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.
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of August, 2005.
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue The issue for determination is whether Respondent committed the offenses set forth in the corrected administrative complaint, and, if so, what action should be taken.
Findings Of Fact At all times material hereto, Kenneth Douglas Glaeser (Respondent) was a licensed physician in the State of Florida, having been issued license number ME 0058606. Respondent's area of specialty is Emergency Medicine. On or about May 30, 1993, at approximately 9:45 p.m., Patient L. H., a 47 year old male, presented to the emergency room (ER) at Parkway Regional Medical Center (PRMC) in Miami, Florida complaining of chest pain. Patient L. H. and his wife were visiting his mother in Miami. At first, Patient L. H. believed he had heartburn, but it would not go away. His mother convinced him to go to the hospital. Patient L. H.'s wife and mother accompanied him to the hospital. His wife parked the vehicle while Patient L. H. and his mother entered the ER. Patient L. H.'s wife completed paperwork for the ER while the ER staff attended to her husband. Patient L. H.'s mother was with him. After completing the paperwork, approximately 10 minutes later, Patient L. H.'s wife joined Patient L. H. and his mother in the examining room. At the time, Respondent was the ER physician on duty at PRMC. Respondent was the only ER physician who attended to Patient L. H. Respondent has no independent recollection of Patient L. H. or what happened during Patient L. H.'s visit to the ER at PRMC. The first goal of an ER physician is to determine if the patient has a life-threatening condition, which, often times than not, involves excluding diagnoses. The second goal of an ER physician is to determine if the patient has a condition which can receive immediate treatment and to provide that immediate treatment whether the condition is life-threatening or not. Respondent obtained Patient L. H.'s history which included the type of pain, description of the pain, location of the pain, associated symptomatology, time frame of the pain (including onset), and past history. Respondent recorded, among other things, that Patient L. H. had chest pressure which radiated bilaterally to his shoulders and a numb left shoulder; that the pain lasted for approximately 10-15 minutes, subsided, and re-occurred 30 minutes later; that Patient L. H. had no shortness of breath, diaphoresis (sweating), nausea or vomiting, or palpitations; and that Patient L. H. had no cardiac history. Respondent's history of Patient L. H. was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent performed a physical examination on Patient L. H. The physical examination included taking vital signs and examination of the cardiovascular system, lungs, and pulses of the extremities. Respondent's physical examination was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent had laboratory work performed on Patient L. H. Respondent ordered SL (sublingual) nitroglycerine for Patient L. H. But, the nitroglycerine was not administered because Patient L. H. was not complaining of chest pains at the time. The ordering of the nitroglycerine and not administering it until chest pain developed was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent ordered diagnostic tests to be performed on Patient L. H. The tests included an electrocardiogram (EKG), a chest x-ray, and cardiac enzymes. Neither Patient L. H.'s wife nor his mother were present during the tests. ER physicians are trained to read EKGs. Generally, a cardiologist is not immediately available to the ER for the reading of EKGs. An ER physician looks for an injury pattern in the EKG, which would evidence an acute cardiac event. Most times, a cardiologist will over-read the EKG a day or two after the EKG is performed on a patient. Respondent's reading of Patient L. H.'s EKG did not show an injury pattern which would evidence an acute cardiac event. Respondent determined that Patient L. H.'s EKG was within normal limits. Even though an abnormality was demonstrated in the EKG, the abnormality could have been a false/positive reading. Respondent's reading of the EKG was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. A cardiologist over-read Patient L. H.'s EKG after he left PMRC. The cardiologist found a "definite abnormality." Respondent's reading of Patient L. H.'s chest x-ray indicated that it was within normal limits. Respondent's reading of the chest x-ray was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent's interpretation of the cardiac enzymes tests (CPK and LDH) indicated that they were within normal limits. If a heart is damaged, often times the enzymes contained in the heart cells will be released, and the cardiac enzymes tests would detect the enzymes. Respondent's interpretation of the cardiac enzymes tests was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. It is undisputed that based upon Patient L. H.'s history, the physical examination, the tests results, including diagnostic and laboratory results, a recommendation to Patient L. H. by Respondent for admission to PRMC was medically warranted. Admission would allow for monitoring and further evaluation. However, a patient has a right to refuse admission. Respondent discussed his findings with the doctor who was listed as Patient L. H.'s primary physician on the ER record. The primary physician was the private physician, a cardiologist, of Patient L. H.'s mother. The primary physician authorized Respondent to contact the physician on-call. Respondent discussed his findings and his concern with Patient L. H. Respondent recommended to Patient L. H. that he be admitted to PRMC. However, Patient L. H. did not wish to be admitted; he wanted to leave the hospital. Patient L. H. rejected Respondent's recommendation for admission to PRMC. 1/ Patient L. H.'s mother attempted to convince him to agree to admission and remain in the hospital, but he refused. It is undisputed that if a patient refuses admission, the physician should advise the patient of the risks involved and recommend admission. In Patient L. H.'s circumstances, it was medically warranted that Respondent advise Patient L. H. that, if he was not admitted, he could suffer a heart attack and die and recommended admission to Patient L. H. Taking the totality of the circumstances, an inference is drawn and a finding is made that Respondent advised Patient L. H. of the risks involved if he rejected admission and recommended to Patient L. H. that he be admitted. Respondent did not record in the ER record that he advised Patient L. H. of the risks involved in rejecting admission and recommended admission. ER physicians are not medically required to spell-out in the medical record what risks are discussed with a patient and that the patient left against medical advice. It is sufficient that the ER physician explains the risks to the patient. Respondent ordered a GI cocktail (Maalox, Donnatal, and viscous Lidocaine) for Patient L. H. 2/ The GI cocktail was not administered until approximately 12:15 a.m. on May 31, 1993. 3/ The ordering or not of the GI cocktail for or the time in which the GI cocktail was given to Patient L. H. has no effect on the standard of care that Respondent provided to Patient L. H. Respondent diagnosed Patient L. H.'s condition as atypical chest pain. This diagnosis essentially indicates that a number of different things may have been causing Patient L. H. to experience chest pain. Patient L. H. left PRMC on May 31, 1993, at approximately 12:20 a.m. against medial advice even though the ER record indicates that he was discharged. 4/ Before leaving PRMC, Patient L. H. was informed by Respondent to, among other things, follow-up with the primary physician and return to the ER if needed. Neither Patient L. H. nor his wife completed any discharge papers or received discharge instructions. It is not uncommon for a patient to be discharged from a hospital without completing discharge papers or receiving discharge instructions. However, hospitals attempt to prevent such occurrences. When a patient leaves PRMC against medical advice, the patient is requested to complete certain documentation. That documentation was not completed in the case of Patient L. H. However, the absence of the documentation is not considered to evidence that Respondent failed to advise Patient L. H. of the risks involved in rejecting admission and to recommend admission. On May 31, 1993, at approximately 8:45 a.m., Patient L. H. went into cardiac arrest at his mother's home. He was transported to the ER at PRMC by emergency vehicle, where he was pronounced dead. On June 1, 1993, Respondent entered an addendum to the ER notes of May 30 and 31, 1993. The addendum provided, among other things, that Patient L. H. was opposed to admission to PRMC and that, even when Respondent explained the risks to Patient L. H., he continued to oppose admission and wanted to leave. Furthermore, the addendum provided, among other things, that Respondent instructed Patient L. H. to return to the ER if the chest pain returns and to follow-up with the primary physician. An addendum to ER notes by an ER physician is not unusual and is an accepted practice. The Dade County Medical Examiner determined that Patient L. H.'s cause of death was occlusive coronary artery disease. Respondent's medical records justified the course of treatment of Patient L. H. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent is a defendant in a pending civil suit brought by Patient L. H.'s surviving spouse.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine dismiss the corrected administrative complaint. DONE AND ENTERED in this 27th day of January 1997 in Tallahassee, Leon County, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 27th day of January 1997.
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.
The Issue The issues are as follows: (a) whether Respondent acted upon Petitioner’s application for renewal as an office surgery accrediting organization within the time frames established under Section 120.60(1), Florida Statutes; and (b) whether Respondent properly denied Petitioner’s application for renewal of its status as an approved physician office surgery accrediting organization.
