The Issue The issues for determination are whether Respondent failed to make reasonable efforts to ensure that a prescription for a resident was refilled in a timely manner in violation of Florida Administrative Code Rule 58A-5.0185(7)(f); and, if so, whether Respondent should reclassify Respondent's license from standard to conditional, impose an administrative fine of $2,000, and impose a survey fee of $500 pursuant to Sections 400.419(1)(b) and 400.419(9), Florida Statutes (2001). (All references to chapters and statutes are to Florida Statutes (2001) unless otherwise stated. Unless otherwise stated, all references to rules are to rules promulgated in the Florida Administrative Code in effect on the date of this Recommended Order.)
Findings Of Fact Petitioner is the state agency responsible for regulating assisted living facilities (ALFs) and for investigating complaints received anonymously by a state hotline in accordance with Chapter 400, Part III, and Rule 58A-5. Respondent is an ALF located at 312 East 124th Avenue, Tampa, Florida 33612 (the facility). Petitioner conducted a complaint survey of the facility on August 10, 2001. Petitioner noted the results of the survey on a form entitled Form 3020-0001 "Statement of Deficiencies and Plan of Correction" (the 3020). The 3020 is the document used to charge ALFs with deficiencies that violate applicable law. The 3020 identifies each alleged deficiency by reference to a tag number. Each tag number on the 3020 includes a narrative description of the allegations against the ALF and cites a provision of the relevant rule or rules that the alleged deficiency violates. The 3020 in this case involves one allegation in Tag A630. Tag A630 alleges that Respondent violated Rule 58A- 5.0185(7)(f) by failing to make every reasonable effort to ensure that prescriptions for residents who receive assistance with self-administration or medication administration are "refilled" in a timely manner. Resident 2 receives assistance with the self- administration of medication. Resident 2 suffers from dementia and chronic obstructive pulmonary disease. Tag A630 alleges that Respondent failed to make reasonable efforts to ensure that a prescription for an antibiotic known as Tequin was refilled in a timely manner on or about August 2, 2001. University Community Hospital (the hospital) admitted Resident 2 on June 27, 2001, with relevant diagnoses of urinary tract infection and sepsis. The hospital administered Tequin to Resident 2 intravenously and discharged Resident 2 to the facility on August 2, 2001. On August 6, 2001, the hospital readmitted Resident 2 for treatment of the urinary tract infection. The discharge instructions from the hospital on August 2, 2001, included instructions for several medications. The instructions indicated that Resident 2 was to continue taking Tequin 200 mg one tab a day for 11 days; Prednisone 20 mg tab take as needed; Albuterol and Atrovent nebulizer every 6 hours as needed; and home O2 2 liters by nasal canula [sic] 24 hours. Resident 2 had prescriptions for all of the medications included in the discharge instructions except Tequin. The hospital discharged Resident 2 late in the evening on August 2, 2001. The next morning, the facility manager faxed the new prescriptions for Resident 2 to the pharmacy that the facility used in the ordinary course of its business. The pharmacy timely filled the new prescriptions. Facility staff never saw a written prescription for Tequin. Resident 2 was in good spirits and had no signs of a urinary tract infection or other signs of infection such as a change in mental status or a loss of appetite. Facility personnel reasonably believed that the hospital had successfully treated the urinary tract infection. Petitioner's surveyor testified that he saw a prescription for Tequin in the facility files for Resident 2 and wrote down the exact wording of the prescription. That testimony is neither credible nor persuasive. Even if the testimony of Petitioner's surveyor were credible and persuasive, other evidence in the case outweighs that testimony. Neither Petitioner's agents, the facility Manager, the facility administrator, the owner of the facility, the hospital, the discharging physician, nor the pharmacy, is able to produce a prescription for Tequin, a copy of the prescription, or a record that the physician ever wrote such a prescription. In addition, a discharge instruction is not a prescription. Finally, Petitioner admits in its PRO that a prescription for Tequin was "missing" when Resident 2 returned to the facility. Respondent could not have failed to refill a prescription for Tequin because there is no credible and persuasive evidence that a prescription for Tequin ever existed between August 2 and 6, 2001. The facility Manager did not compare the discharge instructions with the written prescriptions that accompanied Resident 2 on her discharge from the hospital. While that omission may constitute a violation of some law or rule, it is not the violation alleged in the Administrative Complaint and Tag A630. The omission alleged in the Administrative Complaint and Tag A630 is that Respondent failed to ensure that an existing prescription for Tequin was "refilled." That allegation, in the context of this case, requires Petitioner to show that Respondent failed to ensure that the pharmacist refilled an existing prescription previously issued by a physician and on file with the pharmacist. Petitioner failed to prove that factual allegation. The factual allegations that Petitioner sought to prove in the administrative hearing are substantially different from those contained in either the Administrative Complaint or Tag A630. The Administrative Complaint alleges at paragraph 8 that Respondent failed to make reasonable efforts to ensure that a prescription for Resident 2 was refilled. Tag A630 alleges in relevant part: Based on a review of resident records and on interview with the facility's Owner, Administrator and Manager, the facility failed to fill a prescription for one resident upon the resident's return from the hospital. Per interview with the three employees noted above, on 8/10/01 at 12:45pm, and based on a review of the Resident's files, Resident #2 was admitted to University Community Hospital on 7/27/01, and was there diagnosed with a urinary tract infection and sepsis . . . The Resident was discharged from UCH on 8/2/01, with the following medication instructions; Tequin 200mg one tab a day for 11 X days. . . . These discharge instructions were found in the Resident's file. Also observed in the Resident's file were the prescriptions for the above-noted medications. However, when asked, none of the three employees noted above were aware of the prescription for the wide-spectrum antibiotic; each stated the belief that the Resident's infections had been treated and resolved in the hospital and that an antibiotic wasn't needed. A review of the Resident's Medication Observation Record for 8/01 showed the entry of the other medications per the discharge instructions except for the Tequin. On 8/7/01 the Resident was readmitted to the hospital with symptoms of a urinary tract infection, per Owner, the Administrator and the Manager. (emphasis supplied) It can be reasonably assumed that the facility's failure to note either the Resident's discharge instructions or the prescription slip for the antibiotic (Tequin) resulted in the Resident's continued suffering of a urinary tract infection and the Resident's return to the hospital. Regardless of whether this failure to give the Resident his prescribed medication was primarily responsible for the Resident's continued UTI, the facility failed to properly note the physician's orders and to fill the prescription. Petitioner's Exhibit 4 at pages 2-3. Before the administrative hearing, Tag A630 expressly alleged that a prescription for Tequin existed in the file of Resident 2 at the facility and charged that Respondent failed to fill the existing prescription. The Administrative Complaint alleges that the failure to fill an existing prescription violates the requirement in Rule 58A-5.0185(7)(f) to ensure that prescriptions are refilled. At the hearing, Petitioner sought to prove factual allegations that are different from those in Tag A630 and the Administrative Complaint. Rather than proving that Respondent failed to fill a prescription that existed in the file of Resident 2, as alleged in Tag A630, Petitioner sought to prove that Respondent failed to compare the discharge instructions with the prescriptions issued by the treating physician, remind the physician that he or she failed to issue a prescription for Tequin, retrieve the pretermitted prescription, deliver it to the pharmacist, and then ensure that the pharmacist timely "filled" the new prescription. Petitioner cannot put Respondent on notice in the Administrative Complaint and Tag A630 that Respondent must be prepared to defend the factual allegation that Respondent failed to refill an existing prescription and then prove at the administrative hearing that Respondent committed acts or omissions not alleged in either the Administrative Complaint or Tag A630. To do so, is a violation of fundamental notions of due process and adequate notice of the charges against Respondent in a penal proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent not guilty of the acts and omissions alleged in the Administrative Complaint and Tag A630 and restoring Respondent's previous license rating nunc pro tunc. DONE AND ENTERED this 21st day of October, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 21st day of October, 2002. COPIES FURNISHED: Colleen O'Rouke, Esquire Riley Law Firm, P.A. 4805 West Laurel Street, Suite 230 Tampa, Florida 33607 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 330K St. Petersburg, Florida 33701 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308
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
The Issue The issue in this case is whether Respondent should be sanctioned for an alleged violation of Chapters 395 and 401, Florida Statutes (1989).
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made. HCA Raulerson is the only hospital in Okeechobee County, Florida. As such, it serves all of Okeechobee County and parts of the surrounding counties. It is a small community hospital that is best characterized as a primary care receiving facility as opposed to a secondary hospital or a tertiary care or trauma center hospital. The Hospital does not provide heart-bypass surgery, cardiac catherization, neuro-surgery services or even obstetrical services (other than the emergency delivery of babies.) The Hospital provided approximately three million dollars in uncompensated care to indigent residents of Okeechobee County in the year preceding the incident involved in this case. Under existing Florida law, a hospital is not required to provide either orthopedic surgery services or peripheral vascular services and there is no requirement for a hospital to have on its medical staff any orthopedic surgeons or peripheral vascular surgeons. The Hospital does not have the angiography equipment necessary for peripheral vascular surgery. As a result, the Hospital does not provide peripheral vascular surgery and there are no vascular surgeons on staff. Such services were not offered at the Hospital for at least several months prior to the incident in question. The Hospital has a single orthopedic surgeon on staff, Dr. Zafar Kureshi. Dr. Kureshi is board certified in orthopedic surgery. He has been engaged in the private practice of medicine in Okeechobee, Florida since October of 1986. While many of Dr. Kureshi's patients are treated at the Hospital, Dr. Kureshi is not employed by or under contract with the Hospital. This arrangement is not unusual since surgeons, including orthopedic and vascular surgeons, do not typically become employees of hospitals or enter into contracts with hospitals. The Hospital has tried to recruit additional orthopedic surgeons and other specialists for its medical staff, but has been unsuccessful. There is a shortage of orthopedic surgeons in Florida, especially in rural areas, and recruiting orthopedic surgeons to such areas is extremely difficult. It is unrealistic to expect that the Hospital would be able to recruit or retain any orthopedic surgeons if it required them to be "on call" at all times. For a short time after he first obtained