The Issue Whether Florida Administrative Code Rule 59C-1.008(4) (Rule) constitutes an invalid exercise of delegated legislative authority because it enlarges, modifies, or contravenes the specific provisions of law implemented.
Findings Of Fact The Parties VRBH is an existing hospital in Sarasota County. In the second batching cycle of 2016, VRBH applied to AHCA for a CON to establish a Class I Acute Care Replacement Hospital of up to 312 beds in AHCA District VIII, Subdistrict 8-6, Sarasota County. The CON application was preliminarily approved by AHCA on December 2, 2016. SMH is a public hospital system serving Sarasota County. In the second batching cycle of 2016, SMH applied for a CON to establish a new acute care hospital with 90 beds in AHCA District 8, Acute Care Subdistrict 8-6, Sarasota County. As with the VRBH application, the SMH application also received preliminary approval from AHCA on December 2, 2016. AHCA is designated as the single state agency responsible for administering the CON program under the Health Facility and Services Development Act, sections 408.031 through 408.045, Florida Statutes. The Challenged Rule In part, Florida Administrative Code Rule 59C-1.008(4) requires that CON applications contain the audited financial statements of the applicant, or the applicant’s parent corporation. The Rule states as follows: Certificate of Need Application Contents. An application for a Certificate of Need shall contain the following items: All requirements set forth in Sections 408.037(1), (2) and (3), F.S. The correct application fee. An audited financial statement of the applicant or the applicant’s parent corporation if the applicant’s audited financial statements do not exist. The following provisions apply: The audited financial statement of the applicant, or the applicant’s parent corporation, must be for the most current fiscal year. If the most recent fiscal year ended within 120 days prior to the application filing deadline and the audited financial statements are not yet available, then the prior fiscal year will be considered the most recent. Existing health care facilities must provide audited financial statements for the two most recent consecutive fiscal years in accordance with subparagraph 1. above. Only audited financial statements of the applicant, or the applicant’s parent corporation, will be accepted. Audited financial statements of any part of the applicant or the applicant’s parent corporation, including but not limited to subsidiaries, divisions, specific facilities or cost centers, will not qualify as an audit of the applicant or the applicant’s parent corporation. To comply with Section 408.037(1)(b)1., F.S., which requires a listing of all capital projects, the applicant shall provide the total approximate amount of anticipated expenditures for capital projects which meet the definition in subsection 59C-1.002(7), F.A.C., at the time of initial application submission, or state that there are none. An itemized list or grouping of capital projects is not required, although an applicant may choose to itemize or group its capital projects. The applicant shall also indicate the actual or proposed financial commitment to those projects, and include an assessment of the impact of those projects on the applicant’s ability to provide the proposed project; and, Responses to applicable questions contained in the application forms. The 2008 CON Legislative Changes In 2008, the Florida Legislature made numerous changes to streamline the CON application process for general hospitals. It is these changes that VRBH asserts removed the requirement for general hospitals to submit audited financial statements with CON applications. Section 408.035 was amended to provide as follows: 408.035 Review criteria.— The agency shall determine the reviewability of applications and shall review applications for certificate-of-need determinations for health care facilities and health services in context with the following criteria, except for general hospitals as defined in s. 395.002: The need for the health care facilities and health services being proposed. The availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant. The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care. The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. The extent to which the proposed services will enhance access to health care for residents of the service district. The immediate and long-term financial feasibility of the proposal. The extent to which the proposal will foster competition that promotes quality and cost-effectiveness. The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction. The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. The applicant’s designation as a Gold Seal Program nursing facility pursuant to s. 400.235, when the applicant is requesting additional nursing home beds at that facility. For a general hospital, the agency shall consider only the criteria specified in paragraph (1)(a), paragraph (1)(b), except for quality of care in paragraph (1)(b), and paragraphs (1)(e), (g), and (i). (Emphasis added). Section 408.035 has not been revised since 2008. Additionally, section 408.037 was amended to read as follows: 408.037 Application content.— Except as provided in subsection (2) for a general hospital, an application for a certificate of need must contain: A detailed description of the proposed project and statement of its purpose and need in relation to the district health plan. A statement of the financial resources needed by and available to the applicant to accomplish the proposed project. This statement must include: A complete listing of all capital projects, including new health facility development projects and health facility acquisitions applied for, pending, approved, or underway in any state at the time of application, regardless of whether or not that state has a certificate-of-need program or a capital expenditure review program pursuant to s. 1122 of the Social Security Act. The agency may, by rule, require less- detailed information from major health care providers. This listing must include the applicant’s actual or proposed financial commitment to those projects and an assessment of their impact on the applicant’s ability to provide the proposed project. A detailed listing of the needed capital expenditures, including sources of funds. A detailed financial projection, including a statement of the projected revenue and expenses for the first 2 years of operation after completion of the proposed project. This statement must include a detailed evaluation of the impact of the proposed project on the cost of other services provided by the applicant. An audited financial statement of the applicant or the applicant’s parent corporation if audited financial statements of the applicant do not exist. In an application submitted by an existing health care facility, health maintenance organization, or hospice, financial condition documentation must include, but need not be limited to, a balance sheet and a profit-and-loss statement of the 2 previous fiscal years’ operation. An application for a certificate of need for a general hospital must contain a detailed description of the proposed general hospital project and a statement of its purpose and the needs it will meet. The proposed project’s location, as well as its primary and secondary service areas, must be identified by zip code. Primary service area is defined as the zip codes from which the applicant projects that it will draw 75 percent of its discharges. Secondary service area is defined as the zip codes from which the applicant projects that it will draw its remaining discharges. If, subsequent to issuance of a final order approving the certificate of need, the proposed location of the general hospital changes or the primary service area materially changes, the agency shall revoke the certificate of need. However, if the agency determines that such changes are deemed to enhance access to hospital services in the service district, the agency may permit such changes to occur. A party participating in the administrative hearing regarding the issuance of the certificate of need for a general hospital has standing to participate in any subsequent proceeding regarding the revocation of the certificate of need for a hospital for which the location has changed or for which the primary service area has materially changed. In addition, the application for the certificate of need for a general hospital must include a statement of intent that, if approved by final order of the agency, the applicant shall within 120 days after issuance of the final order or, if there is an appeal of the final order, within 120 days after the issuance of the court’s mandate on appeal, furnish satisfactory proof of the applicant’s financial ability to operate. The agency shall establish documentation requirements, to be completed by each applicant, which show anticipated provider revenues and expenditures, the basis for financing the anticipated cash- flow requirements of the provider, and an applicant’s access to contingency financing. A party participating in the administrative hearing regarding the issuance of the certificate of need for a general hospital may provide written comments concerning the adequacy of the financial information provided, but such party does not have standing to participate in an administrative proceeding regarding proof of the applicant’s financial ability to operate. The agency may require a licensee to provide proof of financial ability to operate at any time if there is evidence of financial instability, including, but not limited to, unpaid expenses necessary for the basic operations of the provider. The applicant must certify that it will license and operate the health care facility. For an existing health care facility, the applicant must be the licenseholder of the facility. (Emphasis added). Section 408.037 