Findings Of Fact Background In Florida, physicians who perform certain surgical procedures in their offices are required to register the office and have the office inspected by Respondent unless the office is accredited by a nationally recognized accrediting agency or an accrediting organization approved by Respondent. § 458.309(3), Fla. Stat. (2003); Fla. Admin. Code R. 64B8-9.0091. In order to avoid physician office inspection by Respondent, a physician must submit written documentation of a current office-accreditation survey by one of the nationally recognized or Board-approved accrediting organizations. Fla. Admin. Code R. 64B8-9.0091(2)(a) and 64B8-9.0091(3)(a). A physician is also required to submit a copy of a current accreditation survey within 30 days of accreditation of the office. Fla. Admin. Code R. 64B8-9.0091(3)(b). Florida Administrative Code Rules 64B8-9.0092(1)(b) and 64B8-9.0092(7) list the approved national and Board-approved accrediting organizations. Petitioner is the only Board-approved accrediting organization. Florida Administrative Code Rule 64B8-9.0092(1)(a) provides that "accredited" means that an office has achieved either "full" accreditation or "provisional" accreditation when the office is in "substantial compliance" with accrediting standards. Petitioner provided Respondent with a complete application for renewal as an office surgery accrediting agency on January 17, 2003. Florida Administrative Code Rule 64B8- 9.0092(5) specifies that such entities must apply for renewal every three years and shall submit their applications for renewal at least three months prior to the third anniversary of their initial approval. Petitioner conducted office surgery accreditation inspections for approximately three years prior to the final hearing in this matter. Physicians who conduct office surgery are required to comply with Florida Administrative Code Rule 64B8-9.009 regarding the Standard of Care for Office Surgery. Florida Administrative Code Rule 64B8-9.0091(2)(a) specifically provides that all nationally recognized and Board-approved accrediting organizations shall be held to the same surgery and anesthesia standards for Florida office surgery sites as adopted by rule. Petitioner's accreditation standards, as outlined in its original application for approval as an accrediting agency and its subsequent application for renewal, include the requirement that physicians comply with the standard of care rules for office surgery as outlined in Florida Administrative Code Rule 64B8-9.009. In fact, Petitioner asserts that its standards meet or exceed the requirements of Chapters 455 and 458, Florida Statutes (2003), and rules promulgated there under. Petitioner's accreditation standards should have remained the same throughout the three years preceding the submission of its renewal application. Petitioner did not file any changes or amendments to its accreditation standards prior to submitting its renewal application on January 17, 2003. Submission of Corrective Action Plans Throughout the first three years of its operation, Petitioner provided Respondent with copies of all the accreditation reports for the facilities it inspected and accredited as required by Florida Administrative Code Rule 64B8- 9.0092(4)(e). That same rule also required Petitioner to furnish Respondent copies of any corrective action plans within 30 days of receipt from the inspected physician office. Petitioner did not provide Respondent with any corrective action plans or any compliance information until after Petitioner filed its renewal application. Petitioner did not offer any corrective action plans as evidence during the hearing even though Petitioner found deficiencies (non- compliance with accreditation standards) in 24 of the 25 office inspection files entered as evidence by the Respondent in this hearing. The only materials submitted by Petitioner that address the deficiency corrections are copies of photographs, invoices, packing slips, order forms, and correspondence from the inspected offices, which are supposed to constitute evidence of subsequent compliance accreditation standards. Beth Sautner is Petitioner's Executive Secretary. Ms. Sautner's duties required her to submit the requisite accreditation materials to Respondent and to communicate with Respondent regarding such activities when needed. The greater weight of the evidence indicates that Respondent's staff never told Ms. Sautner to only send the facility inspection form and that submission of corrective action plans and compliance materials was unnecessary. Ms. Sautner knew that a rule required the submission of corrective action plans. Nevertheless, Petitioner never filed any petition seeking a waiver of such rule. Action on the Application Respondent considered Petitioner's renewal application on three separate occasions. It was first considered on February 8, 2003, in Orlando, Florida, at Respondent's regularly scheduled meeting. At that meeting Petitioner waived the 90-day provision in Section 120.60(1), Florida Statutes (2002), until after Respondent's August 2003 meeting. Respondent next considered Petitioner’s renewal application at a regularly scheduled meeting on June 7, 2003, in Miami, Florida. Finally, Respondent voted to deny the application at the August 2, 2003, meeting in Orlando, Florida. Respondent filed the Notice of Intent to Deny Petitioner's application for renewal as an office surgery accrediting organization on August 28, 2003. Accreditation Process Upon the request and payment of an accreditation fee, Petitioner arranges for the inspection of an office by an inspector. Inspection is required when the physician conducts level II office surgery lasting more than five minutes or level III office surgery. The inspectors are physicians affiliated with Petitioner who personally visit the facility to conduct the inspection. The inspectors use an inspection form when conducting the accreditation inspection. The form contains a pass or fail check-off space next to each statement reflecting an accreditation standard. The form contains comment sections following the standards and at the end provides for a pass or fail designation along with two additional sections. The inspectors use the final sections for outlining minor deficiencies to be corrected within 20 working days and for major deficiencies requiring a second inspection. The form has signature lines for the inspector and the physician being inspected. After completing the inspection, the inspector forwards the form to Ms. Sautner. Next, the inspector and Ms. Sautner review the form to determine what is needed in order to complete the process. The inspector tells Ms. Sautner what is needed and she attempts to collect the requisite compliance documentation from the inspected facility. The appropriate materials are then forwarded to Ms. Sautner who sends them to the inspector for a final accreditation determination. The final accreditation determination is always made by an inspector and never by Ms. Sautner. Once the final accreditation determination is made, Ms. Sautner orders an accreditation certificate from Scribes, Inc. Scribes, Inc. sends the certificate directly to the newly accredited facility. At times, Ms. Saunter orders the certificate in advance but places it on hold until she is notified that an accreditation determination has been made. Ms. Sautner usually contacts Scribes, Inc. by e-mail to request release (delivery) of the certificate. Scribes, Inc. then sends Petitioner a facsimile copy of the physician’s accreditation certificate. Petitioner accredits offices for three years. The accreditation period begins to run from the date of the original office inspection. The certificate that Petitioner issues through Scribes, Inc. contains a month and year which reflect the final month of the facility accreditation. Therefore, if a facility’s accreditation certificate has a May 2005 date, it reflects an accreditation from May 2002 through May 2005. This is true even when the physician did not document that his or her facility fully complied with Petitioner's accreditation standards until, in some cases, months after the initial inspection. After Petitioner requests Scribes, Inc. to send a certificate to a newly accredited facility, Petitioner sends a copy of the facility inspection form, the accreditation certificate, and a cover letter to Respondent. This documentation notifies Respondent that Petitioner has inspected the physician's office and that the office is entitled to recognition as an accredited facility. Throughout the hearing Petitioner's witnesses testified that physicians' offices were not accredited until they demonstrated that they had met all of the accreditation standards. The weight of the evidence indicates that Petitioner routinely accredited a facility retroactive to its inspection date. A review of every accreditation certificate in evidence shows that each facility’s period of accreditation starts the month Petitioner performed the inspection and ends three years later. This is true even when the inspection form reveals that the physician’s office did not fully comply with Petitioner's accreditation standards at the time of inspection and the physician did not demonstrate compliance until months after the initial inspection. Ms. Sautner's testimony adds support for the proposition that Petitioner gave physicians accreditation credit retroactively to the inspection date. She was responsible for notifying Scribes, Inc. to release accreditation certificates bearing specific months and years exactly three years after the date of the inspections, as opposed to three years after the date of compliance with standards. Petitioner's inspectors considered the inspection date to be the accreditation date. They knew the subsequently issued accreditation certificates would reflect compliance with accreditation standards for a period of time before the physicians actually demonstrated compliance. It is noteworthy that, upon completion of the inspections, Petitioner gave a "pass" or, in a couple of cases, a provisional pass, to every physician’s office that Petitioner inspected before it submitted its renewal application. This adds credence to the supposition that Petitioner considered the inspection date to be the date that a facility was entitled to accreditation, even though the physicians did not demonstrate compliance until some time after the inspection. It is clear that Petitioner was not routinely accrediting physicians' offices without requiring some evidence of demonstrated compliance with accreditation standards. Instead, Petitioner usually required the physicians to furnish some documentation showing compliance after an inspection revealed deficiencies but allowed the new period of accreditation to begin retroactively on the date of the