and professional practice interests of the members. The Florida Association of Nurse Anesthetists Petitioner, Florida Association of Nurse Anesthetists (FANA), is a non-profit corporation and professional organization made up of more than 1,600 certified registered nurse anesthetists practicing throughout Florida, many of whom currently provide anesthesia for surgery performed in physicians' offices. As a part of its mission, FANA advocates its members' interests in legal, legislative, and professional practice issues. Rule Challenges by FSA and the Hospitals On July 8, 1999, the FSA filed a Petition for Administrative Determination of Invalidity of Proposed Rule challenging portions of the proposed amendments to Rule 64B- 8.9009 as set forth in the Second Notice of Change. The FSA's Rule challenge was assigned DOAH Case No. 99-2974RP. Also on July 8, 1999, the Hospitals filed a petition for Administrative Determination of the Invalidity of Proposed Rules challenging portions of the proposed amendments to Rule 64B8-9.009 as set forth in the Second Notice of Change. The Hospitals' Rule challenge was assigned DOAH Case No. 99-2975RP. The Board conducted a third public hearing on the proposed Rule amendments on August 7, 1999. The Board published a Third Notice of Change to the proposed Rule amendments in the August 20, 1999, issue of the Florida Administrative Weekly. None of the changes in the Third Notice of Change related to provisions that were in litigation. On January 12, 2000, the Board, the FSA, and the FSPS filed a Joint Stipulation on provisions of Rule 64B8-9.009, Florida Administrative Code (Joint Stipulation) in DOAH Case No. 99-2974RP. The Joint Stipulation released from FSA's Rule challenge, Case No. 99-2974RP, the majority of the proposed amendments to Rule 64B8-9.009 and reserved only the proposed amendments to Subsections (1)(e) and (6)(b)1.a. of Rule 64B8- 9.009 for challenge. On January 26, 2000, the Hospitals filed a Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(b)1. and 2. and (6)(b)1.a. and b. In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(I), (4)(b)1., (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for Adoption. The Board subsequently conducted an additional public meeting and published a fourth notice of change relating to the proposed amendments to Rule 64B8-9.009 still subject to challenge by the FSA and the Hospitals. These changes included the withdrawal of the proposed amendments to Subsection (4)(b)1. which would have changed "transfer agreement" to "transfer protocol." During this public meeting, the Board was informed that those parts of the Rule no longer being challenged had been filed with the Department of State. On January 28, 2000, the Board filed all of its proposed amendments to Rule 64B8-0.009, with the exception of the amendments to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)1. and 2., and (6)(b)1.a-b, for adoption with the Florida Secretary of State. The proposed amendments filed for adoption on January 28, 2000, became effective February 17, 2000. The Board voted to modify some of the proposed amendments to Rule 64B8-9.009 still subject to challenge at its public meeting on February 5, 2000. The FSA filed a Notice of Voluntary Dismissal of its Rule challenge in DOAH Case No. 99-2974RP on February 7, 2000. DOAH case No. 99-2974RP was closed on February 8, 2000. The Hospitals filed a Notice of Voluntary Dismissal of their Rule challenge in DOAH Case No. 99-2975RP on March 9, 2000, and the case was closed on March 10, 2000. The Fourth Notice of Change was published in the February 18, 2000, issue of the Florida Administrative Weekly noticing the changes to proposed amendments to Rule 64B8-9.009 voted on by the Board at its February 5, 2000, meeting. On February 25, 2000, the FACS, Graper, and Smith filed a Petition for an Administrative Determination of the Invalidity of a Proposed Rule challenging the Board's proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. This petition was assigned DOAH Case No. 00-0951RP. On March 8, 2000, the FACS, Graper, and Smith filed an Amended Petition for an Administrative Determination of the Invalidity of a Proposed Rule in DOAH Case No. 00-0951RP challenging the Board's proposed withdrawal of the proposed changes to Subsection (4)(b)1. of Rule 64B8-9.009 and the proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. The Board held a public hearing on April 8, 2000, in Orlando, Florida, and received testimony concerning the Fourth Notice of Change. At the conclusion of the hearing, the Board voted to adjourn without making any changes in the Fourth Notice of Change. On April 17, 2000, the FANA filed its petition challenging the Board's Fourth Notice of Change. The FANA's petition was assigned DOAH Case No. 00-1622RP. DOAH Case Nos. 00-0951RP and 00-1622RP were consolidated by Order of the Administrative Law Judge issued May 4, 2000. The Fourth Notice of Change states that "[t]he proposed changes to Subsection (4)(b)1., shall be withdrawn." With respect to Subsection (6)(b)1.a. of Rule 64B8- 9.009, the Fourth Notice of Change states: Proposed Subsection (6)(b)1.a. shall be changed to read, (b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia. Petitioners