has only been amended once since 2008. The revisions are not relevant to the issue presented in this Rule challenge.2/ The Parties’ Positions In support of its argument that the Rule contravenes the statutes, VRBH asserts that the Rule is an invalid exercise of delegated legislative authority because it enlarges, modifies, or contravenes the laws implemented. Simply put, VRBH contends that the Rule is contrary to sections 408.035 and VRBH advances three reasons for its position that the Rule modifies the laws implemented; all three center on the assertion that in 2008, the Legislature removed the requirement for the submission of audited financial statements with general hospital CON applications: Requiring a general hospital to comply with the requirements of section 408.037(1), Florida Statutes, by submitting an audited financial statement with its CON application violates the express provision of the statute which specifically excludes general hospitals from the requirements of subsection (1); Requiring a general hospital to submit an audited financial statement with the CON application directly contradicts the submission requirements set forth in section 408.037(2), Florida Statutes, which only requires a general hospital to provide a statement of intent that it will “furnish satisfactory proof of the applicant’s financial ability to operate” if the CON application is approved by final order of the agency. Requiring a general hospital to submit an audited financial statement with the CON application contradicts the 2008 legislative changes to section 408.035, Florida Statutes, which streamlined the application process for general hospitals by removing the short and long term financial feasibility of the project as a review criteria. (VRBH Petition, ¶¶ 15-17). AHCA’s ultimate position is that the Rule should be interpreted as not requiring audited financial statements for general hospital CON applicants. To reach this conclusion, AHCA relies on 59C-1.008(4)(a), which provides that a CON application must contain “all requirements set forth in Sections 408.037(1), (2), and (3), Florida Statutes.” AHCA interprets the introductory phrase contained in section 408.037(1)--“except as provided in subsection (2) for a general hospital, an application for a certificate of need must contain”--to mean that only subsection (2) of section 408.037 applies to an application for general hospitals. Because section 408.037(2) does not mention audited financial statements, AHCA reasons that they are not required. Therefore, despite the plain language of the Rule, AHCA contends that the Rule does not require the submission of audited financial statements because: the Rule references sections 408.037(1), (2), and (3); AHCA interprets only section 408.037(2) as applying to general hospitals; and section 408.037(2) does not mention audited financial statements. SMH contends that the Rule does not enlarge, modify, or contravene the laws implemented and, therefore, is a valid exercise of delegated legislative authority. Specifically, SMH contends that section 408.037 itself requires general hospital applicants to submit audited financial statements because subsection (2) does not wholesale replace subsection (1) for general hospitals. Subsection (1) applies to general hospitals, unless there is an exception to those requirements listed in subsection (2). Subsection (1) requires the submission of audited financial statements for all CON applicants; nothing in subsection (2) creates an exception to that requirement. SMH also argues that audited financial statements are reliable documents that AHCA can quickly access for relevant information, including an applicant’s provision of health care services to Medicaid patients and the medically indigent, both of which are prominent considerations during the review of a general hospital’s CON application. See § 408.035(1)(i), (2), Fla. Stat. Post 2008 Rule Challenged Rule 59C-1.008(4) does not expressly exclude or differentiate between general hospital CON applications and other CON applications. Instead the Rule cross-references to the statutory requirement. AHCA asserts that by doing so, the Rule incorporates the statutory scheme by reference and does not require a CON application for a general hospital to include audited financial statements. The above-cited statutory provisions clearly state that a general hospital CON application need not include an audited financial statement and that financial condition is not relevant to the CON application review process. Any rule that requires a general hospital CON applicant to provide an audited financial statement with the application would be contrary to the requirements of section 408.037. It follows, therefore, that a rule contrary to the requirements of a statute would be invalid as it would exceed AHCA’s delegated legislative authority. Requiring a general hospital applicant to comply with the requirements of section 408.037(1) would violate the provision of the statute, which expressly excludes general hospitals from the requirements of subsection (1). Further, requiring a general hospital applicant to submit an audited financial statement with its CON application directly contradicts the submission requirements set forth in section 408.037(2). AHCA’s interpretation of rule 59C-1.008 is that it must be read in conjunction with section 408.037, subsections (1), (2), and (3), and accordingly, AHCA does not require that a general hospital applicant submit an audited financial statement as part of its application. AHCA’s interpretation is consistent with the differences in the content of the CON application forms published by AHCA for general hospital applications when compared to non-general hospital applications, for instance, those seeking other beds and services such as comprehensive medical rehabilitation, psychiatric, hospice, and other CON- regulated beds in a hospital. The requirements of each application type correspond to the statutory requirements for each application type. Application forms for projects “except for general hospitals” correspond to the CON application content requirements of section 408.037(1), which requires a statement of financial resources that must include capital projects (Schedule 2 of the CON application); capital expenditures and source of funds (Schedules 1 and 3 of the CON application); and a detailed financial projection, including revenues and expenses for the first two years (Schedules 5 through 8 of the CON application). The general hospital CON application does not have these requirements. General hospitals are not required to submit proof of financial ability to operate at the time of the submission of the CON application. In accordance with rule 59C-1.010(2)(d), general hospitals are required to comply with the requirements of sections 408.035(2) and 408.037(2). Neither of those statutes requires that a general hospital applicant submit proof of financial ability to operate until 120 days after the issuance of the final CON to the applicant. AHCA’s representative, Marisol Fitch, testified that AHCA does not require applicants for general hospitals to submit audited financial statements in the CON application, and that proof of financial ability to operate is required within 120 days after the final approval of the CON application, consistent with the statutory provisions. She testified that the Rule being challenged, when read in conjunction with the AHCA CON application form (incorporated by reference into the Rule) and other AHCA rules, including 59C-1.010 and 59C-1.030, is consistent with the statute, and that no audited financial statements are required. SMH asserts that an audited financial statement for hospitals might contain useful information, such as information on a hospital’s current payor mix. However, the unrefuted testimony is that audited financial statements are not required to include payor mix information, and normally do not since they are typically used to look at an applicant’s financial feasibility to operate. Further, regardless of whether such information might be “useful,” the specific requirement of section 408.037(2) expressly “excepts” general hospitals from the requirement to include such statements in the CON application. Pursuant to rule 59C-1.010(2)(d), “an application for a general hospital must meet the requirements of Sections 408.035(2) and 408.037(2), F.S.,” neither of which require that a general hospital CON applicant provide audited financials or financial feasibility data with the CON application. However, the challenged language in rule 59C-1.008(4) does not contain the “exception” for general hospital applications. Rule 59C-1.008(4) provides, without qualification, that a CON application must contain audited financial statements. Therefore, rules 59C-1.008(4) and 59C-1.010(2)(d) are contradictory. The primary purpose of an audited financial statement in a CON application is to review the short-term and long-term financial feasibility of the proposal. Requiring this financial information is contrary to the clear language of the 2008 changes to section 408.035, which removed the short-term and long-term financial feasibility of the project as review criteria in order to streamline the general hospital CON application process. AHCA has stated that their interpretation of rule 59C-1.008(4) is that it must be read in pari materia with rule 59C-1.010(2)(d) and sections 408.037 and 408.035, therefore, general hospital CON applicants are not required to submit audited financials with the CON application. According to AHCA’s interpretation, rule 59C-1.008(4) does not require a general hospital CON applicant to submit an audited financial statement with the CON application. However, regardless of AHCA’s interpretation, rule 59C-1.008(4) expressly states that a CON application must contain audited financial statements, in contravention of sections 408.035 and 408.037.