staff privileges, Dr. Kureshi provided "on call" services for the Hospital's emergency room several nights per month. On those occasions, he treated patients irrespective of their financial status. At the time of the incident in question, however, Dr. Kureshi had ceased providing "on call" services. His decision was consistent with the Hospital medical staff by-laws. The by-laws of the Hospital medical staff state that, if there is only one physician on staff in a specialty, then that specialty does not have to make emergency department call rosters available to the emergency room. Since he was the only specialist on staff in his area of practice, Dr. Kureshi was not required to provide "on call" coverage. Subsequent to the incident involved in this case, Dr. Kureshi, at the request of the Hospital, has voluntarily agreed to be "on-call" several nights per month. Even when Dr. Kureshi is not formally "on call," the emergency room staff often contacts him when a patient presents at the emergency room in need of orthopedic care. On some such occasions, Dr. Kureshi will treat the patient if he was capable of doing so. When an orthopedic patient or a peripheral vascular patient presents at the Hospital and Dr. Kureshi can not or will not treat the patient, the Hospital (1) provides such care as can be rendered by the emergency room physician or others on HCA Raulerson's medical staff, (2) stabilizes the patient for transfer, (3) calls hospitals and their on-call physicians to arrange transfer, and (4) arranges suitable transportation and transfers the patient. In the months preceding the incident in question, the Hospital arranged the transfer to other hospitals of approximately eleven patients who presented at the Hospital's emergency room in need of orthopedic care. Four of those patients were "paying" patients covered by third party insurers, four were covered by Medicare or Medicaid and the remaining three were self-pay patients. There is no indication that financial status and/or the ability to pay in any way influenced the Hospital's actions with respect to these patients. HRS contends that Sections 395.0142, 395.0143 and 401.45, Florida Statutes, require a hospital that provides any given specialty service (e.g., orthopedic surgery services) to arrange 24-hour a day, seven day a week coverage for that service, either by providing coverage through physicians on staff or entering into advance transfer agreements with other hospitals to cover any such patients who may present in need of such services. The Hospital has attempted, but has been unsuccessful in its attempts, to obtain advance transfer agreements from other hospitals regarding the transfer of patients presenting themselves at the Hospital's emergency room in need of orthopedic surgery services or in need of peripheral vascular surgery services. The Hospital has limited bargaining power in attempting to induce other hospitals to enter into an advance transfer agreement. Because the Hospital is a small rural hospital, virtually all the services it offers are already available at the neighboring hospitals which are potential transfer partners. The only advance transfer agreements that the Hospital has been offered would require the Hospital to assume full responsibility for payment for services rendered to transferred patients by the transferee hospital. Those proposals have been rejected because the financial burden of such an arrangement would probably cause the Hospital to close. As of August 24, 1989, the date of the incident which is the subject of the Administrative Complaint in this case, HRS had not notified the Hospital of any rule or policy interpreting Sections 395.0142, 395.0143, and 401.45, Florida Statutes. As of August 24, 1989, HRS had not adopted any rule which stated a specific requirement that hospitals which provide orthopedic surgery must staff or provide on-call orthopedic surgery services on a continuous basis, i.e. twenty-four (24) hours per day, 365 days per year or have in place an agreement with another hospital(s) to provide such coverage. HRS contends that this requirement is imposed by the clear language of the statutes. On the evening of August 24, 1989 at approximately 7:45 p.m., K.H., a 28 year old male, presented himself at the Hospital's emergency room for treatment of a shotgun wound to his lower left leg. Dr. Charles Vasser, the emergency room physician on duty when K.H. arrived, stabilized the Patient and provided all the treatment that could be provided by an emergency room physician not trained in orthopedic surgery or vascular surgery. The radiology report prepared at the Hospital diagnosed the Patient's condition as follows: "focal soft tissue injury, with multiple metallic fragments of variable size, super imposed over soft tissues of distal right leg are noted. Comminuted compound fracture of distal tibial shaft, as well as linear fracture through distal fibula at same site, are observed. Findings are due to gun shot injury with residual bullet fragments within soft tissues. Correlation with patient's clinical findings is recommended." Because of the nature of the injury and the extent of the damage to the soft tissue of the Patient's lower leg, Dr. Vasser and the attending staff were concerned about the possibility of vascular damage. They frequently checked and charted the Patient's distal pulses. While the distal pulses appeared normal, the presence of distal pulses does not rule out vascular injury. A vascular injury is possible with a comminuted fracture even when the distal pedal pulses appear normal. A vascular problem is especially likely when the wound was inflicted by a shotgun blast and numerous metallic fragments are involved. After providing initial emergency room services to the Patient, Dr. Vasser felt that the assistance of appropriate specialists, i.e., an orthopedic surgeon and at least a consult with a vascular surgeon, would be required for further treatment. Dr. Vasser called the only orthopedic surgeon on the Hospital's medical staff, Dr. Zafar Kureshi, at 8:50 p.m. Dr. Kureshi was not on call that evening. Based on Dr. Vasser's description of K.H.'s condition, Dr. Kureshi stated that he was not capable of treating K.H. without