inspection. The most persuasive evidence indicates that the date Petitioner completed the accreditation process occurred sometime after the inspection: (a) on the date Ms. Sautner authorized Scribes, Inc., to release the physician's accreditation certificate; or (b) the date that Scribes, Inc., faxed Ms. Sautner a copy of the accreditation certificate sent to the physician. Therefore, the information provided to Petitioner was inaccurate to the extent it reflected that physicians' offices were in full compliance as of their inspections date. Given the above, Respondent presented ample evidence which demonstrates that Petitioner's accreditation process was misleading. At the very least, Petitioner lacked sufficient quality assurance policies and procedures to ensure that physicians were not recognized as accredited before they were entitled to such recognition. Regardless of whether any physicians were actually performing surgery in their offices between the inspection dates and the dates of compliance, Petitioner's accreditation procedure created a false impression of the adequacy of the facilities that Petitioner inspected. This mischaracterization of the status would lend support for the acceptability of procedures performed in that setting when the physician was not entitled to that recognition, with potential consequences to the health and well being of the patients. Marwan Shaykh, M.D. Petitioner inspected Dr. Shaykh’s facility on May 30, 2002. The date that appears on his accreditation certificate is May 2005. Hence, his accreditation covers May 2002 through May 2005. During the inspection, Petitioner determined that Dr. Shaykh’s office did not have the following required medications: adrenalin (expired), dextrose (expired), verapamil hydrochloride (expired), succinylcholine, and nitroglycerin. Petitioner also discovered that Dr. Shaykh’s office did not have the following required monitoring and/or emergency equipment: ambu bag and emergency power able to produce adequate power to run required equipment for a minimum of two hours. (hereinafter “emergency power”). After the inspection, Dr. Shaykh provided Petitioner a copy of an invoice from the Apothecary at Memorial. The invoice indicated that Dr. Shaykh ordered adrenalin (ephedrine), dextrose, verapamil hydrochloride, succinylcholine, and nitroglycerin (nitroquick) on July 2, 2002. The invoice was dated August 15, 2002. Dr. Shaykh also provided Petitioner a copy of an invoice from Physician Sales and Services, Inc. The invoice reflected that Dr. Shaykh ordered an ambu bag (resuscitator adult disp) on July 16, 2002. The invoice was dated July 16, 2002. Finally, Dr. Shaykh provided Petitioner a copy of a letter which read in part: Please find enclosed the copies of the anesthesia record where the EBL is recorded, the physician job description and a copy of the surgery log. In addition, invoices indicate the replacement of Dextrose 50 percent, Isuprel 1:5000, Verapamil 5mg/2ml, succinylcholine 20mg/ml to the crash cart and Administration sets (Micro drips) and Adult Resuscitator bag (Ambu Bag) to the surgery room. The letter appears to be a cover letter that accompanied the above-discussed invoices. The letter is undated and does not indicate when Petitioner received it. However, if it accompanied the medication invoice from the Apothecary, Dr. Shaykh must have sent it to Petitioner on or after August 15, 2002. Ms. Sautner ordered and placed a hold on Dr. Shaykh’s accreditation certificate on June 6, 2002. She released the hold on July 16, 2002. The certificate itself has a fax date of June 11, 2002. It appears that Scribes, Inc., faxed it to Petitioner on that date. Based on the foregoing, it is not clear whether the fax date on Dr. Shaykh’s certificate of June 11, 2002, or Ms. Sautner's stated release date of July 16, 2002, is the actual release date. Nevertheless, regardless of which date is the correct release date, it is apparent that Petitioner sent Dr. Shaykh an accreditation certificate before he documented compliance with Petitioner's accreditation standards because the Apothecary invoice was dated after both possible release dates. Karen Chapman, M.D. Petitioner inspected Dr. Chapman’s facility on April 6, 2002. The date that appears on her accreditation certificate is April 2005. Hence, her accreditation covers April 2002 through April 2005. During the inspection, Petitioner determined that Dr. Chapman’s office did not have multiple (14) medications, one of which was inderal. Petitioner also discovered that Dr. Chapman’s office did not have a required ambu bag among other missing monitoring and/or emergency equipment. After the inspection, Dr. Chapman provided Petitioner copies of invoices from Southern Anesthesia + Surgical dated April 11, 2002, which reflected that Dr. Chapman ordered all the missing medications with the exception of inderal. Dr. Chapman also provided Petitioner a copy of undated correspondence which asserted that Karen Chapman ordered and received inderal 1mg/mL, on April 11, 2002. Both the Southern Anesthesia + Surgical invoice copies and the undated correspondence regarding the inderal contain a fax strip across the top. The date on the fax strip indicates that Dr. Chapman sent the invoice copies and the inderal correspondence to Petitioner on February 12, 2003. Ms. Sautner was unable to provide an order or release date for Dr. Chapman’s accreditation certificate. However, the inspection file contained an accreditation certificate which had a fax date across the top of May 10, 2002. The Southern Anesthesia + Surgical invoice copies and the undated correspondence regarding the inderal were obviously faxed to FLACS over seven months after the accreditation certificate was sent to Dr. Chapman. Petitioner attempts to explain this discrepancy away by claiming that it had all compliance documentation prior to issuing accreditation but in some cases it could not find the documents when it conducted an audit in 2003. In those instances, Petitioner contacted the physicians and asked them to send the compliance materials again after the fact. Such an explanation is unacceptable because it does not explain why the compliance documentation was not in the file in the first place. Additionally, Petitioner has provided no documentation of compliance materials from Dr. Chapman disclosing whether she ever obtained a required ambu bag. Lucien Armand, M.D. Petitioner inspected Dr. Armand’s facility on June 8, 2001. The date that appears on his accreditation certificate is June 2004. Hence, his accreditation covers June 2001 through June 2004. During the inspection, Petitioner determined that Dr. Armand’s office did not have the following required medications: adrenalin (epinephrine) 1/10,000 dilution, calcium chloride, dextrose, dilantin (phenytoin), dopamine, and inderal (propranolol). After the inspection, Dr. Armand provided Petitioner on some unknown date a copy of an invoice from Medical III Pharmacy. The invoice reflected that on April 23, 2001, Dr. Armand ordered dilantin, dopamine, and inderal. The invoice was dated April 30, 2001. Dr. Armand also provided Petitioner, on some unknown date, unsigned correspondence indicating that he had “re- supplied” his emergency cabinet with adrenalin, calcium chloride, dextrose, dilantin, dopamine, and inderal. Ms. Sautner placed Dr. Armand’s accreditation certificate on hold on June 22, 2001. The certificate had a fax date across the top of June 28, 2001. The above-referenced invoice from Medical III Pharmacy is of course not probative as to whether Dr. Armand obtained the missing crash cart medications after the inspection because the invoice indicates that the drugs were ordered before the inspection. Furthermore, Dr. Armand’s unsigned correspondence indicating that he had “resupplied” his emergency cabinet with adrenalin, calcium chloride, dextrose, dilantin, dopamine, and inderal is obviously problematic because it is unsigned and provides no objective proof of compliance. Scott Warren, M.D. Petitioner inspected Dr. Warren’s facility on April 11, 2001. The date that appears on his accreditation certificate is May 2004. Thus, his accreditation covers May 2001 through May 2004. During the inspection, Petitioner determined that Dr. Warren’s office did not have required intubation forceps. After the inspection, Dr. Warren provided Petitioner a copy of an order receipt from an unknown pharmaceutical vendor. The order receipt reflected that, on an unknown date, Dr. Warren ordered adult and child sized McGill Forceps (a type of intubation forceps). The invoice was not dated but a fax strip across the top reveals that Dr. Warren's office faxed a copy of the receipt to Petitioner on July 11, 2001. Ms. Sautner placed a hold on Dr. Warren’s accreditation certificate on June 22, 2001. The certificate had a fax date across the top of June 29, 2001. The copy of the Magill Forceps receipt was faxed to Petitioner ten days after Petitioner released the accreditation certificate to Dr. Warren. Therefore, Petitioner could not have verified compliance prior to the awarding of accreditation. Furthermore, this discrepancy cannot be attributed to Petitioner's 2003 audit because the fax receipt date was approximately one and a half years prior to the audit. Juan Flores, M.D. Petitioner inspected Dr. Flores' facility on July 21, 2002. The date that appears on his accreditation certificate is July 2005. Accordingly, his accreditation covers July 2002 through July 2005. During the inspection, Petitioner determined that Dr. Flores’ office did not have inderal (propranolol) or nasal airways. Dr. Flores provided Petitioner correspondence dated July 30, 2002, from a Laura Leyva. The correspondence indicated that Dr. Flores’ facility had acquired the requisite nasal airways. On November 14, 2003, Petitioner received a fax copy of an invoice numbered 9927 from Prime Medical Care, Inc. The invoice dated July 15, 2002, documents Dr. Flores' acquisition of inderal. Dr. Flores’ accreditation certificate had a fax date of September 6, 2002, across its top. The Prime Medical Care, Inc., invoice copy was faxed to Petitioner on November 14, 2003, over a year after the accreditation certificate was sent to Dr. Flores. Petitioner again explains this discrepancy by raising the 2003 audit excuse. However, the explanation does not explain why the compliance documentation was not in the file in the first place. Mina Selub, M.D. Petitioner inspected Dr. Selub’s facility on May 17, 2002. The date that appears on her accreditation certificate is May 2005. Therefore, her accreditation covers