The Issue The issues are whether Respondent deviated from the applicable standard of care in the practice of medicine by inserting the wrong intraocular lens during cataract surgery, in violation of Section 458.331(1)(t), Florida Statutes, or failed to maintain adequate medical records, in violation of Section 458.331(1)(m), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0030598. Respondent graduated from medical school in 1976 and completed a three-year residency in ophthalmology in 1980. Board-certified in ophthalmology since 1981, Respondent is the medical director of the Treasure Coast Center for Surgery in Stuart (Surgery Center). The Surgery Center is an ambulatory surgery center licensed under Chapter 395, Florida Statutes. Since 1980, Respondent has performed over 20,000 surgeries, including over 10,000 cataract surgeries. In that time, he has never previously misidentified a patient, operated on the wrong site, or inserted the wrong lens. This case involves a wrong lens that Respondent inserted into an 80-year-old patient on October 17, 2000. A local optometrist had referred the patient to Respondent for evaluation of cataracts in both eyes. Respondent performed successful cataract surgery on the patient's right eye on August 22, 2000. A cataract is a partial or complete opacification, or clouding, of a natural lens or its capsule. Typically associated with aging, the cataract is a major cause of a slow loss of vision, making it more difficult for the patient to read or drive, especially at night with the glare of lights. Twenty years ago, conventional cataract surgery comprised an intracapsular cataract extraction with the lens implant placed in the front of the eye. In the last 20 years, the predominant mode of cataract surgery comprises an extracapsular cataract surgery or phacoemulsification with the lens implant placed behind the iris of the eye. In the phacoemulsification process, the surgeon, using a smaller incision than that used in the older procedure, dissolves the cataract-involved natural lens using ultrasound and removes the cataract in smaller pieces than the single-piece removal characteristic of the intracapsular extraction process. The patient was scheduled for phacoemulsification of the cataract-involved lens in her left eye at the Surgery Center as the first patient of the day on October 17, 2000. Respondent handled her case as he handles all of the other cases. Prior to the surgery, Respondent reviews the patient's office chart and brings it, together with the office charts of the other patients scheduled for surgery that day, from his office to the Surgery Center. At the Surgery Center, Respondent delivers the office charts to circulating nurses, who remove each chart, read it to determine the lens to be implanted, find the lens specified in the chart for implantation, and insert the packaged lens into the chart. A nurse then stacks the office charts in a stand in the order of the patients' surgeries scheduled for the day. From the patient's perspective, she is greeted by a receptionist upon arrival. The receptionist pulls the already- prepared materials, including an identification bracelet or armband, and has the patient sign the necessary paperwork. At this point, an admission nurse takes the patient to the preoperative area where the patient lies down on a gurney. The nurse identifies the patient and confirms the eye to be operated on and the procedure to be performed. After verifying this information, the nurse places the identification bracelet on the patient's wrist. In cases such as this, in which an anaesthesiologist administers the anaesthesia, the anaesthesiologist meets with the patient to confirm the identity of the patient, the eye to be operated on, and the procedure to be performed. The Surgery Center's policy requires: "the attending physician and/or anesthesiologist, along with the responsible nurse, will review the patient's medical record, the armband and the Surgery Schedule to confirm the correct operative site. The operative site will also be confirmed by the patient or parent/guardian." The cited language, as well as the surrounding context, reveals a policy to ensure that the correct site--here, left eye--is the subject of the actual surgical procedure; nothing in the policy explicitly requires anyone to match the correct lens with the patient. After completion of the preoperative procedure, the circulating nurse takes the patient from pre-op. Among the nurse's other duties is to check the patient's bracelet against the office chart and to ask the patient if she is the person named on the office chart and bracelet. Accompanying the patient into the operating room are the office chart and Surgery Center chart. Once in the operating room, the circulating nurse places the office chart on a side table used by the scrub nurse and the Surgery Center chart with the anaesthesia equipment. Transferred into the operating room, the patient is scrubbed by a scrub nurse, who drapes the patient from just below her knees to above her head with a gown that opens only at the site of the eye to be operated on. The purpose of the gown is to maintain a sterile field, so no one can lift the gown in the operating room, such as to identify the patient by face or bracelet with the name on the chart, without exposing the patient to a risk of infection. When Respondent enters the operating room, he is already scrubbed and wearing gloves. A stand holds the patient's office chart with the packaged lens implant at the side table. Respondent checks the power of the lens, as disclosed on the package, against the power specified on the office chart. In this case, the two powers matched, as the office chart and the lens implant were for another patient. To maintain sterility, Respondent cannot touch a chart while he is in the operating room; if the necessity arises, a nurse may touch the chart. Before proceeding with surgery, Respondent reads the name of the patient on the office chart. Respondent does not verify that the names on the bracelet and either of the charts are the same. Nor does Respondent confirm with the circulating nurse that she has done so. To check the identity of the patient, Respondent says, "Good morning, Ms. . I'd like you to put your chin up for me." However, patients often have fallen asleep from the three preoperative sedatives that they have already received. Respondent conceded that the patient in this case may not have been alert when he addressed her by name. For whatever reason-- reduced consciousness, unconsciousness, nervousness, or inability of the patient to hear Respondent or Respondent (or others) to hear the patient--the patient in this case did not effectively communicate to Respondent that she was not the patient whose name he stated. Respondent proceeded with the surgery and implanted the wrong lens into the patient's left eye. Respondent had specified a lens with a 21.5 diopter refractive power and implanted a lens with a 20.5 diopter refractive power. The circulating nurse discovered the error when she went to get the next patient and found the office chart of the patient on whom Respondent had just completed surgery. The next day, when the patient visited Respondent at his office for a routine post-operative examination, Respondent informed her that he had placed the wrong lens in her eye and recommended that he recheck her vision in a few days and then decide whether to perform a corrective procedure. Three days after the initial surgery, Respondent found an increased degree of anisometropia, which is the difference in refraction between the two eyes. At this time, the patient complained to Respondent about imbalance. Respondent advised corrective surgery, and, on October 26, Respondent performed surgery to replace the implanted lens with another lens. Although the initial surgery was sutureless, the corrective surgery required sutures. The corrective surgery was generally successful, although two and one-half months later, the patient was complaining that her left eye was sore to the touch--a complaint that she had not made following the initial surgery to the left eye. Petitioner asserts that Respondent's medical records are deficient in two respects: inaccurately describing the treatment and failing to justify the corrective surgery. Respondent dictates his operative reports prior to surgery, even though they bear the date of the surgery--here, October 17, 2000. To accommodate contingencies, Respondent dictates three conditional notes, one of which itself contains two alternatives. As found in the patient's operative report, these conditional notes state: The corneoscleral wound was enlarged, if necessary. * * * If necessary, an interrupted suture was placed for pre-existing against-the-rule astigmatism or to help maintain the water- tightness of the wound. If a suture was placed, the wound was retested to be water- tight. Although Respondent's pre-dictated operative notes for the patient are detailed, they omit a salient element of her surgery--that Respondent inserted a lens of the wrong power. Respondent did not try to conceal this fact. To the contrary, as soon as the nurse informed him of her error, he directed her to attach the sticky label on the lens package, which records the power of the lens, to the