the backup availability of a vascular surgeon and advised that K.H. should be transferred. This recommendation was made not only because Dr. Kureshi was not on call, but also because Dr. Kureshi was not capable of treating the Patient at an acceptable level of medical care without the availability of a vascular surgeon. As indicated in Findings of Fact 3 above, there are no vascular surgeons on staff at the Hospital and the Hospital does not offer vascular surgery services. In determining whether a patient needs the services of a physician in a particular specialty, the Hospital relies upon the medical judgment of the attending physician and any consulting physician. The Hospital did not and should not have ignored the medical determination made by the emergency room physician, in consultation with Dr. Kureshi, that the Patient, K.H., needed vascular backup in order to be properly treated. With the assistance of emergency technician Wendy Johns, Dr. Vasser began placing calls to other hospitals and their on-call physicians at 9:15 p.m. in an effort to arrange a transfer of the Patient. The first physician contacted through another hospital, Dr. Floyd, indicated that he would be unable to treat the Patient because of the extent of the soft-tissue injuries and the corresponding likelihood of vascular involvement. A number of additional hospitals and physicians were contacted and they also refused to accept the transfer of the Patient. All told, nineteen different physicians and/or hospitals were contacted between 9:00 p.m. and 12:00 a.m. A variety of reasons were cited by those who refused to accept the transfer. Many of the reasons given for refusing the transfer were arguably a pretext and/or contravened the language and intent of Sections 395.0142, 395.0143 and 395.0144, Florida Statutes. Several of the doctors who were contacted confirmed that the treatment of the Patient would require the availability of a vascular surgeon as well as an orthopedist. After numerous unsuccessful attempts to transfer the Patient, Dr. Vasser contacted a general surgeon on the Hospital's medical staff, Dr. Husain, at approximately 12:10 a.m. Dr. Vasser and Dr. Husain again contacted Dr. Kureshi. The three physicians concurred that they were unable to treat the Patient because of the need for a vascular backup and the Hospital's inability to provide the necessary vascular backup. After he talked to Dr. Kureshi the second time, Dr. Vasser resumed calling other hospitals and their on-call physicians. The next call was to a vascular surgeon, Dr. Viamentes. Dr. Viamentes was reached through his beeper, but was unable to accept the transfer because he was out of town. At approximately 12:30 a.m., a social worker for the Hospital, Terry Cooper, contacted St. Mary's Hospital in West Palm Beach. After some discussion and deliberation, St. Mary's agreed to accept the transfer of K.H. The Patient was transferred in stable condition via ambulance to St. Mary's Hospital where he arrived at approximately 3:00 a.m. Surgery was initiated at approximately 4:30 a.m. After the Patient was admitted to St. Mary's Hospital, the administration of that hospital filed a complaint with HRS pursuant to Section 395.0142, Florida Statutes. That complaint recites the facts surrounding the transfer of the Patient and the refusal of several other hospitals to accept the transfer. It is not clear whether St. Mary's was questioning the medical necessity of the transfer or simply the refusal of the other hospitals to accept the transfer. HRS initiated an investigation of the transfer of the Patient and submitted the Patient's medical records from both HCA Raulerson and St. Mary's to its expert, Dr. Slevenski, for review. Dr. Slevenski is an emergency room physician who has no specialized training in orthopedic surgery or vascular surgery. Dr. Slevenski testified that he saw no evidence in the Hospital's medical records that a vascular evaluation or consultation was necessary to treat this Patient and that the Hospital inappropriately transferred the Patient to another hospital. Dr. Slevenski's opinions are rejected. Dr. Slevenski erroneously assumed that the Hospital had not attempted to contact an orthopedic surgeon regarding the Patient. In fact, the Hospital contacted Dr. Kureshi, the only orthopedic surgeon on its staff, who indicated he was not qualified to treat the Patient's injury. The evidence established that both the emergency room physician and the orthopedic surgeon who was contacted at home felt that a vascular consult was necessary. These opinions were reasonable under the circumstances. The testimony of Dr. Henderson, the Respondent's expert, is accepted and confirms that the opinions of the emergency room physician and the orthopedic surgeon were reasonable under the circumstances and given the nature of the Patient's injury. There is no evidence that the Patient's care was deficient in any respect at either St. Mary's or the Hospital. The Patient progressed normally and a good result was achieved. In sum, the evidence established that the Hospital secured appropriate treatment for K.H. by providing an on-site emergency room physician and supporting staff who (1) provided immediate emergency care and stabilized the patient for transfer, (2) confirmed with the orthopedic surgeon on the Hospital's medical staff that a transfer was medically necessary, (3) called hospitals and their on-call physicians to arrange the transfer, and (4) arranged suitable transportation and transfer of the patient. The Hospital provided all the care that it could within its service capability. In view of his injury, the Patient's best interests were served by transferring him rather than treating him at the Hospital. The evidence did not establish whether K.H. was a paying or nonpaying patient. The evidence did establish that the decision to transfer K.H. was not based on his financial status.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered which dismisses the Administrative Complaint filed against HCA Raulerson Hospital. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 17th day of January, 1991. J. STEPHEN MENTON 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 17th day of January, 1991.