May 2002 through May 2005. During the inspection, Petitioner determined that Dr. Selub’s office did not have heparin, nasal airways, and intubation forceps. Dr. Selub sent Petitioner a copy of a customer packing slip on an unknown date. The customer packing slip revealed that Dr. Selub ordered heparin from McKesson Medical Surgical on May 3, 2002. The packing slip had a handwritten note indicating that the heparin was received on June 1, 2002. Dr. Selub also submitted a copy of a second customer packing slip to Petitioner on an unknown date. The second customer packing slip revealed that Dr. Selub ordered Magill Forceps from McKesson Medical Surgical on May 13, 2002. The packing slip had a handwritten note indicating that Dr. Selub did not receive the forceps, which were reordered from Henry Schein. Petitioner never received any other documentation indicating that Dr. Selub actually ordered or received intubation forceps. Additionally, Dr. Selub also failed to provide any documentation of compliance with the nasal airway requirement. Ms. Sautner placed a hold on Dr. Selub’s accreditation certificate on June 6, 2002. She released the hold on July 12, 2002. The accreditation certificate has a July 15, 2002, fax date across the top. The above-referenced invoice for heparin from McKesson Medical Surgical indicates that the medication was ordered before the inspection. However, the hand written notation on that same invoice indicates that Dr. Selub's office received the heparin on June 1, 2002. The lack of any documentation regarding the ordering and/or receipt of the intubation forceps is more problematic. Apparently Petitioner issued Dr. Selub's office an accreditation certificate without obtaining further written verification of compliance with accreditation standards. Abelardo Acosta, M.D. Petitioner inspected Dr. Acosta’s facility on November 17, 2001. The date that appears on his accreditation certificate is November 2004. Hence, his accreditation covers November 2001 through November 2004. During the inspection, Petitioner determined that Dr. Acosta’s office did not have the following required medications: succinylcholine, magnesium sulfate, heparin, dopamine, inderal (propranolol), and dilantin (phenytoin). Petitioner also discovered that Dr. Acosta’s office did not have the following required monitoring and/or emergency equipment: tonsillar suction and nasal airways. After the inspection, Dr. Acosta provided Petitioner with the following documentation: (a) a copy of a packing slip from Southern Anesthesia + Surgical dated November 26, 2001, reflecting that Dr. Acosta ordered dopamine, succinylcholine, dilantin, magnesium sulfate, and heparin; (b) a copy of a statement from Southern Anesthesia + Surgical dated July 15, 2002, which reflected that Dr. Acosta had ordered inderal (propranolol); (c) a copy of an invoice from Armstrong Medical Industries, Inc., with an order date of January 2, 2002, which reflected that Dr. Acosta ordered a suction unit; and (d) a copy of a packing slip from Physician Sales & Service dated December 3, 2001, reflecting that Dr. Acosta ordered numerous types of airways and a yankuar suction unit. Ms. Sautner placed a hold on Dr. Acosta’s accreditation certificate on December 5, 2001. She released the hold on December 12, 2001. The certificate has a December 12, 2001, fax date across the top. The statement from Southern Anesthesia + Surgical dated July 15, 2002, which reflected that Dr. Acosta ordered inderal, constitutes undisputed evidence that Petitioner did not verify Dr. Acosta’s full compliance with Petitioner's crash cart accreditation requirements prior to the awarding of actual accreditation on December 12, 2001. Charles Graper, M.D. (Level II Accreditation) Petitioner inspected Dr. Graper’s facility for level II accreditation on March 25, 2001. The date that appears on his accreditation certificate is March 2004. Thus, his accreditation covers March 2001 through March 2004. During the inspection, Petitioner determined that Dr. Graper’s office did not have dextrose 50 percent, a required medication. Dr. Graper failed to provide Petitioner with any subsequent documentation to demonstrate compliance with accreditation standards regarding the need to have dextrose 50 percent as part of the office’s crash cart. Ms. Sautner released Dr. Graper’s accreditation certificate on April 4, 2001. The certificate has a April 19, 2001 fax date across the top. Petitioner failed to verify that Dr. Graper obtained dextrose 50 percent for his crash cart after his inspection for level II surgery and before the release of his accreditation certificate by Petitioner on April 4, 2001. Leigh Phillips, III, M.D. Petitioner inspected Dr. Phillips' facility for level II and III surgery on January 31, 2002. The date that appears on his accreditation certificate is January 2005. Hence, his accreditation covers January 2002 through January 2005. During the inspection, it was determined that Dr. Phillips' office did not have the following required medications: dextrose 50 percent and 36 ampules of dantrolene (missing 18). After the inspection, Dr. Phillips provided Petitioner a copy of an order acknowledgment form from Southern Anesthesia + Surgical dated February 7, 2002. The order acknowledgment form reflected that Dr. Phillips ordered dextrose 50 percent. Dr. Phillips' inspection file also contained a handwritten letter from Dr. Mel Propis dated January 31, 2003. The letter indicated that Dr. Propis had just returned from the office of Dr. Phillips and while there he had counted 36 ampules of dantrolene and the dextrose 50 percent in the crash cart. Ms. Sautner did not know the date that she advised Scribes, Inc., to release Dr. Phillip’s accreditation certificate. However, her records indicate that the certificate was faxed to her on February 19, 2002. Dr. Propis’ correspondence dated January 31, 2003, verifying Dr. Phillips' receipt of the requisite dantrolene was provided to Petitioner approximately 11 months after Petitioner received a copy of Dr. Phillips' accreditation certificate. Such constitutes further undisputed evidence that FLACS did not verify Dr. Phillips' full compliance with accreditation standards prior to awarding him accreditation. Brandon Kallman, M.D. and Francisco Prado, M.D. (combined inspection) Petitioner inspected Drs. Kallman and Prado’s facility on June 2, 2002. The date that appears on their accreditation certificates is June 2005. Hence, their accreditation covers June 2002 through June 2005. During the inspection, Petitioner determined that the physicians’ office did not have the following required medications: adrenalin (1:10,000 dilution), magnesium sulfate, heparin, dopamine, pronestyl (procainamide), and dilantin (phenytoin). Drs. Kallman and Prado provided Petitioner with a copy of a packing slip from Southern Anesthesia + Surgical dated July 12, 2002. The packing slip reveals that Drs. Kallman and Prado ordered the missing adrenalin (epinephrine), dopamine, pronestyl (procainamide), and dilantin (phenytoin). However, as evidenced by the fax strip across the top of the packing slip copy, the documentation was provided to Petitioner via fax transmission on July 22, 2002. Drs. Kallman and Prado also provided Petitioner with a copy of a packing slip from Henry Schein. The packing slip is dated July 18, 2002. The packing slip has a date of July 23, 2002, on the fax strip across the top. The packing slip in the record is illegible. Therefore, one cannot determine whether the packing slip served as documentation for receipt of the missing magnesium sulfate and heparin. Additionally, Drs. Kallman and Prado provided Petitioner with copies of an e-mail dated October 14, 2002, and multiple photos dated October 11, 2002. The photos depict the facility’s crash cart, its drawers, and the presence of dantrium. The original inspection form dated June 2, 2002, did not reveal any missing dantrium. Finally, Dr. Kallman provided one more document which purports to be some attempt at curing the deficiencies that were discovered during the inspection. The document in question is a short handwritten letter on Dr. Kallman’s letterhead signed by Dr. Kallman and dated July 16, 2002. The body of the letter reads as follows: Herewith are the documents requested. I will fax tomorrow a copy of Ms. Mad. Katz RN ACLS certification. Let this letter also reflect that we have ordered from Henry Schein the appropriate missing drugs for the crash cart. They are currently on back order. I will send a copy of the shipping slip upon arrival. Ms. Sautner released Drs. Kallman and Prado’s accreditation certificate on July 17, 2002. The certificate contains a July 23, 2002, fax date across the top. It may be that the illegible packing slip from Henry Schein verifies the receipt of magnesium sulfate and heparin by Drs. Kallman and Prado. Even so, the packing slip was dated July 18, 2002, one day after Ms. Sautner released the accreditation certificate on July 17, 2002. Additionally, the packing slip from Southern Anesthesia + Surgical was provided to Petitioner after the accreditation certificate release date. Needless to say, the e-mail and multiple photos are dated almost three months after the release of the accreditation certificate. The inspection file for Drs. Kallman and Prado is particularly problematic because the handwritten correspondence from Dr. Kallman put Petitioner on notice that he and Dr. Prado did not yet have the requisite drugs needed to meet the accreditation standards. Nevertheless, the very next day, with no further verification, Petitioner released the accreditation certificate. Dr. Luis Zarate, M.D. Petitioner inspected Dr. Zarate’s facility for level II and III office surgery on September 14, 2002. The date that appears on his accreditation certificate is September 2005. Hence, his accreditation covers September 2002 through September 2005. During the inspection, Petitioner determined that Dr. Zarate’s office did not have the required 36 ampules of dantrolene. Petitioner's inspection file for Dr. Zarate does not contain any documentation of ordering or receipt of dantrolene by Dr. Zarate or by anyone else on his behalf. Ms. Sautner did not have a release date for Dr. Zarate’s accreditation certificate. The certificate had an October 3, 2002, fax date. When Petitioner inspected Dr. Zarate, he was working in the same facility as Drs. Kallman and Prado. It is possible that the dantrolene photo contained in Drs. Kallman and Prado’s inspection file was meant to document Dr. Zarate’s compliance with the dantrolene requirement. Even