patient's chart. He also directed her to prepare an incident report, which prompted Petitioner's investigation. The expert testimony in this case was conflicting. Respondent's expert witness was originally contacted by Petitioner and asked for an opinion on the standard-of-care and medical-records issues described above. The witness opined that Respondent met the applicable standard of care and the medical records justified the course of treatment. Respondent then retained this physician as his expert witness. Respondent's expert witness opined that an ophthalmologic surgeon necessarily must rely to a "large extent" on staff for a "certain amount of identification" before the patient is transferred into the operating room. Respondent's expert witness did not explain in detail the qualifications inherent in these statements. Finding an error by the Surgery Center in the insertion of the wrong lens, Respondent's expert witness admitted that Respondent had some control over the circulating nurse, but stated that the nurse administrator basically directs the nurses. Expressing no problem with the conditional notes, Respondent's expert witness testified that it is not unusual for a surgeon to predictate an operative report and then change it if something unusual happens. Petitioner retained another expert witness to replace the expert witness who became Respondent's witness. Petitioner's expert witness opined that Respondent failed to meet the applicable standard of care and the medical records did not justify the course of treatment. Petitioner's expert witness opined that it was never within the applicable standard of care to insert the wrong lens and admitted that he was unaware of the procedures of the Surgery Center and Respondent to avoid this occurrence. Petitioner's expert witness explained that the surgeon is the captain of the ship and ultimately bears the responsibility for the insertion of the wrong lens. Petitioner's expert witness also opined that all pre- dictated operative notes were not "the standard of care" and likewise criticized the conditional notes. Petitioner's expert witness admitted that nothing included in or omitted from the operative notes would adversely affect the future management of the patient's medical care. Respondent's proposed recommended order identifies various deficiencies in the testimony of Petitioner's expert witness, although Respondent's assertion that the expert relied on a not-yet-effective strict-liability statute is not accurate. Most of these deficiencies pertain to the earlier allegations that Respondent failed to meet the applicable standard of care in performing cataract surgery on an 80-year-old patient and in performing the corrective surgery. Citing the recent case of Gross v. Department of Health, 819 So. 2d 997 (Fla. 5th DCA 2002)(Orfinger, J., concurring), Petitioner's proposed recommended order invites the Administrative Law Judge to be guided by common sense in assessing the standard-of-care issue. This invitation may arise from a well-placed concern with the means by which Petitioner's expert reached his conclusion that Respondent deviated from the applicable standard of care. Petitioner's expert witness has opined that the insertion of the wrong lens violates the applicable standard of care, without regard to the safeguards or precautions that a physician may employ to avoid this mishap. In finding a deviation from the applicable standard of care, the Administrative Law Judge relies on inferences and logic not explicitly identified by Petitioner's expert witness. In addressing the standard-of-care issue, Respondent's expert witness adopted the proper approach, which features a close analysis of the facts to determine the reasonableness of the surgeon's acts and omissions. Under that approach, however, the record establishes that Respondent failed to take all reasonable precautions necessary to prevent this mistake. Although the likelihood of the insertion of the wrong lens seems low, based on Respondent's experience, the burden of additional, effective safeguards would be minor. Both parties focused on the location of the bracelet relative to the length of the protective gown. However, an anklet would be in plain view in the operating room because the gown would not extend that far below the patient's knees. Even if the patient identification remains on a wrist bracelet, the surgeon himself could check the patient's name on the bracelet with the name on the office chart just prior to the surgeon and patient entering the operating room. Either practice would add a few seconds to the overall process and would prevent this type of error. On the other hand, the categoric rejection of Respondent's records by Petitioner's expert witness is correct. The date of the operative record is incorrect; it was not dictated on October 17, 2000, but on an earlier date. The three conditions and one alternative present a confused operative history. The operative record fails to indicate if there was a corneoscleral wound; if there was an interrupted suture; if so, if the suture was for a pre-existing astigmatism or for wound protection; and if there was a suture placed at all. With these conditions and alternative, the operative report fails to memorialize accurately material elements of the surgery. Additionally, the operative report omits an indisputably material element of the surgery--the insertion of the wrong lens. Respondent recorded this fact in an office note a few days later, but never amended his predictated operative report to reflect this important fact. Lastly, the justification for the corrective surgery ultimately was the patient's complaint of imbalance, not the difference in refractive power between the lens implanted and the lens specified. Respondent nowhere recorded any such complaint in any records. Based on the foregoing, Petitioner has proved by clear and convincing evidence that Respondent deviated from the applicable standard of care in inserting the wrong lens and failed to maintain medical records justifying the course of treatment with respect to the deficiencies noted in the operative record and post-operative records preceding the corrective surgery.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of violating Section 458.331(1)(t), Florida Statutes, and Section 458.331(1)(m), Florida Statutes, imposing an administrative fine of $10,000, and remanding the case to the Division of Administrative Hearings for findings concerning costs, pursuant to Section 456.072(4), Florida Statutes, if the parties cannot agree as to an amount. DONE AND ENTERED this 18th day of December, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of December, 2002. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Bruce A. Campbell Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Brian A. Newman Pennington, Moore, Wilkinson, Bell, & Dunbar, P. A. 215 South Monroe Street, Suite 200 Post Office Box 10095 Tallahassee, Florida 32302-2095
Findings Of Fact The Respondent, Jayaprakash Kamath, M.D., is a licensed physician in the State of Florida, having license ME 0036704. He is board certified in internal medicine and gastroenterology. He has had no prior complaints of any kind against him since he began practicing medicine in Florida in 1980, and he has a reputation for being a competent and caring physician. On the morning of August 1, 1988, while making rounds at Morton Plant Hospital in Clearwater, Florida, the Respondent was paged by one of his partners, Belur Sreenath, M.D. The Respondent returned the call and was asked to see a patient whom Sreenath had just accepted and admitted on a 23-hour basis at Morton Plant. Sreenath reported that the patient was a referral from the Morton Plant emergency room. The patient's regular physician was on vacation, and the regular physician's on-call cover had recommended to the emergency room physician that the patient be referred to the Respondent and Sreenath to treat the patient for diagnosed fecal impaction. It was reported to the Respondent, through Sreenath, that the patient had come into the emergency room at about five in the morning complaining of abdominal pain and constipation. The emergency room physician, Jerry Julius Chase, M.D., had three X-rays done and had done his own "wet reads" of the X-rays before sending them to the radiology department for a definitive interpretation. According to Chase, the X-rays showed "much fecal matter, no obstruction." Chase did not mention any other significant findings. Chase's preliminary diagnosis was "fecal impaction." Sreenath also reported that he (Sreenath) had ordered enemas for the patient. Soon after the Respondent received the call from his partner, the Respondent called Chase, who was still in the emergency room and still had the X-rays. Chase confirmed what Sreenath had told the Respondent, again not mentioning any other significant findings. After talking to Chase, the Respondent visited the patient in his hospital room. By this time it was about 10:00 a.m. The Respondent took a history from the patient, examined the patient, and read the patient's chart. The chart included the results of lab work and the "ER sheet," which included the emergency room physician's diagnosis of abdominal pain and impaction and the results of his "wet-read" of