Findings Of Fact The Respondent Gonzalez The Respondent Maria B. Gonzalez is a medical doctor holding Florida license number ME 0028019. She has been licensed to practice medicine in Florida since 1975. Prior to the instant proceeding, her license to practice medicine has never been suspended or revoked. The Respondent has taken and passed the written test for board certification as a specialist in obstetrics and gynecology, but was refused permission to complete the exam because her privileges had by then been suspended by Hollywood Memorial Hospital. During the course of her practice in Cuba and Florida, the Respondent has delivered approximately 2,000 babies. To her knowledge, she has never had a maternal or infant death occur during her practice. The Respondent's practice at Memorial Hospital was highly unusual in that almost half of her patients were Medicaid. As a result, Respondent encountered difficulties in dealing with some of the members of the medical staff at Memorial since she believed that her patients medical interests should take precedence over their ability to pay for services. 1/ The Respondent's provisional staff privileges at Memorial were suspended on July 28, 1982, based upon a review by an ad hoc committee of the hospital's obstetrics and gynecology staff, of six cases, five of which form the basis of the instant proceeding. In deciding to terminate the Respondent, the ad hoc committee considered pertinent medical records and statements from witnesses but did not hear the direct testimony of the Respondent. When the decision was made by Memorial to terminate the Respondent, the hospital informed the Petitioner of this fact pursuant to Section 458.337, Florida Statutes, which requires that the Department be notified when any physician has been disciplined by a licensed hospital for any act that constitutes a violation of Chapter 458, Florida Statutes. Count One Aida M. Astiazarian On December 25, 1981, the Respondent performed a bilateral tubal ligation on Aida M. Astiazarian, a patient who had vaginally delivered an infant several hours prior to the operation. During the procedure, the Respondent was assisted by Dr. Purificacion D. Catini, a surgical assistant. The patient was anesthetized by Dr. Gary Karch. The tubal ligation on Astiazarian began with the opening of the abdominal cavity. Several adhesions from prior surgery and two small bleeders were noticeable, specifically a bleeder on the anterior abdominal wall and on the anterior surface of the uterus. The Respondent ligated the bleeder on the anterior abdominal wall and controlled the oozing from that source. The Respondent elected not to suture or ligate the oozing on the anterior surface of the uterus as recommended by Dr. Catini and instead used a four-by-four inch section of Gelfoam to control the bleed. The Gelfoam was applied with a laparotomy paid and removed after a few minutes. Believing that hemostasis had been achieved, the Respondent closed the abdominal cavity. Unlike the Respondent, Dr. Catini believed that hemostasis had not been achieved since she noticed some oozing still occurring after the Gelfoam was applied. Following the operation the patient's hemoglobin, hematocrit and blood pressure began to fall. The likely cause of these symptoms was an intra- abdominal bleed or ooze. The patient was transfused with several units of blood and discharged from the hospital. Although a reasonably prudent physician would not close a patient with an active ooze or bleed, the record fails to establish that the Gelfoam was ineffective and the Respondent knew or should have known that hemostasis had not been achieved. 2/ Uterine oozing in a postpartum patient can occur without any negligence by a treating physician. The loss of blood which occurred following this operation is not inconsistent with the Respondent's assertion that hemostasis had occurred and that sometime later the clot had become dislodged, thereby causing the bleed which resulted in the administration of two units of blood. Count Two Jaclyn R. Osier On December 28, 1981, the Respondent performed a postpartum tubal ligation on Jaclyn R. Osier. She was assisted during the procedure by Dr. David Gordon. During the operation, a tear in the broad ligament occurred and the patient began to hemorrhage profusely. The tear of the broad ligament which occurred during the procedure was an inherent risk of surgery and does not, by itself, demonstrate negligence by the Respondent. The Respondent extended the incision and located one of the bleeders; however, due to the nature of the tear and the physical condition of the patient, she was unable to locate and control other bleeders which were deeper in the abdomen. Due to the blood loss experienced by the patient, Dr. Gordon determined that additional help was needed. He left the operating room and sought assistance from Dr. Raymond Nolan. When Dr. Nolan arrived, he made an additional extension of the incision and with assistance from the Respondent and Dr. Gordon, he was successful in locating the deep bleeders and achieving hemostasis. Under the circumstances, it was appropriate medical practice for either the Respondent or Dr. Gordon to seek additional help when the patient's bleeding was not under control. As noted by Dr. Nolan "...Just as two heads are better than one, four hands are better than two." (Tr. at 369.) Significantly, Dr. Nolan, a surgeon who had operated with the Respondent on this case as well as others, did not believe that the Respondent's license should be revoked based on his actual experiences with the Respondent. Following this incident, Dr. Nolan did not have any immediate concern that the Respondent had acted improperly. Although Dr. Nolan later voted to suspend the Respondent's hospital privileges at Memorial, his vote was based on the recommendation of the hospital's ad hoc committee rather than his own personal experiences with the Respondent or his own independent review of pertinent medical records. The intra-operative complication which occurred in this particular case was not the result of the Respondent's negligence. When the Respondent was unable to control the bleeding with Dr. Gordon after the incision had been extended, another surgeon was called to assist. The Respondent's inability to control the bleed prior to Dr. Nolan being called, does not constitute negligence under the circumstances of this case. Count Three Linda Jones On May 28, 1982, at 9:45 p.m., Linda Jones, a high risk and postdate patient was admitted to Memorial. The Respondent examined the patient on the morning of May 29, 1982, and found her to be in labor. The