if that is the case, Drs. Kallman and Prado's dantrolene photos were dated October 11, 2002, which means that the photos were taken after Petitioner released Dr. Zarate’s accreditation certificate. Dr. Andrew Weiss and Dr. Anthony Rogers Petitioner inspected Drs. Weiss and Rogers’ facility on December 6, 2001. However, the date that appears on their accreditation certificates is November 2004. Hence, their accreditation covers December 2001 through November 2004. During the inspection, Petitioner determined that the physicians’ office did not have two required medications: pronestyl (procainamide) and inderal (propranolol). Drs. Weiss and Rogers provided Petitioner with a copy of an invoice from Henry Schein dated February 6, 2003. The invoice reveals that Drs. Weiss and Rogers ordered the missing pronestyl (procainamide) and inderal (propranolol). The inspection file also contains a printed statement under the title “Andrew Weiss, M.D.” which states that “[a]ll ACLS approved drugs were present at the time of accreditation. Inspector found no deficiencies.” However, during the hearing, Ms. Sautner admitted that the statement was inaccurate and inserted into the file by error. Ms. Sautner placed a hold on the certificates for Drs. Weiss and Rogers on December 5, 2001 and December 10, 2001. She did not know the release dates of the certificates. The fax date on the certificates was December 12, 2001. The above-mentioned Henry Schein invoice dated February 6, 2003, is persuasive evidence that Drs. Weiss and Rogers ordered and received the requisite pronestyl (procainamide) and inderal (propranolol) over one year after Petitioner received a copy of Drs. Weiss and Rogers’ accreditation certificates. Such constitutes undisputed evidence that FLACS did not verify Drs. Weiss and Rogers’ full compliance with FLACS’s accreditation standards prior to awarding accreditation. Richard Edison, M.D. Petitioner inspected Dr. Edison’s facility on April 22, 2001. The date that appears on his accreditation certificate is April 2004. Thus, his accreditation covers April 2001 through April 2004. During the inspection, Petitioner determined that Dr. Edison’s office did not have the following required medications: adrenalin (1:10,000 dilution), succinylcholine, dilantin (phenytoin), and lanoxin (digoxin). Petitioner also discovered that Dr. Edison’s office did not have the following required monitoring and/or emergency equipment: intubation forceps. Dr. Edison’s inspection file contains a handwritten letter dated May 7, 2001, from Pam Rolm, R.N. Ms. Rolm wrote the letter on the letterhead for Dr. Edison’s facility, Cosmetic Surgery Center. The letter reads in part as follows: This letter is in response to request for information for certification. The following medications have been updated and the expired ones disposed of: 1) phenytoin, 2) Lanoxin, 3) succinycholine, and 4) Albuterol Inhaler. We have a McGill forceps in both anesthesia carts and an extra pair in the ORI medication cart. Dr. Edison’s inspection file also contains three invoices from Prime Medical Care, Inc. All three invoices have a fax strip across the top with a February 14, 2003, date and the sender name of Cosmetic Surgery Center. The first invoice dated December 11, 2000, indicates that Dr. Edison ordered ephedrine sulfate 50mg/ml. The second invoice dated October 30, 2001, indicates that Dr. Edison ordered lidocaine, heparin, verapamil, procainamide, and phenylephrine. The third invoice dated April 25, 2001, indicates that Dr. Edison ordered succinylcholine, albuterol inhaler, phenytoin, and digoxin. Ms. Sautner testified that she ordered and placed a hold on the certificate for Dr. Edison on May 4, 2001. She released the hold on May 10, 2001. The certificate has a May 22, 2001, fax date across the top. The above-referenced correspondence dated May 7, 2001, does not address whether Dr. Edison ordered/obtained the missing adrenalin (1:10,000 dilution). Additionally, the first invoice is dated four months prior to the inspection. The second invoice is dated months after Petitioner released the accreditation certificate. The third invoice is appropriately dated but does not show that Dr. Edison ever ordered/obtained the missing adrenalin (1:10,000 dilution). Accordingly, Petitioner released Dr. Edison’s accreditation certificate before he documented compliance with the requirements that he possess adrenalin (1:10,000 dilution) and intubation forceps. Dr. Alton Ingram, M.D. Petitioner inspected Dr. Ingram’s facility on April 28, 2002. The date that appears on his accreditation certificate is April 2005. Therefore, his accreditation covers April 2002 through April 2005. During the inspection, Petitioner determined that Dr. Ingram’s office did not have a required tonsillar suction unit with backup suction. Dr. Ingram’s inspection file contains a copy of a photograph of a tonsillar suction unit with a hand-written date of July 29, 2002. Ms. Sautner placed the certificate for Dr. Ingram on hold on June 6, 2002. She released the hold on July 19, 2002. The date on the certificate is not legible. The date on the photograph of the tonsillar suction unit is after Petitioner released the accreditation certificate. Petitioner accredited Dr. Ingram before he documented full compliance with accreditation standards. Mont Cartwright, M.D. (Heathrow Facility) Petitioner inspected Dr. Cartwright’s Heathrow facility on March 3, 2001. The date that appears on his accreditation certificate is March 2004. Thus, his accreditation covers March 2001 through March 2004. During the inspection, Petitioner determined that Dr. Cartwright’s Heathrow office did not have the required dopamine, heparin, and inderal. In an undated letter, Dr. Cartwright’s staff advised Petitioner that Dr. Cartwright’s Heathrow facility had obtained the missing medications. Ms. Sautner released the hold on Dr. Cartwright’s accreditation certificate on April 4, 2001. The fax date on the certificate is April 19, 2001. Mont Cartwright, M.D. (Orlando Facility) Petitioner inspected Dr. Cartwright’s Orlando facility on May 13, 2001. The date that appears on his accreditation certificate is May 2004. Hence, his accreditation covers May 2001 through May 2004. During the inspection, Petitioner determined that Dr. Cartwright’s Orlando office did not have the required dilantin and heparin. Dr. Cartwright’s office staff sent Petitioner correspondence dated June 7, 2001. The letter claims that the “crash cart” in Dr. Cartwright’s Orlando facility had been “brought up to standards in accordance with compliance. ” Ms. Sautner testified that she released the hold on Dr. Cartwright’s accreditation certificate on June 22, 2001. The fax date on the certificate is June 28, 2001. Inadequate Quality Control Petitioner asserts that it has appropriate quality assurance programs and processes which Respondent reviewed without objection. Dr. R. Gregory Smith, one of Petitioner’s current co-directors for facility inspections, describes Petitioner's quality assurance program in the following manner: Right. We have regular board meetings. We go over the forms and changes and things like that. We talk to inspectors and say, you know, try to check all the boxes and that type of thing. Q. You basically go over your work again – A. Yes. – make sure everything is accurate? A. Right. Plus, I think the actual meeting with the Board of Medicine to iron out any issues is also quality assurance. Petitioner's renewal application included a two-page document titled, “Quality Improvement Plan.” The document can best be described as a description of the quality assurance exercises for physicians' offices. The document does not describe Petitioner's internal quality assurance program. Other than the above-quoted description provided by Dr. Smith, Petitioner failed to present any evidence that outlines Petitioner’s own quality assurance program. In fact, the manner in which Petitioner deals with its own errors indicates that Petitioner has inadequate quality assurance processes. In situations where an inspector fails to check yes or no on an item when conducting an inspection, Petitioner takes the position that an inspector is not to make any changes after the fact. Rather, Petitioner claims that it assumes the worse, treats the blank as a no answer, and asks the physician undergoing inspection to provide a letter of attestation, a packing slip, or some other material that documents compliance with the accrediting standard. Petitioner's inspection files reveal instances where Petitioner did not follow the above-referenced quality assurance policy. For example, the inspection form for Harold Reed, M.D., revealed no check under yes or no on page 3 under the crash cart medication succinylcholine. After the inspection, Dr. Reed did not provide Petitioner with any materials documenting compliance with the requirement to have succinylcholine on the facility's premises. It may be that the inspector made a clerical error during the inspection or he may have remembered seeing the medication in Dr. Reed's refrigerator after the inspection. In any event, Petitioner did not follow its alleged quality assurance policy of requiring the physician to show compliance after the inspection. Dr. Leonard Rubinstein’s inspection file presents another example of Petitioner's failure to follow its alleged quality assurance policies. The inspection form reveals no check under yes or no on page 3 under the crash cart medications lasix and magnesium sulfate and on page 4 under oximeter in the monitoring and emergency equipment section. After the inspection, Dr. Rubinstein did not provide Petitioner with any documentation showing the presence of the missing items. Petitioner did not attempt to determine whether the inspector had made a “clerical error” or whether Dr. Rubinstein procured the missing items. In other words, Petitioner did not follow its own policy regarding the treatment of situations where the inspector fails to check no or yes on an inspection item. Dr. Michael Freeman’s inspection file presents another example of Petitioner’s failure to follow its alleged quality assurance policies. Dr. Freeman’s inspection form reveals no check under yes or no on page 3 under the crash cart medication mazicon. The inspection file contains no deficiency documentation, and thus, does not address the mazicon issue. Again, Petitioner did not follow its own policy regarding the treatment of situations where the inspector fails to check no or yes on an inspection item. Conditions Posing a Potential Immediate Threat Dr. Hector Vila, Jr., a