the X-rays, but it did not yet include a report from the radiology department or the X-rays themselves. The Respondent did not contact the radiology department for a definitive interpretation of the X-rays or obtain the X-rays for his own review. By the time the Respondent saw the patient, the patient already had one enema and seemed to be responding to the treatment. Based on the information he had, the Respondent made a diagnosis of fecal impaction, confirmed his partner's orders for enemas for the patient, and added a stool softener. The nursing staff was ordered to monitor the patient's progress. The patient continued to respond satisfactorily to treatment during the day. Between ten and eleven in the evening of August 1, 1988, the patient complained of some abdominal pain or cramping (symptoms that are consistent with a diagnosis of fecal impaction and enema treatments) and the nurses on duty contacted the Respondent's partner, who was on call. Sreenath ordered a combination of demerol and vistaril as an analgesic. One small dose was enough to relieve the patient's pain, and the patient slept through most of the night. He ate 80% of his breakfast the next morning and was not complaining of pain or asking to see a doctor. At approximately 9:15 a.m. on August 2, 1988, a nurse telephoned the Respondent for a decision whether the patient was being discharged or was being admitted as an inpatient. The Respondent still had not seen the patient's X- rays, seen or had reported to him the radiology report on them, or spoken to the radiologist. On questioning, the nurse reported the patient's status to the Respondent. The nurse's report satisfied the Respondent that the patient was responding to the treatment for fecal impaction and could be discharged. The nurse was given orders to have arrangements made for the patient to see his regular physician within a week and to instruct the patient on symptoms to report if they occurred between discharge and seeing his regular physician. In accordance with the Respondent's telephone instructions, the patient was discharged at approximately 9:30 a.m. on August 2, 1988. Although there were no clinical signs or symptoms of it during the patient's stay at Morton Plant, the patient had a large aortic aneurysm, approximately eight centimeters in diameter, in his abdomen just below the renal arteries. The aneurysm was readily apparent on the X-rays, yet Chase did not report it to either the Respondent or to his partner, Sreenath. The radiologist either did not contact Dr. Chase to point out to him that the report of Chases's "wet read" of the X-rays omitted the aneurysm or, if he did, Chase did not relay this information to the Respondent or his partner. The radiologist's written report, stating that the X-rays revealed the large aneurysm, was sent to Chase, not to the Respondent, and Chase did not relay the information in it to the Respondent or his partner. If the Respondent had known about the aneurysm, he would have considered the aneurysm to be the patient's most serious medical concern. He might not have accepted the patient or, if he did, he probably would have brought a vascular surgeon into the case and had the vascular surgeon, or perhaps a cardiologist, closely monitor the patient for possible leaking or dissecting or rupture of the aneurysm. The Respondent also would have had to give consideration to whether the aneurysm was a cause of the patient's abdominal pain. In addition to treating the aneurysm as the patient's most serious medical concern, giving consideration to whether the aneurysm was a cause of the patient's abdominal pain, the Respondent would have had to give consideration to altering his diagnosis for the patient had he reviewed the X-rays or the radiologist report, or had spoken with the radiologist. In addition to showing the existence of the aneurysm, the X-rays indicated that the patient technically may not have been impacted. (The gas pattern was non-specific.) With respect to this patient, the Respondent practiced medicine below that level of care, skill and treatment which is recognized by a reasonably prudent similar physicians as being acceptable under similar conditions and circumstances (below the standard of care) in that he did not either personally review the X-rays on the patient, read or have reported to him the contents of the radiologist's report, or talk to the radiologist. Instead, he relied totally on the emergency room physician's "wet read." As a result, the Respondent's diagnosis of "fecal impaction" may not have been correct, and he did not give proper consideration to the aneurysm. However, except for the failure regarding the X-rays, the DPR otherwise did not prove that it was below the standard of care for the Respondent, who was treating the patient for fecal impaction, to discharge the patient without seeing him on the morning of August 2, 1988, based on the nurse's report to the Respondent. Although it was below the standard of care for the Respondent not to either read the X-rays himself or obtain the radiologist's definitive interpretation, it was reasonable for the Respondent to expect that the emergency room physician would have told him, and noted in the "ER sheet," that the patient he was being referred had an aneurysm of the kind and size of the one the patient had in this case. Even if the emergency doctor had not initially communicated to the Respondent the existence of the aneurysm, either directly or through the "ER sheet," it was reasonable for the Respondent to expect that, in the normal course, the radiologist reviewing the X-rays would have noted that, according to the "ER sheet," the ER doctor "missed" the aneurysm and would have contacted the ER physician to bring this to his attention, and that the ER doctor then would have contacted the Respondent to advise him of the omission. The patient did not experience abdominal pain after his discharge from Morton Plant, but he began to experience back and groin pain. The aneurysm was becoming symptomatic. The patient's symptoms markedly worsened in the early morning hours of August 4, 1988. The patient's wife had him taken to the emergency room at HCA New Port Richey Hospital at approximately half past midnight. The patient was confused, and was complaining of pain in the back and groin area. His blood sugars were three times normal. He was diagnosed preliminarily in the emergency room as having out-of-control diabetes and confusion and as being near sycope. No X-rays were taken in the emergency room at New Port Richey Hospital, and no information was obtained from Morton Plant Hospital. Because the patient and his wife did not know about the aneurysm, they were unable to report it when the emergency room physician took the patient's history. The patient was admitted to New Port Richey Hospital at approximately 2:30 a.m. on August 4, 1988. However, the admitting physician did not see the patient or order diagnostic medical imaging at that time. The admitting physician saw the patient at approximately 9:00 a.m., and ordered X-rays and a CAT scan. Before the X-rays or CT scan were taken, at approximately ten o'clock, the patient suffered an acute hypotensive event while in his hospital room. An emergency abdominal sonogram was ordered, and it was determined that the patient was suffering from the rupture of the abdominal aortic aneurysm (the same one that was evident on the X-rays taken at Morton Plant). Surgery was attempted to resect the ruptured aneurysm. The patient was a poor candidate for surgery of that kind due to his age and other health factors. The patient died on August 6, 1988. If the patient knew of the aneurysm, it is likely that his treatment on August 4, 1988, would have been far different. First, when the aneurysm became symptomatic, they probably would have contacted the vascular surgeon, who would have been on the case already, either immediately or on arrival at the emergency room. The aneurysm would have been closely monitored from the time of arrival at the hospital, and the vascular surgeon would have been prepared for surgery when indicated. 2/ At the very least, the patient and his wife probably would have reported the aneurysm during the taking of a history in the emergency room at HCA New Port Richey Hospital, and the emergency room surgeon could have immediately taken appropriate steps, such as contacting a vascular surgeon and immediately ordering appropriate diagnostic medical imaging. 3/ The Respondent did not dictate admission notes for the patient until August 17, 1988. The Respondent did not dictate discharge notes. The DPR did not prove that it was below the standard of care for the Respondent to delay the dictation of admission notes or for him not to prepare a discharge summary for a patient in the hospital on a 23-hour basis. The DPR also did not prove that the Respondent failed to keep written medical records justifying the course of treatment of the patient.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent, Jayaprakash Kamath, M.D., guilty of one count of violating Section 458.331(1)(t), but dismissing the other count of the Administrative Complaint; reprimanding him; and (3) fining him $2,000. RECOMMENDED this 27th day of July, 1992, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1992.