practice at Memorial was that provisional staff physicians, such as the Respondent, handle all service or indigent patients. Linda Jones had been handled by Dr. Kast, another provisional staff physician. On the day the Respondent examined the patient, she was covering for Dr. Kast, who had asked as a courtesy to be relieved until 1:30 p.m. The labor and delivery of pregnant service patients at Memorial are handled by nurse/widwives, unless a complication arises which requires a surgical procedure. The patient was scheduled for a normal vaginal delivery. She was doing well and was placed on a fetal monitor. At approximately 12:25 p.m., the patient started having episodes of decelerations. Nurse/Midwife Jean Tease, R.N., turned off the Pitocin which had been administered and turned the patient to relieve the decelerations. The patient continued to progress until approximately 1:22 p.m., when rapid decelerations on the fetal monitor were observed. At approximately 12:00 p.m. the Respondent left Memorial to attend a wedding in Fort Lauderdale which was a twenty minute drive from the hospital. She notified the nursing staff where she was going so that she could respond if needed. 3/ Nurse Tease contacted both Dr. Kast and Respondent when the patient's symptoms began to worsen. The Respondent returned the call and when informed of the problem, advised Tease that she would return to the hospital. The Respondent was returning to the hospital via Interstate 95 when it began to rain very heavily. Her front brakes froze and her car was immobile. While it continued to rain, Respondent pulled over on the side of the Interstate and attempted to flag down help. A wrecker operator stopped and towed her car to a service station where it was repaired. Meanwhile, since the Respondent had not arrived at Memorial as she had stated, Nurse Tease placed a page for any obstetrician in the hospital, and Dr. David Lessin responded. Dr. Lessin performed an emergency cesarean section and produced a living baby. The Amended Administrative Complaint does not allege that the Respondent was negligent in leaving the hospital; rather it charges that the Respondent breached a duty owed to this patient by failing to come to the hospital until approximately four hours after advising hospital personnel that she was in route. Due to mechanical problems with her car and the weather, it was impossible for the Respondent to return to the hospital to attend this patient. The Respondent believed that Dr. Kast was on duty after 1:30 p.m., and she knew she could not arrive at the hospital before that time. Under the circumstances, her actions regarding this patient were not negligent. Count Four Ramona Cardullo Ramona Cardullo was admitted to Memorial on the morning of May 28, 1982. Mrs. Cardullo was pregnant with her third child who was ultimately successfully delivered by cesarean section. Prior to this pregnancy, Mrs. Cardullo had experienced significant difficulties during the delivery of her two other children. Her first child, who was born following induced labor in Texas, was a month post-mature. Her second child was delivered at Memorial by another obstetrician following induced labor. The second child was delivered through the use of forceps. The problems which Mrs. Cardullo encountered in her two previous pregnancies resulted from a uterine dysfunction in which her cervix failed to dilate sufficiently to permit a normal delivery. When Mrs. Cardullo came to the Respondent during her third pregnancy, she related her previous obstetrical history and its attendant difficulties to the Respondent. In addition to her historical problems, Mrs. Cardullo had also gained 80 pounds during her third pregnancy. When Mrs. Cardullo began her prenatal care, she was living in Hollywood, Florida, with her husband. During her pregnancy, the couple moved to Wauchula, Florida. Since Mrs. Cardullo did not believe that Wauchula had appropriate hospital facilities, she commuted to Fort Lauderdale from Wauchula during the last three months of her pregnancy. The Respondent, however, was unaware that Mrs. Cardullo had moved from Hollywood. On May 28, 1982, Mrs. Cardullo, while home in Wauchula, began passing membranes and started to go into labor. She informed her husband that she was in labor, and called the Respondent. After driving from Wauchula, the couple met the Respondent at Memorial where the patient was examined. The examination revealed that Mrs. Cardullo was not dilating and the Respondent told her to begin walking. She walked around the hospital until later that afternoon, when tests were performed by the Respondent to ensure that the baby was okay. The Respondent put the patient in the labor room and began Pitocin to augment her labor. A nurse in the labor room told Mrs. Cardullo that other patients needed the room more than she did and contacted another physician who ordered the Pitocin to be turned off and the patient sent home. Mrs. Cardullo and her husband returned to Wauchula while she was still in labor. Approximately three hours after arriving home, Mrs. Cardullo began passing "... a lot of stuff." (Tr. at 900.) Mr. Cardullo called the Respondent, informed her of his wife's condition, and stated that they were coming back to the hospital. The couple arrived at Memorial on May 30, 1982, and Mrs. Cardullo was readmitted. Although Mrs. Cardullo's labor had continued throughout this period, her cervix had not dilated. The Respondent discussed a cesarean with the patient, who had requested the procedure be done based on her vaginal experiences in two prior pregnancies, and decided to attempt to dilate the cervix before performing surgery. Approximately ten hours after Mrs. Cardullo's readmission and five hours after her water had broken, the Respondent came to the conclusion that the Pitocin was not working since the patient's cervix still had not dilated properly and that a cesarean would be necessary. Mrs. Cardullo had no problems with the cesarean delivery and was pleased with the quality of care she received from the Respondent. Mrs. Cardullo stated that the Respondent was different from other doctors she had encountered in that she believed the Respondent cared about her and her problems. The Respondent's care and treatment of Mrs. Cardullo was appropriate considering the patient's prior medical history. The only criticism that could be directed toward the Respondent in her handling of the Cardullo case is that she waited too long to perform the cesarean by not giving sufficient consideration to the input from her patient. Count Five Elina Carrasco On December 17, 1982, the Respondent performed an abdominal