have challenged the Fourth Notice of Change on the following grounds: (1) the requirement that an anesthesiologist be present for all Level III surgeries in physicians' offices will increase the cost and limit surgical procedures and practice opportunities of Petitioners resulting in a substantial adverse financial impact on Petitioners and patients; (2) the Fourth Notice of Change exceeds the Board of Medicine's rulemaking authority by attempting to regulate nurse anesthetists; (3) the Fourth Notice of Change conflicts with existing statutes governing the practice of nurse anesthetists; (4) the rule is arbitrary and capricious and is not supported by competent evidence and is inconsistent with the law and policies of the federal government and of 49 states; (5) the Fourth Notice of Change is not supported by competent substantial evidence and would not have any measurable effect on patient safety; (6) the Rule was improperly adopted; and (7) that the Fourth Notice of Change conflicted with the existing requirement to provide a choice of anesthesia providers. Each of these arguments is addressed below. Final Order in DOAH Case No. 00-1058RX The Final Order in DOAH Case No. 00-1058RX invalidated certain existing Rule requirements related to transfer agreements and hospital staff privileges as a precondition for certain office surgeries. Specifically, that Final Order invalidated Subsection (4)(b) of Rule 64B8-9.009, which required a transfer agreement for any physician performing Level II office surgery who did not have staff privileges to perform the same procedure at a licensed hospital. In addition, the Final Order invalidated Subsection (6)(b) of Rule 64B8-9.009 which required a physician performing Level III office surgery to have hospital staff privileges for the procedure performed in an out-patient setting. As grounds for invalidating the staff privileges requirement, the Administrative Law Judge determined that the Board lacked specific statutory authority to mandate hospital privileges, thereby exceeding its grant of rulemaking authority. The Final Order further determined that the requirement for hospital privileges was arbitrary, deferred credentialing to individual hospitals, and was not supported by competent substantial evidence. During the prior hearing, the parties did not present specific argument related to, nor did the Final Order consider the proposed changes to the staff privileges requirement set forth in the Fourth Notice of Change due to the separate Rule challenge proceedings. The Proposed Rule Regarding Competency Demonstration Notwithstanding, Subsection 4 of the Fourth Notice of Change proposes to change Subsection (6)(b)1.a. of Rule 64B8- 9.009 to include alternatives to hospital staff privileges as a manner of demonstrating sufficient education, training and competency to perform Level III surgery in an office setting. The proposed change provides that a surgeon who seeks to provide Level III surgery in an office setting can demonstrate training as follows: The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other Board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training, and experience. (emphasis added) The proposed Rule at issue in this proceeding continues to provide for the same mechanism of hospital privileges, previously invalidated. The provision remains invalid for the reasons articulated in the previous Final Order. However, the proposed Rule also provides office surgeons with two alternative methods for objectively demonstrating sufficient training and competency through certification by a recognized medical specialty board or through direct demonstration to the Board of Medicine. That provision of the proposed Rule, provides significant flexibility and meaningful options to physicians seeking to perform office surgery. The Board demonstrated that the options are an appropriate approach for the Board to utilize in exercising its delegated regulatory authority and responsibility to adopt education and training standards for the office setting. The Petitioners adequately challenged the provisions and the Board proved the validity of the proposed alternatives by a preponderance of the evidence. Increased Costs Petitioners contend that the anesthesiologist requirement in the Fourth Notice of Change violates Section 120.52(8)(g), Florida Statutes, by imposing regulatory costs on the regulated person which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives. Petitioners offered credible evidence indicating that the hourly rates charged by anesthesiologists range from 50 to 100 percent higher than the hourly rates charged by CRNAs for similar procedures. Respondent and Intervenor, FSA, on the other hand, demonstrated that hourly rates varied from market to market within Florida and in a few cases, rates for anesthesiologists were approximately the same as for CRNAs. The evidence is clear, however, that the charges for an anesthesiologist are significantly higher than those for CRNAs for similar procedures. Anesthesiologists possess broader expertise, education, and training. As a result, requiring an anesthesiologist for Level III office surgeries will increase the total cost of a