Findings Of Fact Petitioner, Peter P. McKeown, is a graduate of the University of Queensland Medical School in Brisbane, Australia. He holds the degrees of Bachelor of Medicine and Bachelor of Surgery. Doctorates of Medicine, under the British system, are reserved for specialists. Nonetheless, the medical training Petitioner received equates to that leading up to the award of the degree of Doctor of Medicine in the United States, and he is a physician and licensed as such in several states. He has completed residencies in general and thoracic surgery in Australia and the United States and has taken advanced training in cardiovascular and thoracic surgery at Emory University. Immediately before coming to the University of South Florida, (USF), Dr. McKeown was an Assistant Professor of Surgery at the University of Washington. In mid to late 1988, Dr. McKeown responded to an advertisement USF had placed in the Journal of the American Medical Association seeking applicants qualified for appointment at the Associate Professor level "... to join the Department of Surgery at the University of South Florida College of Medicine as the Chief of Cardiothoracic Surgery." He was selected for the position and joined the faculty effective May 1, 1989. All the correspondence leading up to Petitioner's joining the University faculty referred not only to his appointment as Associate Professor but also his assignment as Chief of the Cardiothoracic Surgery Division. Only the actual state employment contract described his employment exclusively as Associate Professor and made no mention of the Chief position. Under these circumstances, Petitioner did not gain any proprietory interest in the position of Chief of the Cardiothoracic Surgery Division. Dr. McKeown held the position of Chief of the Cardiothoracic Surgery Division until April, 1994, when, as a result of a decision made by the Chairman of the school's Department of Surgery, he was replaced as Chief and that position was filled, on a temporary basis, by the Department Chair. Petitioner claims that when he arrived at USF to assume the directorship, an administrative position, he saw an opportunity to develop the position into something significant. He contends he would not have come to USF unless he was to be the Chief of the Division as there was no appeal to him in a position as a general faculty member. He wanted an opportunity to budget, hire people, and develop plans and programs, and in order to advance in academic medicine, one must, at some point, hold an administrative position. Apparently the Department of Surgery had experienced a rapid turnover in faculty. It is not clear whether this caused or was the result of a dispute with administrators and medical staff at Tampa General Hospital, (TGH), where much of the clinical medical school activity is carried on. However, the program was recognized as being weak in cardiothoracic surgery, and this condition offered Petitioner the challenge he wanted. In his five years as Chief, Petitioner increased both the number and quality of personnel and revenues considerably. He developed affiliations with several foreign universities and recruited qualified people, built up the laboratory, secured more grants, developed a program of continuing medical education and raised the examination scores of the school's graduates. He opened new clinical programs and built up both billings and collections to the point where the program revenues were increased at least 2 to 5 times. By 1992- 1993, the Division was making money and generating a surplus and still used clinic funds to support research. During his tenure as Chief of the Division, Petitioner served under two Department of Surgery chairmen. The first was Dr. Connar, the individual who recruited him; and the incumbent is Dr. Carey, the individual who removed him. Petitioner asserts that at no time during his tenure in the position of Chief of the Cardiothoracic Surgery Division was he ever told, by either Department Chairman, that his performance was unsatisfactory. All Division heads within the Department were, from time to time, counseled about personnel costs, and Petitioner admits he had some differences with Dr. Carey about that subject and some other financial aspects of the job, but nothing different than anywhere else in academia. Petitioner was removed by Dr. Carey based in part upon his alleged inability to get along with people. Though he claims this is not true, he admits to three areas of conflict. The first related to his objection to transplants being accomplished by unqualified surgeons which, he alleges, Dr. Carey permitted to further his own ends. The second related to the pediatric heart transplant program for which Petitioner supported one candidate as chair and Dr. Carey supported another. The third related to Petitioner's reluctance to hire a physician whom Dr. Carey wanted to hire but to whom Petitioner purportedly objected. Of the three areas of dispute, only the first two came before his removal, but he contends at no time was he advised his position was a problem for the Department. By the same token, none of Petitioner's annual performance ratings reflected any University dissatisfaction with his performance. At no time was he ever rated unsatisfactory in any performance area; and prior to his removal, he had no indication his position as Chief of the Division was in jeopardy. Dr. Carey indicates he did counsel with Petitioner often regarding his attitude but did not rate him down because he hoped the situation would improve. Dr. McKeown was called to meet with Dr. Carey in his office on April 12, 1994. At that meeting, Dr. Carey was very agitated. He brought up the "Norman" incident and indicated he was going to remove Petitioner as Chief of the Division. Dr. McKeown admits to having made an inappropriate comment regarding Dr. Norman, another physician, to a resident in the operating room while performing an operation. He also admits that it was wrong to do this and apologized to Dr. Norman both orally and in writing shortly thereafter. Dr. Norman accepted his apology and Petitioner asserts that after his removal, Dr. Norman called him and assured him he, Norman, had not prompted the removal action. Dr. Norman did not testify at the hearing. Dr. Carey removed Petitioner from his position as Chief because of the comments he had made regarding Dr. Norman. Almost immediately after the meeting was concluded, Dr. Carey announced in writing his assumption of the Chief's position, in which position he remained until he hired Dr. Robinson as Chief in April, 1995. Petitioner found out that Carey's threat to remove him had been carried out the following day when his nurse told him his removal had been announced at the Moffett Cancer Center. He thereafter heard other reports of his removal from other sources, and based on what had happened, concluded his removal was intended to be and constituted a disciplinary action for his comment regarding Dr. Norman. He was not advised in advance of Carey's intention to impose discipline nor given an opportunity to defend himself before the action was taken. He claims he was not given any reason for his removal before or at the time of his dismissal. It is found, however, that the removal was not disciplinary action but an administrative change in Division leadership. Dr. McKeown at first did nothing about his removal, believing it would blow over. However, after he heard his removal had been publicized, he called several University officials, including a Vice-President, the General Counsel and the Provost, to see how the matter could be handled. He claims he either got no response to his inquiries or was told it was a Medical College problem. He then met with the Dean of the College of Medicine who indicated he could do nothing. After he was removed as Division Chief, Petitioner's salary remained the same as did his supplement from his practice. He claims, however, his removal has had an adverse effect on his reputation in the medical and academic communities. It is his belief that people now feel something is wrong with him. Dr. Carey's blunt announcement of his assumption of the Chief's position, without any reasons being given for that move or credit being given to Petitioner for his past accomplishments has had an impact on his ability to work effectively. After his removal, he received calls from all over the world from people wanting to know what had happened. The removal has, he claims, also made it more difficult for him to get grants and has, thereby, adversely impacted his ability to do productive research. In addition, his removal made it difficult for him to carry out his academic duties. His specialty is still presented in student rotations, only in a different place in the medical curriculum. Dr. McKeown has sought reinstatement to the administrative position of Chief of the Division. He is of the opinion that Dr. Carey's action in removing him from his position as Division Chief was capricious and damaging to the University as well as to his career. Petitioner admits he could have been less confrontational in the performance of his duties as Division Chief, but he knows of no complaints about him from TGH, All Children's Hospital or the VA Hospital. There are, however, letters in the files of the Department Chairman which indicate some dissatisfaction with Petitioner's relationships in some quarters and, as seen below, there were signs of dissatisfaction from both TGH and All Children's Hospitals. Petitioner admits he may have been somewhat overbearing or abrasive, but neither his alleged inability to properly steward finances nor his alleged inability to get along with people were mentioned to him at the time of dismissal or before. After Dr. Carey assumed the Chairmanship of the Department of Surgery in July, 1990, he saw Dr. McKeown frequently on an official basis at first. A Chief, as Petitioner was, has many and varied functions such as administration, teaching, fiscal, research, clinic