hysterectomy on Elina Carrasco at International Hospital in Miami, Florida. During the procedure the Respondent was assisted by Dr. Francisco Sarmiento. The patient had a large amount of fibrous tissue and adhesions from prior abdominal surgery which made it difficult for the Respondent to visualize the operative site. The adhesions which surrounded the uterus, bladder, omentum, intestines, the right ovary, a segment of the left fallopian tube, and the abdominal wall, had formed a mass which required dissection to reach the pelvic cavity. While dissecting the mass of adhesions, the Respondent cut the patient's illiac vein which was located underneath the adhesions, thus causing the operative field to fill with blood. While Dr. Sarmiento placed his finger on the vein to stop the bleed, Respondent requested and placed a hemostatic clamp on the vein and requested a cardiovascular team to assist. At the time of the surgery, the practice at International was to place regular surgical clamps on a surgical tray rather than non-crushing clamps, when a standard gynecological procedure was performed. Accordingly, the sterile surgical tray which was prepared for this patient did not contain non-crushing clamps, although such clamps were available at the hospital. The surgical clamp was left on the patient only until the cardiovascular team arrived. Because a crushing clamp had been used, Dr. Junco, the surgeon who repaired the severed vessel, felt that a crush type injury to the underlying artery which was immediately adjacent to the severed vein, had occurred. The pathology report does not indicate that any clots or sections of artery were removed from the patient, although the operative records indicated two small clots were removed from the artery. The crush injury was not severe in that after the insertion of a fogarty catheter, proximal and distal blood flow was restored without requiring the removal of the crushed portion of the artery. Dr. Junco closed the vein and repaired the artery. After surgery, the patient improved and was discharged from the hospital on December 30, 1982, in stable condition. The basis of the charge against the Respondent in her care and treatment of Ms. Carrasco involves essentially one issue; whether it was below the standard of care for the Respondent to clamp the patient's vein with a device which could and did cause a crush injury to an underlying artery, 4/ in order to control bleeding from the illiac vein. In retrospect, the wiser course in this case would have been to take the time to obtain a non-crushing clamp from the rotating nurse while Dr. Sarmiento controlled the bleed through use of finger pressure. The unfortunate event which occurred in this case did not result from any lack of surgical or other skills by the Respondent. The Petitioner has characterized the Respondent's reaction to the transected artery and use of a hemostatic clamp as panic, while the Respondent has characterized it as a desire to use the first clamp available to control the bleeding as quickly as possible. Additionally, the Respondent needed Dr. Sarmiento to assist and while he was holding the artery, he was obviously unable to offer any other form of help. Under these circumstances, the Respondent's use of a hemostatic clamp does not demonstrate that she "panicked" in the operating room or that her decision to use the clamp fell below an acceptable standard of care. Count Seven Deborah J. Cox On June 6, 1982, the Respondent examined Deborah J. Cox and was present with her in the labor room throughout the patient's labor. The fetus was first on an external and then an internal monitor throughout labor. The Respondent requested that Dr. Antonio Mata, a neonatologist, be present for the delivery. When Dr. Mata came into the labor room, he checked the fetal monitor and noticed signs of moderate fetal distress. The combination of Pitocin, which was administered to the patient, and distressive labor, placed stress on the fetus as indicated by the fetal monitoring strips. The patient was transferred from the labor room to the delivery suite. In an effort to deliver the baby which was exceptionally large, it was necessary for the Respondent to use forceps because the baby's head was high and the mother's uterine surface remained thick even though she was well dilated. When the forceps were applied, the baby went into severe distress. The Respondent called for an emergency cesarean section, but the operating assistant was not available. Since it was necessary to deliver the baby as quickly as possible to avoid a stillbirth or permanent damage, the Respondent reapplied the forceps and attempted delivery. The baby was a very difficult delivery due to its size. It became stuck in the birth canal which required that the Respondent rotate its shoulders to effectuate delivery. While manipulating the baby, shoulder dystocia occurred. The Respondent elected not to perform the cesarean when it was first indicated, because of a hospital rule which prohibited the performance of a cesarean section without the presence of a surgical assistant. Due to the continuing difficulties she had encountered at Memorial, she was understandably reluctant to violate a hospital rule which would have subjected her to additional problems at Memorial. However, notwithstanding the legitimacy of the Respondent's personal concerns, the best interests of this patient required that a cesarean section be performed as soon as it became evident that the baby was not tolerating labor and that a vaginal delivery would place added and unnecessary stress on both the mother and child. The decision not to perform a cesarean, and instead deliver the baby vaginally through the use of forceps, created a situation which resulted in the fetus being born with an Apgar rating of 0 and possible permanent injury. By failing to perform a cesarean section when it was medically indicated, the Respondent's care and treatment of Deborah J. Cox fell below acceptable standards of obstetrical practice.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent (1) guilty of violating Count Seven of the Amended Administrative Complaint; (2) dismissing Counts One, Two, Three, Four and Five of the Amended Administrative Complaint; and (3) placing her on probation for six months subject to the condition that during this period she be required to practice obstetrics and/or gynecology under the general supervision of a board certified physician. DONE and ENTERED this 18th day of November, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Department of Administration Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 1983.