typical in-office plastic or cosmetic surgery procedure between five and ten percent. Furthermore, the evidence demonstrated that although some surgeons periodically use anesthesiologists during Level III office surgery for a variety of reasons, including availability, complexity of procedure, current health of patient and contractual agreements, most surgeons utilize CRNAs due to the considerable cost savings. Petitioners also claimed that the Rule would create a monopoly in the provision of in-office anesthesia for anesthesiologists and would force hundreds of CRNAs out of office practice. The Fourth Notice of Change applies to Level III surgeries, so it is reasonable to conclude that the need for CRNAs to participate in the performance of Level III surgeries under the supervision of an anesthesiologist will be obviated. Their assistance is unnecessary and cost prohibitive. And although nurse anesthetists would still be permitted to provide Level II anesthesia in the office setting under the supervision of the operating surgeon, the proposed Rule imposes a significant increase in the cost of Level III surgeries and severely decreases competition. Rulemaking Authority and Conflicting Law Petitioners mistakenly contend that the proposed anesthesiologists requirement exceeds the scope of the Board of Medicine's rulemaking authority and conflicts with existing law. The authority for the Fourth Notice of Change is contained in part in Section 458.33(1)(v), Florida Statutes, which states in pertinent part: The Board may establish by rule standards of practice and standards of care for particular practice settings, including but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manual in order to establish grounds for disciplining doctors. Specifically, Petitioners allege that the Fourth Notice of Change constitutes an impermissible attempt by the Board of Medicine to regulate nurse anesthetists and conflicts with Chapter 464, Florida Statutes, which permits nurse anesthetists to practice under the supervision of any physician, osteopath, or dentist. The parties have stipulated that Florida-certified registered nurse anesthetists are licensed only by the Florida Board of Nursing and are subject to discipline only by the Florida Board of Nursing. In mandating that office surgeons use an anesthesiologist during in-office Level III surgery, the proposed Rule does not directly regulate any nurse or certified registered nurse anesthetist and does not subject the CRNA to any discipline by the Board of Medicine or by the Board of Nursing. Thus, the Rule on its face does not conflict with the delegated legislative authority to the Board of Medicine for rulemaking in Section 458.331(1)(v). Federal Law, Scientific Evidence, Arbitrary and Capricious, Competent Substantial Evidence Petitioners contend that the Fourth Notice of Change requiring an anesthesiologist be present during Level III surgery is inconsistent with the laws and policies of the federal government and 49 states, contrary to the overwhelming weight of scientific evidence, arbitrary and capricious, and not supported by competent substantial evidence. There is no evidence that the Fourth Notice of Change is inconsistent with the laws and policies of the federal government. There is no federal law or rule which prohibits any state from establishing its own rules governing the rights of various practitioners to administer or supervise the administration of anesthesia in any particular setting. Federal government regulations defer to state law on this subject unless a state establishes a lower standard of care. While it is insignificant whether any other state currently requires an anesthesiologist to be present for the administration or supervision of general anesthesia in an office setting, some states have considered such requirements, including Pennsylvania and New Jersey. With respect to the scientific evidence presented by the parties, it is clear that there is a lack of competent and substantial evidence to demonstrate an increased level of safety for general anesthesia patients who undergo surgery under the care of an anesthesiologist as opposed to a CRNA. CRNAs are advanced registered nurse practitioners. In addition to their nursing training, CRNAs must have at least one year of experience in a critical care setting (such as working in a hospital intensive care unit) prior to beginning their two- to-three year master's level anesthesia training. Nurse anesthetists typically are trained side by side with physician anesthesia residents, use the same textbooks, and are taught by the same instructors. Unlike physician anesthesiologists who receive a general medical-surgical license that may not require any level of training or expertise in the administration of anesthesia, CRNAs must pass a national certifying examination in anesthesia as a condition of state licensure. In addition, CRNAs must complete 40 hours of continuing anesthesia education every two years, and must be recertified every two years to retain their state license. The evidence suggests that the safety of office surgery is comparable to that of hospitals and ambulatory surgery centers. Moreover, under the existing Rule, the office