administration and the like. People skills are important because of the necessary interface with colleagues, faculty, administrators and the public. When Dr. Carey came to USF, Dr. McKeown had not been in place very long, and the Division of Cardiothoracic Surgery was not doing well financially. There were contract negotiations going on with the VA Hospital which were not going well, at least partly because, Dr. Carey asserts, Dr. McKeown had made some major unacceptable demands. As a result, Dr. Carey stepped in, along with Dr. Benke, who was very effective in dealing with the VA, and as a result, an agreement was reached which resulted in somewhere between $275,000 and $300,000 per year coming in which put the Division in the black. Dr. Carey recalls other instances indicating Dr. McKeown's inability to get along with others. One related to the relationship with TGH previously mentioned. TGH had made a decision to use a particular physician as head of its transplant program because, allegedly, Dr. McKeown had so angered private heart patients they would not let him be appointed even though Dr. McKeown was Dr. Carey's choice. As it turned out, Dr. Carey convinced the TGH Director and another physician to agree to a plan whereby Dr. McKeown would be head of the program 50 percent of the time. This would have been good for the University, but Dr. McKeown refused indicating that if he could not be in charge all of the time, he would not be in charge at all. Another incident relates to All Children's Hospital. That institution wanted to initiate a pediatric heart transplant program and a meeting was set up to which Dr. McKeown was invited. Petitioner so infuriated the community surgeons attending that meeting they would not work with him, and without his, Carey's, efforts, Dr. Carey claims the program was doomed to failure. As a result, Carey asked Dr. Nevitsky to help get the program started. This gave the USF an opportunity to participate in the program, but when Nevitsky left, they lost it. Still another example, according to Dr. Carey, is the fact that some surgeons on staff have called to complain about Dr. McKeown's attitude and unwillingness to compromise and negotiate and about his demands for service and staff, all of which creates friction among the hospital staff. A few days before Dr. Carey removed Petitioner as Chief, he spoke with the Dean of the College of Medicine, a Vice-president of the University, and others who would be impacted, about his concern regarding the Cardiothoracic Surgery Division and, in fact, he had had discussions with other officials even before that time. Long before making his decision to remove Petitioner, Carey spoke of his consideration of possibly shifting the emphasis within the Division to non-cardiac thoracic surgery in place of the cardiac program which Dr. Carey felt was not very successful. He believed the program did not do enough procedures to support the medical school affiliation. Dr. Carey chose to dismiss Dr. McKeown as Chief of the Division on April 12, 1994, after learning of McKeown's destructive attack on another surgeon before a junior physician in a public place, an operating room, (the Norman incident). He notes that over the years there was a building concern regarding Dr. McKeown's abilities as an administrator, and this incident with Dr. Norman was the last straw. Dr. Carey had received complaints about Petitioner from other physicians, all of which he discussed with Dr. McKeown. Finally, with the Norman incident, it became abundantly clear that Dr. McKeown's capabilities as a leader had diminished to the point where a change was necessary. Before he dismissed Petitioner, and during the investigation which led up to the dismissal, Dr. Carey admits, he did not give Dr. McKeown any opportunity to give any input to the decision. By the time Carey met with McKeown on April 12, 1994, his mind was made up. The Norman incident was demonstrative of what Carey perceived as McKeown's lack of supervisory ability, and it was that factor which led Carey to the ultimate decision to remove McKeown. He felt it necessary to act then and not leave Dr. McKeown in place during the search for a replacement. Petitioner cites alleged comments made by Carey to others that he would have relieved anyone for doing what Petitioner did in the Norman incident. Dr. Carey cannot recall having made such a statement. He claims he considered disciplinary action against Petitioner for the Norman comments but decided against it. However, it was the last in a series of incidents which caused him to question the propriety of McKeown's placement in the Chief's position, and which ultimately cemented his decision to replace him. Dr. Carey met with Dr. McKeown several times before the dismissal and counseled him about administrative deficiencies in his performance, but he never told Dr. McKeown that unless he improved, he would be dismissed. This is consistent with Petitioner's testimony that he was not warned of his shortcomings or of the administration's dissatisfaction with his performance. Disagreements in conversations between superior and subordinate, meant by the former to be corrective in nature, are not always taken as such by the latter. Dr. Carey did not document any of this in Dr. McKeown's personnel files but put some of the information he received by way of communications from others in the files. These are the letters submitted by the University, pursuant to agreement of the parties, subsequent to the hearing. They contributed to Carey's increasing concern about Dr. McKeown's ability to lead the Division. At no time, however, though he questioned Dr. McKeown's leadership, did Dr. Carey ever question his good faith and sincerity, nor does he do so now. When he finally decided action was necessary, on April 12, 1994, Dr. Carey wrote a memorandum to the Medical College faculty concerning his assumption of the position as Chief of the Cardiothoracic Surgery Division. He also advised Dr. McKeown of his removal. Dr. Carey remained in the Chief's position, holding that title in an administrative capacity and not from a clinical standpoint, for approximately one year, intending to stay in the position only until he could find a fully qualified thoracic surgeon to take the job. After Carey removed Petitioner, he was contacted by the Medical College Dean who asked that he get with McKeown and try to work something out. He thereafter offered Dr. McKeown the position of Chief of the cardiac section of the Division but McKeown declined. Dr. Carey also, on April 26, 1994, wrote to TGH recommending that Dr. McKeown be allowed to have more impact on the hospital's transplant program, pointing out that the change in McKeown's position at the University was occasioned by a need for a change in leadership. According to Dr. Tennyson J. Wright, Associate Provost of the University, disciplinary action against nonunion faculty members is governed by Rule 6C4-10.009, F.A.C., and requires notice of proposed action be given before such disciplinary action is taken. The contract which Dr. McKeown holds and has held since the inception of his tenure at the University, is a standard USF/State University System contract. It reflects Petitioner was hired as an Associate Professor, which is one of the three types of personnel classifications used within the system. These are faculty, administration and support. Petitioner's contract does not refer to his holding the Division Chief position and it is not supposed to. Such a position is an administrative appointment within a Department and a working title used to define the holder's duties, and service in such a position is at the pleasure of the Department Chair. Appointment to or removal from a Chief position is an administrative assignment. The position of Department Chairperson, on the other hand is a separate position and subclassification within the University classification system and is different.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Petitioner, Peter P. McKeown's, grievance against the University of South Florida School of Medicine arising from his removal as Chief, Cardiothoracic Surgery Division in the Department of Surgery be denied. DONE AND ENTERED this 19th day of January, 1996, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of January, 1996. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1832 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 7. Accepted and incorporated herein. Though the documents in question refer to appointment, in actuality the personnel action was an appointment to the faculty with an administrative assignment to the position of Director of the Division. & 10. Accepted. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. - 19. Accepted and incorporate herein. Accepted and incorporated herein. Accepted. Rejected as inconsistent with the better evidence of record. Accepted. Accepted and incorporated herein. Rejected as inconsistent with the better evidence of record. & 27. Accepted. & 29. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. 32. - 34. First sentence accepted. Second sentence rejected as inconsistent with the better evidence of record. 35. - 37. Accepted. 38. Rejected as argument. 39. Accepted. FOR THE RESPONDENT: - 9. Accepted and incorporated herein. Accepted. - 14. Accepted and incorporated herein. 15. & 16. Accepted and incorporated herein. COPIES FURNISHED: Benjamin H. Hill, III, Esquire William C. Guerrant, Jr., Esquire Danelle Dykes, Esquire Hill, Ward & Henderson, P.A. Post Office Box 2231 Tampa, Florida 33601 Thomas M. Gonzalez, Esquire Thompson, Sizemore & Gonzalez 109 North Brush Street, Suite 200 Post Office Box 639 Tampa, Florida 33601 Olga J. Joanow, Esquire University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620 Noreen Segrest, Esquire General Counsel University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620-6250
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.
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.