licensed Florida physician and an Assistant Professor of Anesthesiology and Oncology at the University of South Florida, H. Lee Moffitt Cancer Center, testified during the final hearing on the issue of whether any of the facilities inspected by Petitioner posed a potential immediate threat to patients due to the deficiencies discovered during the inspection. Dr. Vila has administered anesthesia in office surgery settings in the past and currently serves as an office surgery inspector for the Respondent. Dr. Vila is an expert in office surgery and anesthesia. His testimony regarding Petitioner's failure to report conditions posing a potential immediate threat to patients is persuasive. For example, the office of Marwan Shaykh, M.D, posed a potential immediate threat to patients because it did not have nitroglycerin and epinephrine (adrenalin) on the premises. Such medications are necessary to resuscitate a patient who may suffer a respiratory arrest due to either a surgical or anesthetic complication. It would be nearly impossible to resuscitate a patient without such items. Dr. Shaykh failed to provide documentation of compliance with the nitroglycerin and adrenalin requirement until August 15, 2002, or sometime thereafter. Dr. Shaykh demonstrated compliance approximately two months after Petitioner recognized Dr. Shaykh as being accredited. It is true that Dr. Shaykh’s office was located adjacent to a hospital. Therefore, it is possible that the same teams that respond to emergencies in the hospital could go to Dr. Shaykh's office if he needed them. It is also true that Dr. Shaykh performs in vitro fertilization procedures, which could be terminated in case of an emergency. However, after Petitioner recognizes Dr. Shaykh as being accredited, he could practice any type of medicine and perform any procedure as long as he is properly trained to do so. Furthermore, the office surgery accreditation rules do not provide any type of exemption based on the location of the physician’s office because to do so would undermine the reason for the rule. Office surgery facilities are not hospitals no matter how close to the hospital they may be located. If Dr. Shaykh felt that his close proximity to the hospital did not make compliance with the office surgery rules necessary, he should have filed a petition for waiver or variance from the relevant rules rather than ignore the need to have crucial resuscitative drugs in his crash cart. The office of Karen Chapman, M.D., posed a potential immediate threat to patients because it lacked 16 of the 22 medications required in an office surgery facility’s crash cart. The office also lacked an ambu bag, a piece of equipment used to resuscitate patients. Two of the 16 missing medications were the nitroglycerin and adrenalin, which are absolutely necessary to resuscitate a patient who may suffer a respiratory arrest due to either a surgical or anesthetic complication. The ambu bag is also used on patients under respiratory arrest and it is considered a crucial piece of equipment. Dr. Chapman’s office failed to provide documentation of compliance with the crash cart requirements until February 12, 2003. She did not demonstrate compliance until approximately nine months after she obtained her accreditation. Dr. Chapman may have informed Petitioner that she did not intend to open her new practice until she obtained accreditation. However, Dr. Chapman obtained her accreditation and presumably opened her practice almost nine months before she provided Petitioner with documentation of her compliance with the crash cart medication requirements. She never provided any materials documenting whether she obtained the required ambu bag.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent enter a final order denying Petitioner’s application for renewal as an office surgery accrediting agency. DONE AND ENTERED this 15th day of April, 2004, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of April, 2004. COPIES FURNISHED: Alfred W. Clark, Esquire 117 South Gadsden Street, Suite 201 Post Office Box 623 Tallahassee, Florida 32302-0623 Edward A. Tellechea, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 Rosanna Catalano, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint filed July 7, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2006). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2006). Dr. Edison is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 44240. Dr. Edison received his medical degree from the University of Massachusetts; did his residency in general surgery at the Kaiser Foundation in Los Angeles, California; and did a residency in plastic surgery, with specialties in reconstructive surgery and cosmetic surgery. Dr. Edison is certified in plastic surgery by the American Board of Plastic Surgery and is a lifetime diplomate of that Board. Dr. Edison was also certified in Advanced Cardiac Life Support ("ACLS") at the times material to this proceeding. Dr. Edison has been practicing plastic surgery in Florida for 22 years. Prior to the time material to this proceeding, Dr. Edison performed approximately 150-to-200 breast augmentation surgeries each year and approximately 100-to-150 liposuction procedures each year. Dr. Edison practices at the Cosmetic Surgery Center, which is an office that contains two operating rooms, a recovery room, and an overnight recovery facility that is staffed by an ACLS-certified nurse for patients who undergo procedures such as stomach tucks or facelifts. Dr. Edison's surgical practice is limited to Level II office surgery, which is defined in Florida Administrative Code Rule 64B8-9.009, Standard of Care for Office Surgery, in pertinent part as follows: Level II Office Surgery. Scope Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, this making intra and post- operative monitoring necessary. . . . Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Standards for Level II Office Surgery. * * * 4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. . . . The level of pain and anxiety management achieved under Level II sedation is determined by the type of drugs administered and the dosages in which they are administered. Dr. Edison was ACLS certified and was, therefore, authorized to use the services of a registered nurse to administer the drugs that bring patients to Level II sedation. He does not use the services of an anesthesiologist or of a Certified Registered Nurse Anesthetist in his surgical facility. Patient P.L. P.L. first consulted with Dr. Edison on July 5, 2005. P.L. filled out a portion of a Patient Information form, and Dr. Edison took a general medical history from P.L., but he did not weigh P.L. during this initial visit, and the Patient Information form does not include her blood pressure, height, or weight. Dr. Edison found P.L. to be a healthy 29-year-old female, the mother of three children, who had no known allergy or adverse reaction to any medication. P.L. wanted breast implants, and, upon examination, Dr. Edison found that P.L. would be a good candidate, anatomically, for the surgery. Dr. Edison spent the majority of time during this initial consultation talking with P.L. and her husband, A.A., about the various breast implant options. He also discussed with them the risks and possible complications of the surgery. After her visit to Dr. Edison's office on July 5, 2005, P.L. notified Dr. Edison's office that she had decided to have the surgery. Dr. Edison had a cancellation on July 7, 2005, and P.L. was scheduled for surgery for 8:00 a.m. on that date. P.L. returned to Dr. Edison's office on July 6, 2005, for a pre-operative examination. At that time, Dr. Edison did an examination during which he checked P.L.'s heart, lungs, blood pressure, and pulse rate, and he noted the results in his examination notes dated July 6, 2005. He found nothing abnormal and concluded that P.L. was a 29-year-old patient in perfect health, with no known allergy or adverse reaction to any medication. Dr. Edison also had blood drawn during the July 6, 2005, office visit, which was sent to a laboratory for testing. The laboratory report was completed at 8:21 a.m. on July 7, 2005, and showed nothing abnormal. P.L. presented herself at Dr. Edison's office on July 7, 2005, at approximately 8:00 a.m. She was examined by Dr. Edison at 8:10 a.m., and he stated in his office notes that she had decided on the 300 cubic centimeter implant. There were no notations of her vital signs in his office notes. Dr. Edison intended for P.L.'s breast augmentation surgery to be Level II office surgery, and he noted this on P.L.'s Immediate Pre-Op Evaluation, which he completed on July 7, 2005. He also decided to use the transaxillary technique, making incisions under the arms through which to insert the implants under the muscle in P.L.'s chest. Dr. Edison was assisted during surgery by Michelle Hoff, an Advanced Registered Nurse Practitioner, who administered the sedatives and other drugs to P.L. under Dr. Edison's direction. Dr. Edison was also assisted by Liliana Gabor, a surgical technician. Ms. Hoff is not a Certified Registered Nurse Anesthetist, nor has she received any formal training in administering sedative drugs or anesthesia. She has a significant amount of experience administering drugs for pain and anxiety management. Her experience administering drugs to achieve Level II sedation consists of an externship with Dr. Edison while working on her master's degree in nursing and extensive on-the-job training while working in the operating room with Dr. Edison, which she has done every day since beginning to work with Dr. Edison full-time in November 2003. At some point immediately prior to surgery, Dr. Edison asked P.L. her weight, which she reported as 95 pounds, or 43 kilograms, on the morning of surgery. Dr. Edison needed to know P.L.'s weight in order to calculate the correct dosage of the drugs she would be given, and he wrote "95 lbs" on the outside of P.L.'s folder. Dr. Edison noted P.L.'s weight on the outside of the folder so it would be plainly visible to Ms. Hoff when she had the chart on the anesthesia stand.4 Dr. Edison did not enter P.L.'s weight in his examination notes, and the only other mention of P.L.'s weight in the medical records maintained by Dr. Edison is the notation "<100 lbs" on a sheet containing the contact numbers for P.L. and for her husband, who would be picking her up after surgery. At approximately 8:20 a.m. on July 7, 2005, P.L. walked to the operating room. Working under Dr. Edison's direction, Ms. Hoff hooked P.L. up to various monitoring devices, so