surgeon and patient determine the most appropriate anesthesia provider and setting based on the individual patient's needs. The direct testimony and scientific evidence indicate no significant difference in patient outcomes based on whether anesthesia is administered by an anesthesiologist or CRNA. Hence, Florida law and the existing standard of care in Florida permits a surgeon to supervise a CRNA in the office setting. Nearly forty percent of the 1600 CRNA members of FANA provide anesthesia in physicians' offices. Furthermore, the evidence indicates that anesthesiologist supervision of CRNAs in hospitals is extremely inconsistent. "Supervision" as defined by various hospitals requires the anesthesiologists to be within five to thirty minutes of the hospital. Anesthesiologists are often absent for extended periods and typically "supervise" several operating rooms simultaneously. In fact, Federal Medicare regulations permit an anesthesiologist to receive payment for the "medical direction" of as many as four CRNAs at the same time. Moreover, several smaller and often rural hospitals and ambulatory surgical centers in Florida do not have anesthesiologists on staff. CRNAs provide the anesthesia services in those venues. Dr. David Mackey, an anesthesiologist, testified that he had reviewed information on 28 deaths related to office surgery which occurred between 1987 and 1999. Dr. Mackey concluded that there have been nine deaths resulting from office surgery in the past 12 years in which anesthesia was a cause of death. However, Dr. Mackey was able to confirm that a CRNA provided the anesthesia in only two of the nine cases. Office surgeons and related professional societies agree that an office-based surgeon may safely supervise a CRNA. Currently, there are three national accrediting organizations that may accredit office surgery facilities: Joint Commission on Accreditation for Ambulatory Healthcare Organizations; American Association for Accreditation of Ambulatory Surgery Facilities; and Accreditation Association for Ambulatory Health Care. Rule 64B8-9.0091, Florida Administrative Code. None of these accrediting organizations requires that CRNAs be supervised by an anesthesiologist. No other state currently requires anesthesiologist supervision of CRNAs in an office setting. In fact, Florida's Joint Committee of the Boards of Nursing and Medicine identify specific medical acts that may be performed by ARNPs, and the level of physician supervision required for such acts. Section 464.003(a)(c), Florida Statutes. The Joint Committee does not require anesthesiologist supervision of CRNAs in any setting. The U.S. Armed Forces do not require anesthesiologist supervision of CRNAs in any practice setting. And the American Society of Anesthesiologists' has published its own "Recommended Scope of Practice for Nurse Anesthetists" which provides for CRNAs to administer anesthesia under the supervision of the operating surgeon. Studies of Anesthesia Outcomes and Medical Error Michael B. Pine, M.D., a Board-certified cardiologist, former chief of cardiology at Cincinnati Medical school, and a former professor of medicine at Harvard Medical School and two other medical schools, testified as an expert in healthcare quality assessment and improvement. Dr. Pine has served as a healthcare quality assessment and improvement consultant to the JCAHO, the Health Care Financing Administration (HCFA), the American Medical Association (AMA), the American Osteopathic Association, the Hospital Research and Educational Trust of the American Hospital Association, the American Association of Oral and Maxillofacial Surgeons, the American Association of Nurse Anesthetists, Blue Cross/Blue Shield, and Anthem, among others. Dr. Pine characterized his career transition from clinician to consultant as moving from "dealing with diseased individuals to dealing with diseased organizations to help them assess their problems in delivering health care and help them improve and get better." Dr. Pine assisted in the development of clinical indicators for JCAHO, including indicators in anesthesia care. He has worked with the federal Health Care Financing Administration (HCFA) to measure hospital mortality and adjust for patient severity as an indicator of hospital quality. Dr. Pine's consulting experience includes evaluating outcome data for individual practitioners, groups of providers, and whole systems. Dr. Pine testified that the classic study in anesthesia mortality was a 1950's study by Beecher and Todd of 600,000 anesthetic administrations which were followed by about 8,000 deaths, 325 of which were ultimately determined to be anesthetic related. The study reflects an anesthesia mortality rate of about 1:2,500. In the Beecher and Todd study, nurse anesthetists performed twice as many cases as anesthesiologists, but the number of deaths involving nurse anesthetists was virtually the same as the number of deaths involving anesthesiologists. Beecher and Todd initially hypothesized that the greater mortality rate for anesthesiologists could be explained by the severity of illness of the patients seen by anesthesiologists rather than nurse anesthetists, but after correcting for the difference