The Issue The issue for determination in this proceeding is whether the Respondent, the Department of Professional Regulation, should pay the Petitioner, Kirk A. Woodson, M.D., attorney fees and costs under Section 57.011, Fla. Stat. (1989), the Florida Equal Access to Justice Act. As reflected in the Preliminary Statement, the parties stipulate that the Petitioner is a "prevailing small business party" and that reasonable fees and costs exceed $15,000, the statutory cap. The only remaining issue under the statute is whether the Respondent was "substantially justified" in filing the Administrative Complaint in Case No. 90- 5986 against the Petitioner. 1/
Findings Of Fact On or about June 7, 1988, a complaint was filed against the license of the Petitioner, Kirk A. Woodson, M.D., subsequent to closure of a professional malpractice liability claim against him without payment of indemnity. The substance of the complaint was that, on January 1, 1986, Woodson saw and performed a hysterectomy on a patient who had presented at the emergency room at University Community Hospital in Tampa, Florida, with heavy and continuous vaginal bleeding. The complaint stated that post-surgery the patient developed Adult Respiratory Distress Syndrome (ARDS) and died. The complaint questioned whether Woodson failed to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. By letter dated June 30, 1988, the Department of Professional Regulation (the Department or DPR) notified Woodson that it had received the complaint and that it was initiating an investigation. DPR subpoenaed the hospital records which revealed that the patient arrived at the UCH emergency room at 5:28 a.m. on January 1, 1986, with at least a three-day history of vaginal hemorraging. An emergency room physician saw the patient, gave her two units of packed blood cells, and admitted her to Woodson's service. Woodson was called at approximately 8:30 a.m. and saw the patient later that morning. The patient's admission to surgery to determine the cause of the bleeding and perform necessary procedures was delayed until at least approximately 2:00 p.m. because the patient refused to consent to a dilation and curettage (D and C); she was insisting on a hysterectomy only. She finally consented to a D and C to be followed by a hysterectomy if Woodson found it to be medically necessary. During this delay, the patient continued to bleed and was transfused with two more units of packed blood cells at approximately 1:45 p.m. After the consent was given, there was a further delay, not explained by the records, until approximately 6:00 p.m. in getting the patient to surgery. The patient continued to bleed. Surgery took almost five hours. During surgery, the patient's bleeding got worse, and she was transfused with four more units of whole blood during the surgery. The DPR investigator was unable to ascertain from the hospital records the reason for the length of the surgery. The DPR investigator attempted to arrange an interview with Dr. Woodson and his attorney on or about February 28, 1989. The appointment was cancelled. When the DPR investigator contacted Woodson to reschedule the interview, Dr. Woodson questioned why DPR was pursuing the complaint when the malpractice claim was closed without payment of indemnity. Dr. Woodson agreed to be interviewed but expressed his preference that the investigator first review the "extensive depositions" taken in the malpractice litigation. 4/ Having already determined to request an expert evaluation of the case, the investigator decided to postpone the interview with Dr. Woodson. On July 10, 1989, the DPR asked a probable cause panel of the Board of Medicine to authorize the retention of an expert in gynecology to review the information obtained through investigation to that point in time to assist in the determination whether Woodson's treatment of the patient fell below that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. On July 22, 1989, the probable cause met and authorized the expert review. On or about November 2, 1989, the DPR requested an expert review by Doris N. Carson, M.D., a Board-certified gynecologist with extensive surgical experience, including emergency room experience. Dr. Carson reviewed the hospital records supplied by DPR, some of which were difficult to read. By letter dated November 20, 1989, Dr. Carson reported her impressions. Dr. Carson believed the records supported Dr. Woodson's diagnosis and ultimate course of treatment. In the patient's condition, the proper course of treatment was to attempt to stop the vaginal bleeding by doing a D and C; a hysterectomy only should have been attempted if the D and C did not stop the bleeding. However, Dr. Carson perceived other problems that were not explained to her satisfaction by the hospital records. First, Dr. Carson did not see anything in the records to justify the length of the surgical procedures performed by Dr. Woodson. She reported: Careful review indicated that the subject attempted to remove the fibroids vaginally, and when this only increased the bleeding, then decided to do a laparotomy. The uterus, although enlarged, was not huge and the procedure as described seemed to move along without difficulty. When, however, the time is reviewed five hours would indicate very serious problems of technique or what seems more likely a lot if indecision about how to proceed. Evidently there was no physician surgical assistant, and the subject proceeded alone. In retrospect better operationg room help should have been available. Second, Dr. Carson felt that the patient received too much whole blood replacement during the course of the day and the surgery. Her reading of the hospital records indicated to her that five units of whole blood were given to the patient in addition to four units of packed cells. She felt: "Packed cells altogether would have been a better choice in light of the volume given to the patient." Her concern was that "volume overload," rather than ARDS, may have resulted ultimately in the death of the patient. However, she disclaimed the necessary expertise to render a conclusive opinion on the question and recommended that, if the DPR wanted a conclusive opinion on the cause of death, it should have a specialist in intensive care or a respiratory expert review the records. Dr. Carson had some difficulty with the delay in getting the patient to the operating room. The records indicated that at least some of the delay was caused by the patient's unwillingness to give consent to the recommended D and C. But Dr. Carson nonetheless had concerns that the delay added to the amount of blood transfused. Dr. Carson closed her letter with this remark: "In conclusion: A poorly done sugical proceeding below the recognized normal level of care." For reasons not apparent from the evidence presented, DPR did not interview Dr. Woodson before asking the probable cause panel to find probable cause and file a draft Administrative Complaint against Dr. Woodson based on Dr. Carson's expert review and the rest of the investigative report, including the hospital records. The draft Administrative Complaint, drawn in two counts, sought to discipline Dr. Woodson under Count I for failure to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances, in two respects: first, for allegedly causing volume overload in the patient by ordering units of whole blood, instead of packed blood, to replace the patient's blood loss; and, second, for allegedly taking too long, without justification, to perform the necessary surgery. Count II alleged that Woodson failed to keep written medical records justifying the course of treatment of the patient, specifically with respect to ordering whole blood instead of packed units and with respect to the length of the surgical procedures. The probable cause panel considered the matter at its meeting on June 22, 1990. Counsel for the panel pointed out that the "extensive depositions" Woodson had indicated he wanted the DPR investigator to read before Woodson was interviewed were not in the packet of materials reviewed by the panel. 5/ But members of the panel indicated that they had reviewed the material that was in the packet and that they thought the information contained in it was adequate to make a probable cause determination. One of the doctors on the panel called it a "horrendous case." She felt that Woodson had "swamped out the patient" and had performed "inappropriate types of fluid therapy and blood therapy." The other member mentioned the "five-hour operating time . . . without any real explanation." The panel's attorney pointed out the part of the report of investigation that referenced the patient's refusal to consent to Dr. Woodson's proposed surgery and asked whether it constituted "any semblance of an explanation for a delay?" It is not clear from the transcript of the probable cause proceeding how the panel resolved the attorney's question, but the panel voted to find probable cause notwithstanding the question. 6/ There is information in the materials reviewed by Dr. Carson, and by the probable cause panel, which tends to explain some of the time it took for Dr. Woodson to perform surgery on the patient. Some of this partially exculpatory information was difficult to read and decipher in the records. Some of the partially exculpatory information was acknowledged by Dr. Carson and may also have been taken into account independently by the panel. Notwithstanding this partially exculpatory information in the record, the finding of probable cause was substantially justified.