that her heart, blood pressure, and oxygen saturation level could be monitored during surgery. Her vital signs were noted on the anesthesia chart by Ms. Hoff; at 8:20 a.m., P.L.'s heart rate was approximately 104. At 8:20 a.m., Ms. Hoff began to administer drugs to P.L. to achieve Level II sedation in accordance with directions from Dr. Edison; she documented the name of the drugs she administered, together with the time and dosage administered; she monitored and documented P.L.'s vital signs, including heart rate, blood pressure, and oxygen saturation level; and she maintained anesthesia notes. At 8:20 a.m., Ms. Hoff administered two milligrams of Valium; one gram of Ancef, and 0.2 milligrams of Robinol at Dr. Edison's direction. At 8:25 a.m., she administered 10 milligrams of Ketamine and 10 milligrams of Talwin and started the administration of Diprivan by microdrip at the rate of approximately 25 micrograms per kilogram of weight per minute. Ms. Hoff's notes do not indicate the manner in which she administered the Diprivan, nor the dosage or rate of administration. Ms. Hoff also administered nitrous oxide and oxygen at 8:25 a.m., and she noted that Dr. Edison also began administering local anesthetic by injection at 8:25 a.m. Ms. Hoff noted that P.L. was responding to verbal stimuli. Ms. Hoff was not involved with the preparation or administration of local anesthetic to P.L. Dr. Edison prepared a dilute solution of 70 cubic centimeters of 1% Lidocaine with epinephrine with 350 cubic centimeters of saline solution and 10 cubic centimeters of 1/2% marcaine. At approximately 8:25 a.m., Dr. Edison began injecting the Lidocaine solution, which totaled approximately 700 milligrams or approximately 14 milligrams of Lidocaine per kilogram of P.L.'s body weight and 50 milligrams of marcaine, into the tissue surrounding P.L.'s breasts. At 8:30 a.m., Ms. Hoff, at Dr. Edison's direction, administered another 10 milligrams of Talwin. At 8:35 a.m., P.L.'s heart rate was 112 beats per minute and her blood pressure was 142/102. At Dr. Edison's direction, Ms. Hoff administered 1/4 cubic centimeter of Labetalol to help control P.L.'s blood pressure. Ms. Hoff noted that P.L. tolerated the Labetalol well and was responsive to verbal stimuli. At 8:45 a.m., Ms. Hoff noticed a brief facial twitch on P.L.'s face, which is an indication of a possible seizure. At Dr. Edison's direction, she immediately stopped administering all sedatives, and the surgery was cancelled. At Dr. Edison's direction, Ms. Hoff administered 2.5 milligrams of Valium to keep P.L. sedated and to help control the seizure, together with three liters of oxygen by mask. At 8:55 a.m., Ms. Hoff administered another 2.5 milligrams of Valium at Dr. Edison's direction,5 and she noted that P.L.'s status was unchanged, by which Ms. Hoff meant that P.L.'s airway, breathing, and circulation were maintained, that her vital signs were stable, and that she remained responsive to verbal stimuli. Between 8:55 a.m. and 9:15 a.m., P.L.'s status was unchanged. According to Ms. Hoff's notes, P.L.'s airway, breathing, circulation, and vital signs were maintained at normal levels, and she responded well to the Valium and oxygen. Ms. Hoff observed during this time that P.L. was lethargic and appeared to be a little more deeply sedated than typical Level II sedation. P.L. continued breathing on her own and responding to verbal stimuli. During this interval, Dr. Edison was waiting for P.L. to come out of sedation, and he intended to send her home and recommend that she see her doctor about the twitch. Ms. Hoff noticed a second facial twitch between 9:15 a.m. and 9:20 a.m., and Dr. Edison directed Ms. Hoff to call Emergency Medical Services to transport P.L. to the hospital. Ms. Hoff continued to monitor P.L.'s airway, breathing, circulation and vital signs until the Emergency Medical Services team arrived at 9:30 a.m. During this time, Ms. Hoff noted that P.L. responded to verbal stimuli by moving her head a little bit and attempting to open her eyes. P.L.'s oxygen saturation rate was consistently maintained at 99% to 100% between 8:20 a.m. and 9:30 a.m., when Emergency Medical Services arrived. During this time, P.L. was breathing independently and did not need any assistance with her airway. Emergency Medical Services received the call from Dr. Edison's office at 9:21 a.m. and arrived at 9:26 a.m. At that time, P.L. was receiving oxygen, her airway was normal, and her perfusion was good. Her blood pressure was 102/68, her pulse was strong and regular at 120 beats per minute, her respiratory rate was 20, her respiratory effort was normal, and her breath sounds were clear. She was, however, non-responsive: She was not able to open her eyes, she had no motor response, and she was not able to give a verbal response. She appeared to be having seizure activity in the form of twitching on both sides of the jaw line. P.L. was transported to Memorial Regional Hospital at 9:31 a.m., and she arrived at the hospital at 9:36 a.m. A notation on the EMS Report for the incident states that a "[l]ist of sedation medication [was] given to ER staff." Dr. Todd Gardner was the emergency room physician who treated P.L. on her arrival at Memorial Regional Hospital. His diagnosis on admission was status epilepticus and hypoxia. Status epilepticus is seizures that are unrelenting to normal therapeutic intervention, and hypoxia is low oxygen level. Dr. Gardner did not attribute a cause to the status epilepticus. Dr. Gardner's intake notes reflect that, prior to presenting at the emergency room, P.L. had received Ketamine, Labetalol to lower her blood pressure, and Valium to relieve the seizures. Nothing on the intake sheet indicates that P.L. had received Lidocaine, and there is no list of the medications given by Dr. Edison in the hospital file. Dr. Gardner intubated P.L. at 10:02 a.m. and placed her on a ventilator in the emergency room because she was unable to breathe on her own. He also treated her with Valium, Dilantin, and Diprivan, which is used to sedate patients in the intensive care unit. Dr. Robert Alterbaum, an internist specializing in pulmonary medicine and critical care, provided care to P.L. in the intensive care unit of Memorial Regional Hospital. P.L.'s chest X-ray was abnormal and showed pneumonitis, or an inflammation of the lungs, caused by fluid being aspirated into the lungs. Based on the emergency room chart, Dr. Alterbaum diagnosed P.L. with status epilepticus, or seizures, related to the administration of Ketamine during the pre-operative procedure for breast augmentation surgery. There was no objective medical evidence to support Dr. Alterbaum's conclusion that Ketamine was the cause of the seizures; he reached this conclusion because Ketamine was the only medication noted on the chart as having been administered to P.L. Dr. Alterbaum was not aware that P.L. had also received Lidocaine; had he been aware of this, it might have been information he would have considered in reaching his conclusion regarding the cause of P.L.'s seizures.6 P.L. was discharged from Memorial Regional Hospital on July 12, 2005. She had difficulty walking at first, but has fully recovered except that she sometimes experiences a little memory loss. Drugs administered to P.L. Valium Valium is a benzodiazopene used to control anxiety, and the standard dosage ranges from two to 20 milligrams for conscious sedation. Valium is a controlled substance. Ancef Ancef is an antibiotic. Ketamine Ketamine is a disassociative non-barbiturate analgesic used for sedation and general anesthesia; the maximum dosage is 4.5 milligrams per kilogram of body weight. Ketamine causes a large amount of secretions, and its effects last only five to 10 minutes. Ketamine is a controlled substance. Robinol Robinol is an anticholinergic medication used to prevent bradycardia, a heart rate of less than 60 beats per minute, and to help dry out secretions in mucous membranes. Robinol is contraindicated for a patient with tachycardia, or a heart rate of more than 100 beats per minute, however, because it could make the patient's heart rate increase. In a healthy 29 year-old patient such as P.L., however, it was not a violation of the standard of care to administer 0.2 milligrams of Robinol to P.L. even though her heart rate was 104 beats per minute at the time it was administered; a healthy 29-year-old patient could easily sustain a heart rate of 140 beats per minute without ill effects. Dr. Edison administered Robinol to P.L. as a drying agent, to control secretions brought on by the use of Ketamine. Although other drugs can be used to control these secretions, Robinol is the best drug for this purpose and the one most commonly used. Dr. Edison had ample justification for using Robinol under the circumstances, and he did not violate the standard of care by ordering Ms. Hoff to administer the drug even though P.L.'s heart rate slightly exceeded 100 beats per minute. Talwin Talwin is an opiate analgesic that is used to control pain, and the standard dosage is 30 milligrams. Talwin is a controlled substance. Nitrous oxide Nitrous oxide is an anesthetic gas that is used for analgesia and sedation; it was administered to P.L. by nasal cannula, which delivers a relatively small amount of gas. Diprivan Diprivan is a sedative hypnotic medication used both for intravenous sedation and for general anesthesia; the package insert recommends a dosage from 100 to 150 micrograms per kilogram of body weight per minute. Diprivan's clinical effects wear off approximately three minutes after its administration is discontinued. The total dose of Diprivan administered to P.L., 25 milligrams, was included in Dr. Edison's medical records, but the manner of administering the Diprivan and the rate of infusion are not recorded. Diprivan, together with other sedative drugs, may be administered in Florida by a registered nurse at the direction and under the supervision of a surgeon during Level II office surgery.7 Dr. Edison did not deviate from the standard of care in Florida by delegating responsibility to Ms. Hoff, an Advanced Registered Nurse Practitioner, for administering the various drugs to P.L., under his direction and supervision. Based on her training and experience, Ms. Hoff was qualified to administer these drugs to P.L. to achieve Level II sedation under Dr. Edison's direction and supervision. The combination of sedative drugs Dr. Edison ordered administered to P.L., specifically Diprivan, Ketamine, Talwin, Valium, and nitrous oxide, was appropriate to induce Level II sedation in P.L., and the dosage of