in severity of illness, they discovered the nurse anesthetists had actually treated patients who were slightly more sick. Beecher and Todd were unable to explain why physician anesthesiologists, who anesthetized only half as many patients as nurse anesthetists, were involved in an equal number of deaths. Dr. Pine testified that a later study, the Bechtoldt, measured outcomes associated with two million anesthetics in North Carolina between 1969 and 1976. The mortality rate was approximately 1:24,000; a mortality rate ten times better than the rate reflected in the Beecher and Todd study 20 years earlier. The Bechtoldt study compared the outcomes of anesthesiologists working alone, nurse anesthetists working alone, and CRNAs and anesthesiologists working together, the surgeon or dentist administering anesthesia him/herself, and deaths in which no provider could be identified. Bechtoldt concluded that: When we calculated the incidence of anesthetic related deaths for each group which administered the anesthetic, we found that the incidence among the three major groups - the CRNA, the anesthesiologist, and the combination of both - to be rather similar. Although the CRNA working alone accounted for about half the anesthesia- related deaths, the CRNA working alone also accounted for about half the anesthetics administered. A 1980 study by Forrest of 17 hospitals and about 10,0000 patents was one of the first studies to make a formal adjustment for the sickness severity of the patients. Using conservative statistical methods, Forrest concluded that "there were no significant differences in outcomes" between the hospitals that predominately used anesthesiologists and the hospitals that predominately used nurse anesthetists. Anesthesia safety continued to improve as indicated by a British study in the early 1980's, that used a procedure similar to that used by Beecher and Todd in the 1950's. The British study looked at 485,000 surgeries in which anesthesia was provided. There were 4000 deaths, only 3 of which were determined to be anesthetic related, reflecting an anesthesia mortality rate of 1:185,000. The Institute of Medicine report entitled "To Err is Human," published in 1999, reflects an even better anesthesia mortality rate of 1:200,000 to 1:300,000 cases. The Institute of Medicine report states: The gains in anesthesia are very impressive and were accomplished through a variety of mechanisms including improved monitoring techniques, the development and widespread adoption of practice guidelines and other systemic approaches to improving errors . . . . the success of anesthesia, was accomplished through a combination of technological changes, new monitoring equipment, standardization of existing equipment, information-based strategies including the development and adoption of guidelines and standards, application of human factors to improve performance such as the use of simulators for training, formation of the Anesthesia Patient Safety Foundation to bring together stakeholders form different disciplines, physicians, nurses, manufacturers, to create a focus for action and having a leader who would serve as a champion for the cause. Dr. Pine also addressed the recent study regarding anesthesia by Silber published in June 2000. This study examined 7,665 deaths following 217,000 hospital procedures for which medical bills were submitted to HCFA for Medicare reimbursement. The study attempted to characterize the type of anesthesia provider based on whether an anesthesiologist submitted a bill for providing anesthesia or supervising the anesthesia. The study assumed that a CRNA administered the anesthesia if either the CRNA billed for it, or if no bill was located. Moreover, instead of reviewing deaths that occurred within 48 hours after the surgery, the study counted all deaths which occurred within 30 days following surgery, and ignored any non-anesthesia related complications and deaths which were included in the 7,665 death toll. Conversely, the 7,665 deaths in 217,000 procedures produce a mortality rate of 1:28, nearly 100 times greater than the mortality rate in the 1950 Beecher and Todd study, and nearly 10,000 times what the 1999 Institute of Medicine study reflected as the anesthetic mortality rate. The greatly inflated and inconsistent death rate is highly questionable and provides little scientific support for the Board's proposed rule. With respect to Petitioners' argument relating to arbitrary and capricious mandate, the proposed Rule would not permit office-based surgeons to provide a choice of anesthesia provider for Level III office surgeries, since only one anesthesia provider is necessary or justified for Level III office surgery, and the proposed rule mandates the participation of an anesthesiologist. It is unreasonable and not economically feasible for the surgeon or the patient to pay for an anesthesiologist and a CRNA for the same procedure. Based on the current Rule's "choice of anesthesia provider" requirement in subsection (2)(b) of the existing Rule, the proposed anesthesiologist mandate for Level III surgery is inconsistent, confusing and illogical to the reasonable person.
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.