Conclusions Having reviewed the Amended Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part II, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Amended Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The Election of Rights form advised of the right to an administrative hearing. 3. The parties have since entered into the attached Settlement Agreement. (Ex. 2) Based upon the foregoing, it is ORDERED: 1, The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The Respondent shall pay the Agency $500.00. If full payment has been made, the cancelled check acts as receipt of payment and no further payment is required. If full payment has not been made, payment is due within 30 days of the Final Order. Overdue amounts are subject to statutory interest and may be referred to collections. A check made payable to the “Agency for Health Care Administration” and containing the AHCA ten-digit case number should be sent to: Office of Finance and Accounting Revenue Management Unit Agency for Health Care Administration 2727 Mahan Drive, MS 14 Tallahassee, Florida 32308 1 Filed February 20, 2014 10:02 AM Division of Administrative Hearings ORDERED at Tallahassee, Florida, on this | 4 day of Fehon eng , 2014. he. Elizab¢th ae Agen for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and correc. y of this Final Order was served on the below-named persons by the method designated on this /7day of 7 , 2014. Richard Shoop, Agency Cler Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 Jan Mills Finance & Accounting Facilities Intake Unit Revenue Management Unit (Electronic Mail) (Electronic Mail) Deborah E. Leoci Blake J. Delaney, Esquire Office of the General Counsel Buchanan Ingersoll & Rooney PC Agency for Health Care Administration 401 East Jackson Street, Suite 400 (Electronic Mail) Tampa, Florida 33602 Thomas P. Crapps Administrative Law Judge Division of Administrative Hearing (Electronic Mail)
Findings Of Fact Petitioner, Mease Health Care, Inc. (Mease), is a private, not-for- profit acute care community hospital in Dunedin, Florida. It is located in District V, a health planning district established by respondent, Department of Health and Rehabilitative Services (HRS). Intervenors, Morton F. Plant Hospital, Inc. (Plant) and Bayfront Medical Center, Inc. (Bayfront), are acute care hospitals also located within District V. Mease has pending in Case Nos. 89-1652 and 89-4888 a challenge to HRS's fixed need pool determination for new cardiac catherization services and an application for a certificate of need (CON) authorizing it to establish a new inpatient cardiac catherization program in Dunedin, Florida. In the instant case, Mease has challenged an HRS policy as being an illicit rule. Respondent is the state agency responsible for the administration of the Health Facility and Services Development Act. For the purpose of assisting it in administering the act, HRS has promulgated Rule 10-5.011(1)(e), Florida administrative Code (1989), which pertains to inpatient cardiac catherization services and defines the requirements for the establishment of such services. Paragraph 8.c. of the rule contains the formula used for calculating fixed need pools for new inpatient cardiac catherization programs. The formula is: NN PCCPV - ACCPV - APP, where NN is the annual net program volume need, PCCPV is the projected adult cardiac catherization program volume, ACCPV is the actual adult cardiac catherization volume, and APP is the projected program volume for approved programs. This formula was applied by HRS to the September 1988 batching cycle, which was the first batching cycle after the rule became effective. For that cycle, HRS calculated NN to be -53 for District V. NN was therefore less than 300. Paragraph 8.d. of the rule provides the following relevant instructions on how the formula should be applied to batching cycles subsequent to September 1988: If NN is less than 300 in the first batching cycle after the rule becomes effective, the ACCPV value which is subtracted from the PCCPV will be the same value as ACCPV in the first batching cycle until the projected net need in a future batching cycle reaches a program volume of 300 or more. . . For the March and September 1989 batching cycles, which were the two batching cycles immediately subsequent to the first batching cycle after the rule became effective, HRS did not keep the ACCPV value constant, "or the same . . . as in the first batching cycle", even though NN was "less than 300 in the first batching cycle." Put another way, in all batching cycles after September 1988 HRS has recalculated ACCPV even though in the first batching cycle NN was a negative number and therefore was less than 300. HRS's affidavit confirms that this is the manner in which ACCPV has been calculated in all cases since the adoption of the rule. Since the policy has been consistently used in the above manner in all cases, creates rights and requires compliance, and is not apparent from a literal reading of the rule, the policy necessarily constitutes a rule. There is no dispute that the policy has not been formally adopted as a rule.
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.