each of the drugs administered to P.L. was well below the maximum dosage recommended for each of the drugs. These drugs work synergistically, however, and, depending on the patient and the circumstances, the same combination of sedative drugs could induce Level III sedation. Florida Administrative Code Rule 64B8-9.009 defines Level III office surgery and sets forth the standards that must be met, in pertinent part, as follows: Level III Office Surgery. Scope. Level III Office Surgery is that surgery which involves, or reasonable should require, the use of a general anesthesia or major conduction anesthesia and pre- operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II Office Surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions: or Major conduction anesthesia. * * * Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: * * * 4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. . . . One difference between Level II and Level III sedation is the degree of alertness of the patient. At Level II sedation, the patient must be able to respond to verbal and/or tactile stimuli. If a patient's only response is a reflexive withdrawal from a pain stimulus, the patient is sedated beyond Level II. A primary indication that a patient has slipped from Level II to Level III sedation is the loss of the ability to breathe without assistance, and the patient's airway must be partially or totally managed. In Level II sedation, the need for management of the airway is minimal compared to that required at Level III sedation. P.L.'s blood pressure, pulse rate, oxygenation, and mental state were consistent with Level II sedation until P.L. had her first seizure and all medications, except for the one- half therapeutic dose of Valium, were discontinued. She remained responsive to verbal stimuli after the second 2.5 milligram dose of Valium was given to control the seizure activity, even though she was more lethargic than normal under Level II sedation. P.L. was non-responsive when examined by Emergency Medical Services personnel, but she was breathing independently and was not at Level III sedation. Her lack of response was more likely than not the result of the seizures, after which a patient can go into a postictal state, or a trance of sleepiness.8 Dr. Edison did not violate the standard of care for office surgery in ordering the amounts and combination of drugs used to sedate P.L. because P.L. did not reach Level III sedation. In accordance with the standard of care for Level II office surgery, Ms. Hoff, as a registered nurse, was qualified to administer anesthesia to P.L., including Diprivan, Ketamine, and the other sedative drugs used in P.L.'s surgery, at the direction and under the supervision of Dr. Edison. Dosage of Lidocaine As stated above, Dr. Edison injected a dilute solution of Lidocaine with epinephrine and marcaine into the tissue around P.L.'s breasts between 8:25 a.m. and 8:45 a.m., before P.L. had her first seizure at 8:45 a.m. Lidocaine is a local anesthetic used to numb nerves and tissue. In breast augmentation surgery Dr. Edison always uses Lidocaine with epinephrine because epinephrine is a vasoconstrictor that causes intense vasoconstriction, or closing of the small blood vessels, which slows the rate of absorption of the Lidocaine and virtually eliminates bleeding at the site of surgery. Marcaine is also a local anesthetic similar to Lidocaine, but it is slow to take effect and lasts four to six hours and helps control pain after surgery is completed. Marcaine is commonly used with Lidocaine. It is Dr. Edison's practice to perform breast augmentation surgery using the tumescent infiltration technique to infuse a relatively large volume of dilute Lidocaine solution into the breast area as a local anesthetic. Dr. Edison uses this tumescent infiltration technique in breast augmentation surgery because he can deliver a large volume of Lidocaine that is evenly distributed throughout the breast area, which results in more effective pain reduction. The injection technique Dr. Edison uses for tumescent infiltration in the breast area is very specific, and it takes between 20 and 30 minutes to complete the injections. The needle cannot penetrate close to the pectoral muscle, especially in a woman as small as P.L., because of the danger of puncturing a lung. Dr. Edison injects the solution under pressure into the subcutaneous tissue between the breast and the pectoral muscle. Lidocaine is absorbed faster in areas that are highly vascular. The tissue in the aerolar space between the breast and the pectoral muscle does not contain many blood vessels, so Lidocaine injected in this tissue is absorbed more slowly than it would be if injected into highly vascular tissue. In Dr. Edison's experience, because the epinephrine in the Lidocaine solution causes intense vasoconstriction in the tissue surrounding the injection sites, the Lidocaine stays in place and numbs the area in which the surgery is to be performed. The Lidocaine solution is absorbed slowly over approximately 24 hours, and the peak serum concentration of Lidocaine occurs approximately 10 to 12 hours after it is administered. In this case, Dr. Edison prepared approximately 400 cubic centimeters of solution, which contained 700 milligrams of Lidocaine and 50 milligrams of marcaine, together with a small, non-therapeutic dose of epinephrine. According to his surgical notes, Dr. Edison began the injections of Lidocaine at 8:25 a.m. and had completed the injections by the time P.L. had the first seizure at 8:45 a.m., although it is his recollection that he had not used all of the Lidocaine solution he had prepared. Dr. Edison did not, however, record in the medical records the amount of Lidocaine solution he injected, and any remaining solution was discarded without being measured, so he does not know the dosage of Lidocaine P.L. actually received. Had he injected all of the solution, P.L. would have received approximately 14 milligrams of Lidocaine per kilogram of body weight. According to the package insert that accompanies a bottle of Lidocaine, the maximum dosage of Lidocaine without epinephrine is five milligrams per kilogram of body weight, and the maximum dosage of Lidocaine with epinephrine is seven milligrams per kilogram of body weight. There is nothing in Dr. Edison's medical records to indicate that the Lidocaine he used in P.L.'s surgery included epinephrine or that he calculated the amount of Lidocaine to administer to P.L. based on her body weight Using the maximum dosage specified on the package insert, the maximum dosage of Lidocaine without epinephrine for P.L. would have been 215 milligrams, and the maximum dosage of Lidocaine with epinephrine would have been 301 milligrams, using the traditional method of administering the drug. Based on the standard established by the package insert, Dr. Edison exceeded the maximum dosage of Lidocaine with epinephrine injected into P.L. by approximately 400 milligrams, which constituted a toxic dose of Lidocaine when measured by the maximum dosage stated on the package insert. The maximum dosage of Lidocaine with epinephrine stated on the package insert is routinely exceeded by surgeons performing liposuction, which involves suctioning fatty tissue. The tumescent infiltration technique using Lidocaine with epinephrine in a dilute solution is commonly used with liposuction, and Florida Administrative Code Rule 64B8- 9.009(2)(d), which sets out the standards of care for office surgery, specifically provides that a "maximum of fifty (50) mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting." Large dosages of Lidocaine can be safely used in liposuction because Lidocaine is metabolized more slowly by fatty tissue than by muscle or skin, and approximately 20% of the Lidocaine solution is suctioned out of the body with the fat that is aspirated during liposuction. As a result, it is possible to administer what would otherwise be toxic doses of Lidocaine under the maximum dosages specified in the package insert. Dr. Edison has used the tumescent infiltration technique many times in performing breast augmentations without his patients' suffering any ill effects. There is, however, no rule in Florida equivalent to that relating to liposuction that permits the use of high dosages of Lidocaine as local anesthetic in breast augmentation surgery. Furthermore, Dr. Edison has failed to submit persuasive evidence of a standard of care in Florida among plastic surgeons that would permit the use of dosages of Lidocaine with epinephrine in excess of the seven milligrams per kilogram specified on the package insert for breast augmentation surgery.9 Dr. Edison violated the standard of care by injecting approximately of 700 milligrams of Lidocaine with epinephrine into the tissue surrounding P.L.'s breasts when the maximum allowable dosage, according to the insert packaged with the drug and based on P.L.'s weight, was approximately 300 milligrams. Dr. Edison's previous discipline10 Dr. Edison was charged in an Administrative Complaint dated February 21, 1995, with having committed medical malpractice in violation of Section 458.331(1)(t), Florida Statutes. He executed a Consent Agreement in which he neither admitted nor denied the factual allegations in the complaint but agreed that, if proven, the facts would constitute a violation of Section 458.331(1)(t), Florida Statutes. The Agency for Health Care Administration entered a Final Order dated August 20, 1995, adopting the Consent Agreement in relevant part. This Final Order does not establish that Dr. Edison committed a violation of Section 458.331(1)(t), Florida Statutes. In a Final Order entered January 4, 2007, the Board adopted the recommended disposition in the Recommended Order in Department of Health, Board of Medicine v. Richard B. Edison, M.D., DOAH Case No. 06-0598PL (Recommended Order August 25, 2006), that Dr. Edison be found guilty of a single violation of Section 458.331(1)(m), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order Dismissing Counts Three and Four of the Administrative Complaint; Finding Dr. Edison guilty of a single violation of Section 458.331(1)(m), Florida Statutes, and of two violations of Section 458.331(1)(t)1., Florida Statutes; Suspending Dr. Edison's license for a period of 90 days, followed by four years' probation under such terms as shall be imposed by the Board; and Imposing an administrative fine in the amount of $15,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S PATRICIA M. HART 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 1st day of May, 2007.
